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Sample records for hylleraas-type trial functions

  1. Training Residential Staff to Conduct Trial-Based Functional Analyses

    Science.gov (United States)

    Lambert, Joseph M.; Bloom, Sarah E.; Kunnavatana, S. Shanun; Collins, Shawnee D.; Clay, Casey J.

    2013-01-01

    We taught 6 supervisors of a residential service provider for adults with developmental disabilities to train 9 house managers to conduct trial-based functional analyses. Effects of the training were evaluated with a nonconcurrent multiple baseline. Results suggest that house managers can be trained to conduct trial-based functional analyses with…

  2. Training teachers to conduct trial-based functional analyses.

    Science.gov (United States)

    Kunnavatana, S Shanun; Bloom, Sarah E; Samaha, Andrew L; Dayton, Elizabeth

    2013-11-01

    The trial-based functional analysis (FA) is a promising approach to identification of behavioral function and is especially suited for use in educational settings. Not all studies on trial-based FA have included teachers as therapists, and those studies that have, included minimal information on teacher training. The purpose of this study was to determine whether teachers trained via an in-service training would be able to conduct trial-based FAs with high procedural integrity. We trained four teachers to conduct trial-based FAs using a combination of didactic teaching and practice with feedback. All four teachers improved performance following training. Performance remained above baseline levels during an in situ maintenance condition, but for three of four teachers, additional feedback was required to recapture performance observed immediately following training.

  3. Trial-Based Functional Analysis and Functional Communication Training in an Early Childhood Setting

    Science.gov (United States)

    Lambert, Joseph M.; Bloom, Sarah E.; Irvin, Jennifer

    2012-01-01

    Problem behavior is common in early childhood special education classrooms. Functional communication training (FCT; Carr & Durand, 1985) may reduce problem behavior but requires identification of its function. The trial-based functional analysis (FA) is a method that can be used to identify problem behavior function in schools. We conducted…

  4. Construction of A Trial Function In The Variational Procedure of ...

    African Journals Online (AJOL)

    A form of variational method for calculating the ground state energy of a quantum mechanical system is considered. The method is based on a systematic construction of a trial variational function at each step of the calculation of the ground state energy. The construction involves introducing more variational parameters to ...

  5. Cognitive Function in a Randomized Trial of Evolocumab.

    Science.gov (United States)

    Giugliano, Robert P; Mach, François; Zavitz, Kenton; Kurtz, Christopher; Im, Kyungah; Kanevsky, Estella; Schneider, Jingjing; Wang, Huei; Keech, Anthony; Pedersen, Terje R; Sabatine, Marc S; Sever, Peter S; Robinson, Jennifer G; Honarpour, Narimon; Wasserman, Scott M; Ott, Brian R

    2017-08-17

    Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (Pfunction was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .).

  6. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial.

    Science.gov (United States)

    Callahan, Christopher M; Boustani, Malaz A; Schmid, Arlene A; LaMantia, Michael A; Austrom, Mary G; Miller, Douglas K; Gao, Sujuan; Ferguson, Denisha Y; Lane, Kathleen A; Hendrie, Hugh C

    2017-02-07

    Alzheimer disease results in progressive functional decline, leading to loss of independence. To determine whether collaborative care plus 2 years of home-based occupational therapy delays functional decline. Randomized, controlled clinical trial. (ClinicalTrials.gov: NCT01314950). Urban public health system. 180 community-dwelling participants with Alzheimer disease and their informal caregivers. All participants received collaborative care for dementia. Patients in the intervention group also received in-home occupational therapy delivered in 24 sessions over 2 years. The primary outcome measure was the Alzheimer's Disease Cooperative Study Group Activities of Daily Living Scale (ADCS ADL); performance-based measures included the Short Physical Performance Battery (SPPB) and Short Portable Sarcopenia Measure (SPSM). At baseline, clinical characteristics did not differ significantly between groups; the mean Mini-Mental State Examination score for both groups was 19 (SD, 7). The intervention group received a median of 18 home visits from the study occupational therapists. In both groups, ADCS ADL scores declined over 24 months. At the primary end point of 24 months, ADCS ADL scores did not differ between groups (mean difference, 2.34 [95% CI, -5.27 to 9.96]). We also could not definitively demonstrate between-group differences in mean SPPB or SPSM values. The results of this trial are indeterminate and do not rule out potential clinically important effects of the intervention. The authors could not definitively demonstrate whether the addition of 2 years of in-home occupational therapy to a collaborative care management model slowed the rate of functional decline among persons with Alzheimer disease. This trial underscores the burden undertaken by caregivers as they provide care for family members with Alzheimer disease and the difficulty in slowing functional decline. National Institute on Aging.

  7. Applying novel nutrient drink to clinical trial of functional dyspepsia.

    Science.gov (United States)

    Lim, Chul-Hyun; Choi, Myung-Gyu; Baeg, Myong Ki; Moon, Sung Jin; Kim, Jin Su; Cho, Yu Kyung; Park, Jae Myung; Lee, In Seok; Kim, Sang Woo; Choi, Kyu Yong

    2014-04-30

    The drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD). A novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was de-fined as responder. Total aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1 ± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symp-tom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r = 0.480, P < 0.001). Our novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms.

  8. Discrete-Trial Functional Analysis and Functional Communication Training with Three Adults with Intellectual Disabilities and Problem Behavior

    Science.gov (United States)

    Chezan, Laura C.; Drasgow, Erik; Martin, Christian A.

    2014-01-01

    We conducted a sequence of two studies on the use of discrete-trial functional analysis and functional communication training. First, we used discrete-trial functional analysis (DTFA) to identify the function of problem behavior in three adults with intellectual disabilities and problem behavior. Results indicated clear patterns of problem…

  9. Teacher-Conducted Trial-Based Functional Analyses as the Basis for Intervention

    Science.gov (United States)

    Bloom, Sarah E.; Lambert, Joseph M.; Dayton, Elizabeth; Samaha, Andrew L.

    2013-01-01

    Previous studies have focused on whether a trial-based functional analysis (FA) yields the same outcomes as more traditional FAs, and whether interventions based on trial-based FAs can reduce socially maintained problem behavior. We included a full range of behavior functions and taught 3 teachers to conduct a trial-based FA with 3 boys with…

  10. Correlation functions from a unified variational principle: Trial Lie groups

    Energy Technology Data Exchange (ETDEWEB)

    Balian, R., E-mail: roger.balian@cea.fr [Institut de Physique Théorique, CEA Saclay, 91191 Gif-sur-Yvette cedex (France); Vénéroni, M. [Institut de Physique Nucléaire, Université Paris-Sud and IN2P3-CNRS, F-91406 Orsay cedex (France)

    2015-11-15

    Time-dependent expectation values and correlation functions for many-body quantum systems are evaluated by means of a unified variational principle. It optimizes a generating functional depending on sources associated with the observables of interest. It is built by imposing through Lagrange multipliers constraints that account for the initial state (at equilibrium or off equilibrium) and for the backward Heisenberg evolution of the observables. The trial objects are respectively akin to a density operator and to an operator involving the observables of interest and the sources. We work out here the case where trial spaces constitute Lie groups. This choice reduces the original degrees of freedom to those of the underlying Lie algebra, consisting of simple observables; the resulting objects are labeled by the indices of a basis of this algebra. Explicit results are obtained by expanding in powers of the sources. Zeroth and first orders provide thermodynamic quantities and expectation values in the form of mean-field approximations, with dynamical equations having a classical Lie–Poisson structure. At second order, the variational expression for two-time correlation functions separates–as does its exact counterpart–the approximate dynamics of the observables from the approximate correlations in the initial state. Two building blocks are involved: (i) a commutation matrix which stems from the structure constants of the Lie algebra; and (ii) the second-derivative matrix of a free-energy function. The diagonalization of both matrices, required for practical calculations, is worked out, in a way analogous to the standard RPA. The ensuing structure of the variational formulae is the same as for a system of non-interacting bosons (or of harmonic oscillators) plus, at non-zero temperature, classical Gaussian variables. This property is explained by mapping the original Lie algebra onto a simpler Lie algebra. The results, valid for any trial Lie group, fulfill

  11. Updating of attentional and premotor allocation resources as function of previous trial outcome.

    Science.gov (United States)

    Arjona, Antonio; Escudero, Miguel; Gómez, Carlos M

    2014-03-31

    The neural bases of the inter-trial validity/invalidity sequential effects in a visuo-auditory modified version of the Central Cue Posner's Paradigm (CCPP) are analyzed by means of Early Directing Attention Negativity (EDAN), Contingent Negative Variation (CNV) and Lateralized Readiness Potential (LRP). ERPs results indicated an increase in CNV and LRP in trials preceded by valid trials compared to trials preceded by invalid trials. The CNV and LRP pattern would be highly related to the behavioral pattern of lower RTs and higher number of anticipations in trials preceded by valid with respect to trials preceded by invalid trials. This effect was not preceded by a modulation of the EDAN as a result of the previous trial condition. The results suggest that there is a trial-by-trial dynamic modulation of the attentional system as a function of the validity assigned to the cue, in which conditional probabilities between cue and target are continuously updated.

  12. A placebo-controlled trial of itopride in functional dyspepsia.

    Science.gov (United States)

    Holtmann, Gerald; Talley, Nicholas J; Liebregts, Tobias; Adam, Birgit; Parow, Christopher

    2006-02-23

    The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of itopride, a dopamine D2 antagonist with anti-acetylcholinesterase [corrected] effects, in patients with functional dyspepsia. Patients with functional dyspepsia were randomly assigned to receive either itopride (50, 100, or 200 mg three times daily) or placebo. After eight weeks of treatment, three primary efficacy end points were analyzed: the change from baseline in the severity of symptoms of functional dyspepsia (as assessed by the Leeds Dyspepsia Questionnaire), patients' global assessment of efficacy (the proportion of patients without symptoms or with marked improvement), and the severity of pain or fullness as rated on a five-grade scale. We randomly assigned 554 patients; 523 had outcome data and could be included in the analyses. After eight weeks, 41 percent of the patients receiving placebo were symptom-free or had marked improvement, as compared with 57 percent, 59 percent, and 64 percent receiving itopride at a dose of 50, 100, or 200 mg three times daily, respectively (Pitopride). Although the symptom score improved significantly in all four groups, an overall analysis revealed that itopride was significantly superior to placebo, with the greatest symptom-score improvement in the 100- and 200-mg groups (-6.24 and -6.27, vs. -4.50 in the placebo group; P=0.05). Analysis of the combined end point of pain and fullness showed that itopride yielded a greater rate of response than placebo (73 percent vs. 63 percent, P=0.04). Itopride significantly improves symptoms in patients with functional dyspepsia. (ClinicalTrials.gov number, NCT00272103.). Copyright 2006 Massachusetts Medical Society.

  13. Prosecutor In The Criminal Trial (Conceptual, Organizational And Functional Aspects

    Directory of Open Access Journals (Sweden)

    Elena V. Selina

    2014-06-01

    Full Text Available In the present article author in detail analyzes point 1 and 2 of the part 2 of the article 37 of the Criminal Procedural Code of the Russian Federation, devoted to the powers of the execution of the provision of federal law check, registration of messages on crimes commission and making motivated decree on direction of corresponding materials to the investigative body or law-enforcement body for the solution of the question of criminal prosecution on the facts of the criminal legislation violations revealed by the prosecutor. Explanation connecting them in one norm made in the point 1.3. of the Order of the State Office of Public Prosecutor of the Russian Federation of June. 02, 2011 No. 162 "On the organization of public prosecutor's supervision over the procedural activity of the preliminary investigation bodies". Author explains that from the point of the legal decision legitimacy, an explanation of the Prosecutor General of the Russian Federation correspond to the principles of criminal trial and functional concept of the prosecutor participation. Discrepancy of the legal grounds provided in the point 1 and 2 of the part 2 of the article 37 of the Criminal Procedural Code of the Russian Federation for ensuring of powers stated in the point 1 of this article of the Code and its parts. In fact, analogy of the law is applied. In the conclusion author in addition to the Criminal Procedure Code of the Russian Federation is offered.

  14. Performative functions of genocide trials in Rwanda: Reconciliation ...

    African Journals Online (AJOL)

    courtroom stage with participants in the trial as actors (Arendt 1992:4). The role of the gacaca trial process is to establish a narrative of collective memory of the community regarding the trauma of the genocide, involving as many actors within the community as possible, each playing their own role in the justice process.

  15. Discrete-Trial Functional Analysis and Functional Communication Training with Three Individuals with Autism and Severe Problem Behavior

    Science.gov (United States)

    Schmidt, Jonathan D.; Drasgow, Erik; Halle, James W.; Martin, Christian A.; Bliss, Sacha A.

    2014-01-01

    Discrete-trial functional analysis (DTFA) is an experimental method for determining the variables maintaining problem behavior in the context of natural routines. Functional communication training (FCT) is an effective method for replacing problem behavior, once identified, with a functionally equivalent response. We implemented these procedures…

  16. Validating Trial-Based Functional Analyses in Mainstream Primary School Classrooms

    Science.gov (United States)

    Austin, Jennifer L.; Groves, Emily A.; Reynish, Lisa C.; Francis, Laura L.

    2015-01-01

    There is growing evidence to support the use of trial-based functional analyses, particularly in classroom settings. However, there currently are no evaluations of this procedure with typically developing children. Furthermore, it is possible that refinements may be needed to adapt trial-based analyses to mainstream classrooms. This study was…

  17. Trial-dependent psychometric functions accounting for perceptual learning in 2-AFC discrimination tasks.

    Science.gov (United States)

    Kattner, Florian; Cochrane, Aaron; Green, C Shawn

    2017-09-01

    The majority of theoretical models of learning consider learning to be a continuous function of experience. However, most perceptual learning studies use thresholds estimated by fitting psychometric functions to independent blocks, sometimes then fitting a parametric function to these block-wise estimated thresholds. Critically, such approaches tend to violate the basic principle that learning is continuous through time (e.g., by aggregating trials into large "blocks" for analysis that each assume stationarity, then fitting learning functions to these aggregated blocks). To address this discrepancy between base theory and analysis practice, here we instead propose fitting a parametric function to thresholds from each individual trial. In particular, we implemented a dynamic psychometric function whose parameters were allowed to change continuously with each trial, thus parameterizing nonstationarity. We fit the resulting continuous time parametric model to data from two different perceptual learning tasks. In nearly every case, the quality of the fits derived from the continuous time parametric model outperformed the fits derived from a nonparametric approach wherein separate psychometric functions were fit to blocks of trials. Because such a continuous trial-dependent model of perceptual learning also offers a number of additional advantages (e.g., the ability to extrapolate beyond the observed data; the ability to estimate performance on individual critical trials), we suggest that this technique would be a useful addition to each psychophysicist's analysis toolkit.

  18. Steroid prophylaxis for prevention of nerve function impairment in leprosy : trial (TRIPOD 1)

    NARCIS (Netherlands)

    Smith, WCS; Anderson, AM; Withington, SG; van Brakel, WH; Croft, RP; Nicholls, PG; Richardus, JH

    2004-01-01

    Objective To determine whether addition of low dose prednisolone to multidrug treatment can prevent reaction and nerve function impairment in leprosy. Design Multicentre, double blind, randomised, placebo controlled, parallel group trial: Setting Six centres in Bangladesh and Nepal. Participants 636

  19. A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function

    NARCIS (Netherlands)

    Roovers, Jan-Paul W. R.; van der Vaart, C. Huub; van der Bom, Johanna G.; van Leeuwen, Jules H. Schagen; Scholten, Piet C.; Heintz, A. Peter M.

    2004-01-01

    OBJECTIVE: To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function. DESIGN: Randomised trial. SETTING: Three teaching hospitals in The Netherlands. POPULATION:

  20. Preventing decline in function. Evidence from randomized trials around the world.

    OpenAIRE

    Wagner, E.H.

    1997-01-01

    Over the past decade, increasing epidemiologic evidence points to a few important risk factors for loss of mobility and functional decline, such as inactivity, cigarette smoking, obesity, depression, and alcohol and drug misuse. Global interventions addressing these risk factors along with other medical problems have been evaluated in randomized controlled clinical trials. With few exceptions, these trials have shown that intervention has a positive effect on health and functional status, as ...

  1. Implementation and Validation of Trial-Based Functional Analyses in Public Elementary School Settings

    Science.gov (United States)

    Lloyd, Blair P.; Wehby, Joseph H.; Weaver, Emily S.; Goldman, Samantha E.; Harvey, Michelle N.; Sherlock, Daniel R.

    2015-01-01

    Although functional analysis (FA) remains the standard for identifying the function of problem behavior for students with developmental disabilities, traditional FA procedures are typically costly in terms of time, resources, and perceived risks. Preliminary research suggests that trial-based FA may be a less costly alternative. The purpose of…

  2. Functional-task exercise versus resistance strength exercise to improve daily function in older women : A randomized, controlled trial

    NARCIS (Netherlands)

    Samson, MM; van Meeteren, NLU; Duursma, SA; Verhaar, HJJ; de Vreede, P.

    OBJECTIVES: To determine whether a functional-task exercise program and a resistance exercise program have different effects on the ability of community-living older people to perform daily tasks. DESIGN: A randomized, controlled, single-blind trial. SETTING: Community leisure center in Utrecht, the

  3. Finite element methods for neutron transport based on maximum and minimum principles for discontinuous trial functions

    Energy Technology Data Exchange (ETDEWEB)

    Ackroyd, R.T. (Imperial Coll. of Science and Technology, London (United Kingdom). Dept. of Mechanical Engineering)

    Variational principles are given for the first order Boltzmann equation for neutron transport and its equivalent second order forms for even and odd-parity transport. For these extremum principles there are no boundary conditions to be imposed, and across interfaces the trial functions can be discontinuous. Numerical solutions are presented for the even-parity principle. The scale of interface discontinuities is controlled by a penalty parameter [lambda]. As [lambda] is increased for a given basis the degree of satisfaction of the transport equation by the optimised trial function decreases to that for a classical trial function, whereas the interface discontinuities decrease. These trends lend themselves to a simple interpretation in terms of vectors in a Hilbert space. In applications the spatial dependence of a trial function is represented by finite elements, and a spherical harmonic expansion gives the directional dependence of the trial function. The principles are applied in the method of composite solutions in which the order of the spherical harmonic expansion can be varied according to the physical needs of the regions of a system. Large values of [lambda] are used in the method of composite solutions. On the other hand specific values of [lambda] when used with the simplest finite element lead to the well-known central difference equations for neutron transport. (author).

  4. Preventing decline in function. Evidence from randomized trials around the world.

    Science.gov (United States)

    Wagner, E H

    1997-10-01

    Over the past decade, increasing epidemiologic evidence points to a few important risk factors for loss of mobility and functional decline, such as inactivity, cigarette smoking, obesity, depression, and alcohol and drug misuse. Global interventions addressing these risk factors along with other medical problems have been evaluated in randomized controlled clinical trials. With few exceptions, these trials have shown that intervention has a positive effect on health and functional status, as well as reducing length of stay in a hospital or nursing home. The extent to which the success of these programs is attributable to risk-factor reduction or to geriatric assessment and management is uncertain.

  5. Randomized trial of infusion set function: steel versus teflon.

    Science.gov (United States)

    Patel, Parul J; Benasi, Kari; Ferrari, Gina; Evans, Mark G; Shanmugham, Satya; Wilson, Darrell M; Buckingham, Bruce A

    2014-01-01

    This study compared infusion set function for up to 1 week using either a Teflon(®) (Dupont(™), Wilmington, DE) catheter or a steel catheter for insulin pump therapy in type 1 diabetes mellitus. Twenty subjects participating in a randomized, open-labeled, crossover study were asked to wear two Quick-Set(®) and two Sure-T(®) infusion sets (both from Medtronic Minimed, Northridge, CA) until the infusion set failed or was worn for 1 week. All subjects wore a MiniMed continuous glucose monitoring system for the duration of the study. One subject withdrew from the study. There were 38 weeks of Sure-T wear and 39 weeks of Quick-Set wear with no difference in the survival curves of the infusion sets. There was, however, a 15% initial failure rate with the Teflon infusion set. After 7 days, both types of infusion sets had a 64% failure rate. Overall, 30% failed because of hyperglycemia and a failed correction dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration of>10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily insulin requirements when an infusion set was successfully used for 7 days (n=25 of 77 weeks). We found no difference between steel and Teflon infusion sets in their function over 7 days, although 15% of Teflon sets failed because of kinking on insertion. The strongest predictor of prolonged 7-day infusion set function was the individual subject, not the type of infusion set.

  6. Effect of cerebrolysin on gross motor function of children with cerebral palsy: a clinical trial.

    Science.gov (United States)

    Nasiri, Jafar; Safavifar, Faezeh

    2017-06-01

    Gross motor dysfunction is considered as the most challenging problem in cerebral palsy (CP). It is proven that improvement of gross motor function could reduce CP-related disabilities and provide better quality of life in this group of patients. Therefore, the aim of this trial is to evaluate the effectiveness of cerebrolysin (CBL) on gross motor function of children with CP who are undergoing treatment. In this clinical trial study, paediatric patients aged 18-75 months with spastic diplegic or quadriplegic cerebral palsy, who were under rehabilitation therapy, were selected and randomly allocated in control and CBL groups. Patients in CBL group underwent treatment with standard rehabilitation therapy plus CBL. The latter was administrated intramuscularly as a single daily dose of 0.1 cc/kg for 10 days and then continued weekly for 4 months. Gross motor function of participants in the two studied groups, before and after trial, was evaluated and compared using the validated Persian version of gross motor function classification system-expanded and revised (GMFCS-E&R). During this trial, 108 patients with CP were evaluated for eligibility. From these, 50 patients were enrolled and randomly allocated in the CBL and control groups. Four months after trial, the mean level of GMFCS decreased significantly in the two groups (P motor function in patients with CP. This finding is consistent with neurotrophic and neuroprotective effects of CBL, which have been reported in various clinical trials in other neurological disorders. Further studies are recommended to establish the value of continued neuroprotection and to determine the pharmacokinetics/dynamics of CBL in this group of patients.

  7. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  8. Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial.

    Science.gov (United States)

    Wu, Xiao; Zheng, Cuihong; Xu, Xiaohu; Ding, Pei; Xiong, Fan; Tian, Man; Wang, Ying; Dong, Haoxu; Zhang, Mingmin; Wang, Wei; Xu, Shabei; Xie, Minjie; Huang, Guangying

    2017-01-01

    Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p HCI improved the quality of life better than mosapride (p HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride.

  9. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning

    DEFF Research Database (Denmark)

    Talley, N J; Vakil, N; Lauritsen, K

    2007-01-01

    BACKGROUND: Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment. AIM: To evaluate whether a 1-w acid suppression trial is useful for identifying true responders...

  10. Development of a sexual function questionnaire for clinical trials of female sexual dysfunction

    NARCIS (Netherlands)

    Quirk, Frances H.; Heiman, Julia R.; Rosen, Raymond C.; Laan, Ellen; Smith, Michael D.; Boolell, Mitra

    2002-01-01

    OBJECTIVE: To better evaluate efficacy in clinical trials of drugs as potential treatments for female sexual dysfunctions (FSD), a brief, multidimensional measure of female sexual function was developed. METHODS: Data from semistructured interviews with 82 women with or without FSD, aged 19-65

  11. Impact of Attention Training on Academic Achievement, Executive Functioning, and Behavior: A Randomized Controlled Trial

    Science.gov (United States)

    Kirk, Hannah; Gray, Kylie; Ellis, Kirsten; Taffe, John; Cornish, Kim

    2017-01-01

    Children with intellectual and developmental disabilities (IDD) experience significant difficulties in attention, learning, executive functions, and behavioral regulation. Emerging evidence suggests that computerized cognitive training may remediate these impairments. In a double blind controlled trial, 76 children with IDD (4-11 years) were…

  12. Modified Chaihu Shugan Powder for Functional Dyspepsia: Meta-Analysis for Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Nan Yang

    2013-01-01

    Full Text Available Context. Modified Chaihu Shugan powder (MCSP is a popular traditional Chinese herbal formula for functional dyspepsia, which is revised from Chaihu Shugan San and recorded in a medical classic works of China. However, its role and effect in treating functional dyspepsia have not been well established. Objective. To assess the effect and safety of modified Chaihu Shugan powder for functional dyspepsia. Methods. We searched the published and unpublished studies up to August 2012. Only RCTs of modified Chaihu Shugan powder with or without prokinetic drugs versus prokinetic drugs in the patients diagnosed with functional dyspepsia were included. Results. Twenty-two clinical trials involving 1998 participants were included. There were evidences that modified Chaihu Shugan powder (RR = 1.20, 95%, CI 1.14 to 1.27 and modified Chaihu Shugan powder plus prokinetic drugs (RR = 1.18, 95%, CI 1.11 to 1.25 were significantly better treatment options than prokinetic drugs alone in improving symptoms. No serious adverse events were described in the included trials. Conclusions. This meta-analysis showed that modified Chaihu Shugan powder alone or in combination with prokinetic drugs might be more effective than prokinetic drugs alone. However, with poor methodological quality, all the included trials were at high risk of bias. Further large-scale high-quality trials are required for assessment.

  13. Functional treatment versus plaster for simple elbow dislocations (FuncSiE: a randomized trial

    Directory of Open Access Journals (Sweden)

    Verleisdonk Egbert JMM

    2010-11-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation, health-related quality of life (Short-Form 36 and EuroQol-5D, radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications, costs, and cost-effectiveness. Discussion The successful

  14. Trial wave functions for a composite Fermi liquid on a torus

    Science.gov (United States)

    Fremling, M.; Moran, N.; Slingerland, J. K.; Simon, S. H.

    2018-01-01

    We study the two-dimensional electron gas in a magnetic field at filling fraction ν =1/2 . At this filling the system is in a gapless state which can be interpreted as a Fermi liquid of composite fermions. We construct trial wave functions for the system on a torus, based on this idea, and numerically compare these to exact wave functions for small systems found by exact diagonalization. We find that the trial wave functions give an excellent description of the ground state of the system, as well as its charged excitations, in all momentum sectors. We analyze the dispersion of the composite fermions and the Berry phase associated with dragging a single fermion around the Fermi surface and comment on the implications of our results for the current debate on whether composite fermions are Dirac fermions.

  15. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  16. Functional training reduces body fat and improves functional fitness and cholesterol levels in postmenopausal women: a randomized clinical trial.

    Science.gov (United States)

    Neves, Lucas M; Fortaleza, Ana C; Rossi, Fabrício E; Diniz, Tiego A; Codogno, Jamile S; Gobbo, Luis A; Gobbi, Sebastião; Freitas, Ismael F

    2017-04-01

    This randomized clinical trial with concealed allocations, and blinding of the assessors and the data analyst, was aimed at determining the effects of 16 weeks of functional training on the body composition, functional fitness and lipid profiles in postmenopausal women. The study began with 64 subjects (N.=32 functional training and N.=32 control group) and ended with 50 subjects (N.=28 functional training and N.=22 control group). The exercise was conducted in circuit training format with 8 stations related to the development of muscular strength (using elastic bands for resistance) plus 3 stations focused on balance, coordination, and agility. The training session also incorporated an 18 to 30 minute walk. The control group did not participate in the exercise programs during the period of study. The participants were evaluated before and after the training period as regards their body composition (fat and lean mass), functional fitness, abdominal strength and blood chemistry variables. Significant reductions were observed in all body composition variables related to fat (FM= -3.4 and Android FM= -7.7%) (Pfunctional fitness components had significant improvements in coordination (-33.3%), strength (66.5%), agility (-19.5%) and aerobic capacity (-7%), and significant improvement in abdominal strength (188.2%). We observed significant improvements in total cholesterol (-4.4%) and HDL (-9.9%). The observed data lead us to conclude that functional training utilizing with elastic bands and unstable bases causes significantly improved in body composition, functional fitness and lipid profiles.

  17. Dance Improves Functionality and Psychosocial Adjustment in Cerebral Palsy: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Teixeira-Machado, Lavinia; Azevedo-Santos, Isabela; DeSantana, Josimari Melo

    2017-06-01

    This randomized controlled clinical trial aimed to investigate the effect of dance in the functionality and psychosocial adjustment of young subjects with cerebral palsy (CP). Twenty-six young subjects with CP, GMFCS (Gross Motor Function Classification System) levels from II to V, were randomized into two intervention groups: kinesiotherapy and dance (n = 13 each). Twenty-four sessions (1 hour, twice a week) were performed in both groups. Functional Independence Measure (FIM) and World Health Organization Disability Assessment Schedule (WHODAS) by International Classification of Functioning, Disability and Health (ICF) were used before and after each intervention. Dance increased the classification of functioning (P = 0.001), independence function (P = 0.004), self-care (P = 0.01), mobility (P = 0.008), locomotion (P = 0.01), communication (P = 0.02), psychosocial adjustments (P = 0.04), and cognitive function (P = 0.03). Intergroup analysis evidenced significantly greater improvements in classification of functioning (P = 0.0002), independence function (P = 0.0006), self-care (P = 0.01), mobility (P = 0.001), locomotion (P = 0.002), communication (P = 0.0001), psychosocial adjustments (P = 0.002), and cognitive function (P = 0.0001) in dance group. It was shown that this approach could have an influence on basic common points in the body and motion, including emotional and social aspects, supporting the concept of complex multimodal psychomotor adjustments. Dance promoted enhancement on functionality and social activities regarding psychosocial adjustments in cerebral palsy young subjects.

  18. Comparing test cultivars using reliability functions of test-check differences from on-farm trials.

    Science.gov (United States)

    Eskridge, K M; Smith, O S; Byrne, P F

    1993-10-01

    An approach to selection is proposed that is based on the probabilities that a test cultivar outperforms a check by more than an amount d in a future environment. The function that gives these probabilities for all possible values of d is called the reliability function. When d=0, the value of the reliability function is the probability that the test cultivar outperforms the check. The method is illustrated using data from on-farm maize (Zea mays L.) strip test trials grown cooperatively by Pioneer Hi-bred International and farmers. Results indicate that reliability functions are useful for evaluating how test cultivars perform relative to a check across a range of environments since the location, slope and shape of the reliability function may be used to describe a test cultivar's performance, similarity to the check and stability, and identify environments where the test cultivar has performance problems.

  19. Functional electrical stimulation therapy for grasping in traumatic incomplete spinal cord injury: randomized control trial.

    Science.gov (United States)

    Kapadia, Naaz M; Zivanovic, Vera; Furlan, Julio C; Craven, B Cathy; McGillivray, Colleen; Popovic, Milos R

    2011-03-01

    The purpose of this single-site randomized control trial was to assess the short-term and long-term efficacy of functional electrical stimulation (FES) therapy over conventional occupational therapy in improving voluntary hand function in incomplete C4-C7 spinal cord injury individuals. All 22 participants recruited in this randomized control trial received treatment for both the left and right upper extremities. Every participant, irrespective of group allocation, received one dose (60 min per day, 5 days per week for the duration of 8 weeks) of conventional occupational therapy for hand function. Of the 22 participants, 12 individuals received an additional dose of conventional occupational therapy, while the remaining 10 participants received a dose of FES hand therapy. The primary outcome measure was Functional Independence Measure (FIM) self-care subscore. The secondary outcome measures were Spinal Cord Independence Measure (SCIM) self-care subscore and Toronto Rehabilitation Institute Hand Function Test (TRI-HFT). The participants who received FES therapy showed significantly greater improvements in hand function at discharge, and were able to maintain their gains at long-term follow-up as assessed using FIM self-care subscore, SCIM self-care subscore, and TRI-HFT. The FES therapy effectively increased independence and thereby improved quality of life of individuals with tetraplegia when compared with conventional occupational therapy. © 2011, Copyright the Authors. Artificial Organs © 2011, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  20. Brain training game improves executive functions and processing speed in the elderly: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rui Nouchi

    Full Text Available BACKGROUND: The beneficial effects of brain training games are expected to transfer to other cognitive functions, but these beneficial effects are poorly understood. Here we investigate the impact of the brain training game (Brain Age on cognitive functions in the elderly. METHODS AND RESULTS: Thirty-two elderly volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris. This study was completed by 14 of the 16 members in the Brain Age group and 14 of the 16 members in the Tetris group. To maximize the benefit of the interventions, all participants were non-gamers who reported playing less than one hour of video games per week over the past 2 years. Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Each group played for a total of about 20 days. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into four categories (global cognitive status, executive functions, attention, and processing speed. Results showed that the effects of the brain training game were transferred to executive functions and to processing speed. However, the brain training game showed no transfer effect on any global cognitive status nor attention. CONCLUSIONS: Our results showed that playing Brain Age for 4 weeks could lead to improve cognitive functions (executive functions and processing speed in the elderly. This result indicated that there is a possibility which the elderly could improve executive functions and processing speed in short term training. The results need replication in large samples. Long-term effects and relevance for every-day functioning remain uncertain as yet. TRIAL REGISTRATION: UMIN Clinical Trial Registry 000002825.

  1. Brain Training Game Improves Executive Functions and Processing Speed in the Elderly: A Randomized Controlled Trial

    Science.gov (United States)

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Akitsuki, Yuko; Shigemune, Yayoi; Sekiguchi, Atsushi; Kotozaki, Yuka; Tsukiura, Takashi; Yomogida, Yukihito; Kawashima, Ryuta

    2012-01-01

    Background The beneficial effects of brain training games are expected to transfer to other cognitive functions, but these beneficial effects are poorly understood. Here we investigate the impact of the brain training game (Brain Age) on cognitive functions in the elderly. Methods and Results Thirty-two elderly volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). This study was completed by 14 of the 16 members in the Brain Age group and 14 of the 16 members in the Tetris group. To maximize the benefit of the interventions, all participants were non-gamers who reported playing less than one hour of video games per week over the past 2 years. Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Each group played for a total of about 20 days. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into four categories (global cognitive status, executive functions, attention, and processing speed). Results showed that the effects of the brain training game were transferred to executive functions and to processing speed. However, the brain training game showed no transfer effect on any global cognitive status nor attention. Conclusions Our results showed that playing Brain Age for 4 weeks could lead to improve cognitive functions (executive functions and processing speed) in the elderly. This result indicated that there is a possibility which the elderly could improve executive functions and processing speed in short term training. The results need replication in large samples. Long-term effects and relevance for every-day functioning remain uncertain as yet. Trial Registration UMIN Clinical Trial Registry 000002825 PMID:22253758

  2. Using Trial-Based Functional Analysis to Design Effective Interventions for Students Diagnosed with Autism Spectrum Disorder

    Science.gov (United States)

    Larkin, Wallace; Hawkins, Renee O.; Collins, Tai

    2016-01-01

    Functional behavior assessments and function-based interventions are effective methods for addressing the challenging behaviors of children; however, traditional functional analysis has limitations that impact usability in applied settings. Trial-based functional analysis addresses concerns relating to the length of time, level of expertise…

  3. Improving function in age-related macular degeneration: design and methods of a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Tasman, William S

    2011-03-01

    Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD's prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population. Copyright © 2010 Elsevier Inc. All rights reserved.

  4. Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Röhricht, Frank; Sauer, Nina; Noll-Hussong, Michael; Ronel, Joram; Henrich, Gerhard; von Arnim, Angela; Loew, Thomas

    2010-01-01

    Irritable bowel syndrome (IBS) is a frequently disabling and almost invariably distressing disease with a high overall prevalence. Numerous trials identified the importance of psychogenic and emotional etiological factors, and this is obvious in clinical practice. Although relaxation techniques are frequently recommended, there is still a lack of evidence for their efficacy in the management of IBS. This study therefore aims to determine the efficacy of functional relaxation (FR) in IBS. The subjects were 80 patients with IBS. Participants were randomly allocated either to FR or to enhanced medical care (EMC: treatment as usual plus two counseling interviews) as control intervention with 2 weekly sessions over the 5-week trial each. Thirty-nine (39) patients completed FR and 39 received EMC. An impairment-severity score (IS) was employed as the primary outcome parameter with assessment at baseline, after treatment, and again after 3-month follow-up. FR was significantly superior to EMC with a standardized effect size of 0.85. The achieved effects through FR remained stable in terms of psychic and bodily impairment after 3-month follow-up. The results of our trial suggest a positive effect of FR training on subjective functional impairment in the IS, if provided in addition to treatment as usual (TAU). There appears to be a clinically relevant long-term benefit of FR as a nonpharmacological and complementary therapy approach in IBS.

  5. Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

    Directory of Open Access Journals (Sweden)

    Iole Macchia

    2013-01-01

    Full Text Available The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs and tumor-associated antigens (TAAs and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM- based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma.

  6. Dental amalgam restorations and children's neuropsychological function: the New England Children's Amalgam Trial.

    Science.gov (United States)

    Bellinger, David C; Daniel, David; Trachtenberg, Felicia; Tavares, Mary; McKinlay, Sonja

    2007-03-01

    A concern persists that children's exposure to mercury vapor from dental amalgams produces neurotoxicity. Our goal was to compare the neuropsychological function of children, without prior exposure to dental amalgam, whose caries were repaired using either dental amalgam or mercury-free composite materials. We conducted a randomized controlled trial involving 534 6- to 10-year-old urban and rural children who were assessed yearly for 5 years using a battery of tests of intelligence, achievement, language, memory, learning, visual-spatial skills, verbal fluency, fine motor function, problem solving, attention, and executive function. Although the mean urinary mercury concentration was greater among children in the amalgam group than the composite group (0.9 vs. 0.6 microg/g creatinine), few significant differences were found between the test scores of children in the two groups. The differences found were inconsistent in direction. Analyses using two cumulative exposure indices--surface years of amalgam and urinary mercury concentration--produced similar results. Exposure to elemental mercury in amalgam at the levels experienced by the children who participated in the trial did not result in significant effects on neuropsychological function within the 5-year follow-up period.

  7. Hydrotherapy improves pain and function in older women with knee osteoarthritis: a randomized controlled trial.

    Science.gov (United States)

    Dias, João Marcos; Cisneros, Lígia; Dias, Rosângela; Fritsch, Carolina; Gomes, Wellington; Pereira, Leani; Santos, Mary Luci; Ferreira, Paulo Henrique

    Currently, there is poor evidence of the effect of hydrotherapy alone on patients with hip or knee osteoarthritis. The study aimed to assess the impact of hydrotherapy on pain, function, and muscle function in older women with knee osteoarthritis. A randomized controlled trial was conducted to evaluate the efficacy of hydrotherapy in women with knee osteoarthritis. Seventy-three women aged 65 and older were randomized to hydrotherapy (n=36) or a control group (n=37). The hydrotherapy group received the intervention program in a heated pool (twice per week for six weeks) and an educational protocol while the control group received an educational protocol only. Primary outcomes (before and post-treatment) were pain intensity (0-100) and function (0-100), assessed with the WOMAC questionnaire. Secondary outcomes (before and post-treatment) were knee extensor and knee flexor muscle performance (strength, power, and endurance), assessed by an isokinetic dynamometer. The magnitude of change between the groups for the outcomes was calculated using linear regression models adjusted by baseline outcome values. The hydrotherapy group had better outcomes for pain (adjusted mean difference=11 points, 95% CI: 3-18) and function (adjusted mean difference=12 points, 95% CI: 5-18). Patients receiving hydrotherapy had better performance for knee flexor and extensor strength, knee flexor power, and knee extensor endurance. Older women with knee osteoarthritis are likely to have benefits from a course of hydrotherapy exercises. Registry of clinical trials (Trial number RBR-8F57KR) - http://www.ensaiosclinicos.gov.br/rg/RBR-8f57kr/. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  8. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia.

    Science.gov (United States)

    Grant, Paul M; Huh, Gloria A; Perivoliotis, Dimitri; Stolar, Neal M; Beck, Aaron T

    2012-02-01

    Low-functioning patients with chronic schizophrenia have high direct treatment costs and indirect costs incurred due to lost employment and productivity and have a low quality of life; antipsychotic medications and psychosocial interventions have shown limited efficacy to promote improved functional outcomes. To determine the efficacy of an 18-month recovery-oriented cognitive therapy program to improve psychosocial functioning and negative symptoms (avolition-apathy, anhedonia-asociality) in low-functioning patients with schizophrenia. Design, Setting, and A single-center, 18-month, randomized, single-blind, parallel group trial enrolled 60 low-functioning, neurocognitively impaired patients with schizophrenia (mean age, 38.4 years; 33.3% female; 65.0% African American). Cognitive therapy plus standard treatment vs standard treatment alone. The primary outcome measure was the Global Assessment Scale score at 18 months after randomization. The secondary outcomes were scores on the Scale for the Assessment of Negative Symptoms and the Scale for the Assessment of Positive Symptoms at 18 months after randomization. Patients treated with cognitive therapy showed a clinically significant mean improvement in global functioning from baseline to 18 months that was greater than the improvement seen with standard treatment (within-group Cohen d, 1.36 vs 0.06, respectively; adjusted mean [SE], 58.3 [3.30] vs 47.9 [3.60], respectively; P = .03; between-group d = 0.56). Patients receiving cognitive therapy as compared with those receiving standard treatment also showed a greater mean reduction in avolition-apathy (adjusted mean [SE], 1.66 [0.31] vs 2.81 [0.34], respectively; P = .01; between-group d = -0.66) and positive symptoms (hallucinations, delusions, disorganization) (adjusted mean [SE], 9.4 [3.3] vs 18.2 [3.8], respectively; P = .04; between-group d = -0.46) at 18 months. Age was controlled in the analyses, and there were no meaningful group differences in

  9. Using a Modified Pyramidal Training Model to Teach Special Education Teachers to Conduct Trial-Based Functional Analyses

    Science.gov (United States)

    Kunnavatana, S. Shanun; Bloom, Sarah E.; Samaha, Andrew L.; Lignugaris/Kraft, Benjamin; Dayton, Elizabeth; Harris, Shannon K.

    2013-01-01

    Functional behavioral assessments are commonly used in school settings to assess and develop interventions for problem behavior. The trial-based functional analysis is an approach that teachers can use in their classrooms to identify the function of problem behavior. The current study evaluates the effectiveness of a modified pyramidal training…

  10. Moderators, mediators and nonspecific predictors of outcome after cognitive rehabilitation of executive functions in a randomised controlled trial

    OpenAIRE

    Tornås, Sveinung; Stubberud, Jan; Solbakk, Anne-Kristin; Evans, Jonathan; Schanke, Anne-Kristine; Løvstad, Marianne

    2017-01-01

    Moderators, mediators and nonspecific predictors of treatment after cognitive rehabilitation of executive functions in a randomised controlled trial\\ud \\ud Objective: To explore moderators, mediators and nonspecific predictors of executive functioning after cognitive rehabilitation in a randomised controlled trial, comparing Goal Management Training (GMT) with an active psycho-educative control-intervention, in patients with chronic acquired brain injury.\\ud \\ud Methods: Seventy patients with...

  11. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Peña, Javier; Ibarretxe-Bilbao, Naroa; Sánchez, Pedro; Iriarte, Maria B; Elizagarate, Edorta; Garay, Maria A; Gutiérrez, Miguel; Iribarren, Aránzazu; Ojeda, Natalia

    2016-01-01

    This study examined the efficacy of an integrative cognitive remediation program (REHACOP) in improving cognition and functional outcome in patients with schizophrenia. The program combines cognitive remediation, social cognitive intervention, and functional skills training. Few studies have attempted this approach. One hundred and eleven patients diagnosed with schizophrenia were randomly assigned to either the cognitive remediation group (REHACOP) or an active control group (occupational activities) for 4 months (three sessions per week, 90 min). Primary outcomes were change on general neurocognitive performance and social cognition, including theory of mind (ToM), emotion perception (EP), attributional style, and social perception (SP). Secondary outcomes included changes on clinical symptoms (Positive and Negative Syndrome Scale) and functional outcome (UCSD Performance-Based Skills Assessment and the Global Assessment of Functioning). The trial was registered with clinicaltrials.gov (NCT02796417). No baseline group differences were found. Significant differences were found in the mean change between the REHACOP group and control group in neurocognition ([Formula: see text]), SP ([Formula: see text]), ToM ([Formula: see text]), EP ([Formula: see text]), negative symptoms ([Formula: see text]), emotional distress ([Formula: see text]), Global Assessment of Functioning ([Formula: see text]), and UCSD Performance-Based Skills Assessment ([Formula: see text]). The combination of cognitive remediation, social cognitive intervention, and functional skills training demonstrated statistically significant and clinically meaningful changes in neurocognition, social cognition, negative, and functional disability.

  12. Review of information and communication technology devices for monitoring functional and cognitive decline in Alzheimer's disease clinical trials.

    Science.gov (United States)

    Pillai, Jagan A; Bonner-Jackson, Aaron

    2015-01-01

    Detecting and monitoring early cognitive impairment in Alzheimer's disease (AD) is a significant need in the field of AD therapeutics. Successful AD clinical trial designs have to overcome challenges related to the subtle nature of early cognitive changes. Continuous unobtrusive assessments using Information and Communication Technology (ICT) devices to capture markers of intra-individual change over time to assess cognitive and functional disability therefore offers significant benefits. We review the literature and provide an overview on randomized clinical trials in AD that use intelligent systems to monitor functional decline, as well as strengths, weaknesses, and future directions for the use of ICTs in a new generation of AD clinical trials.

  13. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ma Yingying

    2011-06-01

    Full Text Available Abstract Background and Objective Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of two blends of encapsulated juice powder concentrates (with and without added berry powders on endothelial function in persons with metabolic syndrome, a risk factor for type 2 diabetes and cardiovascular disease. Methods Randomized, double blind, placebo controlled crossover clinical trial with three treatment arms. 64 adults with metabolic syndrome were enrolled and received 8-week sequences of each blend of the concentrates and placebo. The primary outcome measure was change in endothelial function (assessed as flow-mediated dilatation of the brachial artery 2 hr after consuming a 75 g glucose load, after 8-weeks of daily consumption (sustained or 2 hr after consumption of a single dose (acute. Secondary outcome measures included plasma glucose, serum insulin, serum lipids, and body weight. Results No significant between-group differences in endothelial function with daily treatment for 8 weeks were seen. No other significant treatment effects were discerned in glucose, insulin, lipids, and weight. Conclusion Encapsulated fruit and vegetable juice powder concentrates did not alter insulin or glucose measures in this sample of adults with metabolic syndrome. Trial Registration clinicaltrials.gov NCT01224743

  14. Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

    OpenAIRE

    Zahra Pourmoghaddas; Hossein Saneian; Hamidreza Roohafza; Ali Gholamrezaei

    2014-01-01

    We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6–18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥2 point reduction in the 6-point pain scale or “no pain.” Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and int...

  15. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Ko, Seok-Jae; Park, Jae-Woo; Kim, Jinsung; Yeo, Inkwon; Lee, Hyejung; Kim, Song-Yi; Lee, Hyangsook

    2014-03-22

    Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck's depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers' Institutional Review Boards. Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. ClinicalTrials.gov Identifier: NCT01921504.

  16. Brain training game improves executive functions and processing speed in the elderly: a randomized controlled trial.

    Science.gov (United States)

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Akitsuki, Yuko; Shigemune, Yayoi; Sekiguchi, Atsushi; Kotozaki, Yuka; Tsukiura, Takashi; Yomogida, Yukihito; Kawashima, Ryuta

    2012-01-01

    The beneficial effects of brain training games are expected to transfer to other cognitive functions, but these beneficial effects are poorly understood. Here we investigate the impact of the brain training game (Brain Age) on cognitive functions in the elderly. Thirty-two elderly volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). This study was completed by 14 of the 16 members in the Brain Age group and 14 of the 16 members in the Tetris group. To maximize the benefit of the interventions, all participants were non-gamers who reported playing less than one hour of video games per week over the past 2 years. Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Each group played for a total of about 20 days. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into four categories (global cognitive status, executive functions, attention, and processing speed). Results showed that the effects of the brain training game were transferred to executive functions and to processing speed. However, the brain training game showed no transfer effect on any global cognitive status nor attention. Our results showed that playing Brain Age for 4 weeks could lead to improve cognitive functions (executive functions and processing speed) in the elderly. This result indicated that there is a possibility which the elderly could improve executive functions and processing speed in short term training. The results need replication in large samples. Long-term effects and relevance for every-day functioning remain uncertain as yet. UMIN Clinical Trial Registry 000002825.

  17. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Richard Bergholz

    Full Text Available BACKGROUND: ZK 200775 is an antagonist at the alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA receptor and had earned attention as a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within phase I trials reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system were analyzed in detail. METHODOLOGY: In a randomised controlled trial we examined eyes and vision before and after the intravenous administration of two different doses of ZK 200775 and placebo. There were 3 groups of 6 probands each: Group 1 recieved 0.03 mg/kg/h, group 2 0.75 mg/kg/h of ZK 200775, the control group received 0.9% sodium chloride solution. Probands were healthy males aged between 57 and 69 years. The following methods were applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP, ON-OFF and full-field electroretinogram (ERG. PRINCIPAL FINDINGS: No effect of ZK 200775 was seen on eye position or motility, stereopsis, pupillary function or central visual field testing. Visual acuity and dark vision deteriorated significantly in both treated groups. Color vision was most remarkably impaired. The dark-adapted ERG revealed a reduction of oscillatory potentials (OP and partly of the a- and b-wave, furthermore an alteration of b-wave morphology and an insignificantly elevated b/a-ratio. Cone-ERG modalities showed decreased amplitudes and delayed implicit times. In the ON-OFF ERG the ON-answer amplitudes increased whereas the peak times of the OFF-answer were reduced. The pattern VEP exhibited lower amplitudes and prolonged peak times. CONCLUSIONS: The AMPA receptor blockade led to a strong impairment of typical OFF-pathway functions like color vision and the cone ERG. On the other hand the ON-pathway as measured by dark vision and the scotopic ERG was affected as well

  18. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial.

    Science.gov (United States)

    Kwon, Jeong-Yi; Chang, Hyun Jung; Yi, Sook-Hee; Lee, Ji Young; Shin, Hye-Yeon; Kim, Yun-Hee

    2015-01-01

    To examine whether hippotherapy has a clinically significant effect on gross motor function in children with cerebral palsy (CP). Randomized controlled trial. Outpatient therapy center. Ninety-two children with CP, aged 4-10 years, presenting variable function (Gross Motor Function Classification System [GMFCS] levels I-IV). Hippotherapy (30 minutes twice weekly for 8 consecutive weeks). Gross Motor Function Measure (GMFM)-88, GMFM-66, and Pediatric Balance Scale. Pre- and post-treatment measures were completed by 91 children (45 in the intervention group and 46 in the control group). Differences in improvement on all three measures significantly differed between groups after the 8-week study period. Dimensions of GMFM-88 improved significantly after hippotherapy varied by GMFCS level: dimension E in level I, dimensions D and E in level II, dimensions C and D in level III, and dimensions B and C in level IV. Hippotherapy positively affects gross motor function and balance in children with CP of various functional levels.

  19. Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

    Science.gov (United States)

    Shah, Krupa N; Majeed, Zahraa; Yoruk, Yilmaz B; Yang, Hongmei; Hilton, Tiffany N; McMahon, James M; Hall, William J; Walck, Donna; Luque, Amneris E; Ryan, Richard M

    2016-06-01

    HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p autonomous motivation, depression, and QOL in HOA with functional limitations. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  20. Resveratrol and exercise to treat functional limitations in late life: Design of a randomized controlled trial

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    Andrew S. Layne

    2017-06-01

    Full Text Available Skeletal muscle mitochondrial function declines with age and is a key factor in the maintenance of physical function among older adults. Research studies from animals and humans have consistently demonstrated that exercise improves skeletal muscle mitochondrial function in early and middle adulthood. However, mitochondrial adaptations to both acute and chronic exercise are attenuated in late life. Thus, there is an important need to identify adjuvant therapies capable of augmenting mitochondrial adaptations to exercise (e.g. improved mitochondrial respiration, muscle mitochondria biogenesis among older adults. This study is investigating the potential of resveratrol supplementation for this purpose. The objective of this randomized, double-masked pilot trial is to evaluate the efficacy of resveratrol supplementation combined with a comprehensive supervised exercise program exercise for improving physical function among older adults. Moderately functioning, sedentary participants aged ≥60 years will perform 24 sessions (2 day/wk for 12 weeks of center-based walking and resistance training and are randomly assigned to receive either (1 500 mg/day resveratrol (2 1000 mg/day resveratrol or (3 placebo. Study dependent outcomes include changes in 1 knee extensor strength, 2 objective measures of physical function (e.g. 4 m walk test, Short Physical Performance Battery, 3 subjective measures of physical function assessed by Late Life Function and Disability Instrument, and 4 skeletal muscle mitochondrial function. This study will provide novel information regarding the therapeutic potential of resveratrol supplementation combined with exercise while also informing about the long-term clinical viability of the intervention by evaluating participant safety and willingness to engage in the intervention.

  1. Protocol for Shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mortensen Ole S

    2011-01-01

    Full Text Available Abstract Background Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Such musculoskeletal pain - which is often associated with restricted range of motion and loss of muscle strength - is one of the most common conditions treated by physical therapists. The exact mechanism of neck pain is rarely revealed by clinical examination and the treatment has varied from passive rest to active treatments. Active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct training of the painful area. Our study investigates the effect of the latter approach. Methods/Design A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training with training supervision or to a reference group receiving advice to stay physically active. Shoulder function training primarily focuses on the serratus anterior and lower trapezius muscle with only minimal activation the upper trapezius. An announcement was sent to the administrative section of the university including jobs characterized by intensive computer work. The first 100 positive replies entered the study. Among these inclusion criteria were pain intensity in the neck/shoulder of at least 3 on a 0-9 scale. Exclusion criteria were cardiovascular disease, trauma, hypertension, or serious chronic disease. Before and after the intervention period the participants replied to a questionnaire about musculoskeletal disorders and work disability, and underwent a standardized clinical examination of the neck and shoulder girdle. Further, on a weekly basis the participants log pain intensity of the neck and shoulder during the previous week. The primary outcome measure is pain in the neck and shoulders at week 10 based on the weekly pain registration and results

  2. Pre-trial reported defendants in the Netherlands with intellectual disability, borderline and normal intellectual functioning.

    Science.gov (United States)

    Vinkers, David J

    2013-09-01

    Intellectually disabled offenders may have different characteristics than offenders with average intellectual functioning. We therefore compared pre-trial reported defendants with an IQ score ≤70, 71-84 and ≥85 points. Nationwide database of pre-trial psychiatric reports requested by Dutch courts between 2000 and 2006 with a reported level of intellectual functioning (n = 12 186). Defendants with an IQ score between 71 and 84 (n = 2 439 reports; 20.0%) and ≤70 (n = 539 reports; 4.4%) were younger, more often from an ethnic minority and more often diagnosed with psycho-organic syndromes, developmental and conduct disorders as compared with defendants with an IQ score of 85 or higher. In addition, there was an increased risk of attention deficit hyperactivity disorder and rape as indicted crime and a decreased odds ratio of having a steady job and cannabis abuse in defendants with an IQ score of 71-84. Intellectually disabled defendants have different characteristics than defendants without intellectually disability. © 2013 John Wiley & Sons Ltd.

  3. Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial.

    Science.gov (United States)

    Schenkman, M; Cutson, T M; Kuchibhatla, M; Chandler, J; Pieper, C F; Ray, L; Laub, K C

    1998-10-01

    The effectiveness of an exercise intervention for people in early and midstage Parkinson's disease (stages 2 and 3 of Hoehn and Yahr) in improving spinal flexibility and physical performance in a sample of community-dwelling older people is described. Fifty-one men and women, aged 55-84 years, identified through advertisement, local support groups, and local neurologists were enrolled into a randomized, controlled trial. Subjects were assigned randomly to an intervention or a usual care arm (i.e., no specific exercise). Of the original 51 participants, 46 completed the randomized, controlled trial. Participants in the exercise arm (n = 23) received individual instruction three times per week for 10 weeks. Participants in the usual care arm (n = 23) were "wait listed" for intervention. Changes over 10 weeks in spinal flexibility (i.e., functional axial rotation) and physical performance (i.e., functional reach, timed supine to stand) were the primary outcome measures. MANOVA conducted for the three primary outcome variables demonstrated significant differences (P exercise program for people in the early and midstages of PD.

  4. A Randomized Trial of Vitamin D Supplementation on Vascular Function in CKD.

    Science.gov (United States)

    Kumar, Vivek; Yadav, Ashok Kumar; Lal, Anupam; Kumar, Vinod; Singhal, Manphool; Billot, Laurent; Gupta, Krishan Lal; Banerjee, Debasish; Jha, Vivekanand

    2017-10-01

    Vitamin D deficiency associates with mortality in patients with CKD, and vitamin D supplementation might mitigate cardiovascular disease risk in CKD. In this randomized, double-blind, placebo-controlled trial, we investigated the effect of cholecalciferol supplementation on vascular function in 120 patients of either sex, aged 18-70 years, with nondiabetic CKD stage 3-4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml). We randomized patients using a 1:1 ratio to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in endothelium-dependent brachial artery flow-mediated dilation at 16 weeks. Secondary outcome measures included changes in pulse wave velocity and circulating biomarkers. Cholecalciferol supplementation significantly increased endothelium-dependent brachial artery flow-mediated dilation at 16 weeks, whereas placebo did not (between-group difference in mean change: 5.49%; 95% confidence interval, 4.34% to 6.64%; P vitamin D deficiency, vitamin D supplementation may improve vascular function. This study is registered with the Clinical Trials Registry of India (no.: CTRI/2013/05/003648). Copyright © 2017 by the American Society of Nephrology.

  5. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial

    National Research Council Canada - National Science Library

    Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Lauridsen, Jørgen T; Sjøgaard, Gisela; Toft, Palle

    2015-01-01

    .... It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit...

  6. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

    Directory of Open Access Journals (Sweden)

    Kayambu Geetha

    2011-10-01

    Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

  7. Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial.

    Science.gov (United States)

    Reed, Susan D; Mitchell, Caroline M; Joffe, Hadine; Cohen, Lee; Shifren, Jan L; Newton, Katherine M; Freeman, Ellen W; Larson, Joseph C; Manson, JoAnn E; LaCroix, Andrea Z; Guthrie, Katherine A

    2014-08-01

    To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes. In an 8-week randomized controlled trial among women aged 40-62 years, sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day (both compared with a placebo). Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress. Participants were aged 54.6 years (standard deviation [SD] 3.8) years, 59% white, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline Female Sexual Function Index score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 (95% confidence interval [CI] -0.4 to 3.2) for estradiol, 1.1 (95% CI -0.5 to 2.7) for venlafaxine, and -0.3 (95% CI -1.6 to 1.0) for placebo. Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo (P=.38, P=.30) or venlafaxine and placebo (P=.79, P=.48). Among sexually active women, Female Sexual Function Index domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0-0.6) for estradiol, -0.6 (95% CI -1.2 to 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2-1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction. Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although a subtle increase in desire (estradiol) and decreases in orgasm and pain (venlafaxine) may exist. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01418209. I.

  8. Simulating real world functioning in schizophrenia using a naturalistic city environment and single-trial, goal-directed navigation

    Directory of Open Access Journals (Sweden)

    John A Zawadzki

    2013-11-01

    Full Text Available Objective: To develop a virtual reality platform that would serve as a functionally meaningful measure of cognition in schizophrenia that would complement standard batteries of cognitive tests during clinical trials for cognitive treatments in schizophrenia, be amenable to human neuroimaging research, yet lend itself to neurobiological comparison with rodent analogues.Method: Thirty-three patients with schizophrenia and 33 healthy controls matched for age, sex, video gaming experience and education completed eight rapid, single-trial virtual navigation tasks within a naturalistic virtual city. Four trials tested their ability to find different targets seen during the passive viewing of a closed path that led them around different city blocks. Four subsequent trials tested their ability to return to four different starting points after viewing a path that took them several blocks away from the starting position. Results: Individuals with schizophrenia had difficulties in way-finding, measured as distance travelled to find targets previously encountered within the virtual city. They were also more likely not to notice the target during passive viewing, less likely to find novel shortcuts to targets and more likely to become lost and fail completely in finding the target. Total travel distances across all eight trials strongly correlated (negatively with neurocognitive measures and, for 49 participants who completed the Quality of Life Scale, psychosocial functioning. Conclusion: Single-trial, goal-directed navigation in a naturalistic virtual environment is a functionally meaningful measure of cognitive functioning in schizophrenia.

  9. Simulating real world functioning in schizophrenia using a naturalistic city environment and single-trial, goal-directed navigation.

    Science.gov (United States)

    Zawadzki, John A; Girard, Todd A; Foussias, George; Rodrigues, Alicia; Siddiqui, Ishraq; Lerch, Jason P; Grady, Cheryl; Remington, Gary; Wong, Albert H C

    2013-01-01

    To develop a virtual reality platform that would serve as a functionally meaningful measure of cognition in schizophrenia and that would also complement standard batteries of cognitive tests during clinical trials for cognitive treatments in schizophrenia, be amenable to human neuroimaging research, yet lend itself to neurobiological comparison with rodent analogs. Thirty-three patients with schizophrenia and 33 healthy controls matched for age, sex, video gaming experience, and education completed eight rapid, single-trial virtual navigation tasks within a naturalistic virtual city. Four trials tested their ability to find different targets seen during the passive viewing of a closed path that led them around different city blocks. Four subsequent trials tested their ability to return to four different starting points after viewing a path that took them several blocks away from the starting position. Individuals with schizophrenia had difficulties in way-finding, measured as distance travelled to find targets previously encountered within the virtual city. They were also more likely not to notice the target during passive viewing, less likely to find novel shortcuts to targets, and more likely to become lost and fail completely in finding the target. Total travel distances across all eight trials strongly correlated (negatively) with neurocognitive measures and, for 49 participants who completed the Quality of Life Scale, psychosocial functioning. Single-trial, goal-directed navigation in a naturalistic virtual environment is a functionally meaningful measure of cognitive functioning in schizophrenia.

  10. A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials.

    Science.gov (United States)

    Conroy, Elizabeth J; Arch, Barbara; Harman, Nicola L; Lane, J Athene; Lewis, Steff C; Norrie, John; Sydes, Matthew R; Gamble, Carrol

    2017-12-08

    The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC, the CONSORT Statement does not explicitly require reporting of TSC activity, although is included as an example of good reporting. A lack of guidance on TSC reporting can impact transparency of trial oversight, ultimately leading to a misunderstanding regarding role and, subsequently, further variation in practice. This review aimed to establish reporting practice of TSC involvement in RCTs, and thus make recommendations for reporting. A cohort examination identifying reporting practice was undertaken. The cohort comprised RCTs published in three leading medical journals (the British Medical Journal, The Lancet and the New England Journal of Medicine) within 6 months in 2012 and the full NIHR HTA Monograph series. Details of TSC constitution and impact were extracted from main publications and published supplements. Of 415 publications, 264 were eligible. These were typical in terms of trial design. Variations in reporting between journals and monographs was notable. TSC presence was identified in approximately half of trials (n = 144), of which 109 worked alongside a DMC. No publications justified not convening a TSC. When reported, the role of the committee and examples of impact in design, conduct and analysis were summarised. We present the first review of reporting TSC activity in the published academic literature. An absence of reporting standards with regards to TSC constitution, activity and impact on trial conduct was identified which can influence transparency of reporting trial oversight. Consistent reporting is vital for the benefits and impact of the TSC role to be understood to support adoption of this oversight structure and reduce global variations in

  11. A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

    Science.gov (United States)

    Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet

    2018-01-01

    Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional

  12. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial.

    Science.gov (United States)

    Bergholz, Richard; Staks, Thomas; Rüther, Klaus

    2010-08-12

    ZK 200775 is an antagonist at the alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention as a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within phase I trials reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system were analyzed in detail. In a randomised controlled trial we examined eyes and vision before and after the intravenous administration of two different doses of ZK 200775 and placebo. There were 3 groups of 6 probands each: Group 1 recieved 0.03 mg/kg/h, group 2 0.75 mg/kg/h of ZK 200775, the control group received 0.9% sodium chloride solution. Probands were healthy males aged between 57 and 69 years. The following methods were applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG). No effect of ZK 200775 was seen on eye position or motility, stereopsis, pupillary function or central visual field testing. Visual acuity and dark vision deteriorated significantly in both treated groups. Color vision was most remarkably impaired. The dark-adapted ERG revealed a reduction of oscillatory potentials (OP) and partly of the a- and b-wave, furthermore an alteration of b-wave morphology and an insignificantly elevated b/a-ratio. Cone-ERG modalities showed decreased amplitudes and delayed implicit times. In the ON-OFF ERG the ON-answer amplitudes increased whereas the peak times of the OFF-answer were reduced. The pattern VEP exhibited lower amplitudes and prolonged peak times. The AMPA receptor blockade led to a strong impairment of typical OFF-pathway functions like color vision and the cone ERG. On the other hand the ON-pathway as measured by dark vision and the scotopic ERG was affected as well. This further elucidates the interdependence of both pathways. ClinicalTrials

  13. Effects of Exercise on Cognitive Function in Older People with Dementia: A Randomized Controlled Trial.

    Science.gov (United States)

    Toots, Annika; Littbrand, Håkan; Boström, Gustaf; Hörnsten, Carl; Holmberg, Henrik; Lundin-Olsson, Lillemor; Lindelöf, Nina; Nordström, Peter; Gustafson, Yngve; Rosendahl, Erik

    2017-01-01

    Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia. To investigate effects of exercise on cognitive function in people with dementia. The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months. Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p = 0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p = 0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p = 0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p = 0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p = 0.707). A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.

  14. Effect of periodontal therapy on arterial structure and function among aboriginal australians: a randomized, controlled trial.

    Science.gov (United States)

    Kapellas, Kostas; Maple-Brown, Louise J; Jamieson, Lisa M; Do, Loc G; O'Dea, Kerin; Brown, Alex; Cai, Tommy Y; Anstey, Nicholas M; Sullivan, David R; Wang, Hao; Celermajer, David S; Slade, Gary D; Skilton, Michael R

    2014-10-01

    Observational studies and nonrandomized trials support an association between periodontal disease and atherosclerotic vascular disease. Both diseases occur frequently in Aboriginal Australians. We hypothesized that nonsurgical periodontal therapy would improve measures of arterial function and structure that are subclinical indicators of atherosclerotic vascular disease. This parallel-group, randomized, open label clinical trial enrolled 273 Aboriginal Australians aged ≥18 years with periodontitis. Intervention participants received full-mouth periodontal scaling during a single visit, whereas controls received no treatment. Prespecified primary end points measured 12-month change in carotid intima-media thickness, an indicator of arterial structure, and 3- and 12-month change in pulse wave velocity, an indicator of arterial function. ANCOVA used complete case data to evaluate treatment group differences. End points could be calculated for 169 participants with follow-up data at 3 months and 168 participants at 12 months. Intima-media thickness decreased significantly after 12 months in the intervention group (mean reduction=-0.023 [95% confidence interval {CI}, -0.038 to -0.008] mm) but not in the control group (mean increase=0.002 [95% CI, -0.017 to 0.022] mm). The difference in intima-media thickness change between treatment groups was statistically significant (-0.026 [95% CI, -0.048 to -0.003] mm; P=0.03). In contrast, there were no significant differences between treatment groups in pulse wave velocity at 3 months (mean difference, 0.06 [95% CI, -0.17 to 0.29] m/s; P=0.594) or 12 months (mean difference, 0.21 [95% CI, -0.01 to 0.43] m/s; P=0.062). Periodontal therapy reduced subclinical arterial thickness but not function in Aboriginal Australians with periodontal disease, suggesting periodontal disease and atherosclerosis are significantly associated. © 2014 American Heart Association, Inc.

  15. Benefits of Exercise on the Executive Functions in People with Parkinson Disease: A Controlled Clinical Trial.

    Science.gov (United States)

    de Oliveira, Renata Terra; Felippe, Lilian Assunção; Bucken Gobbi, Lilian Teresa; Barbieri, Fabio Augusto; Christofoletti, Gustavo

    2017-05-01

    We have made a 3-arm trial (group vs. individual exercise vs. no treatment) to test the effects of a 6-month exercise program upon the executive functions in participants with Parkinson disease. Twenty-four subjects were randomly allocated in 3 groups and undertook individualized exercises (G1, n = 8), group exercises (G2, n = 8), or monitoring (G3, n = 8). Executive functions were evaluated by means of the Wisconsin card sorting test and the Raven colored matrices, both assessed at the beginning of the program and after 6 months. The statistical analyses consisted of the application of repeated measurement tests, with a significant level of 5%. The findings showed similar behavior of groups in terms of the Wisconsin card sorting test (P = 0.792), reporting no benefit of the program on such instrument. Differently, Raven colored matrices evidenced a significant benefit provided by the intervention (P = 0.032). Compared with the control group, individuals from G1 had a substantial improvement on executive functions (P = 0.031) and from G2 had a trend of significance (P = 0.072). Findings of this study show that 6 months of exercise improved some aspects of executive functions when compared with control peers. Individual therapy seems to have a more prominent improvement than group therapy.

  16. Effectiveness of combined exercise training to improve functional fitness in older adults: A randomized controlled trial.

    Science.gov (United States)

    Sousa, Nelson; Mendes, Romeu; Abrantes, Catarina; Sampaio, Jaime; Oliveira, José

    2014-10-01

    The present randomized controlled trial evaluated the impact of different exercise training modalities on functional fitness responses in apparently healthy older men. A total of 59 community-dwelling older men were randomly assigned to an aerobic training group (ATG, n=19), a combined aerobic and resistance training group (CTG, n=20) or a control group (n=20). Both exercise training programs were moderate-to-vigorous intensity, 3 days/week for 9 months. Six independent functional fitness tests (back scratch, chair sit-and-reach, 30-s chair stand, arm curl, 8-ft up-and-go, 6-min walk) were measured on five different occasions. The data were analyzed using a mixed-model ANOVA. ANOVA showed a significant main effect of group (Pfunctional fitness tests, with significant differences between both training groups and controls. However, the ATG only improved the chair sit-and-reach and the 30-s chair stand performance, whereas CTG improved in all functional fitness tests. ANOVA also identified a significant main effect of time for 8-ft up-and-go (P=0.031) in the CTG. Only the combined exercise program was effective in improving all functional fitness components related to daily living activities. © 2014 Japan Geriatrics Society.

  17. DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

    Science.gov (United States)

    Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

    2016-01-01

    As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.

  18. Trial

    NARCIS (Netherlands)

    Vasiliev, S.V.; Reydams, L.; Wouters, J.; Ryngaert, C.

    2012-01-01

    This book examines the prosecution as an institution and a function in a dozen international and hybrid criminal tribunals, from Nuremberg to the International Criminal Court. It is the result of a sustained collaborative effort among some twenty scholars and (former) tribunal staffers. The starting

  19. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

    Science.gov (United States)

    Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

    Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

  20. Lactobacillus casei rhamnosus Lcr35 in the Management of Functional Constipation in Children: A Randomized Trial.

    Science.gov (United States)

    Wojtyniak, Katarzyna; Horvath, Andrea; Dziechciarz, Piotr; Szajewska, Hania

    2017-05-01

    To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children. A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 10(8) colony-forming units, n = 48) or placebo (n = 46), twice daily, for 4 weeks. The primary outcome measure was treatment success, defined as 3 or more spontaneous stools per week, without episodes of fecal soiling, in the last week of the intervention. Analyses were by intention to treat. Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P constipation in children constipation. ClinicalTrials.gov: NCT01985867. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Executive function fails to predict smoking outcomes in a clinical trial to motivate smokers to quit.

    Science.gov (United States)

    Fox, Andrew T; Martin, Laura E; Bruce, Jared; Moreno, Jose L; Staggs, Vincent S; Lee, Hyoung S; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber; Patten, Christi; Catley, Delwyn

    2017-06-01

    Executive function (EF) is considered an important mediator of health outcomes. It is hypothesized that those with better EF are more likely to succeed in turning their intentions into actual health behaviors. Prior studies indicate EF is associated with smoking cessation. Experimental and longitudinal studies, however, have yielded mixed results. Few studies have examined whether EF predicts post-treatment smoking behavior. Fewer still have done so prospectively in a large trial. We sought to determine if EF predicts quit attempts and cessation among community smokers in a large randomized trial evaluating the efficacy of motivational interventions for encouraging cessation. Participants (N=255) completed a baseline assessment that included a cognitive battery to assess EF (Oral Trail Making Test B, Stroop, Controlled Oral Word Association Test). Participants were then randomized to 4 sessions of Motivational Interviewing or Health Education or one session of Brief Advice to quit. Quit attempts and cessation were assessed at weeks 12 and 26. In regression analyses, none of the EF measures were statistically significant predictors of quit attempts or cessation (all ps>0.20). Our data did not support models of health behavior that emphasize EF as a mediator of health outcomes. Methodological shortcomings weaken the existing support for an association between EF and smoking behavior. We suggest methodological improvements that could help move this potentially important area of research forward. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Mebeverine for pediatric functional abdominal pain: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Pourmoghaddas, Zahra; Saneian, Hossein; Roohafza, Hamidreza; Gholamrezaei, Ali

    2014-01-01

    We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6-18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥ 2 point reduction in the 6-point pain scale or "no pain." Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and intention-to-treat (ITT) analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117 [0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503 [0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723) or after 12 weeks (P = 0.870) in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted.

  3. Protocol for Shoulder function training reducing musculoskeletal pain in shoulder and neck: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Christoffer H; Andersen, Lars L; Mortensen, Ole S

    2011-01-01

    ABSTRACT: BACKGROUND: Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Such musculoskeletal pain - which is often associated with restricted range of motion and loss of muscle strength - is one of the most common conditions...... treated by physical therapists. The exact mechanism of neck pain is rarely revealed by clinical examination and the treatment has varied from passive rest to active treatments. Active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct...... training of the painful area. Our study investigates the effect of the latter approach. METHODS/DESIGN: A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training...

  4. Executive function predicts response to antiaggression treatment in schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Krakowski, Menahem I; Czobor, Pal

    2012-01-01

    Despite extensive experience with antipsychotic medications, we have limited capacity to predict which patients will benefit from which medications and for what symptoms. Such prediction is of particular importance for the proper treatment of violence. Our goal was to determine whether executive function predicts outcome of treatment for aggressive behavior and whether such prediction varies across medication groups. Ninety-nine physically aggressive inpatients (aged 18-60 years) with schizophrenia or schizoaffective disorder (diagnosed according to DSM-IV) who completed tests of executive function were randomly assigned in a double-blind, parallel-group, 12-week trial to clozapine (n = 32), olanzapine (n = 32), or haloperidol (n = 35). The number and severity of aggressive events as measured by the Modified Overt Aggression Scale (MOAS) were the outcome measures. Psychopathology and medication side effects were also assessed. The study was conducted from 1999 to 2004. Poor executive function predicted higher levels of aggression, as measured by MOAS scores over the 12-week period, in all 3 medication groups (F(1,98) = 222.2, P aggression in patients with schizophrenia. clinicaltrials.gov Identifier: NCT01123408. © Copyright 2012 Physicians Postgraduate Press, Inc.

  5. Radiofrequency in female external genital cosmetics and sexual function: a randomized clinical trial.

    Science.gov (United States)

    Lordêlo, Patrícia; Leal, Mariana Robatto Dantas; Brasil, Cristina Aires; Santos, Juliana Menezes; Lima, Maria Clara Neves Pavie Cardoso; Sartori, Marair Gracio Ferreira

    2016-11-01

    Female sexual behavior goes through cultural changes constantly, and recently, some women have shown the desire the ideal genitalia. In this study, we aimed to evaluate clinical responses to nonablative radiofrequency (RF) in terms of its cosmetic outcome in the female external genitalia and its effect on sexual function. A single-masking randomized controlled trial was conducted in 43 women (29 sexually active) who were unsatisfied with the appearance of their external genitalia. The women were divided into an RF group (n = 21, 14 sexually active) and a control group (n = 22, 15 sexually active). Eight sessions of RF were performed once a week. Photographs (taken before the first session and 8 days after the last session) were evaluated by the women and three blinded health professionals by using two 3-point Likert scales (unsatisfied, unchanged, and satisfied; and worst, unchanged, and improved). Sexual function was evaluated using the Female Sexual Function Index (FSFI) and analyzed using the Student t test. Women's satisfaction and health professional evaluation were analyzed using the chi-square test and inter- and intragroup binomial comparisons. Satisfaction response rates were 76 and 27 % for the RF and control groups, respectively (p = 0.001). All professionals found a clinical improvement association in the treated group with RF in comparison with the control group (p cosmetic outcome for the female external genitalia, with positives changes in patients' satisfaction and FSFI scores.

  6. Breakfast consumption has no effect on neuropsychological functioning in children: a repeated-measures clinical trial.

    Science.gov (United States)

    Iovino, Isabella; Stuff, Janice; Liu, Yan; Brewton, Christie; Dovi, Allison; Kleinman, Ronald; Nicklas, Theresa

    2016-09-01

    Although many studies have investigated the relation between breakfast consumption and various domains of cognitive functioning within children, some of the reported findings are inconsistent. We sought to determine the short-term effects of a breakfast meal on the neuropsychological functioning of healthy school-aged children after an overnight fast. The study was conducted in a clinical research center with the use of a counterbalanced repeated-measures design among children who either consumed breakfast or were fasting. The administered neuropsychological tests included measures of attention, impulsivity, short-term memory, cognitive processing speed, and verbal learning. The sample consisted of children aged 8-10 y (n = 128), of whom 52% were female, 38% were African American, 31% were Hispanic, 28% were white, and 3% were of another race/ethnicity. There were no significant (P ≥ 0.004) differences between breakfast meal consumption and fasting for any of the neuropsychological measures administered. Breakfast consumption had no short-term effect on neuropsychological functioning in healthy school-aged children. This trial was registered at clinicaltrials.gov as NCT01943604. © 2016 American Society for Nutrition.

  7. Flixweed vs. Polyethylene Glycol in the Treatment of Childhood Functional Constipation: A Randomized Clinical Trial.

    Science.gov (United States)

    Nimrouzi, Majid; Sadeghpour, Omid; Imanieh, Mohammad Hadi; Shams Ardekani, Mohammadreza; Salehi, Alireza; Minaei, Mohamad Bagher; Zarshenas, Mohammad M

    2015-04-01

    Polyethylene glycol (PEG) is often considered as the first-line treatment for functional constipation in children. Descurainia sophia (L.) Webb et Berth (D. sophia) is a safe recommended medicine in Iranian folk and Traditional Persian Medicine for the treatment of constipation. To clinically compare D. sophia with PEG 4000 (without electrolyte) in pediatric constipation and to assess its efficacy and side effects. 120 patients aged 2 - 12 years with constipation for at least 3 months were included in an 8 weeks lasting randomized controlled trial within two parallel-groups. Children received either PEG, 0.4 g/kg/day, or D. sophia seeds, 2 grams (for children aged 2 - 4 years) and 3 grams (for those aged > 4 years) per day. A total of 109 patients completed the study (56 in D. sophia and 53 in PEG group). At the end of the study, 36 (64.3%) patients in D. sophia group and 29 (54.7%) in PEG group were out of Rome III criteria (P = 0.205). Median weekly stool frequency in 0, 1, 2, 3 weeks of the treatment was found to be 2, 5, 5, 5 in D. sophia and 3, 4, 4, 5 in PEG group (P = 0.139, 0.076, 0.844, 0.294), respectively. The number of patients who suffered flatulence was less (5, 8.9%) in D. sophia group as compared to PEG group (6, 11.3%) at the end of the trial (P = 0.461). D. sophia taste was less tolerated. D. sophia is introduced as a cheap and available medication which can be applied as a safe alternative to conventional PEG in the management of pediatric chronic functional constipation.

  8. Dynamic Balance Training Improves Physical Function in Individuals With Knee Osteoarthritis: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Takacs, Judit; Krowchuk, Natasha M; Garland, S Jayne; Carpenter, Mark G; Hunt, Michael A

    2017-08-01

    To examine the effect of a targeted balance training program on dynamic balance and self-reported physical function in people with medial tibiofemoral osteoarthritis (OA). Single-blind randomized controlled trial. Exercise gymnasium and community dwellings. Individuals with medial compartment knee OA (N=40). Ten weeks of partially supervised exercises targeting dynamic balance and strength performed 4 times per week or no intervention (nonintervention group). Dynamic balance was measured using the Community Balance and Mobility Scale (CB&M), and self-reported physical function was measured using the Western Ontario and McMaster Universities Arthritis Index physical function subscale. Secondary outcomes included knee pain, fear of movement, knee joint proprioception, and muscle strength. Forty individuals underwent baseline testing, with 36 participants completing follow-up testing. Adherence to exercise in the training group was high, with 82.2% of all home-based exercise sessions completed. No significant changes were observed in any outcome in the nonintervention group at follow-up. Significant improvements in self-reported pain, physical function, and fear of movement were observed in the training group when compared with the nonintervention group. No other within- or between-group differences were observed. A 10-week dynamic balance training program for people with knee OA significantly improved self-reported knee pain, physical function, and fear of movement; however, there was no change in dynamic balance as quantified by the CB&M. Further research is needed to investigate how exercise may result in improvement on objective measures of dynamic balance. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial.

    Science.gov (United States)

    Geller, Elizabeth J; Dumond, Julie B; Bowling, J Michael; Khandelwal, Christine M; Wu, Jennifer M; Busby-Whitehead, Jan; Kaufer, Daniel I

    This study aimed to investigate the effect of trospium chloride on cognitive function in postmenopausal women treated for overactive bladder (OAB). Randomized double-blind placebo-controlled trial conducted from April 2013 to April 2015. Women aged 50 years or older seeking treatment for OAB were randomized to either trospium chloride XR 60 mg daily or placebo. Baseline cognitive function was assessed via Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam, Mini Mental Status X, Digit Span, Trails A, Trails B, and Epworth Sleepiness Scale. Cognitive function was reassessed at week 1 and week 4. A priori power analysis determined that 21 subjects were needed per group. Although 59 women were enrolled and randomized (28 trospium and 31 placebo), 45 completed assessment (21 trospium and 24 placebo). Mean age was 68 years, 78% were white, and 44% had previously taken OAB medication. For the primary outcome, there was no difference in HVLT-R total score between trospium and placebo groups at week 4 (P = 0.29). There were also no differences based on the other cognitive tests. There was a correlation between age and the following week-4 tests: HVLT-R total score (r = -0.3, P = 0.02), HVLT-R total recall subscale (r = -0.4, P = 0.007), Trails A (r = 0.4, P = 0.002), and Trails B (r = 0.4, P = 0.004). A linear regression model found that HVLT-R total score decreased by 0.372 points for each increased year of age. In women aged 50 years and older, there were no changes in cognitive function between those taking trospium and placebo. Cognitive function was correlated with age.

  10. Improving function in age-related macular degeneration: a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S

    2013-08-01

    To compare the efficacy of problem-solving therapy (PST) with supportive therapy (ST) to improve targeted vision function (TVF) in age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized clinical trial with outcome assessments at 3 months (main trial endpoint) and 6 months (maintenance effects). Patients with AMD (n = 241) attending retina practices. Whereas PST uses a structured problem-solving approach to reduce vision-related task difficulty, ST is a standardized attention-control treatment. We assessed TVF, the 25-item National Eye Institute Vision Function Questionnaire plus Supplement (NEI VFQ), the Activities Inventory (AI), and vision-related quality of life (QoL). There were no between-group differences in TVF scores at 3 (P = 0.47) or 6 (P = 0.62) months. For PST subjects, mean ± standard deviation TVF scores improved from 2.71±0.52 at baseline to 2.18±0.88 at 3 months (P = 0.001) and were 2.18±0.95 at 6 months (change from 3 to 6 months, P = 0.74). For ST subjects, TVF scores improved from 2.73±0.52 at baseline to 2.14±0.96 at 3 months (P = 0.001) and were 2.15±0.96 at 6 months (change from 3 to 6 months, P = 0.85). Similar proportions of PST and ST subjects had less difficulty performing a TVF goal at 3 months (77.4% vs 78.6%, respectively; P = 0.83) and 6 months (76.2% vs 79.1%, respectively; P = 0.61). There were no changes in the NEI VFQ or AI. Vision-related QoL improved for PST relative to ST subjects at 3 months (F(4, 192) = 2.46; P = 0.05) and at 6 months (F(4, 178) = 2.55; P = 0.05). The PST subjects also developed more adaptive coping strategies than ST subjects. We found that PST was not superior to ST at improving vision function in patients with AMD, but that PST improved their vision-related QoL. Despite the benefits of anti-vascular endothelial growth factor treatments, AMD remains associated with disability, depression, and diminished QoL. This clinical reality necessitates new rehabilitative

  11. Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

    Science.gov (United States)

    Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

    2017-10-01

    While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

  12. A controlled pilot trial of two commercial video games for rehabilitation of arm function after stroke.

    Science.gov (United States)

    Chen, Mei-Hsiang; Huang, Lan-Ling; Lee, Chang-Franw; Hsieh, Ching-Lin; Lin, Yu-Chao; Liu, Hsiuchih; Chen, Ming-I; Lu, Wen-Shian

    2015-07-01

    To investigate the acceptability and potential efficacy of two commercial video games for improving upper extremity function after stroke in order to inform future sample size and study design. A controlled clinical trial design using sequential allocation into groups. A clinical occupational therapy department. Twenty-four first-stroke patients. Patients were assigned to one of three groups: conventional group, Wii group, and XaviX group. In addition to regular one-hour conventional rehabilitation, each group received an additional half-hour of upper extremity exercises via conventional devices, Wii games, or XaviX games, for eight weeks. The Fugl-Meyer Assessment of motor function, Box and Block Test of Manual Dexterity, Functional Independence Measure, and upper extremity range of motion were used at baseline and postintervention. Also, a questionnaire was used to assess motivation and enjoyment. The effect size of differences in change scores between the Wii and conventional groups ranged from 0.71 (SD 0.59) to 0.28 (SD 0.58), on the Fugl-Meyer Assessment of motor function (d = 0.74) was larger than that between the XaviX and conventional groups, ranged from 0.44 (SD 0.49) to 0.28 (SD 0.58) (d = 0.30). Patient enjoyment was significantly greater in the video game groups (Wii mean 4.25, SD 0.89; XaviX mean 4.38, SD 0.52) than in the conventional group (mean 2.25, SD 0.89, F = 18.55, p video games in rehabilitation. A sample size of 72 patients (24 per group) would be appropriate for a full study. © The Author(s) 2014.

  13. Relationship between bone turnover and left ventricular function in primary hyperparathyroidism: The EPATH trial.

    Directory of Open Access Journals (Sweden)

    Nicolas Verheyen

    Full Text Available Observational studies suggested a link between bone disease and left ventricular (LV dysfunction that may be pronounced in hyperparathyroid conditions. We therefore aimed to test the hypothesis that circulating markers of bone turnover correlate with LV function in a cohort of patients with primary hyperparathyroidism (pHPT. Cross-sectional data of 155 subjects with pHPT were analyzed who participated in the "Eplerenone in Primary Hyperparathyroidism" (EPATH Trial. Multivariate linear regression analyses with LV ejection fraction (LVEF, systolic function or peak early transmitral filling velocity (e', diastolic function as dependent variables and N-terminal propeptide of procollagen type 1 (P1NP, osteocalcin (OC, bone-specific alkaline phosphatase (BALP, or beta-crosslaps (CTX as the respective independent variable were performed. Analyses were additionally adjusted for plasma parathyroid hormone, plasma calcium, age, sex, HbA1c, body mass index, mean 24-hours systolic blood pressure, smoking status, estimated glomerular filtration rate, antihypertensive treatment, osteoporosis treatment, 25-hydroxy vitamin D and N-terminal pro-brain B-type natriuretic peptide. Independent relationships were observed between P1NP and LVEF (adjusted β-coefficient = 0.201, P = 0.035 and e' (β = 0.188, P = 0.042, respectively. OC (β = 0.192, P = 0.039 and BALP (β = 0.198, P = 0.030 were each independently related with e'. CTX showed no correlations with LVEF or e'. In conclusion, high bone formation markers were independently and paradoxically related with better LV diastolic and, partly, better systolic function, in the setting of pHPT. Potentially cardio-protective properties of stimulated bone formation in the context of hyperparathyroidism should be explored in future studies.

  14. Effects of Mediterranean diets on kidney function: a report from the PREDIMED trial.

    Science.gov (United States)

    Díaz-López, Andrés; Bulló, Mònica; Martínez-González, Miguel Ángel; Guasch-Ferré, Marta; Ros, Emilio; Basora, Josep; Covas, María-Isabel; del Carmen López-Sabater, Maria; Salas-Salvadó, Jordi

    2012-09-01

    Epidemiologic observations have linked healthy dietary patterns to improved kidney function. We assessed the effects of the Mediterranean diet (MedDiet) on kidney function in both a cross-sectional assessment and after a 1-year intervention in a cohort of the PREDIMED (Prevención con Dieta Mediterránea) Study, a multicenter 3-arm randomized clinical trial to determine the efficacy of the MedDiet on primary cardiovascular prevention. Community-dwelling men aged 55-80 years and women aged 60-80 years at high risk of cardiovascular disease from Reus, Spain. Participants were randomly assigned to 3 ad libitum diets: a MedDiet supplemented with virgin olive oil (MedDiet + olive oil), a MedDiet supplemented with mixed nuts (MedDiet + nuts), or a control low-fat diet. Estimated glomerular filtration rate (eGFR) and urinary albumin-creatinine ratio (ACR). Nutrient intake, adherence to the MedDiet, lifestyle variables, cardiovascular risk factors, serum urea and creatinine concentrations, eGFR, and urinary ACR were evaluated at baseline and after intervention for 1 year. Baseline kidney function markers were similar across quartiles of adherence to the MedDiet in 785 participants (55% women; mean age, 67 years). After a 1-year intervention in 665 participants, the 3 dietary approaches were associated with improved kidney function, with similar average increases in eGFR (4.7 [95% CI, 3.2-6.2], 3.5 [95% CI, 1.9-5.0], and 4.1 [95% CI, 2.8-5.5] mL/min/1.73 m(2) for the MedDiet + olive oil, MedDiet + nuts, and control groups, respectively [P cardiovascular risk. Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  15. Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fernandes, Giovana; Jennings, Fabio; Nery Cabral, Michele Vieira; Pirozzi Buosi, Ana Letícia; Natour, Jamil

    2016-08-01

    To evaluate the effect of swimming on pain, functional capacity, aerobic capacity, and quality of life in patients with fibromyalgia (FM). Randomized controlled trial. Rheumatology outpatient clinics of a university hospital. Women with FM (N=75; age range, 18-60y) randomly assigned to a swimming group (SG) (n=39) or a walking group (WG) (n=36). The SG performed 50 minutes of swimming 3 times a week for 12 weeks, with a heart rate at 11 beats under the anaerobic threshold. The WG performed walking with a heart rate at the anaerobic threshold, with the same duration and frequency as the SG. Participants were evaluated before the exercise protocols (t0), at 6 weeks (t6), and at 12 weeks (t12) after the onset of the protocols. The primary outcome measure was the visual analog scale for pain. The secondary measurements were the Fibromyalgia Impact Questionnaire and the Medical Outcomes Study 36-Item Short-Form Health Survey for quality of life; a spiroergometric test for cardiorespiratory variables; and the timed Up & Go test for functional performance. Patients in both groups experienced improvement in pain after the 12-week program, with no difference between groups (P=.658). The same results were found regarding functional capacity and quality of life. Moreover, no statistical difference between groups was found regarding aerobic capacity over time. Swimming, like walking, is an effective method for reducing pain and improving both functional capacity and quality of life in patients with FM. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  16. DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL

    Science.gov (United States)

    Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

    2016-01-01

    Background: As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. Materials and Methods: One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. Results: There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. Conclusion: This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation. PMID:28852716

  17. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

    Science.gov (United States)

    2012-01-01

    Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455 PMID:22672287

  18. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function.

    Science.gov (United States)

    Jovancevic, Jelena; Rosano, Caterina; Perera, Subashan; Erickson, Kirk I; Studenski, Stephanie

    2012-06-06

    Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span.The study is IRB approved and the number is: PRO08080012ClinicalTrials.gov Identifier: NCT01443455.

  19. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

    Directory of Open Access Journals (Sweden)

    Jovancevic Jelena

    2012-06-01

    Full Text Available Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. Methods/Design This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. Discussion This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span. The study is IRB approved and the number is: PRO08080012 ClinicalTrials.gov Identifier: NCT01443455

  20. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Staehr Anne K

    2012-07-01

    Full Text Available Abstract Background A high perioperative inspiratory oxygen fraction (FiO2 may reduce the frequency of surgical site infection. Perioperative atelectasis is caused by absorption, compression and reduced function of surfactant. It is well accepted, that ventilation with 100% oxygen for only a few minutes is associated with significant formation of atelectasis. However, it is still not clear if a longer period of 80% oxygen results in more atelectasis compared to a low FiO2. Our aim was to assess if a high FiO2 is associated with impaired oxygenation and decreased pulmonary functional residual capacity (FRC. Methods Thirty-five patients scheduled for laparotomy for ovarian cancer were randomized to receive either 30% oxygen (n = 15 or 80% oxygen (n = 20 during and for 2 h after surgery. The oxygenation index (PaO2/FiO2 was measured every 30 min during anesthesia and 90 min after extubation. FRC was measured the day before surgery and 2 h after extubation by a rebreathing method using the inert gas SF6. Results Five min after intubation, the median PaO2/FiO2 was 69 kPa [53-71] in the 30%-group vs. 60 kPa [47-69] in the 80%-group (P = 0.25. At the end of anesthesia, the PaO2/FiO2 was 58 kPa [40-70] vs. 57 kPa [46-67] in the 30%- and 80%-group, respectively (P = 0.10. The median FRC was 1993 mL [1610-2240] vs. 1875 mL [1545-2048] at baseline and 1615 mL [1375-2318] vs. 1633 mL [1343-1948] postoperatively in the 30%- and 80%-group, respectively (P = 0.70. Conclusion We found no significant difference in oxygenation index or functional residual capacity between patients given 80% and 30% oxygen for a period of approximately 5 hours. Trial registration ClinicalTrials.gov Identifier: NCT00637936.

  1. Effect of Yoga on Psychological Functioning of Nursing Students: A Randomized Wait List Control Trial.

    Science.gov (United States)

    Mathad, Monali Devaraj; Pradhan, Balaram; Sasidharan, Rajesh K

    2017-05-01

    Nursing students experience considerable amount of stress to meet their professional demands. Yoga is an effective practice to reduce stress and improve psychological well being. However, improvement in psychological well being aids in stress management. To evaluate the effectiveness of eight week yoga intervention on psychological functioning of nursing students. This was a randomised Wait List Control (WLC) trial, we recruited total 100 students from Kempegowda Institute of Nursing, Bengaluru, Karnataka, India and randomized them into two groups (yoga=50 and WLC=50 students). The following instruments were used to collect the data, Freiburg Mindfulness Inventory (FMI), Self-Compassion Scale- Short Form (SCS-SF), Connor-Davidson Resilience Scale (CD-RISC), Satisfaction with Life Scale (SWLS), Jefferson Scale of Empathy HPS-Version (JSE-HPS), and Perceived Stress Scale (PSS). Data was analysed using Repeated Measures Analysis of Variance (RM-ANOVA) followed by post-hoc Bonferroni correction for all psychological variables. The results of our study report that eight week yoga intervention was significantly effective in improving self compassion and mindfulness among nursing students in experimental group than compared to WLC group. Even though there were improvements in resilience, satisfaction in life and perceived stress, results were not statistically significant. Overall, results of the present study have demonstrated impact of eight week yoga intervention on the psychological functioning of nursing students. Yoga intervention can be inculcated in the nursing education to meet demands of the profession.

  2. Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

    Science.gov (United States)

    Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

    2017-04-01

    The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (pyoga than the control group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (pyoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

  3. Tai chi improves cognitive and physical function in the elderly: a randomized controlled trial

    Science.gov (United States)

    Sun, Jiao; Kanagawa, Katsuko; Sasaki, Junko; Ooki, Syuichi; Xu, Huali; Wang, Li

    2015-01-01

    [Purpose] To investigate the effect of Tai Chi on cognitive and physical function in the elderly. [Subjects and Methods] A randomized trial design was used. A total 150 subjects were enrolled and were divided into Tai Chi and control groups. Subjects in the Tai Chi group participated Tai Chi for 6 months, and subjects in the control group participated in other non-athletic activities. [Results] There were no differences between the groups in the one leg standing time with eyes open, left grip strength, or the Frontal Assessment Battery at bedside after 3 and 6 months of intervention. The Mini-Mental State Examination scores after 3 and 6 months were higher in the Tai Chi group than in the control group. The right grip strength after 3 months increased more in the Tai Chi group than in the control group. Both the 5-m high walking speed and 10-m normal walking speed were significantly lower after 3 and 6 months of Tai Chi practice. [Conclusion] These results suggest that regular Tai Chi practice may improve cognitive and physical function in the elderly. PMID:26157242

  4. Pilot Trial: Pregabalin on Colonic Sensorimotor Functions in Irritable Bowel Syndrome

    Science.gov (United States)

    Iturrino, Johanna; Camilleri, Michael; Busciglio, Irene; Burton, Duane; Zinsmeister, Alan R.

    2013-01-01

    Background In prior studies, pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome (IBS) and healthy adults, suggesting reduction of afferent function. Aim To assess effects of pregabalin on colonic compliance, sensory and motor functions in patients with constipation-predominant IBS (IBS-C). Methods In a pilot, double-blind, placebo-controlled, parallel-group study, we tested oral pregabalin, 200mg, in 18 IBS-C adults. With a barostatically-controlled polyethylene balloon in the left colon, we assessed sensation thresholds and colonic compliance using ascending method of limits, sensation ratings over 4 levels of distension, fasting and postprandial colonic tone and phasic motility. ANCOVA (adjusted for the corresponding pre-drug response) was used to compare placebo and pregabalin. After 45% participants completed studies, we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial. Results Pregabalin did not significantly affect colonic compliance, sensation thresholds, sensation ratings, fasting or postprandial tone or motility index. The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size. Conclusion Pregabalin, 200mg, might not reduce distension-related colonic pain in IBS-C patients. PMID:24095618

  5. Effect of modafinil on cognitive functions in alcohol dependent patients: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Joos, Leen; Goudriaan, Anna E; Schmaal, Lianne; van den Brink, Wim; Sabbe, Bernard G C; Dom, Geert

    2013-11-01

    Cognitive deficits are highly prevalent in alcohol-dependent (AD) patients and may have a detrimental impact on treatment response and treatment outcome. Enhancing cognitive functions may improve treatment success. Modafinil is a promising compound in this respect. Therefore, a randomized double-blind placebo-controlled trial was conducted with modafinil (300 mg/d) or placebo in 83 AD patients for 10 weeks. Various cognitive functions (digit span task, Tower of London task, Stroop task) were measured at baseline, during and after treatment. Compared to placebo, modafinil improved verbal short-term memory (number of forward digit spans) (p=0.030), but modafinil exerted a negative effect on the working memory score of the digit span task (p=0.003). However, subgroup analyses revealed that modafinil did improve both working memory and verbal short-term memory in AD patients with a poor working memory ability at baseline (25% worst performers), whereas no significant treatment effect of modafinil was found on these two dependent variables in patients with good working memory skills at baseline (25% best performers). No effect of modafinil was found on measures of planning (Tower of London task) and selective attention (Stroop task). Further research is needed to better understand the relationship between cognitive remediation and treatment outcome in order to design targeted treatments.

  6. Test-retest reliability of memory task functional magnetic resonance imaging in Alzheimer disease clinical trials.

    Science.gov (United States)

    Atri, Alireza; O'Brien, Jacqueline L; Sreenivasan, Aishwarya; Rastegar, Sarah; Salisbury, Sibyl; DeLuca, Amy N; O'Keefe, Kelly M; LaViolette, Peter S; Rentz, Dorene M; Locascio, Joseph J; Sperling, Reisa A

    2011-05-01

    To examine the feasibility and test-retest reliability of encoding-task functional magnetic resonance imaging (fMRI) in mild Alzheimer disease (AD). Randomized, double-blind, placebo-controlled study. Memory clinical trials unit. We studied 12 patients with mild AD (mean [SEM] Mini-Mental State Examination score, 24.0 [0.7]; mean Clinical Dementia Rating score, 1.0) who had been taking donepezil hydrochloride for more than 6 months from the placebo arm of a larger 24-week study (n = 24, 4 scans on weeks 0, 6, 12, and 24, respectively). Placebo and 3 face-name, paired-associate encoding, block-design blood oxygenation level-dependent fMRI scans in 12 weeks. We performed whole-brain t maps (P < .001, 5 contiguous voxels) and hippocampal regions-of-interest analyses of extent (percentage of active voxels) and magnitude (percentage of signal change) for novel-greater-than-repeated face-name contrasts. We also calculated intraclass correlation coefficients and power estimates for hippocampal regions of interest. Task tolerability and data yield were high (95 of 96 scans yielded favorable-quality data). Whole-brain maps were stable. Right and left hippocampal regions-of-interest intraclass correlation coefficients were 0.59 to 0.87 and 0.67 to 0.74, respectively. To detect 25.0% to 50.0% changes in week-0 to week-12 hippocampal activity using left-right extent or right magnitude with 80.0% power (2-sided α = .05) requires 14 to 51 patients. Using left magnitude requires 125 patients because of relatively small signal to variance ratios. Encoding-task fMRI was successfully implemented in a single-site, 24-week, AD randomized controlled trial. Week 0 to 12 whole-brain t maps were stable, and test-retest reliability of hippocampal fMRI measures ranged from moderate to substantial. Right hippocampal magnitude may be the most promising of these candidate measures in a leveraged context. These initial estimates of test-retest reliability and power justify evaluation of

  7. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial.

    Science.gov (United States)

    Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Lauridsen, Jørgen T; Sjøgaard, Gisela; Toft, Palle

    2015-07-23

    Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative impact on the degree of independence and quality of life. In the NONSEDA trial we randomize critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit. It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit. Investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 700 patients in total, with a substudy concerning 200 of these patients. Inclusion criteria will be intubated, mechanically ventilated patients with expected duration of mechanical ventilation >24 h. Exclusion criteria will be patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2mechanical ventilation. The control intervention will be sedation with a daily wake-up trial. The co-primary outcome will be quality of life regarding physical function (SF-36, physical component) and degree of independence in activities of daily living (Barthel Index), and this will be assessed for all 700 patients participating in the NONSEDA trial. The secondary outcomes, which will be assessed for the subpopulation of 200 NONSEDA patients in the trial site, Kolding, will be 6-min walking distance, handgrip strength, muscle size (ultrasonographic measurement of the rectus femoris muscle cross-sectional area) and biomechanical data on lower extremity function (maximal voluntary contraction, rate of force development and endurance). This study is the first to investigate the effect of no sedation during critical illness on physical function

  8. Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Zahra Pourmoghaddas

    2014-01-01

    Full Text Available We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP. Children with FAP (n = 115, aged 6–18 years received mebeverine (135 mg, twice daily or placebo for 4 weeks. Response was defined as ≥2 point reduction in the 6-point pain scale or “no pain.” Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine. Per-protocol and intention-to-treat (ITT analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117 [0.469] and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503 [0.416]. There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723 or after 12 weeks (P = 0.870 in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted.

  9. Review of Information and Communication Technology Devices for Monitoring Functional and Cognitive Decline in Alzheimer's Disease Clinical Trials

    Directory of Open Access Journals (Sweden)

    Jagan A. Pillai

    2015-01-01

    Full Text Available Detecting and monitoring early cognitive impairment in Alzheimer's disease (AD is a significant need in the field of AD therapeutics. Successful AD clinical trial designs have to overcome challenges related to the subtle nature of early cognitive changes. Continuous unobtrusive assessments using Information and Communication Technology (ICT devices to capture markers of intra-individual change over time to assess cognitive and functional disability therefore offers significant benefits. We review the literature and provide an overview on randomized clinical trials in AD that use intelligent systems to monitor functional decline, as well as strengths, weaknesses, and future directions for the use of ICTs in a new generation of AD clinical trials.

  10. Does the use of Nintendo Wii SportsTMimprove arm function? Trial of WiiTMin Stroke: a randomized controlled trial and economics analysis.

    Science.gov (United States)

    Adie, Katja; Schofield, Christine; Berrow, Margie; Wingham, Jennifer; Humfryes, John; Pritchard, Colin; James, Martin; Allison, Rhoda

    2017-02-01

    The Trial of Wii™ in Stroke investigated the efficacy of using the Nintendo Wii Sports™ (Wii TM ) to improve affected arm function after stroke. Multicentre, pragmatic, parallel group, randomized controlled trial. Home-based rehabilitation. A total of 240 participants aged 24-90 years with arm weakness following a stroke within the previous six months. Participants were randomly assigned to exercise daily for six weeks using the Wii TM or arm exercises at home. Primary outcome was change in the affected arm function at six weeks follow-up using the Action Research Arm Test. Secondary outcomes included occupational performance, quality of life, arm function at six months and a cost effectiveness analysis. The study was completed by 209 participants (87.1%). There was no significant difference in the primary outcome of affected arm function at six weeks follow-up (mean difference -1.7, 95% CI -3.9 to 0.5, p = 0.12) and no significant difference in secondary outcomes, including occupational performance, quality of life or arm function at six months, between the two groups. No serious adverse events related to the study treatment were reported. The cost effectiveness analysis showed that the Wii TM was more expensive than arm exercises £1106 (SD 1656) vs. £730 (SD 829) (probability 0.866). The trial showed that the Wii TM was not superior to arm exercises in home-based rehabilitation for stroke survivors with arm weakness. The Wii TM was well tolerated but more expensive than arm exercises.

  11. Oral domperidone has no additional effect on chronic functional constipation in children: a randomized clinical trial.

    Science.gov (United States)

    Dehghani, Seyed Mohsen; Askarian, Mehrdad; Kaffashan, Heidar Ali

    2014-03-01

    Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children. A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment. A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment. There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation.

  12. Effects of pentoxifylline on renal function and blood pressure in cardiac transplant recipients: a randomized trial.

    Science.gov (United States)

    Frantz, R P; Edwards, B S; Olson, L J; Schwab, M K; Adams, T F; Textor, S C; Daly, R C; McGregor, C G; Rodeheffer, R J

    1997-06-15

    The current success of cardiac transplantation is in part attributable to the development of effective immunosuppressive agents such as cyclosporine. However, concern remains regarding the potential for cyclosporine-induced nephrotoxicity. Animal studies and early reports of renal protective effects of pentoxifylline in bone marrow transplant recipients prompted a randomized trial in cardiac transplant recipients. Twenty-nine patients were randomized to receive pentoxifylline 400 mg p.o. t.i.d. or matching placebo for 1 year after cardiac transplantation. Renal function was assessed preoperatively and at 1, 6, and 12 months postoperatively. Glomerular filtration rate and renal plasma flow were measured with iothalamate and para-aminohippurate, respectively. Serum creatinine was also measured. Ambulatory blood pressure monitoring after withdrawal of antihypertensives for 3 days was performed 12 months postoperatively. Twenty-seven patients completed the study. Glomerular filtration rate rose between 1 and 6 months after transplantation, presumably due to the reduction in goal cyclosporine level in that period, and then fell modestly between 6 and 12 months, presumably due to ongoing nephrotoxic effects of cyclosporine. No difference in glomerular filtration rate or creatinine was seen between pentoxifylline and placebo groups at any interval. Renal plasma flow increased modestly between baseline and 6 months in the pentoxifylline group, but not in the placebo group, and then fell between 6 and 12 months. Serum creatinine increased between baseline and 6 months in both groups, apparently due to increased body weight. Results of 18-hr ambulatory blood pressure monitoring obtained 1 year after transplantation was not different between groups. Renal function declines only modestly in the first year after cardiac transplantation. Pentoxifylline did not attenuate this process and had no effect on blood pressure. The modest decline in renal function may be related to

  13. Acute dark chocolate and cocoa ingestion and endothelial function: a randomized controlled crossover trial.

    Science.gov (United States)

    Faridi, Zubaida; Njike, Valentine Yanchou; Dutta, Suparna; Ali, Ather; Katz, David L

    2008-07-01

    Studies suggest cardioprotective benefits of dark chocolate containing cocoa. This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults. Randomized, placebo-controlled, single-blind crossover trial of 45 healthy adults [mean age: 53 y; mean body mass index (in kg/m(2)): 30]. In phase 1, subjects were randomly assigned to consume a solid dark chocolate bar (containing 22 g cocoa powder) or a cocoa-free placebo bar (containing 0 g cocoa powder). In phase 2, subjects were randomly assigned to consume sugar-free cocoa (containing 22 g cocoa powder), sugared cocoa (containing 22 g cocoa powder), or a placebo (containing 0 g cocoa powder). Solid dark chocolate and liquid cocoa ingestion improved endothelial function (measured as flow-mediated dilatation) compared with placebo (dark chocolate: 4.3 +/- 3.4% compared with -1.8 +/- 3.3%; P cocoa: 5.7 +/- 2.6% and 2.0 +/- 1.8% compared with -1.5 +/- 2.8%; P cocoa compared with placebo (dark chocolate: systolic, -3.2 +/- 5.8 mm Hg compared with 2.7 +/- 6.6 mm Hg; P cocoa: systolic, -2.1 +/- 7.0 mm Hg compared with 3.2 +/- 5.6 mm Hg; P cocoa (5.7 +/- 2.6% compared with 2.0 +/- 1.8%; P cocoa improved endothelial function and lowered blood pressure in overweight adults. Sugar content may attenuate these effects, and sugar-free preparations may augment them.

  14. Effect of singing on respiratory function, voice, and mood after quadriplegia: a randomized controlled trial.

    Science.gov (United States)

    Tamplin, Jeanette; Baker, Felicity A; Grocke, Denise; Brazzale, Danny J; Pretto, Jeffrey J; Ruehland, Warren R; Buttifant, Mary; Brown, Douglas J; Berlowitz, David J

    2013-03-01

    To explore the effects of singing training on respiratory function, voice, mood, and quality of life for people with quadriplegia. Randomized controlled trial. Large, university-affiliated public hospital, Victoria, Australia. Participants (N=24) with chronic quadriplegia (C4-8, American Spinal Injury Association grades A and B). The experimental group (n=13) received group singing training 3 times weekly for 12 weeks. The control group (n=11) received group music appreciation and relaxation for 12 weeks. Assessments were conducted pre, mid-, immediately post-, and 6-months postintervention. Standard respiratory function testing, surface electromyographic activity from accessory respiratory muscles, sound pressure levels during vocal tasks, assessments of voice quality (Perceptual Voice Profile, Multidimensional Voice Profile), and Voice Handicap Index, Profile of Mood States, and Assessment of Quality of Life instruments. The singing group increased projected speech intensity (P=.028) and maximum phonation length (P=.007) significantly more than the control group. Trends for improvements in respiratory function, muscle strength, and recruitment were also evident for the singing group. These effects were limited by small sample sizes with large intersubject variability. Both groups demonstrated an improvement in mood (P=.002), which was maintained in the music appreciation and relaxation group after 6 months (P=.017). Group music therapy can have a positive effect on not only physical outcomes, but also can improve mood, energy, social participation, and quality of life for an at-risk population, such as those with quadriplegia. Specific singing therapy can augment these general improvements by improving vocal intensity. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  15. Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial.

    Science.gov (United States)

    Pbert, Lori; Madison, J Mark; Druker, Susan; Olendzki, Nicholas; Magner, Robert; Reed, George; Allison, Jeroan; Carmody, James

    2012-09-01

    This study evaluated the efficacy of a mindfulness training programme (mindfulness-based stress reduction (MBSR)) in improving asthma-related quality of life and lung function in patients with asthma. A randomised controlled trial compared an 8-week MBSR group-based programme (n=42) with an educational control programme (n=41) in adults with mild, moderate or severe persistent asthma recruited at a university hospital outpatient primary care and pulmonary care clinic. Primary outcomes were quality of life (Asthma Quality of Life Questionnaire) and lung function (change from baseline in 2-week average morning peak expiratory flow (PEF)). Secondary outcomes were asthma control assessed by 2007 National Institutes of Health/National Heart Lung and Blood Institute guidelines, and stress (Perceived Stress Scale (PSS)). Follow-up assessments were conducted at 10 weeks, 6 and 12 months. At 12 months MBSR resulted in clinically significant improvements from baseline in quality of life (differential change in Asthma Quality of Life Questionnaire score for MBSR vs control: 0.66 (95% CI 0.30 to 1.03; pMBSR also resulted in clinically significant improvements in perceived stress (differential change in PSS score for MBSR vs control: -4.5 (95% CI -7.1 to -1.9; p=0.001)). There was no significant difference (p=0.301) in percentage of patients in MBSR with well controlled asthma (7.3% at baseline to 19.4%) compared with the control condition (7.5% at baseline to 7.9%). MBSR produced lasting and clinically significant improvements in asthma-related quality of life and stress in patients with persistent asthma, without improvements in lung function. Asthma and Mindfulness-Based Reduction (MBSR) Identifier: NCT00682669. clinicaltrials.gov.

  16. Assessing the spatiotemporal evolution of neuronal activation with single-trial event-related potentials and functional MRI

    NARCIS (Netherlands)

    Eichele, T.; Specht, K.; Moosmann, M.; Jongsma, M.L.A.; Quian Quiroga, R.; Nordby, H.; Hugdahl, K.

    2005-01-01

    The brain acts as an integrated information processing system, which methods in cognitive neuroscience have so far depicted in a fragmented fashion. Here, we propose a simple and robust way to integrate functional MRI (fMRI) with single trial event-related potentials (ERP) to provide a more complete

  17. Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J.; ten Dam, Hester; Zuithoff, Nicolaas P. A.; Numans, Mattijs E.; de Wit, Niek J.

    Objectives To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Design Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Setting Primary care setting, 39 general practices in the Netherlands.

  18. Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Irene Drubbel; Niek J. de Wit; Prof. Dr. Marieke J. Schuurmans; Mattijs E. Numans; Hester ten Dam; Nienke Bleijenberg; Nicolaas P.F. Zuidhoff

    2016-01-01

    OBJECTIVES: To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. DESIGN: Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. SETTING: Primary care setting, 39 general practices in the

  19. Brain Training Game Boosts Executive Functions, Working Memory and Processing Speed in the Young Adults: A Randomized Controlled Trial

    OpenAIRE

    Rui Nouchi; Yasuyuki Taki; Hikaru Takeuchi; Hiroshi Hashizume; Takayuki Nozawa; Toshimune Kambara; Atsushi Sekiguchi; Carlos Makoto Miyauchi; Yuka Kotozaki; Haruka Nouchi; Ryuta Kawashima

    2013-01-01

    BACKGROUND: Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. METHODS: We conducted a double-blind (de facto masking) randomized controlled trial using a p...

  20. Social skills improvement in children with high-functioning autism: a pilot randomized controlled trial.

    Science.gov (United States)

    Baghdadli, A; Brisot, J; Henry, V; Michelon, C; Soussana, M; Rattaz, C; Picot, M C

    2013-07-01

    High-functioning autism (HFA) is characterized by persistent impairment in social interaction despite the absence of mental retardation. Although an increasing number of group-based programs for the improvement of social skills have been described, randomized controlled trials are needed to evaluate their efficacy. To compare the effect of a Social Skills Training Group-based Program (SST-GP) and a Leisure Activities Group-based Program (LA-GP) on the perception of facial emotions and quality of life (QoL) in young people with HFA. Eligible patients were children and adolescents with HFA. Participants were randomized to the SST or LA group. The primary outcome was defined as an improvement of 2 points in error rates for facial emotion labeling (DANVA2) from baseline. After the 6-month training period, the SST Group made fewer errors in labeling anger on adult faces, whereas error rates in the LA Group remained stable. Progress in the ability to recognize anger in the SST Group was due to better recognition of low intensity stimuli on adult faces. QoL increased in the SST Group in the dimension of school environment, as a marker of the transfer of skills acquired in the treatment setting to their use in the community. The SST-GP had higher efficacy than the LA-GP. Data justify replication using larger samples.

  1. Yoga and immune system functioning: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Falkenberg, R I; Eising, C; Peters, M L

    2018-02-10

    Yoga is an ancient mind-body practice that is increasingly recognized to have health benefits in a variety of clinical and non-clinical conditions. This systematic review summarizes the findings of randomized controlled trials examining the effects of yoga on immune system functioning which is imperative to justify its application in the clinic. Fifteen RCTs were eligible for the review. Even though the existing evidence is not entirely consistent, a general pattern emerged suggesting that yoga can downregulate pro-inflammatory markers. In particular, the qualitative evaluation of RCTs revealed decreases in IL-1beta, as well as indications for reductions in IL-6 and TNF-alpha. These results imply that yoga may be implemented as a complementary intervention for populations at risk or already suffering from diseases with an inflammatory component. Beyond this, yoga practice may exert further beneficial effects by enhancing cell-mediated and mucosal immunity. It is hypothesized that longer time spans of yoga practice are required to achieve consistent effects especially on circulating inflammatory markers. Overall, this field of investigation is still young, hence the current body of evidence is small and for most immune parameters, more research is required to draw distinct conclusions.

  2. Effect of Standing or Walking at a Workstation on Cognitive Function: A Randomized Counterbalanced Trial.

    Science.gov (United States)

    Bantoft, Christina; Summers, Mathew J; Tranent, Peter J; Palmer, Matthew A; Cooley, P Dean; Pedersen, Scott J

    2016-02-01

    In the present study, we examined the effect of working while seated, while standing, or while walking on measures of short-term memory, working memory, selective and sustained attention, and information-processing speed. The advent of computer-based technology has revolutionized the adult workplace, such that average adult full-time employees spend the majority of their working day seated. Prolonged sitting is associated with increasing obesity and chronic health conditions in children and adults. One possible intervention to reduce the negative health impacts of the modern office environment involves modifying the workplace to increase incidental activity and exercise during the workday. Although modifications, such as sit-stand desks, have been shown to improve physiological function, there is mixed information regarding the impact of such office modification on individual cognitive performance and thereby the efficiency of the work environment. In a fully counterbalanced randomized control trial, we assessed the cognitive performance of 45 undergraduate students for up to a 1-hr period in each condition. The results indicate that there is no significant change in the measures used to assess cognitive performance associated with working while seated, while standing, or while walking at low intensity. These results indicate that cognitive performance is not degraded with short-term use of alternate workstations. © 2015, Human Factors and Ergonomics Society.

  3. Sexual Function in Women on Estradiol or Venlafaxine for Hot Flushes: A Randomized Controlled Trial

    Science.gov (United States)

    Reed, Susan D.; Mitchell, Caroline M.; Joffe, Hadine; Cohen, Lee; Shifren, Jan L.; Newton, Katherine M.; Freeman, Ellen W.; Larson, Joseph C.; Manson, JoAnn E.; LaCroix, Andrea Z.; Guthrie, Katherine A.

    2014-01-01

    Objective To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes. Methods In an 8-week randomized controlled trial among women aged 40-62 years, sexual function was compared between oral estradiol 0.5 mg/day or venlafaxine 75 mg/day (both compared with placebo). Measures included composite and 6 domain scores from the Female Sexual Function Index (FSFI) and sexually related personal distress. Results Participants were aged 54.6 (standard deviation [SD] 3.8) years, 59% Caucasian, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline FSFI score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean FSFI change from baseline to week-8 was 1.4 (95% Confidence Interval [CI] -0.4, 3.2) for estradiol, 1.1 (95% CI -0.5, 2.7) for venlafaxine and -0.3 (95% CI -1.6, 1.0) for placebo. Composite FSFI and sexually-related distress change from baseline did not differ between estradiol and placebo (p= 0.38, p=0.30) or venlafaxine and placebo (p=0.79, p=0.48). Among sexually active women, FSFI domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0, 0.6) for estradiol; -0.6 (95% CI -1.2, 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2, 1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction. Conclusions Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8-weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although subtle increase in desire (estradiol), and decreases in orgasm and pain (venlafaxine) may exist. PMID:25004335

  4. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    Full Text Available Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS. We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74 vs. active control (n = 61 training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30, despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006. This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction.Clinicaltrials.gov NCT02141386.

  5. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial.

    Science.gov (United States)

    Charvet, Leigh E; Yang, Jie; Shaw, Michael T; Sherman, Kathleen; Haider, Lamia; Xu, Jianjin; Krupp, Lauren B

    2017-01-01

    Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS). We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR) program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74) vs. active control (n = 61) training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30), despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006). This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction. Clinicaltrials.gov NCT02141386.

  6. Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial.

    Science.gov (United States)

    Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Stylsvig, Mette; Lauridsen, Jørgen T; Toft, Palle

    2016-06-01

    The effects of non-sedation on cognitive function in critically ill patients on mechanical ventilation are not yet certain. This trial is a substudy of the NONSEDA trial where critically ill patients are randomized to non-sedation or to sedation with a daily wake-up attempt during mechanical ventilation in the intensive care unit (ICU). The aim of this substudy is to assess the effects of non-sedation versus sedation with a daily wake-up attempt on long-term cognitive function. This is an investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 200 patients. Inclusion criteria will be adult patients who are intubated and on mechanical ventilation with an expected duration of more than 24 hours. Exclusion criteria will be patients who are comatose at admission and patients with conditions requiring therapeutic coma (i.e., severe head trauma, status epilepticus, patients treated with therapeutic hypothermia and patients with severe hypoxia). The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up attempt. The primary outcome will be cognitive function 3 months after discharge from intensive care. The secondary outcomes will be the results of seven specific cognitive tests, performed 3 months after discharge from intensive care, and the association between hypoactive and agitated delirium during ICU admission and long-term cognitive function. If non-sedation can improve long-term cognitive function, it could be an approach worth considering for a larger group of critically ill patients. The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02035436 , registered on 10 January 2014).

  7. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rui Nouchi

    Full Text Available BACKGROUND: Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age on a wide range of cognitive functions in young adults. METHODS: We conducted a double-blind (de facto masking randomized controlled trial using a popular brain training game (Brain Age and a popular puzzle game (Tetris. Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris. Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability. RESULTS AND DISCUSSION: Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed in the healthy young adults. CONCLUSIONS: Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields

  8. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Boissonnat Pascale

    2012-12-01

    Full Text Available Abstract Background Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. Methods In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130  Results At 12 months, the mean (± SD creatinine value was 120.7 μmol/L (± 35.8 in the low-dose group and 132.3 μmol/L (± 49.1 in the standard-dose group (P = 0.162. Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. Conclusions In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. Trial registration ClinicalTrials.gov NCT00159159

  9. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Luanda A. C. Grecco

    2013-02-01

    Full Text Available BACKGROUND: Treadmill gait training as a therapeutic resource in the rehabilitation of children with cerebral palsy has recently been the focus of many studies; however, little is still known regarding its effect on static and functional balance in children. OBJECTIVE: The aim of the present study was to compare the effects of treadmill training and over ground gait training in children with cerebral palsy. METHOD: A randomized controlled trial with blinded evaluator was conducted with children with cerebral palsy between three and 12 years of age categorized in Levels I to III of the Gross Motor Function Classification System. Assessments were performed before and after the intervention and involved the Berg balance scale as well as the determination of oscillations from the center of pressure in the anteroposterior and mediolateral directions with eyes open and closed. The experimental group was submitted to treadmill training and the control group performed gait training over the ground. The intervention consisted of two 30-minute sessions per week for seven weeks. RESULTS: Both groups exhibited better functional balance after the protocol. The experimental group had higher Berg balance scale scores and exhibited lesser mediolateral oscillation with eyes open in comparison to the control group. CONCLUSIONS: Treadmill training had a greater effect on functional balance and mediolateral oscillation in comparison to over ground gait training in children with cerebral palsy. Trial registration: RBR-5v3kg9.(Brazilian Registry of Clinical Trials.

  10. Randomized controlled trial of yoga for chronic poststroke hemiparesis: motor function, mental health, and quality of life outcomes.

    Science.gov (United States)

    Immink, Maarten A; Hillier, Susan; Petkov, John

    2014-01-01

    To assess the efficacy of yoga for motor function, mental health, and quality of life outcomes in persons with chronic poststroke hemiparesis. Twenty-two individuals participated in a randomized controlled trial involving assessment of task-orientated function, balance, mobility, depression, anxiety, and quality of life domains before and after either a 10-week yoga intervention (n = 11) or no treatment (n = 11). The yoga intervention did not result in any significant improvements in objective motor function measures, however there was a significant improvement in quality of life associated with perceived motor function (P = .0001) and improvements in perceived recovery approached significance (P = .072). Memory-related quality of life scores significantly improved after yoga intervention (P = .022), and those participating in the intervention exhibited clinically relevant decreases in state and trait anxiety. Preliminary results offer promise for yoga as an intervention to address mental health and quality of life in persons with stroke-related activity limitations. There is a need to more rigorously evaluate these yoga benefits with a larger randomized controlled trial, which, based on this preliminary trial, is feasible.

  11. Effect of nut consumption on vascular endothelial function: A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xiao, Yunjun; Huang, Wei; Peng, Chaoqiong; Zhang, Jinzhou; Wong, Carmen; Kim, Jean H; Yeoh, Eng-Kiong; Su, Xuefen

    2017-04-20

    nut consumption has consistently been found to be associated with a reduced risk of cardiovascular diseases (CVD) and mortality in prospective studies. However, its effect on endothelial function, a prognostic marker of CVD, is still controversial in clinical trials. This meta-analysis of randomized controlled trials (RCTs) aimed to quantitatively assess the effect of nuts on vascular endothelial function. Major electronic databases were searched for published RCTs that reported the effect of nuts on flow mediated dilation (FMD) as a measurement of endothelial function in the adult population (age eighteen years or over). We calculated the pooled estimates of weighted mean differences (WMDs) and their 95% confidence intervals (CIs) by using random-effects models. A total of nine papers (10 trials) involving 374 participants were included. The pooled estimates found that nut consumption significantly improved FMD (WMD: 0.41%; 95% CI: 0.18%, 0.63%; P = 0.001). Moderate and marginally significant heterogeneity was observed among the studies (I(2) = 39.5%, P = 0.094). Subgroup analyses indicated that walnuts significantly improved FMD (WMD: 0.39%; 95% CI: 0.16%, 0.63%; P = 0.001). In addition, nut consumption had a significant effect on FMD in the trials with study duration consumption significantly improved endothelial function. However, the beneficial effect was limited to walnuts. More studies examining the effect of other nuts on endothelial function are needed in the future. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  12. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  13. Tolvaptan and Neurocognitive Function in Mild to Moderate Chronic Hyponatremia: A Randomized Trial (INSIGHT).

    Science.gov (United States)

    Verbalis, Joseph G; Ellison, Howard; Hobart, Mary; Krasa, Holly; Ouyang, John; Czerwiec, Frank S

    2016-06-01

    This trial assessed the effect of tolvaptan on cognition, gait, and postural stability in adult patients with mild to moderate asymptomatic hyponatremia. Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group pilot study. 57 men and women 50 years or older with chronic asymptomatic euvolemic or hypervolemic hyponatremia (serum sodium concentration >120-tolvaptan or matching placebo beginning at a dose of 15mg/d, with titration to 30 or 60mg/d based on change in serum sodium concentration and tolerance. Primary: change from baseline in the neurocognitive composite score of speed domains. Secondary: changes from baseline in individual neurocognitive domain scores, overall neurocognitive composite score, gait and postural stability test results, and serum sodium concentrations. Mean serum sodium concentration increased from 129 to 136 mEq/L in the tolvaptan group and from 130 to 132 mEq/L in the placebo group (Ptolvaptan (treatment effect, 0.27; 95% CI, 0.04-0.51; P=0.03). There were some imbalances between treatment groups in baseline neurocognitive function scores and some baseline test results were near normal, leaving little opportunity for improvement. Formal sample size calculations were not performed because this was a pilot study. The study population was small (n=57) and treatment was of short duration (3 weeks). The primary end point of the study was not significant; thus, subgroup analyses are subject to errors of multiplicity and should be regarded as hypothesis generating. Tolvaptan was effective in reversing chronic hyponatremia, and this correlated with improvements in results of a variety of neurocognition tests, particularly rapid motor movements, which tended to reverse following return to a low baseline serum sodium concentration after treatment withdrawal. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  14. Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: A crossover, double-blind, controlled trial

    Science.gov (United States)

    Guerra, Paula VP; Lima, Luiza N; Souza, Tassia C; Mazochi, Vanessa; Penna, Francisco J; Silva, Andreia M; Nicoli, Jacques R; Guimarães, Elizabet V

    2011-01-01

    AIM: To evaluate the treatment of pediatric functional chronic intestinal constipation (FCIC) with a probiotic goat yogurt. METHODS: A crossover double-blind formula-controlled trial was carried out on 59 students (age range: 5-15 years) of a public school in Belo Horizonte, MG, Brazil, presenting a FCIC diagnostic, according to Roma III criteria. The students were randomized in two groups to receive a goat yogurt supplemented with 109 colony forming unit/mL Bifidobacterium longum (B. longum) (probiotic) daily or only the yogurt for a period of 5 wk (formula). Afterwards, the groups were intercrossed for another 5 wk. Defecation frequency, stool consistency and abdominal and defecation pain were assessed. RESULTS: Both treatment groups demonstrated improvement in defecation frequency compared to baseline. However, the group treated with probiotic showed most significant improvement in the first phase of the study. An inversion was observed after crossing over, resulting in a reduction in stool frequency when this group was treated by formula. Probiotic and formula improved stool consistency in the first phase of treatment, but the improvement obtained with probiotic was significantly higher (P = 0.03). In the second phase of treatment, the group initially treated with probiotic showed worseningstool consistency when using formula. However, the difference was not significant. A significant improvement in abdominal pain and defecation pain was observed with both probiotic and formula in the first phase of treatment, but again the improvement was more significant for the group treated with B. longum during phase I (P yogurt and yogurt only for defecation frequency (P = 0.012), defecation pain (P = 0.046) and abdominal pain (P = 0.015). CONCLUSION: An improvement in defecation frequency and abdominal pain was observed using both supplemented and non-supplemented yogurt, but an additional improvement with B. longum supplementation was obtained. PMID:22025880

  15. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sartor Cristina

    2012-03-01

    Full Text Available Abstract Background Polyneuropathy is a complication of diabetes mellitus that has been very challenging for clinicians. It results in high public health costs and has a huge impact on patients' quality of life. Preventive interventions are still the most important approach to avoid plantar ulceration and amputation, which is the most devastating endpoint of the disease. Some therapeutic interventions improve gait quality, confidence, and quality of life; however, there is no evidence yet of an effective physical therapy treatment for recovering musculoskeletal function and foot rollover during gait that could potentially redistribute plantar pressure and reduce the risk of ulcer formation. Methods/Design A randomised, controlled trial, with blind assessment, was designed to study the effect of a physiotherapy intervention on foot rollover during gait, range of motion, muscle strength and function of the foot and ankle, and balance confidence. The main outcome is plantar pressure during foot rollover, and the secondary outcomes are kinetic and kinematic parameters of gait, neuropathy signs and symptoms, foot and ankle range of motion and function, muscle strength, and balance confidence. The intervention is carried out for 12 weeks, twice a week, for 40-60 min each session. The follow-up period is 24 weeks from the baseline condition. Discussion Herein, we present a more comprehensive and specific physiotherapy approach for foot and ankle function, by choosing simple tasks, focusing on recovering range of motion, strength, and functionality of the joints most impaired by diabetic polyneuropathy. In addition, this intervention aims to transfer these peripheral gains to the functional and more complex task of foot rollover during gait, in order to reduce risk of ulceration. If it shows any benefit, this protocol can be used in clinical practice and can be indicated as complementary treatment for this disease. Trial Registration ClinicalTrials

  16. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  17. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial.

    Science.gov (United States)

    Tyson, Anna F; Kendig, Claire E; Mabedi, Charles; Cairns, Bruce A; Charles, Anthony G

    2015-03-01

    Changes in pulmonary dynamics following laparotomy are well documented. Deep breathing exercises, with or without incentive spirometry, may help counteract postoperative decreased vital capacity; however, the evidence for the role of incentive spirometry in the prevention of postoperative atelectasis is inconclusive. Furthermore, data are scarce regarding the prevention of postoperative atelectasis in sub-Saharan Africa. To determine the effect of the use of incentive spirometry on pulmonary function following exploratory laparotomy as measured by forced vital capacity (FVC). This was a single-center, randomized clinical trial performed at Kamuzu Central Hospital, Lilongwe, Malawi. Study participants were adult patients who underwent exploratory laparotomy and were randomized into the intervention or control groups (standard of care) from February 1 to November 30, 2013. All patients received routine postoperative care, including instructions for deep breathing and early ambulation. We used bivariate analysis to compare outcomes between the intervention and control groups. Adult patients who underwent exploratory laparotomy participated in postoperative deep breathing exercises. Patients in the intervention group received incentive spirometers. We assessed pulmonary function using a peak flow meter to measure FVC in both groups of patients. Secondary outcomes, such as hospital length of stay and mortality, were obtained from the medical records. A total of 150 patients were randomized (75 in each arm). The median age in the intervention and control groups was 35 years (interquartile range, 28-53 years) and 33 years (interquartile range, 23-46 years), respectively. Men predominated in both groups, and most patients underwent emergency procedures (78.7% in the intervention group and 84.0% in the control group). Mean initial FVC did not differ significantly between the intervention and control groups (0.92 and 0.90 L, respectively; P=.82 [95% CI, 0.52-2.29]). Although

  18. The effect of vibration therapy on spasticity and motor function in children with cerebral palsy: a randomized controlled trial.

    Science.gov (United States)

    Katusic, Ana; Alimovic, Sonja; Mejaski-Bosnjak, Vlatka

    2013-01-01

    As the motor system relies heavily on deep sensory stimulation, recent studies have investigated the effect of vibration stimuli. Although research suggests a positive influence of vibration on motor performance in individuals with neurological disorders, there are very limited numbers of studies in children with cerebral palsy (CP). The objective of the present study was to evaluate the effects of sound wave vibration therapy on spasticity and motor function in children with CP. In this 3-month trial, 89 children with spastic CP were randomized to either continue their physiotherapy treatment (PT) or to receive vibration therapy twice a week in addition to their PT program. The randomization was stratified according to the Gross Motor Function Classification System (GMFCS) level to ensure similar functional ability. Children were assessed at baseline and after the 12-week intervention period. The outcomes measured were spasticity level as assessed by Modified Modified Ashworth Scale (MMAS) and gross motor function as assessed by Gross Motor Function Measurement (GMFM-88). Subgroup analysis was performed for the GMFCS. Significant differences between groups were detected for changes in spasticity level and gross motor function after the three months intervention. In conclusion, vibration therapy may decrease spasticity and improve motor performance in children with CP. The results of the present trial serve as valuable input for evidence-based treatments in paediatric neurorehabilitation.

  19. Review of Information and Communication Technology Devices for Monitoring Functional and Cognitive Decline in Alzheimer's Disease Clinical Trials

    OpenAIRE

    Pillai, Jagan A.; Aaron Bonner-Jackson

    2015-01-01

    Detecting and monitoring early cognitive impairment in Alzheimer's disease (AD) is a significant need in the field of AD therapeutics. Successful AD clinical trial designs have to overcome challenges related to the subtle nature of early cognitive changes. Continuous unobtrusive assessments using Information and Communication Technology (ICT) devices to capture markers of intra-individual change over time to assess cognitive and functional disability therefore offers significant benefits. We ...

  20. Dental amalgam restorations and children’s neuropsychological function: The New England Children’s Amalgam Trial

    OpenAIRE

    Daniel, David; Trachtenberg, Felicia; McKinlay, Sonja; Bellinger, David C.; Tavares, Mary Angela

    2006-01-01

    Background: A concern persists that children’s exposure to mercury vapor from dental amalgams produces neurotoxicity. Objective: Our goal was to compare the neuropsychological function of children, without prior exposure to dental amalgam, whose caries were repaired using either dental amalgam or mercury-free composite materials. Methods: We conducted a randomized controlled trial involving 534 6- to 10-year-old urban and rural children who were assessed yearly for 5 years using a battery of ...

  1. Cognitive Function and Treatment Response in a Randomized Clinical Trial of Computer-Based Training in Cognitive-Behavioral Therapy

    OpenAIRE

    Carroll, Kathleen M.; Kiluk, Brian D.; Nich, Charla; Babuscio, Theresa A.; Brewer, Judson A.; Marc N. Potenza; Ball, Samuel A.; Martino, Steve; Rounsaville, Bruce J.; Lejuez, Carl W.

    2011-01-01

    Cognitive-behavioral therapy (CBT), because of its comparatively high level of cognitive demand, is likely to be challenging for substance users with limitations in cognitive function. However, it is not known whether computer-assisted versions of CBT will be particularly helpful (e.g., allowing individualized pace and repetition) or difficult (e.g., via complexity of computerized delivery) for such patients. In this secondary analysis of data collected from a randomized clinical trial evalua...

  2. Effects of Sex Education and Kegel Exercises on the Sexual Function of Postmenopausal Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Nazarpour, Soheila; Simbar, Masoumeh; Ramezani Tehrani, Fahimeh; Alavi Majd, Hamid

    2017-07-01

    The sex lives of women are strongly affected by menopause. Non-pharmacologic approaches to improving the sexual function of postmenopausal women might prove effective. To compare two methods of intervention (formal sex education and Kegel exercises) with routine postmenopausal care services in a randomized clinical trial. A randomized clinical trial was conducted of 145 postmenopausal women residing in Chalus and Noshahr, Iran. Their sexual function statuses were assessed using the Female Sexual Function Index (FSFI) questionnaire. After obtaining written informed consents, they were randomly assigned to one of three groups: (i) formal sex education, (ii) Kegel exercises, or (iii) routine postmenopausal care. After 12 weeks, all participants completed the FSFI again. Analysis of covariance was used to compare the participants' sexual function before and after the interventions, and multiple linear regression analysis was used to determine the predictive factors for variation in FSFI scores in the postintervention stage. Sexual function was assessed using the FSFI. There were no statistically significant differences in demographic and socioeconomic characteristics and FSFI total scores among the three study groups at the outset of the study. After 12 weeks, the scores of arousal in the formal sex education and Kegel groups were significantly higher compared with the control group (3.38 and 3.15 vs 2.77, respectively). The scores of orgasm and satisfaction in the Kegel group were significantly higher compared with the control group (4.43 and 4.88 vs 3.95 and 4.39, respectively). Formal sex education and Kegel exercises were used as two non-pharmacologic approaches to improve the sexual function of women after menopause. The main strength of this study was its design: a well-organized randomized trial using precise eligibility criteria with a small sample loss. The second strength was the methods of intervention used, namely non-pharmacologic approaches that are

  3. Mechanisms of Functional Improvement in a Two-Year Trial of Cognitive Enhancement Therapy for Early Schizophrenia

    Science.gov (United States)

    Eack, Shaun M.; Pogue-Geile, Michael F.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2013-01-01

    Background Cognitive rehabilitation has emerged as an effective treatment for addressing cognitive impairments and functional disability in schizophrenia; however, the degree to which changes in various social and non-social cognitive processes translate into improved functioning during treatment remains unclear. This research sought to identify the neurocognitive and social-cognitive mechanisms of functional improvement during a two-year trial of Cognitive Enhancement Therapy (CET) for early course schizophrenia. Method Patients in the early course of schizophrenia were randomly assigned to CET (n = 31) or an Enriched Supportive Therapy control (n = 27) and treated for up to two years. A comprehensive neurocognitive assessment battery and the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) were completed annually, along with measures of functioning. Mediator analyses using mixed-effects growth models were conducted to examine the effects of neurocognitive and social-cognitive improvement on functional change. Results Two-year improvement in neurocognition and the emotion management branch of the MSCEIT were found to be significantly related to improved functional outcome in early course schizophrenia patients. Neurocognitive improvement, primarily in executive functioning, and social-cognitive change in emotion management also mediated the robust effects of CET on functioning. Conclusions Improvements in neurocognition and social cognition that result from cognitive rehabilitation are both significant mediators of functional improvement in early course schizophrenia. Cognitive rehabilitation programs for schizophrenia may need to target deficits in both social and non-social cognition to achieve an optimal functional response. PMID:20860867

  4. Cognitive function and treatment response in a randomized clinical trial of computer-based training in cognitive-behavioral therapy.

    Science.gov (United States)

    Carroll, Kathleen M; Kiluk, Brian D; Nich, Charla; Babuscio, Theresa A; Brewer, Judson A; Potenza, Marc N; Ball, Samuel A; Martino, Steve; Rounsaville, Bruce J; Lejuez, Carl W

    2011-01-01

    Cognitive-behavioral therapy (CBT), because of its comparatively high level of cognitive demand, is likely to be challenging for substance users with limitations in cognitive function. However, it is not known whether computer-assisted versions of CBT will be particularly helpful (e.g., allowing individualized pace and repetition) or difficult (e.g., via complexity of computerized delivery) for such patients. In this secondary analysis of data collected from a randomized clinical trial evaluating computer-assisted CBT, four aspects of cognitive functioning were evaluated among 77 participants. Those with higher levels of risk taking completed fewer sessions and homework assignments and had poorer substance use outcomes.

  5. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial.

    Science.gov (United States)

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Kambara, Toshimune; Sekiguchi, Atsushi; Miyauchi, Carlos Makoto; Kotozaki, Yuka; Nouchi, Haruka; Kawashima, Ryuta

    2013-01-01

    Do brain training games work? The beneficial effects of brain training games are expected to transfer to other cognitive functions. Yet in all honesty, beneficial transfer effects of the commercial brain training games in young adults have little scientific basis. Here we investigated the impact of the brain training game (Brain Age) on a wide range of cognitive functions in young adults. We conducted a double-blind (de facto masking) randomized controlled trial using a popular brain training game (Brain Age) and a popular puzzle game (Tetris). Thirty-two volunteers were recruited through an advertisement in the local newspaper and randomly assigned to either of two game groups (Brain Age, Tetris). Participants in both the Brain Age and the Tetris groups played their game for about 15 minutes per day, at least 5 days per week, for 4 weeks. Measures of the cognitive functions were conducted before and after training. Measures of the cognitive functions fell into eight categories (fluid intelligence, executive function, working memory, short-term memory, attention, processing speed, visual ability, and reading ability). Our results showed that commercial brain training game improves executive functions, working memory, and processing speed in young adults. Moreover, the popular puzzle game can engender improvement attention and visuo-spatial ability compared to playing the brain training game. The present study showed the scientific evidence which the brain training game had the beneficial effects on cognitive functions (executive functions, working memory and processing speed) in the healthy young adults. Our results do not indicate that everyone should play brain training games. However, the commercial brain training game might be a simple and convenient means to improve some cognitive functions. We believe that our findings are highly relevant to applications in educational and clinical fields. UMIN Clinical Trial Registry 000005618.

  6. Effects of vitamin D supplementation on cognitive and emotional functioning in young adults--a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Angela J Dean

    Full Text Available BACKGROUND: Epidemiological research links vitamin D status to various brain-related outcomes. However, few trials examine whether supplementation can improve such outcomes and none have examined effects on cognition. This study examined whether Vitamin D supplementation led to improvements in diverse measures of cognitive and emotional functioning, and hypothesised that supplementation would lead to improvements in these outcomes compared to placebo. METHODS/PRINCIPAL FINDINGS: Healthy young adults were recruited to a parallel-arm, double-blind trial conducted at The University of Queensland. Participants were randomly allocated to receive Vitamin D (one capsule daily, containing 5000 IU cholecalciferol or identical placebo capsule for six weeks. All participants and outcome assessors were blinded to group assignment. Primary outcome measures assessed at baseline and 6 weeks were working memory, response inhibition and cognitive flexibility. Secondary outcomes were: hallucination-proneness, psychotic-like experiences, and ratings of depression, anxiety and anger. 128 participants were recruited, randomised and included in primary analyses (vitamin D n = 63; placebo n = 65. Despite significant increases in vitamin D status in the active group, no significant changes were observed in working memory (F = 1.09; p = 0.30, response inhibition (F = 0.82; p = 0.37, cognitive flexibility (F = 1.37; p = 0.24 or secondary outcomes. No serious adverse effects were reported. CONCLUSIONS: Our findings indicate that vitamin D supplementation does not influence cognitive or emotional functioning in healthy young adults. Future controlled trials in targeted populations of interest are required to determine whether supplementation can improve functioning in these domains. Australian and New Zealand Clinical Trials Registry; ACTRN12610000318088.

  7. Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ko, Seok-Jae; Park, Kyungmo; Kim, Jieun; Kim, Minji; Kim, Joo-Hee; Lee, Jeungchan; Mohamed, Abdalla Z; Yeo, Inkwon; Kim, Jinsung; Choi, Sun-Mi; Kim, Honggeol; Park, Jae-Woo; Lee, Jun-Hwan

    2016-04-02

    Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare. ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

  8. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial.

    Science.gov (United States)

    Bohula, Erin A; Giugliano, Robert P; Ruff, Christian T; Kuder, Julia F; Murphy, Sabina A; Antman, Elliott M; Braunwald, Eugene

    2016-07-05

    Edoxaban, an oral factor Xa inhibitor with 50% renal clearance, was noninferior to well-managed warfarin for stroke or systemic embolism (S/SE) prevention and reduced bleeding in patients with atrial fibrillation. We evaluated the efficacy and safety of edoxaban versus warfarin across the range of baseline creatinine clearance (CrCl) in the ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction Study 48) with a focus on the higher-dose edoxaban regimen (HDER) and the upper range of CrCl. A total of 14 071 patients with atrial fibrillation at moderate to high risk for stroke were randomized to warfarin or HDER (60 mg daily or a 50% dose reduction to 30 mg daily for CrCl 30-50 mL/min, body weight of ≤60 kg, or use of a potent phosphorylated glycoprotein inhibitor). CrCl 50 mL/min (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.72-1.04) was similar to that in patients with CrCl ≤50 mL/min (HR, 0.87; 95% CI, 0.65-1.18; P for interaction=0.94). Several exploratory analyses suggested lower relative efficacy for the prevention of S/SE with HDER compared with warfarin at higher levels of CrCl (CrCl ≤50 mL/min: HR, 0.87; 95% CI, 0.65-1.18; CrCl >50-95 mL/min: HR, 0.78; 95% CI, 0.64-0.96; CrCl >95 mL/min: HR, 1.36; 95% CI, 0.88-2.10; P for interaction=0.08). Bleeding rates were lower at all levels of CrCl with HDER (P for interaction=0.11). Because of the preserved effect on bleeding, the net clinical outcome was more favorable with HDER across the range of CrCl (P for interaction=0.73). Similar findings were observed in the sensitivity analysis using the CKD-EPI formula. Although there was an apparent decrease in relative efficacy to prevent arterial thromboembolism in the upper range of CrCl, the safety and net clinical benefit of HDER compared with warfarin are consistent across the range of renal function. URL: http://www.clinicaltrials.gov. Unique identifier: NCT

  9. Short-term aerobic exercise and vascular function in CKD stage 3: a randomized controlled trial.

    Science.gov (United States)

    Headley, Samuel; Germain, Michael; Wood, Richard; Joubert, Jyovani; Milch, Charles; Evans, Elizabeth; Poindexter, Anthony; Cornelius, Allen; Brewer, Britton; Pescatello, Linda S; Parker, Beth

    2014-08-01

    The present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease (CKD) stage 3. Randomized controlled trial with a parallel-group design. Testing and training sessions were performed at Springfield College. 46 (treatment group, n=25; control group, n=21) patients with CKD with diabetes and/or hypertension completed the study. The aerobic training program consisted of 16 weeks of supervised exercise training at 50%-60% peak oxygen uptake (Vo2peak) 3 times per week, while the control group remained sedentary. Identical testing procedures were performed following the 16-week intervention. The primary outcome was arterial stiffness. Secondary outcomes were aerobic capacity, various blood parameters (endothelin 1, nitrate/nitrite, and high-sensitivity C-reactive protein), and health-related quality of life. Arterial stiffness was assessed with aortic pulse wave velocity (PWV), aerobic capacity by Vo2peak, blood parameters by enzyme-linked immunosorbent assays, and health-related quality of life by the 36-Item Short Form Health Survey (SF-36). Participants attended 4 sessions before being randomly assigned to either the treatment or control group. Participants gave consent during the first session, whereas a graded exercise test with measurement of Vo2peak was completed during the second session. During sessions 3 and 4, aortic PWV was measured at rest prior to 40 minutes of either moderate-intensity exercise training or seated rest. A venous blood sample was obtained prior to exercise or rest and participants completed the SF-36 questionnaire. 16 weeks of training led to an 8.2% increase in Vo2peak for the treatment group (P=0.05), but no changes in aortic PWV . Randomization was not concealed and was violated on one occasion; also, use of an indirect measurement of endothelial function and the short duration of the intervention. Short-term moderate-intensity exercise

  10. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial.

    Science.gov (United States)

    Cherian, Jeffrey J; Bhave, Anil; Kapadia, Bhaveen H; Starr, Roland; McElroy, Mark J; Mont, Michael A

    2015-05-01

    Pneumatic unloader bracing with extension assists have been proposed as a non-operative modality that may delay the need for knee surgery by reducing pain and improving function. This prospective, randomized trial evaluated 52 patients who had knee osteoarthritis for changes in: (1) muscle strength; (2) objective functional improvements; (3); subjective functional improvements; (4) pain; (5) quality of life; and (6) conversion to total knee arthroplasty (TKA) compared to standard of care. Patient outcomes were evaluated at a minimum 3 months. Braced patient's demonstrated significant improvements in muscle strength, several functional tests, and patient reported outcomes when compared to the matched cohort. These results are encouraging and suggest that this device may represent a promising alternative to standard treatment methods for knee osteoarthritis. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Imaging vascular function for early stage clinical trials using dynamic contrast-enhanced magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Leach, M.O.; Orton, M. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Cancer Research UK and EPSRC Cancer Imaging Centre, Sutton, Surrey (United Kingdom); Morgan, B. [Univ. of Leicester, College of Medicine, Biological Sciences and Psychology, Leicester (United Kingdom); Tofts, P.S. [Brighton and Sussex Medical School, Univ. of Sussex, Clinical Imaging Sciences Centre, Sussex (United Kingdom); Buckley, D.L. [University of Leeds, Division of Medical Physics, Leeds (United Kingdom); Huang, W. [Oregon Health and Science Univ., Advanced Imaging Research Centre, Portland, OR (United States); Horsfield, M.A. [Medical Physics Section, Leicester Royal Infirmary, Dept. of Cardiovascular Sciences, Leicester (United Kingdom); Chenevert, T.L. [Univ. of Michigan Health System, Ann Arbor, MI (United States); Collins, D.J. [Royal Marsden Hospital NHS Foundation Trust, Cancer Research UK and EPSRC Cancer Imaging Centre, Sutton, Surrey (United Kingdom); Jackson, A. [Univ. of Manchester, Wolfson Molecular Imaging Centre, Withington, Manchester, M20 3LJ (United Kingdom); Lomas, D. [Univ. of Cambridge, Dept. of Radiology, Cambridge (United Kingdom); Whitcher, B. [Unit 2 Greenways Business Park, Mango Solutions, Chippenham (United Kingdom); Clarke, L. [Cancer Imaging Program, Imaging Technology Development Branch, Rockville, MD (United States); Plummer, R. [Univ. of Newcastle Upon Tyne, The Medical School, Medical Oncology, Northern Inst. for Cancer Research, Newcastle Upon Tyne (United Kingdom); Judson, I. [Royal Marsden Hospital, Sutton, Surrey (United Kingdom); Jones, R. [Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom); Alonzi, R. [Mount Vernon Cancer Centre, Northwood (United Kingdom); Brunner, T. [Gray Inst. for Radiation, Oncology and Biology, Oxford (United Kingdom); Koh, D.M. [Royal Marsden NHS Foundation Trust, Diagnostic Radiology, Sutton, Surrey (United Kingdom)] [and others

    2012-07-15

    Many therapeutic approaches to cancer affect the tumour vasculature, either indirectly or as a direct target. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) has become an important means of investigating this action, both pre-clinically and in early stage clinical trials. For such trials, it is essential that the measurement process (i.e. image acquisition and analysis) can be performed effectively and with consistency among contributing centres. As the technique continues to develop in order to provide potential improvements in sensitivity and physiological relevance, there is considerable scope for between-centre variation in techniques. A workshop was convened by the Imaging Committee of the Experimental Cancer Medicine Centres (ECMC) to review the current status of DCE-MRI and to provide recommendations on how the technique can best be used for early stage trials. This review and the consequent recommendations are summarised here. (orig.)

  12. Columbia SMA Project: A Randomized, Control Trial of the Effects of Exercise on Motor Function and Strength in Patients With Spinal Muscular Atrophy (SMA)

    Science.gov (United States)

    2011-06-01

    Exercise, Ambulatory, Clinical Trial 21 Table of Contents...VO2max is substantially lower than predicted, and likely reflects the effects of deconditioning resulting from limited engagement in physical activity...randomized and controlled clinical trial of the effect of exercise on an established functional outcome measure will have immediate impact on

  13. Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Nelson, Nicole L; Churilla, James R

    2017-09-01

    Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

  14. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Dickerson, Faith B; Stallings, Cassie; Origoni, Andrea; Katsafanas, Emily; Savage, Christina L G; Schweinfurth, Lucy A B; Goga, Joshana; Khushalani, Sunil; Yolken, Robert H

    2014-01-01

    A range of immune system abnormalities have been associated with schizophrenia. Probiotic compounds modulate the immune response and offer a potential treatment strategy for schizophrenia. Probiotic compounds have also been observed to improve gastrointestinal dysfunction, which is a common problem in individuals with schizophrenia. We performed a randomized, double-blind, placebo-controlled trial to examine whether probiotic supplementation can reduce symptom severity in patients with schizophrenia receiving antipsychotic treatment and also whether probiotics are associated with bowel functioning. Outpatients with schizophrenia (N = 65) meeting DSM-IV criteria and with at least moderately severe psychotic symptoms were enrolled in the study from December 2010-August 2012. Following a 2-week placebo run-in period, patients were randomly assigned to 14 weeks of double-blind adjunctive probiotic (combined Lactobacillus rhamnosus strain GG and Bifidobacterium animalis subsp. lactis strain Bb12) or placebo therapy. Psychiatric symptoms were assessed biweekly with the Positive and Negative Syndrome Scale (PANSS), and patients were queried weekly about their gastrointestinal functioning. Repeated-measures analysis of variance showed no significant differences in the PANSS total score between probiotic and placebo supplementation (F = 1.28, P = .25). However, patients in the probiotic group were less likely to develop severe bowel difficulty over the course of the trial (hazard ratio = 0.23; 95% CI, 0.09-0.61, P = .003). Probiotic supplementation may help prevent a common somatic symptom associated with schizophrenia. ClinicalTrials.gov identifier: NCT01242371.

  15. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women

    Directory of Open Access Journals (Sweden)

    Reyes Laura M

    2009-11-01

    Full Text Available Abstract Background Preeclampsia (PE is a common maternal disease that complicates 5 to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality. Cost-effective interventions aimed at preventing the development of preeclampsia are urgently needed. However, the pathogenesis of PE is not well known. Multiple mechanisms such as oxidative stress, endothelial dysfunction and insulin resistance may contribute to its development. Regular aerobic exercise recovers endothelial function; improves insulin resistance and decreases oxidative stress. Therefore the purpose of this clinical trial is to determine the effect of regular aerobic exercise on endothelial function, on insulin resistance and on pregnancy outcome. Methods and design 64 pregnant women will be included in a blind, randomized clinical trial, and parallel assignment. The exercise group will do regular aerobic physical exercise: walking (10 minutes, aerobic exercise (30 minutes, stretching (10 minutes and relaxation exercise (10 minutes in three sessions per week. Control group will do the activities of daily living (bathing, dressing, eating, and walking without counselling from a physical therapist. Trial registration NCT00741312.

  16. Effects of Aerobic Exercise Applied Early After Coronary Artery Bypass Grafting on Pulmonary Function, Respiratory Muscle Strength, and Functional Capacity: A Randomized Controlled Trial.

    Science.gov (United States)

    Borges, Daniel L; Silva, Mayara Gabrielle; Silva, Luan Nascimento; Fortes, João Vyctor; Costa, Erika Thalita; Assunção, Rebeca Pessoa; Lima, Carlos Magno; da Silva Nina, Vinícius José; Bernardo-Filho, Mário; Caputo, Danúbia Sá

    2016-09-01

    Physical activity is beneficial in several clinical situations and recommended for patients with ischemic heart disease, as well as for those undergoing cardiac surgery. In a randomized controlled trial, 34 patients underwent coronary artery bypass grafting. A randomized control group (n = 15) submitted to conventional physiotherapy. The intervention group (n = 19) received the same protocol plus additional aerobic exercise with cycle ergometer. Pulmonary function by spirometry, respiratory muscle strength by manovacuometry, and functional capacity through 6-minute walking test was assessed before surgery and at hospital discharge. There was significant reduction in pulmonary function in both groups. In both groups, inspiratory muscle strength was maintained while expiratory muscle strength significantly decreased. Functional capacity was maintained in the intervention group (364.5 [324.5 to 428] vs. 348 [300.7 to 413.7] meters, P = .06), but it decreased significantly in control group patients (320 [288.5 to 393.0] vs. 292 [237.0 to 336.0] meters, P = .01). A significant difference in functional capacity was also found in intergroup analyses at hospital discharge (P = .03). Aerobic exercise applied early on coronary artery bypass grafting patients may promote maintenance of functional capacity, with no impact on pulmonary function and respiratory muscle strength when compared with conventional physiotherapy.

  17. Effect of treadmill gait training on static and functional balance in children with cerebral palsy: a randomized controlled trial.

    Science.gov (United States)

    Grecco, Luanda A C; Tomita, Sandra M; Christovão, Thaluanna C L; Pasini, Hugo; Sampaio, Luciana M M; Oliveira, Claudia S

    2013-01-01

    Treadmill gait training as a therapeutic resource in the rehabilitation of children with cerebral palsy has recently been the focus of many studies; however, little is still known regarding its effect on static and functional balance in children. The aim of the present study was to compare the effects of treadmill training and over ground gait training in children with cerebral palsy. A randomized controlled trial with blinded evaluator was conducted with children with cerebral palsy between three and 12 years of age categorized in Levels I to III of the Gross Motor Function Classification System. Assessments were performed before and after the intervention and involved the Berg balance scale as well as the determination of oscillations from the center of pressure in the anteroposterior and mediolateral directions with eyes open and closed. The experimental group was submitted to treadmill training and the control group performed gait training over the ground. The intervention consisted of two 30-minute sessions per week for seven weeks. Both groups exhibited better functional balance after the protocol. The experimental group had higher Berg balance scale scores and exhibited lesser mediolateral oscillation with eyes open in comparison to the control group. Treadmill training had a greater effect on functional balance and mediolateral oscillation in comparison to over ground gait training in children with cerebral palsy. RBR-5v3kg9.(Brazilian Registry of Clinical Trials).

  18. Dental Amalgam Restorations and Children’s Neuropsychological Function: The New England Children’s Amalgam Trial

    Science.gov (United States)

    Bellinger, David C.; Daniel, David; Trachtenberg, Felicia; Tavares, Mary; McKinlay, Sonja

    2007-01-01

    Background A concern persists that children’s exposure to mercury vapor from dental amalgams produces neurotoxicity. Objective Our goal was to compare the neuropsychological function of children, without prior exposure to dental amalgam, whose caries were repaired using either dental amalgam or mercury-free composite materials. Methods We conducted a randomized controlled trial involving 534 6- to 10-year-old urban and rural children who were assessed yearly for 5 years using a battery of tests of intelligence, achievement, language, memory, learning, visual–spatial skills, verbal fluency, fine motor function, problem solving, attention, and executive function. Results Although the mean urinary mercury concentration was greater among children in the amalgam group than the composite group (0.9 vs. 0.6 μg/g creatinine), few significant differences were found between the test scores of children in the two groups. The differences found were inconsistent in direction. Analyses using two cumulative exposure indices—surface years of amalgam and urinary mercury concentration—produced similar results. Conclusions Exposure to elemental mercury in amalgam at the levels experienced by the children who participated in the trial did not result in significant effects on neuropsychological function within the 5-year follow-up period. PMID:17431496

  19. Are the contents of treatment outcomes in fibromyalgia trials represented in the International Classification Of Functioning, Disability, and Health?

    Science.gov (United States)

    Offenbächer, Martin; Cieza, Alarcos; Brockow, Thomas; Amann, Edda; Kollerits, Barbara; Stucki, Gerold

    2007-10-01

    To identify the concepts contained in treatment outcomes of randomized controlled trials (RCTs) for interventions in patients with fibromyalgia (FM) using the International Classification of Functioning, Disability, and Health (ICF) as external reference. RCTs between 1992 and 2001 were located in MEDLINE and selected according to predefined eligibility criteria. The outcome measures were extracted and the concepts within the outcome measures were identified and linked to the ICF using a content-analytical approach. Forty-two trials on FM were included. Twenty-seven different questionnaires were extracted. Of all, 79.2% (N=236) of the clinical and physiologic outcomes could be linked to 31 different ICF categories and 84.7% (N=964) of the concepts contained in the health-status questionnaire to 113 ICF categories. The ICF provides a useful external reference to identify the concepts contained in outcome measures used in RCTs in FM.

  20. Assessing Cognitive Function in Bipolar Disorder: Challenges and Recommendations for Clinical Trial Design

    Science.gov (United States)

    Burdick, Katherine E.; Ketter, Terence A.; Goldberg, Joseph F.; Calabrese, Joseph R.

    2015-01-01

    OBJECTIVE Neurocognitive impairment in schizophrenia has been recognized for more than a century. In contrast, only recently have significant neurocognitive deficits been recognized in bipolar disorder. Converging data suggest the importance of cognitive problems in relation to quality of life in bipolar disorder, highlighting the need for treatment and prevention efforts targeting cognition in bipolar patients. Future treatment trials targeting cognitive deficits will be met with methodological challenges due to the inherent complexity and heterogeneity of the disorder, including significant diagnostic comorbidities, the episodic nature of the illness, frequent use of polypharmacy, cognitive heterogeneity, and a lack of consensus regarding measurement of cognition and outcome in bipolar patients. Guidelines for use in designing future trials are needed. PARTICIPANTS The members of the consensus panel (each of the bylined authors) were selected based upon their expertise in bipolar disorder. Dr. Burdick is a neuropsychologist who has studied cognition in this illness for 15 years; Drs. Ketter, Calabrese, and Goldberg each bring considerable expertise in the treatment of bipolar disorder both within and outside of controlled clinical trials. This consensus statement was derived from work together at scientific meetings (e.g. symposium presention at the 2014 Annual meeting of the American Society of Clinical Psychopharmacology, among others) and ongoing discussions by conference call. With the exception of the public presentations on this topic, these meetings were closed to outside participants. EVIDENCE A literature review was undertaken by the authors to identify illness-specific challenges relevant to the design and conduct of treatment trials targeting neurocognition in bipolar disorder. Expert opinion from each of the authors guided the consensus recommendations. CONSENSUS PROCESS Consensus recommendations, reached by unanimous opinion of the authors, are

  1. Immediate effect of a functional wrist orthosis for children with cerebral palsy or brain injury: A randomized controlled trial.

    Science.gov (United States)

    Jackman, Michelle; Novak, Iona; Lannin, Natasha; Galea, Claire

    2017-10-28

    Two-group randomized controlled trial. Upper limb orthoses worn during functional tasks are commonly used in pediatric neurologic rehabilitation, despite a paucity of high-level evidence. The purpose of this study was to investigate if a customized functional wrist orthosis, when placed on the limb, leads to an immediate improvement in hand function for children with cerebral palsy or brain injury. A 2-group randomized controlled trial involving 30 children was conducted. Participants were randomized to either receive a customized functional wrist orthosis (experimental, n = 15) or not receive an orthosis (control, n = 15). The box and blocks test was administered at baseline and repeated 1 hour after experimental intervention, with the orthosis on if randomized to the orthotic group. After intervention, there were no significant differences on the box and blocks test between the orthotic group (mean, 10.13; standard deviation, 11.476) and the no orthotic group (mean, 14.07; standard deviation, 11.106; t[28], -0.954; P = .348; and 95% confidence interval, -12.380 to 4.513). In contrast to the findings of previous studies, our results suggest that a functional wrist orthosis, when supporting the joint in a 'typical' position, may not lead to an immediate improvement in hand function. Wearing a functional wrist orthosis did not lead to an immediate improvement in the ability of children with cerebral palsy or brain injury to grasp and release. Further research is needed combining upper limb orthoses with task-specific training and measuring outcomes over the medium to long term. Copyright © 2017 Hanley & Belfus. All rights reserved.

  2. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial

    Directory of Open Access Journals (Sweden)

    Buggeskov Katrine B

    2013-01-01

    Full Text Available Abstract Background Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB creates a whole body systemic inflammatory response syndrome (SIRS that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate solution. Methods/Design The Pulmonary Protection Trial (PP-Trial randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI. The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations. Discussion Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial. Trial registration ClinicalTrials.gov: NCT01614951.

  3. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial.

    Science.gov (United States)

    Boissonnat, Pascale; Gaillard, Ségolène; Mercier, Catherine; Redonnet, Michel; Lelong, Bernard; Mattei, Marie-Françoise; Mouly-Bandini, Annick; Pattier, Sabine; Sirinelli, Agnès; Epailly, Eric; Varnous, Shaida; Billes, Marc-Alain; Sebbag, Laurent; Ecochard, René; Cornu, Catherine; Gueyffier, François

    2012-12-03

    Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 Cyclosporine A (200 transplant months along with mycophenolate mofetil and corticosteroids. Participants had a stable haemodynamic status, a serum creatinine level transplants were excluded. The change in serum creatinine level over 12 months was used as the main criterion for renal function. Intention-to-treat analysis was performed on the 95 randomised patients and a mixed generalised linear model of covariance was applied. At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. ClinicalTrials.gov NCT00159159.

  4. Combined arm stretch positioning and neuromuscular electrical stimulation during rehabilitation does not improve range of motion, shoulder pain or function in patients after stroke : a randomised trial

    NARCIS (Netherlands)

    de Jong, Lex D.; Dijkstra, Pieter U.; Gerritsen, Johan; Geurts, Alexander C. H.; Postema, Klaas

    2013-01-01

    Question: Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation (NMES) in the subacute phase after stroke have beneficial effects on basic arm body functions and activities? Design: Multicentre randomised trial with concealed allocation, assessor blinding,

  5. Long-term effects of amlodipine and lisinopril on left ventricular mass and diastolic function in elderly, previously untreated hypertensive patients : the ELVERA trial

    NARCIS (Netherlands)

    Terpstra, WF; May, JF; Smit, AJ; De Graeff, PA; Havinga, TK; van den Veur, E; Schuurman, FH; Meyboom-de Jong, B; Crijns, HJGM

    Objective To compare the effects of a calcium antagonist (amlodipine) and an angiotensin converting enzyme inhibitor (lisinopril) on left Ventricular mass and diastolic function in elderly, previously untreated hypertensives. Design A double-blind randomized parallel group trial. Effects of

  6. Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

    Science.gov (United States)

    Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

    2017-01-01

    Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

  7. The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST trial for stroke: study design and protocol

    Directory of Open Access Journals (Sweden)

    Dunning K

    2013-02-01

    Full Text Available Kari Dunning,1 Michael O'Dell,2 Patricia Kluding,3 Samuel S Wu,4 Jody Feld,5 Jivan Ginosian,6 Keith McBride61Department of Rehabilitation Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, 2Department of Rehabilitation Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, 3Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS, 4Department of Biostatistics, University of Florida, Gainesville, FL, 5Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC, 6Bioness Inc, Valencia, CA, USABackground: Surface electrical stimulation for foot drop (foot drop stimulation [FDS] technology has greatly improved over the last decade, leading to increased use in the clinic environment and the community. Despite numerous studies suggesting the benefit of FDS among persons with stroke, there are no randomized controlled trials comparing FDS to standard of care (ankle foot orthosis [AFO]. The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST study is a single-blinded randomized controlled trial with the primary purpose of comparing FDS and AFO among persons with stroke conducted at eleven sites throughout the USA.Methods: Persons ≥ 3 months poststroke are randomized to wear either FDS or AFO for 30 weeks. After 30 weeks, AFO participants crossover to wear an FDS. All participants are followed for 42 weeks with repeated measures at baseline and Weeks 6, 12, 30, 36, and 42. The primary analysis will compare gait speed between FDS and AFO at 30 weeks. Secondary outcomes span the International Classification of Functioning, Disability, and Health categories and include functional gait, balance, motor control, falls, and quality of life. Tertiary analyses will be performed using Weeks 36 and 42 time points.Conclusion: This pivotal trial is the first longitudinal

  8. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Arroyo-Morales, Manuel; Saavedra-Hernández, Manuel; Fernández-Sola, Cayetano; Moreno-Lorenzo, Carmen

    2011-09-01

    To determine the effect of myofascial release techniques on pain symptoms, postural stability and physical function in fibromyalgia syndrome. A randomized, placebo-controlled trial was undertaken. Eighty-six patients with fibromyalgia syndrome were randomly assigned to an experimental group and a placebo group. Patients received treatments for 20 weeks. The experimental group underwent 10 myofascial release modalities and the placebo group received sham short-wave and ultrasound electrotherapy. Outcome variables were number of tender points, pain, postural stability, physical function, clinical severity and global clinical assessment of improvement. Outcome measures were assessed before and immediately after, at six months and one year after the last session of the corresponding intervention. After 20 weeks of myofascial therapy, the experimental group showed a significant improvement (P  myofascial release techniques can be a complementary therapy for pain symptoms, physical function and clinical severity but do not improve postural stability in patients with fibromyalgia syndrome.

  9. Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: improvement in functioning and experiential negative symptoms.

    Science.gov (United States)

    Granholm, Eric; Holden, Jason; Link, Peter C; McQuaid, John R

    2014-12-01

    Identifying treatments to improve functioning and reduce negative symptoms in consumers with schizophrenia is of high public health significance. In this randomized clinical trial, participants with schizophrenia or schizoaffective disorder (N = 149) were randomly assigned to cognitive behavioral social skills training (CBSST) or an active goal-focused supportive contact (GFSC) control condition. CBSST combined cognitive behavior therapy with social skills training and problem-solving training to improve functioning and negative symptoms. GFSC was weekly supportive group therapy focused on setting and achieving functioning goals. Blind raters assessed functioning (primary outcome: Independent Living Skills Survey [ILSS]), CBSST skill knowledge, positive and negative symptoms, depression, and defeatist performance attitudes. In mixed-effects regression models in intent-to-treat analyses, CBSST skill knowledge, functioning, amotivation/asociality negative symptoms, and defeatist performance attitudes improved significantly more in CBSST relative to GFSC. In both treatment groups, comparable improvements were also found for positive symptoms and a performance-based measure of social competence. The results suggest CBSST is an effective treatment to improve functioning and experiential negative symptoms in consumers with schizophrenia, and both CBSST and supportive group therapy actively focused on setting and achieving functioning goals can improve social competence and reduce positive symptoms.

  10. Randomized Clinical Trial of Cognitive Behavioral Social Skills Training for Schizophrenia: Improvement in Functioning and Experiential Negative Symptoms

    Science.gov (United States)

    Granholm, Eric; Holden, Jason; Link, Peter C.; McQuaid, John R.

    2014-01-01

    Objective Identifying treatments to improve functioning and reduce negative symptoms in consumers with schizophrenia is of high public health significance. Method In this randomized clinical trial, participants with schizophrenia or schizoaffective disorder (N=149) were randomly assigned to cognitive behavioral social skills training (CBSST) or an active goal-focused supportive contact (GFSC) control condition. CBSST combined cognitive behavior therapy with social skills training and problem solving training to improve functioning and negative symptoms. GFSC was weekly supportive group therapy focused on setting and achieving functioning goals. Blind raters assessed functioning (primary outcome: Independent Living Skills Survey (ILSS)), CBSST skill knowledge, positive and negative symptoms, depression, and defeatist performance attitudes. Results In mixed-effects regression models in intent-to-treat analyses, CBSST skill knowledge, functioning, amotivation/asociality negative symptoms and defeatist performance attitudes improved significantly more in CBSST relative to GFSC. In both treatment groups, comparable improvements were also found for positive symptoms and a performance-based measure of social competence. Conclusions The results suggest CBSST is an effective treatment to improve functioning and experiential negative symptoms in consumers with schizophrenia, and both CBSST and supportive group therapy that is actively focused on setting and achieving functioning goals can improve social competence and reduce positive symptoms. PMID:24911420

  11. Executive Function, Survival, and Hospitalization in Chronic Obstructive Pulmonary Disease. A Longitudinal Analysis of the National Emphysema Treatment Trial (NETT).

    Science.gov (United States)

    Dodd, James W; Novotny, Paul; Sciurba, Frank C; Benzo, Roberto P

    2015-10-01

    Cognitive dysfunction has been demonstrated in chronic obstructive pulmonary disease (COPD), but studies are limited to cross-sectional analyses or incompletely characterized populations. We examined longitudinal changes in sensitive measures of executive function in a well-characterized population of patients with severe COPD. This study was performed on patients enrolled in the National Emphysema Treatment Trial. To assess executive function, we analyzed trail making (TM) A and B times at enrollment in the trial (2,128 patients), and at 12 (731 patients) and 24 months (593 patients) after enrollment, adjusted for surgery, marriage status, age, education, income, depression, PaO2, PaCO2, and smoking. Associations with survival and hospitalizations were examined using Cox regression and linear regression models. The average age of the patients was 66.4 years, and the average FEV1 was 23.9% predicted. At the time of enrolment, 38% had executive dysfunction. Compared with those who did not, these patients were older, less educated, had higher oxygen use, higher PaCO2, worse quality of life as measured by the St. George's Respiratory Quotient, reduced well-being, and lower social function. There was no significant change over 2 years in TM A or B times after adjustment for covariables. Changes in TM B times were modestly associated with survival, but changes in TM B-A times were not. Changes in TM scores were not associated with frequency of hospitalization. Lung function, PaO2, smoking, survival, and hospitalizations were not significantly different in those with executive dysfunction. In this large population of patients with severe emphysema and heavy cigarette smoking exposure, there was no significant decline over 2 years in cognitive executive function as measured by TM tests. There was no association between executive function impairment and frequency of hospitalization, and there was a possible modest association with survival. It is plausible that

  12. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gudavalli R Maruti

    2011-06-01

    associated with changes in self-report outcome assessments. Discussion This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT00830596, registered on January 27, 2009. The first participant was allocated on 30 January 2009 and the final participant was allocated on 17 March 2011.

  13. Characterization of Black Raspberry Functional Food Products for Cancer Prevention Human Clinical Trials

    Science.gov (United States)

    Gu, Junnan; Ahn-Jarvis, Jennifer H.; Riedl, Kenneth M.; Schwartz, Steven J.; Clinton, Steven K.; Vodovotz, Yael

    2014-01-01

    Our team is designing and fully characterizing black raspberry (BRB) food products suitable for long-term cancer prevention studies. The processing, scale-up, and storage effects on the consistency, quality, bioactive stability, and sensory acceptability of two BRB delivery systems of various matrices are presented. BRB dosage, pH, water activity, and texture were consistent in the scale-up production. Confections retained >90% of anthocyanins and ellagitannin after processing. Nectars had >69% of anthocyanins and >66% of ellagitannin retention, which varied with BRB dosage due to the processing difference. Texture remained unchanged during storage. BRB products consumed in a prostate cancer clinical trial were well accepted in sensory tests. Thus, this study demonstrates that two different BRB foods can be formulated to meet quality standards with a consistent bioactive pattern and successfully scaled up for a large human clinical trial focusing on cancer risk and other health outcomes. PMID:24345009

  14. Exercise therapy for functional capacity in chronic diseases: an overview of meta-analyses of randomised controlled trials.

    Science.gov (United States)

    Pasanen, Tero; Tolvanen, Samppa; Heinonen, Ari; Kujala, Urho M

    2017-10-01

    To summarise all meta-analyses of randomised controlled trials that have evaluated the effects of exercise therapy on functional capacity in patients with chronic diseases. Umbrella review of meta-analyses of randomised controlled trials. We systematically searched the CENTRAL, CINAHL, DARE, Medline, OTSeeker, PEDro, SPORTDiscus, ProQuest Nursing & Allied Health Database, Web of Science, Scopus, OpenGrey and BMC Proceedings from database inception to 1 September 2016. We included meta-analyses that compared the effects of exercise therapy with no treatment or usual care in adults with non-communicable chronic diseases and included outcomes related to functional capacity. We excluded meta-analyses with less than 100 patients. Eighty-five meta-analyses with 22 different chronic diseases were included. The exercise interventions resulted in statistically significant (pmeta-analyses. Exercise therapy appears to be a safe way to improve functional capacity and reduce disability in individuals with chronic disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. J-pouch versus Roux-en-Y reconstruction after gastrectomy: functional assessment and quality of life (randomized trial).

    Science.gov (United States)

    Zonča, Pavel; Malý, Tomáš; Ihnát, Peter; Peteja, Matus; Kraft, Otakar; Kuca, Kamil

    2017-01-01

    The aim of this study was to evaluate the quality of life and functional emptying of J-pouch versus Roux-en-Y reconstruction after total gastrectomy for malignancy. This study was designed as a prospective, nonblinded, randomized, parallel clinical trial (Trial Number: MN Ostrava, 200604). With informed consent, patients undergoing gastrectomy for malignancy were randomized to J-pouch or Roux-en-Y reconstruction. The time taken for a test semisolid meal labeled with 99mTc-sulfur colloid to exit the reconstructed parts was measured by dynamic scintigraphy 1 year after resection. Quality of life was measured using the Eypasch questionnaire at the same time as functional emptying assessment. This trial was investigator-initiated. In all, 72 patients were included into the study. The time taken for the test meal to exit the postgastrectomy reconstruction was 16.5±10.0 minutes (mean ± standard deviation) in the Roux-en-Y group and 89.4±37.8 minutes in the "J-pouch" group; the difference was statistically significant (PJ-pouch appeared to be a linear decreasing function compared to the exponential pattern seen in the Roux-en-Y group. The quality of life measurement showed scores of 106±18.8 points (mean ± standard deviation) in the Roux-en-Y group compared to 122±22.5 points in the J-pouch group; the difference was statistically significant (P=0.0016). There were no important adverse events. After total gastrectomy, a J-pouch reconstruction empties more slowly and is associated with higher quality of life compared to Roux-en-Y reconstruction. Whether these two observations have a direct causative link remains unanswered.

  16. Intensive Psychosocial Intervention Enhances Functioning in Patients With Bipolar Depression: Results From a 9-Month Randomized Controlled Trial

    Science.gov (United States)

    Miklowitz, David J.; Otto, Michael W.; Frank, Ellen; Reilly-Harrington, Noreen A.; Kogan, Jane N.; Sachs, Gary S.; Thase, Michael E.; Calabrese, Joseph R.; Marangell, Lauren B.; Ostacher, Michael J.; Patel, Jayendra; Thomas, Marshall R.; Araga, Mako; Gonzalez, Jodi M.; Wisniewski, Stephen R.

    2013-01-01

    Objective Psychosocial interventions are effective adjuncts to pharmacotherapy in delaying recurrences of bipolar disorder; however, to date their effects on life functioning have been given little attention. In a randomized trial, the authors examined the impact of intensive psychosocial treatment plus pharmacotherapy on the functional outcomes of patients with bipolar disorder over the 9 months following a depressive episode. Method Participants were 152 depressed outpatients with bipolar I or bipolar II disorder in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. All patients received pharmacotherapy. Eighty-four patients were randomly assigned to intensive psychosocial intervention (30 sessions over 9 months of interpersonal and social rhythm therapy, cognitive behavior therapy [CBT], or family-focused therapy), and 68 patients were randomly assigned to collaborative care (a 3-session psychoeducational treatment). Independent evaluators rated the four subscales of the Longitudinal Interval Follow-Up Evaluation–Range of Impaired Functioning Tool (LIFE-RIFT) (relationships, satisfaction with activities, work/role functioning, and recreational activities) through structured interviews given at baseline and every 3 months over a 9-month period. Results Patients in intensive psychotherapy had better total functioning, relationship functioning, and life satisfaction scores over 9 months than patients in collaborative care, even after pretreatment functioning and concurrent depression scores were covaried. No effects of psychosocial intervention were observed on work/role functioning or recreation scores during this 9-month period. Conclusions Intensive psychosocial treatment enhances relationship functioning and life satisfaction among patients with bipolar disorder. Alternate interventions focused on the specific cognitive deficits of individuals with bipolar disorder may be necessary to enhance vocational functioning

  17. Unilateral versus bilateral robot-assisted rehabilitation on arm-trunk control and functions post stroke: a randomized controlled trial.

    Science.gov (United States)

    Wu, Ching-Yi; Yang, Chieh-Ling; Chen, Ming-de; Lin, Keh-Chung; Wu, Li-Ling

    2013-04-12

    Although the effects of robot-assisted arm training after stroke are promising, the relative effects of unilateral (URT) vs. bilateral (BRT) robot-assisted arm training remain uncertain. This study compared the effects of URT vs. BRT on upper extremity (UE) control, trunk compensation, and function in patients with chronic stroke. This was a single-blinded, randomized controlled trial. The intervention was implemented at 4 hospitals. Fifty-three patients with stroke were randomly assigned to URT, BRT, or control treatment (CT). Each group received UE training for 90 to 105 min/day, 5 days/week, for 4 weeks. The kinematic variables for arm motor control and trunk compensation included normalized movement time, normalized movement units, and the arm-trunk contribution slope in unilateral and bilateral tasks. Motor function and daily function were measured by the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and ABILHAND Questionnaire. The BRT and CT groups elicited significantly larger slope values (i.e., less trunk compensation) at the start of bilateral reaching than the URT group. URT led to significantly better effects on WMFT-Time than BRT. Differences in arm control kinematics and performance on the MAL and ABILHAND among the 3 groups were not significant. BRT and URT resulted in differential improvements in specific UE/trunk performance in patients with stroke. BRT elicited larger benefits than URT on reducing compensatory trunk movements at the beginning of reaching. In contrast, URT produced better improvements in UE temporal efficiency. These relative effects on movement kinematics, however, did not translate into differential benefits in daily functions. ClinicalTrials.gov: NCT00917605.

  18. Biomarkers of splenic function in infants with sickle cell anemia: baseline data from the BABY HUG Trial

    Science.gov (United States)

    Wang, Winfred C.; Luo, Zhaoyu; Iyer, Rathi V.; Shalaby-Rana, Eglal; Dertinger, Stephen D.; Shulkin, Barry L.; Miller, John H.; Files, Bea; Lane, Peter A.; Thompson, Bruce W.; Miller, Scott T.; Ware, Russell E.

    2011-01-01

    We evaluated spleen function in 193 children with sickle cell anemia 8 to 18 months of age by 99mTc sulfur-colloid liver-spleen scan and correlated results with clinical and laboratory parameters, including 2 splenic biomarkers: pitted cell counts (PIT) and quantitative Howell-Jolly bodies (HJB) enumerated by flow cytometry. Loss of splenic function began before 12 months of age in 86% of infants in association with lower total or fetal hemoglobin and higher white blood cell or reticulocyte counts, reinforcing the need for early diagnosis and diligent preventive care. PIT and HJB correlated well with each other and liver-spleen scan results. Previously described biomarker threshold values did define patients with abnormal splenic function, but our data suggest that normal spleen function is better predicted by PIT of ≤ 1.2% or HJB ≤ 55/106 red blood cells and absent function by PIT ≥ 4.5% or HJB ≥ 665/106. HJB is methodologically advantageous compared with PIT, but both are valid biomarkers of splenic function. This trial was registered at www.clinicaltrials.gov as #NCT00006400. PMID:21217080

  19. The effect of using an abdominal binder on postoperative gastrointestinal function, mobilization, pulmonary function, and pain in patients undergoing major abdominal surgery: A randomized controlled trial.

    Science.gov (United States)

    Arici, Emine; Tastan, Sevinc; Can, Mehmet Fatih

    2016-10-01

    Evidence on the effectiveness of using a binder following abdominal surgery and its effect on gastrointestinal function, mobilization, pulmonary function, and pain is currently unclear. The purpose of this study is to determine the effect of abdominal binder usage on gastrointestinal function, mobilization, pulmonary function, and postoperative pain in patients undergoing major abdominal surgery. This research was conducted as a randomized controlled trial. The study was conducted at the Department of General Surgery at a military education and research hospital in Ankara, Turkey, between September 2013 and April 2014. 104 patients were assessed for eligibility. The study was conducted on 84 eligible patients. The study sample consisted of 84 patients who underwent effective major abdominal surgery. The patients were randomized into two groups, the intervention group, which used an abdominal binder and the control group, which did not. Gastrointestinal function, mobilization, pulmonary function, and the pain status of both groups were evaluated on the first, fourth, and seventh days before and after surgery, and the intergroup results were compared. No significant difference was found between the two groups in terms of gastrointestinal and pulmonary function on the first, fourth, and seventh days following surgery (p>0.05). A comparative assessment of mobility by walking distance showed that patients in the intervention group were able to walk further on the fourth [mean (SD); 221.19 (69.08) m] and seventh [227.85 (60.02) m] days after surgery (p=0.003, pbinder does not have any effect on postoperative gastrointestinal and pulmonary function. However, an abdominal binder increases patient mobility soon after surgery. There was also a measurable effect on pain, with lower scores reported by patients who used an abdominal binder after any exercise or activity. These results indicate that the use of a routine abdominal binder is helpful for patients undergoing major

  20. Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Talley, N J; Tack, J; Ptak, T; Gupta, R; Giguère, M

    2008-06-01

    Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD. Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18-65 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for Helicobacter pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life. The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591). In this population with FD, itopride did not show a difference in symptom response from placebo.

  1. Effectiveness of an exercise programme on physical function in patients discharged from hospital following critical illness: a randomised controlled trial (the REVIVE trial).

    Science.gov (United States)

    McDowell, Kathryn; O'Neill, Brenda; Blackwood, Bronagh; Clarke, Chris; Gardner, Evie; Johnston, Paul; Kelly, Michaeline; McCaffrey, John; Mullan, Brian; Murphy, Sally; Trinder, T John; Lavery, Gavin; McAuley, Daniel F; Bradley, Judy M

    2017-07-01

    To investigate the effectiveness of a 6-week exercise programme in patients discharged home following critical illness compared with standard care. Multicentre prospective phase II randomised controlled trial, with blinded outcome assessment after hospital discharge, following the 6-week intervention and at 6 months. 60 patients (30 per group) aged ≥18 years, mechanically ventilated >96 hours, and not in other rehabilitation, that is, cardiac or pulmonary rehabilitation programmes. Participants in the intervention group completed an individually tailored (personalised) exercise programme. Primary outcome measure was SF-36 physical functioning following the intervention. Secondary outcomes included a range of performance-based and patient-reported measures. Improvements in the primary outcome did not differ significantly between groups (mean difference (95% CI) 3.0 (-2.2 to 8.2), p=0.26). The intervention group showed significant improvement compared with the control group (mean difference (95% CI)) in SF-36 role physical (6.6 (0.73 to 12.5), p=0.03); incremental shuttle walk test (83.1 m (8.3 to 157.9), p=0.03); functional limitations profile (-4.8 (-8.7 to -0.9), p=0.02); self-efficacy to exercise (2.2 (0.8 to 3.7), p=0.01) and readiness to exercise (1.3 (0.8 to 1.9), pexercise. Improvements in all other secondary outcome measures were not significant. There was no statistically significant difference in the primary outcome measure of self-reported physical function following this 6-week exercise programme. Secondary outcome results will help inform future studies. NCT01463579. (results), https://clinicaltrials.gov/. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. Magnetic resonance lung function – a breakthrough for lung imaging and functional assessment? A phantom study and clinical trial

    Directory of Open Access Journals (Sweden)

    Rauh Manfred

    2006-08-01

    Full Text Available Abstract Background Chronic lung diseases are a major issue in public health. A serial pulmonary assessment using imaging techniques free of ionizing radiation and which provides early information on local function impairment would therefore be a considerably important development. Magnetic resonance imaging (MRI is a powerful tool for the static and dynamic imaging of many organs. Its application in lung imaging however, has been limited due to the low water content of the lung and the artefacts evident at air-tissue interfaces. Many attempts have been made to visualize local ventilation using the inhalation of hyperpolarized gases or gadolinium aerosol responding to MRI. None of these methods are applicable for broad clinical use as they require specific equipment. Methods We have shown previously that low-field MRI can be used for static imaging of the lung. Here we show that mathematical processing of data derived from serial MRI scans during the respiratory cycle produces good quality images of local ventilation without any contrast agent. A phantom study and investigations in 85 patients were performed. Results The phantom study proved our theoretical considerations. In 99 patient investigations good correlation (r = 0.8; p ≤ 0.001 was seen for pulmonary function tests and MR ventilation measurements. Small ventilation defects were visualized. Conclusion With this method, ventilation defects can be diagnosed long before any imaging or pulmonary function test will indicate disease. This surprisingly simple approach could easily be incorporated in clinical routine and may be a breakthrough for lung imaging and functional assessment.

  3. Identifying the concepts contained in outcome measures of clinical trials on depressive disorders using the International Classification of Functioning, Disability and Health as a reference.

    Science.gov (United States)

    Brockow, Thomas; Wohlfahrt, Kathrin; Hillert, Andreas; Geyh, Szilvia; Weigl, Martin; Franke, Thomas; Resch, Karl Ludwig; Cieza, Alarcos

    2004-07-01

    First, to systematically identify the concepts contained in outcome measures of trials on depressive disorders using the International Classification of Functioning, Disability and Health (ICF) as a reference. Secondly, to explore differences in the use of ICF categories across different intervention types. Thirdly, to examine which and how often health status measures have been applied in trials on depressive disorders. Randomized controlled trials between 1991 and 2000 were located in MEDLINE and selected according to predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. A random sample of 203 (50%) of 406 eligible studies were included. The 5 most used ICF categories (range 88-94%) were sleep functions (b134), emotional functions (b152), energy and drive functions (b130), thought functions (b160) and higher-level cognitive functions (b164), all belonging to the body functions component. The use of ICF categories did not vary across different intervention types. A total of 126 different health status measures were extracted. The Hamilton Rating Scale for Depression was the most used health status measure applied in 80% of the studies. Concepts about execution of tasks/actions, participation in life situations, and the influence of the environment were under-represented in the outcome assessment of trials on depressive disorders. These observations indicate that most trials were limited in their ability to assess more global individual outcomes.

  4. Bobath Concept versus constraint-induced movement therapy to improve arm functional recovery in stroke patients: a randomized controlled trial.

    Science.gov (United States)

    Huseyinsinoglu, Burcu Ersoz; Ozdincler, Arzu Razak; Krespi, Yakup

    2012-08-01

    To compare the effects of the Bobath Concept and constraint-induced movement therapy on arm functional recovery among stroke patients with a high level of function on the affected side. A single-blinded, randomized controlled trial. Outpatient physiotherapy department of a stroke unit. A total of 24 patients were randomized to constraint-induced movement therapy or Bobath Concept group. The Bobath Concept group was treated for 1 hour whereas the constraint-induced movement therapy group received training for 3 hours per day during 10 consecutive weekdays. Main measures were the Motor Activity Log-28, the Wolf Motor Function Test, the Motor Evaluation Scale for Arm in Stroke Patients and the Functional Independence Measure. The two groups were found to be homogeneous based on demographic variables and baseline measurements. Significant improvements were seen after treatment only in the 'Amount of use' and 'Quality of movement' subscales of the Motor Activity Log-28 in the constraint-induced movement therapy group over the the Bobath Concept group (P = 0.003; P = 0.01 respectively). There were no significant differences in Wolf Motor Function Test 'Functional ability' (P = 0.137) and 'Performance time' (P = 0.922), Motor Evaluation Scale for Arm in Stroke Patients (P = 0.947) and Functional Independence Measure scores (P = 0.259) between the two intervention groups. Constraint-induced movement therapy and the Bobath Concept have similar efficiencies in improving functional ability, speed and quality of movement in the paretic arm among stroke patients with a high level of function. Constraint-induced movement therapy seems to be slightly more efficient than the Bobath Concept in improving the amount and quality of affected arm use.

  5. Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial

    Directory of Open Access Journals (Sweden)

    Bruna Wageck

    2016-07-01

    Full Text Available Question: Does Kinesio Taping reduce pain and swelling, and increase muscle strength, function and knee-related health status in older people with knee osteoarthritis? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded assessment. Participants: Seventy-six older people with knee osteoarthritis. Intervention: The experimental group received three simultaneous Kinesio Taping techniques to treat pain, strength and swelling. The control group received sham taping. All participants kept the taping on for 4 days. Outcome measures: The outcomes were: concentric muscle strength of knee extensors and flexors, measured by isokinetic dynamometry with an angular velocity of 60 deg/second normalised for body mass [(Nm/kg x 100 (%]; pressure pain threshold via digital pressure algometry (kgf/cm2; lower-limb swelling via volumetry (l and perimetry (cm; physical function via the Lysholm Knee Scoring Scale (0 = worst to 100 = best; and knee-related health status via the Western Ontario and McMaster (WOMAC osteoarthritis index (0 = best to 96 = worst. Outcomes were measured at Day 4 (end of the taping period and Day 19 (follow-up after the start of the treatment. Results: At Day 4, there were no significant between-group differences for knee extensor muscle strength (MD –1%, 95% CI –7 to 5, knee flexor muscle strength (MD 2%, 95% CI –3 to 7, the pressure pain threshold at any measured point, volumetry (MD 0.05 L, 95% CI –0.01 to 0.11, perimetry at any measured point, Lysholm score (MD –4 points, 95% CI –9 to 2, or WOMAC score (MD –2 points, 95% CI –8 to 4. The lack of significant between-group difference was also seen at the follow-up assessment on Day 19. Conclusion: The Kinesio Taping techniques investigated in this study provided no beneficial effects for older people with knee osteoarthritis on any of the assessed outcomes. Trial registration: Brazilian Registry of Clinical Trials, RBR

  6. Effects of Oral Lycopene Supplementation on Vascular Function in Patients with Cardiovascular Disease and Healthy Volunteers: A Randomised Controlled Trial

    Science.gov (United States)

    Gajendragadkar, Parag R.; Hubsch, Annette; Mäki-Petäjä, Kaisa M.; Serg, Martin; Wilkinson, Ian B.; Cheriyan, Joseph

    2014-01-01

    Aims The mechanisms by which a ‘Mediterranean diet’ reduces cardiovascular disease (CVD) burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV). Methods and Results We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV), sodium nitroprusside (endothelium-independent vasodilatation; EIDV), and NG-monomethyl-L-arginine (basal nitric oxide (NO) synthase activity) were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo) without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: −45% to −10%, P = 0.008), despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: −1.6 to −0.9 mmol/L, Plycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: −30% to +30%, P = 0.85), also suggesting lycopene improved endothelial function. Conclusions Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. Trial Registration ClinicalTrials.gov NCT01100385 PMID:24911964

  7. Effects of oral lycopene supplementation on vascular function in patients with cardiovascular disease and healthy volunteers: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Parag R Gajendragadkar

    Full Text Available AIMS: The mechanisms by which a 'Mediterranean diet' reduces cardiovascular disease (CVD burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV. METHODS AND RESULTS: We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV, sodium nitroprusside (endothelium-independent vasodilatation; EIDV, and NG-monomethyl-L-arginine (basal nitric oxide (NO synthase activity were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: -45% to -10%, P = 0.008, despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: -1.6 to -0.9 mmol/L, P<0.001. Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: -30% to +30%, P = 0.85, also suggesting lycopene improved endothelial function. CONCLUSIONS: Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01100385.

  8. The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

    Science.gov (United States)

    van Engelenburg-van Lonkhuyzen, Marieke L; Bols, Esther M J; Benninga, Marc A; Verwijs, Wim A; Bluijssen, Netty M W L; de Bie, Rob A

    2013-08-02

    Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. This section discusses the relevance of publishing the study design and the development of

  9. Current transcatheter devices to treat functional tricuspid regurgitation with discussion of issues relevant to clinical trial design.

    Science.gov (United States)

    Hahn, Rebecca T

    2017-05-01

    Functional or secondary tricuspid regurgitation (TR) has seen increased attention in recent times as relationships with clinically-relevant outcomes have come to light. Despite the association of increased mortality with significant TR, the disease remains under-recognized and thus relatively untreated. In addition, the disease itself has not been extensively studied and the interactions between annular dilatation, right heart disease and pulmonary hypertension are poorly understood. However, the high mortality and recurrence rate with current surgical replacement or repair techniques is well recognised, opening the door to transcatheter therapies for functional TR. The current perspective reviews the rationale for transcatheter solutions, describes some of the current approaches and discusses the ongoing questions of a poorly-studied condition which may limit the design of clinical trials for this disease.

  10. A pilot study examining functional brain activity 6 months after memory retraining in MS: the MEMREHAB trial.

    Science.gov (United States)

    Dobryakova, Ekaterina; Wylie, Glenn R; DeLuca, John; Chiaravalloti, Nancy D

    2014-09-01

    Cognitive impairment in individuals with multiple sclerosis (MS) is now well recognized. One of the most common cognitive deficits is found in memory functioning, largely due to impaired acquisition. We examined functional brain activity 6 months after memory retraining in individuals with MS. The current report presents long term follow-up results from a randomized clinical trial on a memory rehabilitation protocol known as the modified Story Memory Technique. Behavioral memory performance and brain activity of all participants were evaluated at baseline, immediately after treatment, and 6 months after treatment. Results revealed that previously observed increases in patterns of cerebral activation during learning immediately after memory training were maintained 6 months post training.

  11. Functional multidisciplinary rehabilitation versus outpatient physiotherapy for non specific low back pain: randomized controlled trial.

    OpenAIRE

    Henchoz, Y.; de Goumoëns, P.; So, A.K.; Paillex, R.

    2010-01-01

    INTRODUCTION: In recent decades the treatment of non-specific low back pain has turned to active modalities, some of which were based on cognitive-behavioural principles. Non-randomised studies clearly favour functional multidisciplinary rehabilitation over outpatient physiotherapy. However, systematic reviews and meta-analysis provide contradictory evidence regarding the effects on return to work and functional status. The aim of the present randomised study was to compare long-term function...

  12. The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial

    Science.gov (United States)

    Boele, Florien W.; Douw, Linda; de Groot, Marjolein; van Thuijl, Hinke F.; Cleijne, Wilmy; Heimans, Jan J.; Taphoorn, Martin J.B.; Reijneveld, Jaap C.; Klein, Martin

    2013-01-01

    Background Fatigue, cognitive deficits, and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue, depression, health-related quality of life (HRQOL), and cognitive functioning in PBT patients, we performed a multicenter, double-blind placebo-controlled crossover trial. Methods Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period, the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]), depression (Center for Epidemiologic Studies Depression Scale [CES-D]), HRQOL (Short-Form Health Survey [SF-36]), and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing. Results In total, 37 patients participated. Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021, respectively) and the placebo condition (P Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow, and relatively many patients dropped out during the trial, due mostly to side effects. Other, preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients. PMID:23925452

  13. CNGB3-Achromatopsia Clinical Trial With CNTF: Diminished Rod Pathway Responses With No Evidence of Improvement in Cone Function

    Science.gov (United States)

    Zein, Wadih M.; Jeffrey, Brett G.; Wiley, Henry E.; Turriff, Amy E.; Tumminia, Santa J.; Tao, Weng; Bush, Ronald A.; Marangoni, Dario; Wen, Rong; Wei, Lisa L.; Sieving, Paul A.

    2014-01-01

    Purpose. Ciliary neurotrophic factor (CNTF) protects rod photoreceptors from retinal degenerative disease in multiple nonhuman models. Thus far, CNTF has failed to demonstrate rod protection in trials for human retinitis pigmentosa. Recently, CNTF was found to improve cone photoreceptor function in a canine CNGB3 achromatopsia model. This study explores whether this finding translates to humans with CNGB3 achromatopsia. Methods. A five-subject, open-label Phase I/II study was initiated by implanting intraocular microcapsules releasing CNTF (nominally 20 ng/d) into one eye each of CNGB3 achromat participants. Fellow eyes served as untreated controls. Subjects were followed for 1 year. Results. Pupil constriction in treated eyes gave evidence of intraocular CNTF release. Additionally, scotopic ERG responses were reduced, and dark-adapted psychophysical absolute thresholds were increased, attributable to diminished rod or rod pathway activity. Optical coherence tomography revealed that the cone-rich fovea underwent structural changes as the foveal hyporeflective zone (HRZ) became diminished in CNTF-treated eyes. No objectively measurable enhancement of cone function was found by assessments of visual acuity, mesopic increment sensitivity threshold, or the photopic ERG. Careful measurements of color hue discrimination showed no change. Nonetheless, subjects reported beneficial changes of visual function in the treated eyes, including reduced light sensitivity and aversion to bright light, which may trace to decreased effective ambient light from the pupillary constriction; further they noted slowed adaptation to darkness, consistent with CNTF action on rod photoreceptors. Conclusions. Ciliary neurotrophic factor did not measurably enhance cone function, which reveals a species difference between human and canine CNGB3 cones in response to CNTF. (ClinicalTrials.gov number, NCT01648452.) PMID:25205868

  14. Brazil nuts intake improves lipid profile, oxidative stress and microvascular function in obese adolescents: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koury Josely C

    2011-05-01

    Full Text Available Abstract Background Obesity is a chronic disease associated to an inflammatory process resulting in oxidative stress that leads to morpho-functional microvascular damage that could be improved by some dietary interventions. In this study, the intake of Brazil nuts (Bertholletia excelsa, composed of bioactive substances like selenium, α- e γ- tocopherol, folate and polyunsaturated fatty acids, have been investigated on antioxidant capacity, lipid and metabolic profiles and nutritive skin microcirculation in obese adolescents. Methods Obese female adolescents (n = 17, 15.4 ± 2.0 years and BMI of 35.6 ± 3.3 kg/m2, were randomized 1:1 in two groups with the diet supplemented either with Brazil nuts [BNG, n = 08, 15-25 g/day (equivalent to 3 to 5 units/day] or placebo [PG (lactose, n = 09, one capsule/day] and followed for 16 weeks. Anthropometry, metabolic-lipid profiles, oxidative stress and morphological (capillary diameters and functional [functional capillary density, red blood cell velocity (RBCV at baseline and peak (RBCVmax and time (TRBCVmax to reach it during post-occlusive reactive hyperemia, after 1 min arterial occlusion] microvascular variables were assessed by nailfold videocapillaroscopy at baseline (T0 and after intervention (T1. Results T0 characteristics were similar between groups. At T1, BNG (intra-group variation had increased selenium levels (p = 0.02, RBCV (p = 0.03 and RBCVmax (p = 0.03 and reduced total (TC (p = 0.02 and LDL-cholesterol (p = 0.02. Compared to PG, Brazil nuts intake reduced TC (p = 0.003, triglycerides (p = 0.05 and LDL-ox (p = 0.02 and increased RBCV (p = 0.03. Conclusion Brazil nuts intake improved the lipid profile and microvascular function in obese adolescents, possibly due to its high level of unsaturated fatty acids and bioactive substances. Trial Registration Clinical Trials.gov NCT00937599

  15. Effect of Monthly, High-Dose, Long-Term Vitamin D on Lung Function: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John D. Sluyter

    2017-12-01

    Full Text Available Although observational studies suggest positive vitamin D-lung function associations, randomized trials are inconsistent. We examined effects of vitamin D supplementation on lung function. We recruited 442 adults (50–84 years, 58% male into a randomized, double-blinded, placebo-controlled trial. Participants received, for 1.1 years (median; range = 0.9–1.5 years, either (1 vitamin D3 200,000 IU, followed by monthly 100,000 IU doses (n = 226; or (2 placebo monthly (n = 216. At baseline and follow-up, spirometry yielded forced expiratory volume in 1 s (FEV1; primary outcome. Mean (standard deviation 25-hydroxyvitamin D increased from 61 (24 nmol/L at baseline to 119 (45 nmol/L at follow-up in the vitamin D group, but was unchanged in the placebo group. There were no significant lung function improvements (vitamin D versus placebo in the total sample, vitamin D-deficient participants or asthma/chronic obstructive pulmonary disease (COPD participants. However, among ever-smokers (n = 217, the mean (95% confidence interval FEV1 increase in the vitamin D versus placebo was 57 (4, 109 mL (p = 0.03. FEV1 increases were larger among vitamin D-deficient ever-smokers (n = 54: 122 (8, 236 mL (p = 0.04. FEV1 improvements were largest among ever-smokers with asthma/COPD (n = 60: 160 (53, 268 mL (p = 0.004. Thus, vitamin D supplementation did not improve lung function among everyone, but benefited ever-smokers, especially those with vitamin D deficiency or asthma/COPD.

  16. The effect of physical activity on cognitive function in patients with dementia: A meta-analysis of randomized control trials.

    Science.gov (United States)

    Groot, C; Hooghiemstra, A M; Raijmakers, P G H M; van Berckel, B N M; Scheltens, P; Scherder, E J A; van der Flier, W M; Ossenkoppele, R

    2016-01-01

    Non-pharmacological therapies, such as physical activity interventions, are an appealing alternative or add-on to current pharmacological treatment of cognitive symptoms in patients with dementia. In this meta-analysis, we investigated the effect of physical activity interventions on cognitive function in dementia patients, by synthesizing data from 802 patients included in 18 randomized control trials that applied a physical activity intervention with cognitive function as an outcome measure. Post-intervention standardized mean difference (SMD) scores were computed for each study, and combined into pooled effect sizes using random effects meta-analysis. The primary analysis yielded a positive overall effect of physical activity interventions on cognitive function (SMD[95% confidence interval]=0.42[0.23;0.62], pactivity interventions were equally beneficial in patients with Alzheimer's disease (AD, SMD=0.38[0.09;0.66], pcognition, while this association was absent for non-aerobic exercise interventions (SMD=-0.10[-0.38;0.19], p=.51). Finally, we found that interventions offered at both high frequency (SMD=0.33[0.03;0.63], pcognitive function. This meta-analysis suggests that physical activity interventions positively influence cognitive function in patients with dementia. This beneficial effect was independent of the clinical diagnosis and the frequency of the intervention, and was driven by interventions that included aerobic exercise. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. Effectiveness of functional training on cardiorespiratory parameters: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Rezende Barbosa, Marianne Penachini da Costa de; Oliveira, Vinicius Cunha; Silva, Anne Kastelianne França da; Pérez-Riera, Andrés Ricardo; Vanderlei, Luiz Carlos

    2017-07-28

    Functional training is a new training vision that was prepared from the gesture imitation of daily activities. Although your use has become popular in clinical practice, the influence of the several cardiorespiratory adjustments performed during the functional training in different populations and conditions is unknown. So, the aim of this systematic review was to gather information in the literature regarding the influence of functional training on cardiorespiratory parameters. We conducted search strategies on MEDLINE, PEDro, EMBASE, SportDiscus and Cochrane to identify randomized controlled trials investigating the effects of functional training on cardiorespiratory parameters. Methodological quality of the included studies was assessed using the PEDro scale. Grading of Recommendations Assessment, Development and Evaluation (GRADE) summarized the evidence. Five original studies were included. Effects favoured functional training on oxygen consumption (VO2 ) at intermediate-term follow-up: weighted mean difference -1·0 (95% CI: 5·4-3·3), P = 0·642, and a small and not clinically important effect observed on VO2 favouring control at intermediate-term follow-up (i.e. mean difference of 1·30 (95% CI 1·07-1·53), Pfunctional training is better than other interventions to improve cardiovascular parameters. This result encourages new searches about the theme. © 2017 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

  18. Kinesio taping effect on quadriceps strength and lower limb function of healthy individuals: A blinded, controlled, randomized, clinical trial.

    Science.gov (United States)

    Fernandes de Jesus, Julio; de Almeida Novello, Aline; Bezerra Nakaoka, Gustavo; Curcio Dos Reis, Amir; Fukuda, Thiago Yukio; Fernandes Bryk, Flavio

    2016-03-01

    To analyze kinesio taping (KT) effect on quadriceps strength and lower limb function over a 7-day period. Blind randomized clinical trial. Hospital's Physical Therapy Department. Sixty healthy individuals (30 men and 30 women) were randomly distributed into three groups: Control--without KT application; Placebo--placebo KT application and Experimental--A KT application designed to stimulate quadriceps femoris activity. The quadriceps strength was measured using a manual dynamometer whereas lower limb function was assessed using the Single Hop Test for Distance. Evaluations occurred at five time-points: baseline; immediately, 3 and 5 days after KT application; and 72 h post KT withdrawal. There was no significant interaction between time-points and groups for muscle strength: dominant (P = 0.13) and non-dominant (P = 0.41) and lower limb function: dominant (P = 0.09) and non-dominant (P = 0.53); but lower limb function within-group comparisons showed improvements in all groups at the evolution of all time-points analyzed for both limbs (P = 0.001). This is possibly due to a learning effect as the participants became more familiar with executing the assessment tests. KT did not improve quadriceps strength and lower limb function of healthy individuals and its application with these objectives should be reconsidered. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Effects of Community Exercise Therapy on Metabolic, Brain, Physical, and Cognitive Function Following Stroke: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Moore, Sarah A; Hallsworth, Kate; Jakovljevic, Djordje G; Blamire, Andrew M; He, Jiabao; Ford, Gary A; Rochester, Lynn; Trenell, Michael I

    2015-08-01

    Exercise therapy could potentially modify metabolic risk factors and brain physiology alongside improving function post stroke. To explore the short-term metabolic, brain, cognitive, and functional effects of exercise following stroke. A total of 40 participants (>50 years, >6 months post stroke, independently mobile) were recruited to a single-blind, parallel, randomized controlled trial of community-based exercise (19 weeks, 3 times/wk, "exercise" group) or stretching ("control" group). Primary outcome measures were glucose control and cerebral blood flow. Secondary outcome measures were cardiorespiratory fitness, blood pressure, lipid profile, body composition, cerebral tissue atrophy and regional brain metabolism, and physical and cognitive function. Exercise did not change glucose control (homeostasis model assessment 1·5 ± 0·8 to 1·5 ± 0·7 vs 1·6 ± 0·8 to 1·7 ± 0·7, P = .97; CI = -0·5 to 0·49). Medial temporal lobe tissue blood flow increased with exercise (38 ± 8 to 42 ± 10 mL/100 g/min; P physical function, and cognition also improved with exercise. Exercise therapy improves short-term metabolic, brain, physical, and cognitive function, without changes in glucose control following stroke. The long-term impact of exercise on stroke recurrence, cardiovascular health, and disability should now be explored. © The Author(s) 2014.

  20. Functional multidisciplinary rehabilitation versus outpatient physiotherapy for non specific low back pain: randomized controlled trial.

    Science.gov (United States)

    Henchoz, Yves; de Goumoëns, Pierre; So, Alexander Kai Lik; Paillex, Roland

    2010-12-22

    In recent decades the treatment of non-specific low back pain has turned to active modalities, some of which were based on cognitive-behavioural principles. Non-randomised studies clearly favour functional multidisciplinary rehabilitation over outpatient physiotherapy. However, systematic reviews and meta-analysis provide contradictory evidence regarding the effects on return to work and functional status. The aim of the present randomised study was to compare long-term functional and work status after 3-week functional multidisciplinary rehabilitation or 18 supervised outpatient physiotherapy sessions. 109 patients with non-specific low back pain were randomised to either a 3-week functional multidisciplinary rehabilitation programme, including physical and ergonomic training, psychological pain management, back school and information, or 18 sessions of active outpatient physiotherapy over 9 weeks. Primary outcomes were functional disability (Oswestry) and work status. Secondary outcomes were lifting capacity (Spinal Function Sort and PILE test), lumbar range-of-motion (modified-modified Schöber and fingertip-to-floor tests), trunk muscle endurance (Shirado and Biering-Sörensen tests) and aerobic capacity (modified Bruce test). Oswestry disability index was improved to a significantly greater extent after functional multidisciplinary rehabilitation compared to outpatient physiotherapy at follow-up of 9 weeks (P = 0.012), 9 months (P = 0.023) and 12 months (P = 0.011). Work status was significantly improved after functional multidisciplinary rehabilitation only (P = 0.012), resulting in a significant difference compared to outpatient physiotherapy at 12 months' follow-up (P = 0.012). Secondary outcome results were more contrasted. Functional multidisciplinary rehabilitation was better than outpatient physiotherapy in improving functional and work status. From an economic point of view, these results should be backed up by a cost-effectiveness study.

  1. Single-trial classification of motor imagery differing in task complexity: a functional near-infrared spectroscopy study

    Directory of Open Access Journals (Sweden)

    Wolf Martin

    2011-06-01

    Full Text Available Abstract Background For brain computer interfaces (BCIs, which may be valuable in neurorehabilitation, brain signals derived from mental activation can be monitored by non-invasive methods, such as functional near-infrared spectroscopy (fNIRS. Single-trial classification is important for this purpose and this was the aim of the presented study. In particular, we aimed to investigate a combined approach: 1 offline single-trial classification of brain signals derived from a novel wireless fNIRS instrument; 2 to use motor imagery (MI as mental task thereby discriminating between MI signals in response to different tasks complexities, i.e. simple and complex MI tasks. Methods 12 subjects were asked to imagine either a simple finger-tapping task using their right thumb or a complex sequential finger-tapping task using all fingers of their right hand. fNIRS was recorded over secondary motor areas of the contralateral hemisphere. Using Fisher's linear discriminant analysis (FLDA and cross validation, we selected for each subject a best-performing feature combination consisting of 1 one out of three channel, 2 an analysis time interval ranging from 5-15 s after stimulation onset and 3 up to four Δ[O2Hb] signal features (Δ[O2Hb] mean signal amplitudes, variance, skewness and kurtosis. Results The results of our single-trial classification showed that using the simple combination set of channels, time intervals and up to four Δ[O2Hb] signal features comprising Δ[O2Hb] mean signal amplitudes, variance, skewness and kurtosis, it was possible to discriminate single-trials of MI tasks differing in complexity, i.e. simple versus complex tasks (inter-task paired t-test p ≤ 0.001, over secondary motor areas with an average classification accuracy of 81%. Conclusions Although the classification accuracies look promising they are nevertheless subject of considerable subject-to-subject variability. In the discussion we address each of these aspects, their

  2. Static stretching alters neuromuscular function and pacing strategy, but not performance during a 3-km running time-trial.

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    Mayara V Damasceno

    Full Text Available Previous studies report that static stretching (SS impairs running economy. Assuming that pacing strategy relies on rate of energy use, this study aimed to determine whether SS would modify pacing strategy and performance in a 3-km running time-trial.Eleven recreational distance runners performed a a constant-speed running test without previous SS and a maximal incremental treadmill test; b an anthropometric assessment and a constant-speed running test with previous SS; c a 3-km time-trial familiarization on an outdoor 400-m track; d and e two 3-km time-trials, one with SS (experimental situation and another without (control situation previous static stretching. The order of the sessions d and e were randomized in a counterbalanced fashion. Sit-and-reach and drop jump tests were performed before the 3-km running time-trial in the control situation and before and after stretching exercises in the SS. Running economy, stride parameters, and electromyographic activity (EMG of vastus medialis (VM, biceps femoris (BF and gastrocnemius medialis (GA were measured during the constant-speed tests.The overall running time did not change with condition (SS 11:35±00:31 s; control 11:28±00:41 s, p = 0.304, but the first 100 m was completed at a significantly lower velocity after SS. Surprisingly, SS did not modify the running economy, but the iEMG for the BF (+22.6%, p = 0.031, stride duration (+2.1%, p = 0.053 and range of motion (+11.1%, p = 0.0001 were significantly modified. Drop jump height decreased following SS (-9.2%, p = 0.001.Static stretch impaired neuromuscular function, resulting in a slow start during a 3-km running time-trial, thus demonstrating the fundamental role of the neuromuscular system in the self-selected speed during the initial phase of the race.

  3. Late Conversion of Kidney Transplant Recipients from Ciclosporin to Tacrolimus Improves Graft Function: Results from a Randomized Controlled Trial.

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    Max Plischke

    Full Text Available Tacrolimus (TAC to ciclosporin A (CSA conversion studies in stable kidney transplant recipients have reported varying effects on graft function. Here we study graft function (eGFR trajectories using linear mixed models, which provide effect estimates on both slope and baseline level of GFR and offer increased statistical power.Secondary analysis of a randomized controlled trial of CSA treated kidney transplant recipients with stable graft function assigned to receive 0.1 mg/kg/day TAC (target 5-8 ng/ml or to continue CSA based immunosuppression (target 70-150 ng/ml at a 2:1 ratio. Renal graft function was estimated via the MDRD (eGFRMDRD and CKD-EPI (eGFRCKD-EPI formulas.Forty-five patients continued CSA and 96 patients were converted to TAC with a median follow up of 24 months. Baseline demographics (except for recipient age including native kidney disease, transplant characteristics, kidney graft function, medication use and comorbid conditions did not differ between groups. In respect to long-term renal graft function, linear mixed models showed significantly improved eGFR trajectories (eGFRMDRD: p<0.001, eGFRCKD-EPI: p<0.001 in the TAC versus CSA group over 24 months of follow up. Estimated eGFRCKD-EPI group differences between TAC and CSA were -3.49 (p = 0.019 at 3 months, -5.50 (p<0.001 at 12 months, and -4.48 ml/min/1.73m2 (p = 0.003 at 24 months of follow up. Baseline eGFR was a significant predictor of eGFR trajectories (eGFRMDRD: p<0.001, eGFRCKD-EPI: p<0.001. Significant effects for randomization group were evident despite short-term trough levels in the supratherapeutic range (27% (n = 26 of TAC patients at week one. Median TAC trough levels were within target range at week 4 after conversion.Conversion of CSA treated kidney transplant recipients with stable graft function to TAC (target 5-8 ng/ml showed significantly improved long-term eGFR trajectories when compared to CSA maintenance (target 70-150 ng/ml.ClinicalTrials.gov NCT

  4. Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

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    Z Pourmoghaddas

    2014-04-01

    Eighty seven patients completed the trial (44 in the mebeverine group. Response rate in the mebeverine and the placebo group was 54.5% and 39.5% at week 4 (P=0.117 and 72.7% and 53.4% at week 12 (P=0.050, respectively. No significant difference was observed between the two groups in change of the global severity or improvement at week 4 (P=0.723 and 0.057 or at week 12 (P=0.870 and 0.183, respectively. In regression analysis, male gender (Beta=3.470, P=0.025 and baseline pain score (Beta=3.665, P

  5. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

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    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  6. Do nuisance alarms decrease functionality of smoke alarms near the kitchen? Findings from a randomised controlled trial.

    Science.gov (United States)

    Yang, Jingzhen; Jones, Michael P; Cheng, Gang; Ramirez, Marizen; Taylor, Craig; Peek-Asa, Corinne

    2011-06-01

    Many home fires begin in the kitchen. Kitchen smoke alarms are more likely to produce nuisance alarms, but few previous studies have examined the role of alarm sensor and battery types on the functionality of smoke alarms located nearest to the kitchen. Data were analysed from a 2×2 factorial randomised controlled trial conducted in rural Iowa homes (n=628). Enrolled households were randomly assigned into one of four smoke alarm/battery combinations: ionisation/zinc, ionisation/lithium, photoelectric/zinc and photoelectric/lithium. Alarm functionality was determined using a smoke test. Alarm type and battery type were compared using an intent-to-treat analysis. Logistic regression was used to identify factors that might impact the functionality of smoke alarms located nearest to the kitchen 42 months after installation. Photoelectric alarms with lithium batteries had the highest rate of functionality (90.2%), whereas ionisation alarms with carbon/zinc batteries had the lowest (76.5%). Forty-two months following installation, 6.4% more of photoelectric alarms were functional than ionisation alarms, and 7.9% more of alarms with lithium batteries were functional than those with carbon/zinc batteries. Logistic regression revealed that when the indicator of nuisance alarms was included, the effect of alarm type became statistically insignificant and ionisation alarms were less likely to be functional at 42 months, partly due to increased nuisance alarms. Alarm type is an important consideration for certain locations. Photoelectric alarms may be more appropriate for installation nearest to the kitchen despite their increased cost. These findings can help guide consumer choices to increase protection against home fire-related injuries and deaths.

  7. Effect of Periodontal Therapy on Arterial Structure and Function Among Aboriginal Australians: A Randomized, Controlled Trial

    National Research Council Canada - National Science Library

    Kapellas, Kostas; Maple-Brown, Louise J; Jamieson, Lisa M; Do, Loc G; O’Dea, Kerin; Brown, Alex; Cai, Tommy Y; Anstey, Nicholas M; Sullivan, David R; Wang, Hao; Celermajer, David S; Slade, Gary D; Skilton, Michael R

    2014-01-01

    .... Both diseases occur frequently in Aboriginal Australians. We hypothesized that nonsurgical periodontal therapy would improve measures of arterial function and structure that are subclinical indicators of atherosclerotic vascular disease...

  8. Modified chaihu shugan powder for functional dyspepsia: meta-analysis for randomized controlled trial

    National Research Council Canada - National Science Library

    Yang, Nan; Jiang, Xuehua; Qiu, Xuelan; Hu, Zhiqiang; Wang, Ling; Song, Minxian

    2013-01-01

    Context. Modified Chaihu Shugan powder (MCSP) is a popular traditional Chinese herbal formula for functional dyspepsia, which is revised from Chaihu Shugan San and recorded in a medical classic works of China...

  9. Effect of posture-control insoles on function in children with cerebral palsy: Randomized controlled clinical trial

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    Pasini Neto Hugo

    2012-10-01

    Full Text Available Abstract Introduction Cerebral palsy (CP is a posture and movement disorder and different therapeutic modalities, such as the use of braces, have sought to favor selective motor control and muscle coordination in such patients. The aim of the proposed study is to determine the effect of the combination of posture-control insoles and ankle-foot orthoses (AFOs improving functional limitation in children with CP. Methods/Design The sample will be composed of 24 children with CP between four and 12 years of age. After the signing of the statement of informed consent, the children will be randomly allocated to two groups: a control group using AFOs alone and an experimental group using both posture-control insoles and AFOs. Evaluations will be performed on five occasions: without any accessory (insoles or AFOs, immediately after, one month after, six months after and one year after AFOs or insole and AFOs use. The evaluation will involve the analysis of gait, static and functional balance, mobility and hypertonia. The three-dimensional assessment of gait will involve the eight-camera SMART-D SMART-D 140® system (BTS Engineering, two Kistler force plates (model 9286BA and an eight-channel, wireless FREEEMG® electromyography (BTS Engineering. Static balance will be assessed using a Kistler force plate (model 9286BA. Clinical functional balance and mobility will be assessed using the Berg Balance Scale, Timed Up-and-Go Test and Six-Minute Walk Test. The posture-control insoles will be made of ethylene vinyl acetate, with thermal molding for fixation. The fixed orthoses will be made of polypropylene and attached to the ankle region (AFO. The results will be analyzed statistically, with the level significance set to 5% (p Trial Registration Trial Registration Number: RBR6d342s (http://www.ensaiosclinicos.gov.br/news/

  10. Effect of prophylactic non-invasive mechanical ventilation on functional capacity after heart valve replacement: a clinical trial

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    Amaro Afrânio de Araújo-Filho

    Full Text Available OBJECTIVE: During cardiac surgery, several factors contribute to the development of postoperative pulmonary complications. Non-invasive ventilation is a promising therapeutic tool for improving the functionality of this type of patient. The aim of this study is to evaluate the functional capacity and length of stay of patients in a nosocomial intensive care unit who underwent prophylactic non-invasive ventilation after heart valve replacement. METHOD: The study was a controlled clinical trial, comprising 50 individuals of both sexes who were allocated by randomization into two groups with 25 patients in each group: the control group and experimental group. After surgery, the patients were transferred to the intensive care unit and then participated in standard physical therapy, which was provided to the experimental group after 3 applications of non-invasive ventilation within the first 26 hours after extubation. For non-invasive ventilation, the positive pressure was 10 cm H2O, with a duration of 1 hour. The evaluation was performed on the 7th postoperative day/discharge and included a 6-minute walk test. The intensive care unit and hospitalization times were monitored in both groups. Brazilian Registry of Clinical Trials (REBeC: RBR number 8bxdd3. RESULTS: Analysis of the 6-minute walk test showed that the control group walked an average distance of 264.34±76 meters and the experimental group walked an average distance of 334.07±71 meters (p=0.002. The intensive care unit and hospitalization times did not differ between the groups. CONCLUSION: Non-invasive ventilation as a therapeutic resource was effective toward improving functionality; however, non-invasive ventilation did not influence the intensive care unit or hospitalization times of the studied cardiac patients.

  11. The effects of plant stanol ester consumption on arterial stiffness and endothelial function in adults: a randomised controlled clinical trial.

    Science.gov (United States)

    Gylling, Helena; Halonen, Janne; Lindholm, Harri; Konttinen, Jussi; Simonen, Piia; Nissinen, Markku J; Savolainen, Aslak; Talvi, Airi; Hallikainen, Maarit

    2013-07-10

    The hypocholesterolemic effect of plant stanol ester consumption has been studied extensively, but its effect on cardiovascular health has been less frequently investigated. We studied the effects of plant stanol esters (staest) on arterial stiffness and endothelial function in adults without lipid medication. Ninety-two asymptomatic subjects, 35 men and 57 women, mean age of 50.8±1.0 years (SEM) were recruited from different commercial companies. It was randomized, controlled, double-blind, parallel trial and lasted 6 months. The staest group (n=46) consumed rapeseed oil-based spread enriched with staest (3.0 g of plant stanols/d), and controls (n=46) the same spread without staest. Arterial stiffness was assessed via the cardio-ankle vascular index (CAVI) in large and as an augmentation index (AI) in peripheral arteries, and endothelial function as reactive hyperemia index (RHI). Lipids and vascular endpoints were tested using analysis of variance for repeated measurements. At baseline, 28% of subjects had a normal LDL cholesterol level (≤3.0 mmol/l) and normal arterial stiffness (cholesterol concentrations declined by 6.6, 10.2, and 10.6% compared with controls (pcholesterol levels achieved by staest was related to the improvement in RHI (r=-0.452, p=0.006 and -0.436, p=0.008). Lowering LDL and non-HDL cholesterol by 10% with staest for 6 months reduced arterial stiffness in small arteries. In subgroup analyses, staest also had a beneficial effect on arterial stiffness in large arteries in men and on endothelial function. Further research will be needed to confirm these results in different populations. Clinical Trials Register # NCT01315964.

  12. A randomised controlled trial investigating motor skill training as a function of attentional focus in old age

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    Swanenburg Jaap

    2009-05-01

    Full Text Available Abstract Background Motor learning research has had little impact on clinical applications and rarely extended to research about how older adults learn motor skills. There is consistent evidence that motor skill performance and learning can be enhanced by giving learners instructions that direct their attention. The aim of this study was to test whether elderly individuals that receive an external focus instruction during training of dynamic balance skills would learn in a different manner compared to individuals that received an internal focus instruction. Methods This randomised trial included 26 older persons (81 ± 6 years that were training functional balance twice a week for the duration of 5 weeks. Learning outcomes were recorded after every training session. Weight shifting score and dynamic balance parameters (Biodex Balance System, components of the Extended Timed-Get-Up-and-Go test, five chair rises, and falls efficacy (FES-I was assessed at baseline and post-intervention. Results Participation for training sessions was 94%. No differences between groups were found following 5 weeks of training for weight shifting score, dynamic balance index and dynamic balance time (p p = 0.16, p Sit-to-stand, p = .036; Gait initiation, p = .039; Slow down, stop, turnaround, and sit down, p = 0.011 and the Fes-I (p = 0.014 showed improvements for the total group, indicating that function improved compared to baseline. Conclusion A 5-week balance training improved weight shifting scores and dynamic balance parameters as well as functional abilities. The observed improvements were independent from the type of attentional focus instructions. The findings provide support for the proposition of different motor learning principles in older adults compared to younger adults. Trial Registration ISRCTN44627088

  13. Effect of niacin on endothelial function: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Sahebkar, Amirhossein

    2014-02-01

    Endothelial dysfunction is an independent predictor of incident atherosclerotic cardiovascular disease (ACVD). Niacin possesses high-density lipoprotein (HDL)-elevating, antioxidant and anti-inflammatory properties, all potentially contributing to the amelioration of endothelial function. However, controversies exist among trials reporting the effects of niacin on endothelium-dependent flow-mediated dilation (FMD) as a reliable surrogate of endothelial function. The objective of this study was to assess the effect of niacin on brachial artery FMD using a meta-analysis of available evidence. MEDLINE and Scopus databases were searched for randomized controlled trials investigating the impact of niacin therapy on brachial artery FMD. Meta-analysis of eligible studies was conducted using a random-effects model. Pooled effects were measured by weighted mean difference (WMD) and 95% confidence intervals (CIs). Quality assessment, and subgroup, meta-regression and sensitivity analyses were conducted using standard methods. Among 596 citations, 19 full-text articles were read and seven were found to be eligible for inclusion. Eligible studies involved 441 subjects comprising 228 in the niacin and 213 in the control groups. Niacin therapy significantly improved FMD (WMD: 1.98%; 95% CI: 0.91-3.05%; p = 0.0003) and this effect was robust in the sensitivity analysis. The effect size was greater in the subgroup of studies administering higher doses of niacin (≥ 2000 mg/day) as well as those studies administering niacin for primary prevention of ACVD. Meta-regression indicated no association between niacin-induced changes in FMD and changes in plasma HDL-cholesterol, low-density lipoprotein-cholesterol or triglycerides. None of the included studies could find any significant effect of niacin on nitroglycerin-mediated dilation. In conclusion, treatment with niacin improves endothelial function.

  14. Trial wave functions for ring-trapped ions and neutral atoms: Microscopic description of the quantum space-time crystal

    Science.gov (United States)

    Yannouleas, Constantine; Landman, Uzi

    2017-10-01

    A constructive theoretical platform for the description of quantum space-time crystals uncovers for N interacting and ring-confined rotating particles the existence of low-lying states with proper space-time crystal behavior. The construction of the corresponding many-body trial wave functions proceeds first via symmetry breaking at the mean-field level followed by symmetry restoration using projection techniques. The ensuing correlated many-body wave functions are stationary states and preserve the rotational symmetries, and at the same time they reflect the point-group symmetries of the mean-field crystals. This behavior results in the emergence of sequences of select magic angular momenta Lm. For angular-momenta away from the magic values, the trial functions vanish. Symmetry breaking beyond the mean-field level can be induced by superpositions of such good-Lm many-body stationary states. We show that superposing a pair of adjacent magic angular momenta states leads to formation of special broken-symmetry states exhibiting quantum space-time-crystal behavior. In particular, the corresponding particle densities rotate around the ring, showing undamped and nondispersed periodic crystalline evolution in both space and time. The experimental synthesis of such quantum space-time-crystal wave packets is predicted to be favored in the vicinity of ground-state energy crossings of the Aharonov-Bohm-type spectra accessed via an externally applied, natural or synthetic, magnetic field. These results are illustrated here for Coulomb-repelling fermionic ions and for a lump of contact-interaction attracting bosons.

  15. Kinesio Taping Improves Perceptions of Pain and Function of Patients with Knee Osteoarthritis. A Randomized, Controlled Trial.

    Science.gov (United States)

    Rahlf, Anna Lina; Braumann, Klaus-Michael; Zech, Astrid

    2018-02-21

    Although increasingly used for therapeutic treatment only limited evidence exists regarding the effects of kinesio taping on patients with knee osteoarthritis. To determine the effects of kinesio taping on pain, function, gait and neuromuscular control concerning patients with knee osteoarthritis (OA). Randomized sham-controlled trial. University laboratory. 141 Patients (65.1±7.0 years) with a clinical and radiographic diagnosis of knee osteoarthritis. Kinesio tape, sham tape or no tape for 3 consecutive days. Self-reported pain, stiffness and function were measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Further tests included the Balance Error Scoring System (BESS-Test), 10-m Walk Test (10MWT), the maximum voluntary isometric contraction force (MVIC) of the quadriceps femoris and knee active range of motion (active ROM). At baseline, there were no differences in all outcomes between groups except for knee flexion. Significant effects were found for WOMAC pain (tape vs. sham p=0.053; tape vs. control p=0.047), stiffness (tape vs. sham p=0.012; tape vs. control p≤0.001) and physical function (tape vs. sham p=0.034; tape vs. control p=0.004). No interactions were found for balance, muscle strength, walking speed or active ROM. Wearing kinesio tape for three consecutive days had beneficial effects regarding self-reported clinical outcomes of pain, joint stiffness and function. This emphasizes that kinesio taping might be an adequate conservative treatment for the symptoms of knee osteoarthritis.

  16. Effects of exercise on functional aerobic capacity in adults with fibromyalgia syndrome: A systematic review of randomized controlled trials.

    Science.gov (United States)

    García-Hermoso, Antonio; Saavedra, Jose M; Escalante, Yolanda

    2015-01-01

    Patients with fibromyalgia present a reduced capacity of upper and lower limb physical performance and affect their independence in performing everyday activities. The purpose of the present systematic review was to summarize evidence for the effectiveness and structure of exercise programs on functional aerobic capacity in patients with fibromyalgia syndrome. Keyword searches were made of seven databases. The systematic review was limited to English language studies of people with FM that evaluated the effects of exercise programs on functional aerobic capacity (6-minute walk test). The criteria for inclusion were satisfied by 12 randomized controlled trial (RCT) studies. The main cumulative evidence indicates that the programs based on aerobic exercise alone and on aquatic exercises have large (effect size = 0.85) and moderate (effect size = 0.44) effects. Aerobic and aquatic exercises at the proper intensity favour the increased functional aerobic capacity of fibromyalgia patients; however, most works do not adequately detail the intensity of the exercises. Moderate intensity exercise (aerobic and aquatic exercise) performed at least two times per week and 30-60 minutes a day is effective for increasing functional aerobic capacity, favouring the daily activities of daily living in this population.

  17. Dark chocolate and vascular function in patients with peripheral artery disease: a randomized, controlled cross-over trial.

    Science.gov (United States)

    Hammer, Alexandra; Koppensteiner, Renate; Steiner, Sabine; Niessner, Alexander; Goliasch, Georg; Gschwandtner, Michael; Hoke, Matthias

    2015-01-01

    Flavonoid-rich dark chocolate has positive effects on vascular function in healthy subjects and in patients at risk of atherosclerosis. The impact of dark chocolate on endothelial and microvascular function in patients with symptomatic peripheral artery disease (PAD) has not been investigated so far. In an investigator blinded, randomized, controlled, cross-over trial we assessed the effect of flavonoid-rich dark chocolate and cocoa-free control chocolate on flow-mediated dilatation (FMD) of the brachial artery and on microvascular function (assessed by Laser Doppler fluxmetry) in 21 patients with symptomatic (Fontaine stage II) PAD. Measurements were done in each patient on 2 single days, with an interval of 7 days, at baseline and at 2 hours after ingestion of 50 g dark chocolate or 50 g white chocolate, respectively. FMD remained unchanged after intake of dark chocolate (baseline and 2 hours after ingestion, %: 5.1 [IQR 4.4 to 7.3] and 5.5 [IQR 3.9 to 10.4]; p = 0.57, and after intake of white chocolate (baseline and 2 hours after ingestion, %: 6.4 [IQR 4.5 to 11.4] and 4.4 [IQR 2.6 to 8.7]; p = 0.14. Similarly, microcirculatory parameters were not significantly altered after intake of any chocolate compared with the respective baseline values. In conclusion, a single consumption of 50 g dark chocolate has no effect on endothelial and microvascular function in patients with symptomatic PAD.

  18. Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Dimbwadyo-Terrer, I; Gil-Agudo, A; Segura-Fragoso, A; de los Reyes-Guzmán, A; Trincado-Alonso, F; Piazza, S; Polonio-López, B

    2016-01-01

    The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients' satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra(®) virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η (2) = 0,22) in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35.

  19. Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    I. Dimbwadyo-Terrer

    2016-01-01

    Full Text Available The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients’ satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra® virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η2 = 0,22 in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35.

  20. Efficacy of Tailored Exercise Therapy on Physical Functioning in Patients With Knee Osteoarthritis and Comorbidity: A Randomized Controlled Trial.

    Science.gov (United States)

    de Rooij, Mariëtte; van der Leeden, Marike; Cheung, John; van der Esch, Martin; Häkkinen, Arja; Haverkamp, Daniël; Roorda, Leo D; Twisk, Jos; Vollebregt, Joke; Lems, Willem F; Dekker, Joost

    2017-06-01

    To evaluate the efficacy on physical functioning and safety of tailored exercise therapy in patients with knee osteoarthritis (OA) and comorbidities. In a randomized controlled trial, 126 participants were included with a clinical diagnosis of knee OA and at least 1 of the following target comorbidities: coronary disease, heart failure, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or obesity (body mass index ≥30 kg/m(2) ), with severity score ≥2 on the Cumulative Illness Rating Scale. The intervention group received a 20-week, individualized, comorbidity-adapted exercise program consisting of aerobic and strength training and training of daily activities. The control group received their current medical care for knee OA and were placed on a waiting list for exercise therapy. Primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, subscale physical functioning (WOMAC-pf), and the 6-minute walk test (6MWT). Measurements were performed at baseline, after 20 weeks (directly posttreatment), and at 3 months posttreatment. Statistically significant physical functioning differences over time were found between the intervention and control group (WOMAC: B = -7.43 [95% confidence interval (95% CI) -9.99, -4.87], P exercise therapy is efficacious in improving physical functioning and safe in patients with knee OA and severe comorbidities. © 2016, American College of Rheumatology.

  1. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation-effects on physical function

    DEFF Research Database (Denmark)

    Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Lauridsen, Jørgen T

    2015-01-01

    ). DISCUSSION: This study is the first to investigate the effect of no sedation during critical illness on physical function. If an effect is found, it will add important information on how to prevent muscle weakness following critical illness. TRIAL REGISTRATION: The study has been approved by the relevant...... scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02034942 , 9 January 2014)....

  2. Vessel-sparing Radiotherapy for Localized Prostate Cancer to Preserve Erectile Function: A Single-arm Phase 2 Trial.

    Science.gov (United States)

    Spratt, Daniel E; Lee, Jae Y; Dess, Robert T; Narayana, Vrinda; Evans, Cheryl; Liss, Adam; Winfield, Raymond; Schipper, Matthew J; Lawrence, Theodore S; McLaughlin, Patrick W

    2017-10-01

    Erectile dysfunction remains the most common side effect from radical treatment of localized prostate cancer. We hypothesized that the use of vessel-sparing radiotherapy, analogous to the functional anatomy approach of nerve-sparing radical prostatectomy (RP), would improve erectile function preservation while maintaining tumor control for men with localized prostate cancer. To determine erectile function rates after vessel-sparing radiotherapy. Men with localized prostate cancer were enrolled in a phase 2 single-arm trial (NCT02958787) at a single academic center. Patients received vessel-sparing radiotherapy utilizing a planning MRI and MRI-angiogram to delineate and avoid the erectile vasculature. Both physician- and patient-reported inventories were used to capture erectile function at baseline and at 2 and 5 yr after treatment. Validated model-based comparisons were performed to compare vessel-sparing results to nerve-sparing RP and conventional radiotherapy. From 2001 to 2009, 135 men underwent vessel-sparing radiotherapy. After a planned interim analysis, the trial was stopped after meeting the primary endpoint. The median follow-up was 8.7 yr, with a ≥94% response rate to all inventories at each time point. At 5 yr, 88% of patients were sexually active with or without the use of sexual aids. The 2-yr erectile function rates were significantly improved with vessel-sparing radiotherapy (78%, 95% confidence interval [CI] 71-85%) compared to modeled rates for convention radiotherapy (42%, 95% CI 38-45%; pfunction when compared to historical series and model-predicted outcomes following nerve-sparing RP or conventional radiotherapy, with maintenance of tumor control. This approach warrants independent validation. In this interim analysis we looked at using a novel approach to spare critical erectile structures to preserve erectile function after prostate cancer radiotherapy. We found that almost 90% of patients at 5 yr after treatment remained sexually active

  3. Kinesio Taping does not improve the symptoms or function of older people with knee osteoarthritis: a randomised trial.

    Science.gov (United States)

    Wageck, Bruna; Nunes, Guilherme S; Bohlen, Nicolas Bernardon; Santos, Gilmar Moraes; de Noronha, Marcos

    2016-07-01

    Does Kinesio Taping reduce pain and swelling, and increase muscle strength, function and knee-related health status in older people with knee osteoarthritis? Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded assessment. Seventy-six older people with knee osteoarthritis. The experimental group received three simultaneous Kinesio Taping techniques to treat pain, strength and swelling. The control group received sham taping. All participants kept the taping on for 4 days. The outcomes were: concentric muscle strength of knee extensors and flexors, measured by isokinetic dynamometry with an angular velocity of 60 deg/second normalised for body mass [(Nm/kg) x 100 (%)]; pressure pain threshold via digital pressure algometry (kgf/cm(2)); lower-limb swelling via volumetry (l) and perimetry (cm); physical function via the Lysholm Knee Scoring Scale (0 = worst to 100=best); and knee-related health status via the Western Ontario and McMaster (WOMAC) osteoarthritis index (0=best to 96=worst). Outcomes were measured at Day 4 (end of the taping period) and Day 19 (follow-up) after the start of the treatment. At Day 4, there were no significant between-group differences for knee extensor muscle strength (MD -1%, 95% CI -7 to 5), knee flexor muscle strength (MD 2%, 95% CI -3 to 7), the pressure pain threshold at any measured point, volumetry (MD 0.05 L, 95% CI -0.01 to 0.11), perimetry at any measured point, Lysholm score (MD -4 points, 95% CI -9 to 2), or WOMAC score (MD -2 points, 95% CI -8 to 4). The lack of significant between-group difference was also seen at the follow-up assessment on Day 19. The Kinesio Taping techniques investigated in this study provided no beneficial effects for older people with knee osteoarthritis on any of the assessed outcomes. Brazilian Registry of Clinical Trials, RBR-36r3t5. [Wageck B, Nunes GS, Bohlen NB, Santos GM, de Noronha M (2016) Kinesio Taping does not improve the symptoms or function of

  4. Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial.

    Science.gov (United States)

    Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; Silva, Ageo Mário Cândido da; Caporossi, Fernanda Stephan; Caporossi, Cervantes

    2015-01-01

    To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength.

  5. Functional goal achievement in post-stroke spasticity patients: the BOTOX® Economic Spasticity Trial (BEST).

    Science.gov (United States)

    Ward, Anthony B; Wissel, Jörg; Borg, Jörgen; Ertzgaard, Per; Herrmann, Christoph; Kulkarni, Jai; Lindgren, Kristina; Reuter, Iris; Sakel, Mohamed; Säterö, Patrik; Sharma, Satyendra; Wein, Theodore; Wright, Nicola; Fulford-Smith, Antony

    2014-06-01

    Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity. Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks. The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks (or 10 weeks after an optional second injection). Secondary endpoints included achievement of a different active or a passive goal at this timepoint. The intent-to-treat population comprised 273 patients. The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care. Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care (60.0%) vs. placebo + standard of care (38.6%) (odds ratio, 2.46; 95% confidence interval, 1.18-5.14) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups. Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function.

  6. Prospective, randomized controlled trial of physiotherapy and acupuncture on motor function and daily activities in patients with ischemic stroke.

    Science.gov (United States)

    Bai, Yu-Long; Li, Li; Hu, Yong-Shan; Wu, Yi; Xie, Pei-Jing; Wang, Song-Wei; Yang, Ming; Xu, Yi-Ming; Zhu, Bing

    2013-08-01

    To assess the value of acupuncture for promoting the recovery of patients with ischemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. Prospective randomized controlled trial. Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, P. R. China. 120 inpatients and outpatients (84 men and 36 women). Acupuncture, physiotherapy, and physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA). The modified Barthel index (MBI) was used to rate activities of daily living. All evaluations were performed by assessors blinded to treatment group. On the first day of therapy (day 0, baseline), FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on the 28th day of therapy the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on the 56th day, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively (pphysiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group pphysiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these findings.

  7. Acupuncture for Functional Dyspepsia: What Strength Does It Have? A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Bo Pang

    2016-01-01

    Full Text Available Background. Although the effectiveness of acupuncture therapy on functional dyspepsia (FD has been systematically reviewed, the available reports are still contradictive and no robust evidence has been provided to date. Objective. To assess the current evidence of high quality on the effects of acupuncture for patients with FD. Methods. A comprehensive literature database search was conducted to identify randomized controlled trials (RCTs comparing acupuncture therapies (including manual acupuncture and electroacupuncture to sham acupuncture and medication use. A meta-analysis was performed following a strict methodology. Results. 16 RCTs involving 1436 participants were included. The majority of the trials were determined to be of low quality. Positive results were found for acupuncture in improving the Nepean Dyspepsia Index (NDI and scores of the MOS 36-Item Short-Form Health Survey (SF-36, as well as in alleviating relevant symptoms (especially postprandial fullness and early satiation of FD patients. Conclusion. Based on current available evidence, acupuncture therapy achieves statistically significant effect for FD in comparison with sham acupuncture and is superior to medication (prokinetic agents in improving the symptoms and quality of life of FD patients. Nonetheless, despite stringent methodological analyses, the conclusion of our review still needs to be strengthened by additional RCTs of higher quality.

  8. Acupuncture for Functional Dyspepsia: What Strength Does It Have? A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Li, Jing; Li, Bo; Hu, Ya-Cai; Cai, Qiu-Han

    2016-01-01

    Background. Although the effectiveness of acupuncture therapy on functional dyspepsia (FD) has been systematically reviewed, the available reports are still contradictive and no robust evidence has been provided to date. Objective. To assess the current evidence of high quality on the effects of acupuncture for patients with FD. Methods. A comprehensive literature database search was conducted to identify randomized controlled trials (RCTs) comparing acupuncture therapies (including manual acupuncture and electroacupuncture) to sham acupuncture and medication use. A meta-analysis was performed following a strict methodology. Results. 16 RCTs involving 1436 participants were included. The majority of the trials were determined to be of low quality. Positive results were found for acupuncture in improving the Nepean Dyspepsia Index (NDI) and scores of the MOS 36-Item Short-Form Health Survey (SF-36), as well as in alleviating relevant symptoms (especially postprandial fullness and early satiation) of FD patients. Conclusion. Based on current available evidence, acupuncture therapy achieves statistically significant effect for FD in comparison with sham acupuncture and is superior to medication (prokinetic agents) in improving the symptoms and quality of life of FD patients. Nonetheless, despite stringent methodological analyses, the conclusion of our review still needs to be strengthened by additional RCTs of higher quality. PMID:28119758

  9. Plasticity of Attentional Functions in Older Adults after Non-Action Video Game Training: A Randomized Controlled Trial

    Science.gov (United States)

    Mayas, Julia; Parmentier, Fabrice B. R.; Andrés, Pilar; Ballesteros, Soledad

    2014-01-01

    A major goal of recent research in aging has been to examine cognitive plasticity in older adults and its capacity to counteract cognitive decline. The aim of the present study was to investigate whether older adults could benefit from brain training with video games in a cross-modal oddball task designed to assess distraction and alertness. Twenty-seven healthy older adults participated in the study (15 in the experimental group, 12 in the control group. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the intervention using a cross-modal oddball task measuring alertness and distraction. The results showed a significant reduction of distraction and an increase of alertness in the experimental group and no variation in the control group. These results suggest neurocognitive plasticity in the old human brain as training enhanced cognitive performance on attentional functions. Trial Registration ClinicalTrials.gov NCT02007616 PMID:24647551

  10. Functional weight-bearing mobilization after Achilles tendon rupture enhances early healing response: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Valkering, Kars P; Aufwerber, Susanna; Ranuccio, Francesco; Lunini, Enricomaria; Edman, Gunnar; Ackermann, Paul W

    2017-06-01

    Functional weight-bearing mobilization may improve repair of Achilles tendon rupture (ATR), but the underlying mechanisms and outcome were unknown. We hypothesized that functional weight-bearing mobilization by means of increased metabolism could improve both early and long-term healing. In this prospective randomized controlled trial, patients with acute ATR were randomized to either direct post-operative functional weight-bearing mobilization (n = 27) in an orthosis or to non-weight-bearing (n = 29) plaster cast immobilization. During the first two post-operative weeks, 15°-30° of plantar flexion was allowed and encouraged in the functional weight-bearing mobilization group. At 2 weeks, patients in the non-weight-bearing cast immobilization group received a stiff orthosis, while the functional weight-bearing mobilization group continued with increased range of motion. At 6 weeks, all patients discontinued immobilization. At 2 weeks, healing metabolites and markers of procollagen type I (PINP) and III (PIIINP) were examined using microdialysis. At 6 and 12 months, functional outcome using heel-rise test was assessed. Healing tendons of both groups exhibited increased levels of metabolites glutamate, lactate, pyruvate, and of PIIINP (all p mobilization group demonstrated significantly higher concentrations of glutamate compared to the non-weight-bearing cast immobilization group (p = 0.045).The upregulated glutamate levels were significantly correlated with the concentrations of PINP (r = 0.5, p = 0.002) as well as with improved functional outcome at 6 months (r = 0.4; p = 0.014). Heel-rise tests at 6 and 12 months did not display any differences between the two groups. Functional weight-bearing mobilization enhanced the early healing response of ATR. In addition, early ankle range of motion was improved without the risk of Achilles tendon elongation and without altering long-term functional outcome. The relationship between functional

  11. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    Background: Loss of functional capabilities due to inactivity is one of the most common reasons for fall accidents, and it has been well established that loss of capabilities can be effectively reduced by physical activity. Pilot studies indicate a possible improvement in functional abilities......). Secondary outcomes related to adherence, motivation and acceptability will be investigated through semi-structured interviews. Data will be collected from pre-and post-tests. Data will be analyzed for statistically significant differences by checking that there is a Gaussian distribution and then using...

  12. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial.

    Science.gov (United States)

    Shakouri, Seyed Kazem; Salekzamani, Yaghoub; Taghizadieh, Ali; Sabbagh-Jadid, Hamed; Soleymani, Jamal; Sahebi, Leyla; Sahebi, Roya

    2015-01-01

    Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B's, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG). Thirty nine males (65%) and 21 females (35%) with mean age of 8.10 ± 9.56 were analyzed. The mean differences were statistically significant for predicted forced vital capacity (FVC) (CI 95%:1.3 to 8.7) and Predicted Peak Flow indices (PEF) (CI 95%: 1.9 to 9.4) of spirometry indicator, PCO2 index (of ABG parameter) (CI 95%: 1.4 to 8.9) and mean oxygen saturation (mean Spo2) (CI 95%: 0.6 to 1.7) of ABG index in two groups. The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  13. Cardiovascular exercise training extends influenza vaccine seroprotection in sedentary older adults: the immune function intervention trial.

    Science.gov (United States)

    Woods, Jeffrey A; Keylock, K Todd; Lowder, Thomas; Vieira, Victoria J; Zelkovich, William; Dumich, Sara; Colantuano, Kim; Lyons, Kristin; Leifheit, Kurt; Cook, Marc; Chapman-Novakofski, Karen; McAuley, Edward

    2009-12-01

    To determine whether cardiovascular exercise training resulted in improved antibody responses to influenza vaccination in sedentary elderly people who exhibited poor vaccine responses. Single-site randomized parallel-arm 10-month controlled trial. University of Illinois at Urbana-Champaign. One hundred forty-four sedentary, healthy older (69.9 +/- 0.4) adults. Moderate (60-70% maximal oxygen uptake) cardiovascular exercise was compared with flexibility and balance training. The primary outcome was influenza vaccine response, as measured according to hemagglutination inhibition (HI) anti-influenza antibody titer and seroprotective responses (HI titer > or =40). Secondary measures included cardiovascular fitness and body composition. Of the 160 participants enrolled, 144 (90%) completed the 10-month intervention with excellent compliance ( approximately 83%). Cardiovascular, but not flexibility, exercise intervention resulted in improvements in indices of cardiovascular fitness, including maximal oxygen uptake. Although not affecting peak (e.g., 3 and 6 weeks) postvaccine anti-influenza HI titers, cardiovascular exercise resulted in a significant increase in seroprotection 24 weeks after vaccination (30-100% dependent on vaccine variant), whereas flexibility training did not. Participants randomized to cardiovascular exercise experienced improvements in influenza seroprotection throughout the entire influenza season, whereas those in the balance and flexibility intervention did not. Although there were no differences in reported respiratory tract infections, the exercise group exhibited reduced overall illness severity and sleep disturbance. These data support the hypothesis that regular endurance exercise improves influenza vaccine responses.

  14. A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients

    Science.gov (United States)

    Sherman, Christy A.; Mist, Scott D.; Carson, James W.; Bennett, Robert M.; Li, Fuzhong

    2017-01-01

    Previous researchers have found that 10-form Tai chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study was to further investigate earlier findings and add a focus on functional mobility. We conducted a parallel-group randomized controlled trial FM-modified 8-form Yang-style Tai chi program compared to an education control. Participants met in small groups twice weekly for 90 min over 12 weeks. The primary endpoint was symptom reduction and improvement in self-report physical function, as measured by the Fibromyalgia Impact Questionnaire (FIQ), from baseline to 12 weeks. Secondary endpoints included pain severity and interference (Brief Pain Inventory (BPI), sleep (Pittsburg sleep Inventory), self-efficacy, and functional mobility. Of the 101 randomly assigned subjects (mean age 54 years, 93 % female), those in the Tai chi condition compared with the education condition demonstrated clinically and statistically significant improvements in FIQ scores (16.5 vs. 3.1, p=0.0002), BPI pain severity (1.2 vs. 0.4, p=0.0008), BPI pain interference (2.1 vs. 0.6, p=0.0000), sleep (2.0 vs. −0.03, p=0.0003), and self-efficacy for pain control (9.2 vs. −1.5, p=0.0001). Functional mobility variables including timed get up and go (−.9 vs. −.3, p=0.0001), static balance (7.5 vs. −0.3, p= 0.0001), and dynamic balance (1.6 vs. 0.3, p=0.0001) were significantly improved with Tai chi compared with education control. No adverse events were noted. Twelve weeks of Tai chi, practice twice weekly, provided worthwhile improvement in common FM symptoms including pain and physical function including mobility. Tai chi appears to be a safe and an acceptable exercise modality that may be useful as adjunctive therapy in the management of FM patients. (ClinicalTrials.gov Identifier, NCT01311427) PMID:22581278

  15. Cognitive Function and Kidney Disease: Baseline Data From the Systolic Blood Pressure Intervention Trial (SPRINT).

    Science.gov (United States)

    Weiner, Daniel E; Gaussoin, Sarah A; Nord, John; Auchus, Alexander P; Chelune, Gordon J; Chonchol, Michel; Coker, Laura; Haley, William E; Killeen, Anthony A; Kimmel, Paul L; Lerner, Alan J; Oparil, Suzanne; Saklayen, Mohammad G; Slinin, Yelena M; Wright, Clinton B; Williamson, Jeff D; Kurella Tamura, Manjula

    2017-09-01

    Chronic kidney disease is common and is associated with cardiovascular disease, cerebrovascular disease, and cognitive function, although the nature of this relationship remains uncertain. Cross-sectional cohort using baseline data from the Systolic Blood Pressure Intervention Trial (SPRINT). Participants in SPRINT, a randomized clinical trial of blood pressure targets in older community-dwelling adults with cardiovascular disease, chronic kidney disease, or high cardiovascular disease risk and without diabetes or known stroke, who underwent detailed neurocognitive testing in the cognition substudy, SPRINT-Memory and Cognition in Decreased Hypertension (SPRINT-MIND). Urine albumin-creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR). Cognitive function, a priori defined as 5 cognitive domains based on 11 cognitive tests using z scores, and abnormal white matter volume quantified by brain magnetic resonance imaging. Of 9,361 SPRINT participants, 2,800 participated in SPRINT-MIND and 2,707 had complete data; 637 had brain imaging. Mean age was 68 years, 37% were women, 30% were black, and 20% had known cardiovascular disease. Mean eGFR was 70.8±20.9mL/min/1.73m2 and median urine ACR was 9.7 (IQR, 5.7-22.5) mg/g. In adjusted analyses, higher ACR was associated with worse global cognitive function, executive function, memory, and attention, such that each doubling of urine ACR had the same association with cognitive performance as being 7, 10, 6, and 14 months older, respectively. Lower eGFR was independently associated with worse global cognitive function and memory. In adjusted models, higher ACR, but not eGFR, was associated with larger abnormal white matter volume. Cross-sectional only, no patients with diabetes were included. In older adults, higher urine ACR and lower eGFR have independent associations with global cognitive performance with different affected domains. Albuminuria concurrently identifies a higher burden of abnormal brain

  16. Test-retest reliability of pulse amplitude tonometry measures of vascular endothelial function: implications for clinical trial design.

    Science.gov (United States)

    McCrea, Cindy E; Skulas-Ray, Ann C; Chow, Mosuk; West, Sheila G

    2012-02-01

    Endothelial dysfunction is an important outcome for assessing vascular health in intervention studies. However, reliability of the standard non-invasive method (flow-mediated dilation) is a significant challenge for clinical applications and multicenter trials. We evaluated the repeatability of pulse amplitude tonometry (PAT) to measure change in pulse wave amplitude during reactive hyperemia (Itamar Medical Ltd, Caesarea, Israel). Twenty healthy adults completed two PAT tests (mean interval = 19.5 days) under standardized conditions. PAT-derived measures of endothelial function (reactive hyperemia index, RHI) and arterial stiffness (augmentation index, AI) showed strong repeatability (intra-class correlations = 0.74 and 0.83, respectively). To guide future research, we also analyzed sample size requirements for a range of effect sizes. A crossover design powered at 0.90 requires 28 participants to detect a 15% change in RHI. Our study is the first to show that PAT measurements are repeatable in adults over an interval greater than 1 week.

  17. Randomized Controlled Trial of Mind Reading and In Vivo Rehearsal for High-Functioning Children with ASD.

    Science.gov (United States)

    Thomeer, Marcus L; Smith, Rachael A; Lopata, Christopher; Volker, Martin A; Lipinski, Alanna M; Rodgers, Jonathan D; McDonald, Christin A; Lee, Gloria K

    2015-07-01

    This randomized controlled trial evaluated the efficacy of a computer software (i.e., Mind Reading) and in vivo rehearsal treatment on the emotion decoding and encoding skills, autism symptoms, and social skills of 43 children, ages 7-12 years with high-functioning autism spectrum disorder (HFASD). Children in treatment (n = 22) received the manualized protocol over 12 weeks. Primary analyses indicated significantly better posttest performance for the treatment group (compared to controls) on 3 of the 4 measures of emotion decoding and encoding and these were maintained at 5-week follow-up. Analyses of secondary measures favored the treatment group for 1 of the 2 measures; specifically, ASD symptoms were significantly lower at posttest and follow-up.

  18. Enhancing positive parent-child interactions and family functioning in a poverty sample: a randomized control trial.

    Science.gov (United States)

    Negrão, Mariana; Pereira, Mariana; Soares, Isabel; Mesman, Judi

    2014-01-01

    This study tested the attachment-based intervention program Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in a randomized controlled trial with poor families of toddlers screened for professional's concerns about the child's caregiving environment. The VIPP-SD is an evidence-based intervention, but has not yet been tested in the context of poverty. The sample included 43 families with 1- to 4-year-old children: mean age at the pretest was 29 months and 51% were boys. At the pretest and posttest, mother-child interactions were observed at home, and mothers reported on family functioning. The VIPP-SD proved to be effective in enhancing positive parent-child interactions and positive family relations in a severely deprived context. Results are discussed in terms of implications for support services provided to such poor families in order to reduce intergenerational risk transmission.

  19. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial

    NARCIS (Netherlands)

    Vlieger, Arine M.; Menko-Frankenhuis, Carla; Wolfkamp, Simone C. S.; Tromp, Ellen; Benninga, Marc A.

    2007-01-01

    BACKGROUND & AIMS: Functional abdominal pain (FAP) and irritable bowel syndrome (IBS) are highly prevalent in childhood. A substantial proportion of patients continues to experience long-lasting symptoms. Gut-directed hypnotherapy (HT) has been shown to be highly effective in the treatment of adult

  20. Effect of modafinil on cognitive functions in alcohol dependent patients: a randomized, placebo-controlled trial

    NARCIS (Netherlands)

    Joos, Leen; Goudriaan, Anna E.; Schmaal, Lianne; van den Brink, Wim; Sabbe, Bernard G. C.; Dom, Geert

    2013-01-01

    Cognitive deficits are highly prevalent in alcohol-dependent (AD) patients and may have a detrimental impact on treatment response and treatment outcome. Enhancing cognitive functions may improve treatment success. Modafinil is a promising compound in this respect. Therefore, a randomized

  1. Effects of Aerobic Exercise on Overweight Children's Cognitive Functioning: A Randomized Controlled Trial

    Science.gov (United States)

    Davis, Catherine L.; Tomporowski, Phillip D.; Boyle, Colleen A.; Waller, Jennifer L.; Miller, Patricia H.; Naglieri, Jack A.; Gregoski, Mathew

    2007-01-01

    The study tested the effect of aerobic exercise training on executive function in overweight children. Ninety-four sedentary, overweight but otherwise healthy children (mean age = 9.2 years, body mass index [greater than or equal to] 85th percentile) were randomized to a low-dose (20 min/day exercise), high-dose (40 min/day exercise), or control…

  2. Student and Teacher Outcomes of the Class-Wide Function-Related Intervention Team Efficacy Trial

    Science.gov (United States)

    Wills, Howard; Kamps, Debra; Fleming, Kandace; Hansen, Blake

    2016-01-01

    Schools continue to strive for the use of evidenced-based interventions and policies to foster well-managed classrooms that promote improved student outcomes. The present study examined the effects of the Class-Wide Function-related Intervention Teams (CW-FIT), a group contingency intervention, on the on-task and disruptive behavior of elementary…

  3. Yoga Therapy for Abdominal Pain-Related Functional Gastrointestinal Disorders in Children: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Korterink, Judith J.; Ockeloen, Lize E.; Hilbink, Mirrian; Benninga, Marc A.; Deckers-Kocken, Judith M.

    2016-01-01

    The aim of the present study was to compare effects of 10 weeks of yoga therapy (YT) and standard medical care (SMC) on abdominal pain and quality of life (QoL) in children with abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). Sixty-nine patients, ages 8 to 18 years, with

  4. Functional exercise after total hip replacement (FEATHER): a randomised control trial.

    LENUS (Irish Health Repository)

    Monaghan, Brenda

    2012-11-01

    Prolonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR). It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life.

  5. Epidermal growth factor receptor (EGFR) and EGFR mutations, function and possible role in clinical trials

    National Research Council Canada - National Science Library

    Rude Voldborg, B; Damstrup, L; Spang-Thomsen, M; Skovgaard Poulsen, H

    1997-01-01

    ... ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Epidermal growth factor receptor (EGFR) and EGFR mutations, function a n dp o s s i b l er o l ei nc l i n i c a lt r i a l s B. Rude V oldborg, 1 L. Damstrup, 1 M...

  6. Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Natour, Jamil; Cazotti, Luciana de Araujo; Ribeiro, Luiza Helena; Baptista, Andréia Salvador; Jones, Anamaria

    2015-01-01

    To assess the effectiveness of pilates method on patients with chronic non-specific low back pain (LBP). A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP. Patients were randomly assigned to one of two groups: Experimental Group (EG) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group (CG) that continue medication treatment with use of NSAID and did not undergo any other intervention. A blinded assessor performed all evaluations at baseline (T0), after 45, 90, and 180 days (T45, T90 and T180) for: pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36), satisfaction with treatment (Likert scale), flexibility (sit and reach test) and NSAID intake. The groups were homogeneous at baseline. Statistical differences favoring the EG were found with regard to pain (P pain (P pain medication at T45, T90 and T180 (P pilates method can be used by patients with LBP to improve pain, function and aspects related to quality of life (functional capacity, pain and vitality). Moreover, this method has no harmful effects on such patients. © The Author(s) 2014.

  7. Comparison effect of physiotherapy with surgery on sexual function in patients with pelvic floor disorder: A randomized clinical trial

    Science.gov (United States)

    Eftekhar, Tahereh; Sohrabi, Maryam; Haghollahi, Fedyeh; Shariat, Mamak; Miri, Elahe

    2014-01-01

    Background: Female sexual dysfunction is a common problem among general population, especially in urogynecological patient, and can lead to a decrease in quality of life and affect martial relationship. Objective: This study was compared the effect of surgical methods versus physiotherapy on sexual function in pelvic floor disorder. Materials and Methods: This randomized controlled trial was performed in Urogynecology clinic since August 2007 to December 2009 on 90 patients aged from 25-55 years with previous delivery, positive history of sexual dysfunction with stage Kegel exercises). The female sexual function index (FSFI) used to evaluate the sexual function in cases before and after intervention. Frequency of variable scores (libido, orgasm, dysparunia) included without disorder, frequently good, sometimes good, very much and extreme were compared between two groups. Results: Libido and arousal were improved in both groups (p=0.007, p=0.001 respectively). Orgasm and dyspareunia were improved in group B (p=0.001). Dysparunia was more painful in group A. There was significant difference between two groups (improvement of orgasm and dysparunia in group B) (p=0.001). Conclusion: It seems that physiotherapy is an appropriate method for treatment of sexual disorder in pelvic floor disorder. Registration ID in IRCT: IRCT2013031112790N1. PMID:24799856

  8. Comparison of the effects of xenon and sevoflurane anaesthesia on leucocyte function in surgical patients: a randomized trial.

    Science.gov (United States)

    Fahlenkamp, A V; Coburn, M; Rossaint, R; Stoppe, C; Haase, H

    2014-02-01

    While most anaesthetics are known to suppress immune reactions, data from experimental studies indicate the enhancement of reactivity to inflammatory stimulators under xenon treatment. We investigated the effect of xenon anaesthesia on leucocyte function in surgical patients. We performed a subgroup analysis of subjects undergoing xenon or sevoflurane anaesthesia in a randomized clinical trial. After oral premedication with midazolam, two separate blood samples were obtained from subjects undergoing elective abdominal surgery, directly before and 1 h after induction of anaesthesia. General anaesthesia was maintained with either 60% xenon or 2.0% sevoflurane in 30% O2. Leucocyte count, phagocytotic function, and pro-inflammatory cytokine release after ex vivo lipopolysaccharide (LPS) stimulation were determined. Except for lymphocyte numbers, leucocyte subpopulations did not differ between the groups. Phagocytosis and oxidative burst of granulocytes were reduced in both groups after 1 h of anaesthesia, whereas monocytes were not affected. Pro-inflammatory cytokine release in response to LPS was not affected. In vivo, xenon and sevoflurane anaesthesia did not have a pro-inflammatory effect, at least in combination with the types of surgery performed in this study. Notably, the impact of xenon anaesthesia did not differ significantly from sevoflurane anaesthesia with regard to leucocyte function. However, an underestimation of treatment effects due to limited sample sizes cannot be fully excluded.

  9. Comparison effect of physiotherapy with surgery on sexual function in patients with pelvic floor disorder: A randomized clinical trial.

    Science.gov (United States)

    Eftekhar, Tahereh; Sohrabi, Maryam; Haghollahi, Fedyeh; Shariat, Mamak; Miri, Elahe

    2014-01-01

    Female sexual dysfunction is a common problem among general population, especially in urogynecological patient, and can lead to a decrease in quality of life and affect martial relationship. This study was compared the effect of surgical methods versus physiotherapy on sexual function in pelvic floor disorder. This randomized controlled trial was performed in Urogynecology clinic since August 2007 to December 2009 on 90 patients aged from 25-55 years with previous delivery, positive history of sexual dysfunction with stage female sexual function index (FSFI) used to evaluate the sexual function in cases before and after intervention. Frequency of variable scores (libido, orgasm, dysparunia) included without disorder, frequently good, sometimes good, very much and extreme were compared between two groups. Libido and arousal were improved in both groups (p=0.007, p=0.001 respectively). Orgasm and dyspareunia were improved in group B (p=0.001). Dysparunia was more painful in group A. There was significant difference between two groups (improvement of orgasm and dysparunia in group B) (p=0.001). It seems that physiotherapy is an appropriate method for treatment of sexual disorder in pelvic floor disorder. IRCT2013031112790N1.

  10. "Keep your brain fit!" Effectiveness of a psychoeducational intervention on cognitive functioning in healthy adults: A randomised controlled trial.

    Science.gov (United States)

    Reijnders, Jennifer S A M; Geusgens, Chantal A V; Ponds, Rudolf W H M; van Boxtel, Martin P J

    2017-06-01

    A psychoeducational intervention (Keep your brain fit!) was designed for the middle-aged and older working population. The intervention focuses on increasing knowledge and awareness about cognitive ageing and teaching strategies to cope with cognitive changes. The primary aim of this study was to investigate the effectiveness of the e-health intervention in terms of subjective cognitive functioning. As secondary aims, objective cognitive functioning and psychological well-being were also measured. A randomised controlled trial that included people aged 40 to 65 years was conducted. A maximum of 4 weeks was allowed to complete the intervention. The outcome measures were obtained from an online test battery that was administered at baseline, post-test and at 4-week follow-up. A total of 376 participants completed the whole study. After the intervention, the experimental group reported more feelings of stability concerning memory functioning and perceived greater locus of control over memory compared to the control group. These effects were maintained at the 4-week follow-up. Taking into account the relatively low costs and easy accessibility of this e-health intervention, we consider the programme to be a valuable contribution to public healthcare interventions for middle-aged and older adults.

  11. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency.

    Science.gov (United States)

    Kapadia, Naaz; Masani, Kei; Catharine Craven, B; Giangregorio, Lora M; Hitzig, Sander L; Richards, Kieva; Popovic, Milos R

    2014-09-01

    Multi-channel surface functional electrical stimulation (FES) for walking has been used to improve voluntary walking and balance in individuals with spinal cord injury (SCI). To investigate short- and long-term benefits of 16 weeks of thrice-weekly FES-assisted walking program, while ambulating on a body weight support treadmill and harness system, versus a non-FES exercise program, on improvements in gait and balance in individuals with chronic incomplete traumatic SCI, in a randomized controlled trial design. Individuals with traumatic and chronic (≥18 months) motor incomplete SCI (level C2 to T12, American Spinal Cord Injury Association Impairment Scale C or D) were recruited from an outpatient SCI rehabilitation hospital, and randomized to FES-assisted walking therapy (intervention group) or aerobic and resistance training program (control group). Outcomes were assessed at baseline, and after 4, 6, and 12 months. Gait, balance, spasticity, and functional measures were collected. Spinal cord independence measure (SCIM) mobility sub-score improved over time in the intervention group compared with the control group (baseline/12 months: 17.27/21.33 vs. 19.09/17.36, respectively). On all other outcome measures the intervention and control groups had similar improvements. Irrespective of group allocation walking speed, endurance, and balance during ambulation all improved upon completion of therapy, and majority of participants retained these gains at long-term follow-ups. Task-oriented training improves walking ability in individuals with incomplete SCI, even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES-assisted treadmill training is superior to aerobic and strength training.

  12. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse".

    Science.gov (United States)

    Jansen, Merel; van Alfen, Nens; Geurts, Alexander C H; de Groot, Imelda J M

    2013-01-01

    Physical training might delay the functional deterioration caused by disuse in boys with Duchenne muscular dystrophy (DMD). The "No Use Is Disuse" study is the first explorative, randomized controlled trial in boys with DMD to examine whether assisted bicycle training is feasible, safe, and beneficial. Ambulatory and recently wheelchair-dependent boys with DMD were allocated to the intervention or control group. The intervention group received assisted bicycle training of the legs and arms during 24 weeks. The control group received the same training after a waiting period of 24 weeks. The primary study outcomes were the Motor Function Measure (MFM) and the Assisted 6-Minute Cycling Test (A6MCT). Group differences were examined by an analysis of covariance. Thirty boys (mean age 10.5 ± 2.6 years, 18 ambulant and 12 wheelchair-dependent) were allocated to the intervention (n = 17) or the control (n = 13) group. All boys in the intervention group (except one) completed the training. After 24 weeks, the total MFM score remained stable in the intervention group, whereas it had significantly decreased in the control group (Δ = 4.9, 95% confidence interval = 2.2-7.6). No significant group differences were found for the A6MCT. No serious adverse events were observed. Our results suggest that assisted bicycle training of the legs and arms is feasible and safe for both ambulant and wheelchair-dependent children and may decline the deterioration due to disuse. Progressive deterioration, however, may compromise the design of trials for DMD.

  13. Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations.

    Science.gov (United States)

    Rief, Winfried; Burton, Chris; Frostholm, Lisbeth; Henningsen, Peter; Kleinstäuber, Maria; Kop, Willem J; Löwe, Bernd; Martin, Alexandra; Malt, Ulrik; Rosmalen, Judith; Schröder, Andreas; Shedden-Mora, Meike; Toussaint, Anne; van der Feltz-Cornelis, Christina

    The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.

  14. Evaluating the effectiveness of a family empowerment program on family function and pulmonary function of children with asthma: A randomized control trial.

    Science.gov (United States)

    Yeh, Hsiu-Ying; Ma, Wei-Fen; Huang, Jing-Long; Hsueh, Kai-Chung; Chiang, Li-Chi

    2016-08-01

    Empowerment can be an effective strategy for changing an individual's health behaviours. However, how to empower whole families to manage their children's asthma is a challenge that requires innovative nursing intervention based on family-centred care. To evaluate the effectiveness of a family empowerment program on family function and pulmonary function of children with asthma compared to those receiving traditional self-management only. A randomized control trial. Sixty-five families were recruited from one asthma clinic in a medical centre in Taiwan. After random assignment, 34 families in the experimental group received the family empowerment program consisting of four counselling dialogues with the child and its family. We empowered the family caregiver's ability to manage their child's asthma problems through finding the problems in the family, discovery and discussion about the way to solve problems, and enabling the family's cooperation and asthma management. The other 31 families received the traditional care in asthma clinics. The Parental Stress Index and Family Environment Scale of family caregivers, and pulmonary function, and asthma signs of children with asthma were collected at pre-test, 3-month post-test, and one-year follow-up. We utilized the linear mixed model in SPSS (18.0) to analyze the effects between groups, across time, and the interaction between group and time. The family empowerment program decreased parental stress (F=13.993, pfamily function (cohesion, expression, conflict solving, and independence) (F=19.848, pfamily caregiver's observations. We empowered families by listening, dialogues, reflection, and taking action based on Freire's empowerment theory. Nurses could initiate the families' life changes and assist children to solve the problems by themselves, which could yield positive health outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Pediatric functional constipation treatment with Bifidobacterium-containing yogurt: A crossover, double-blind, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Paula VP Guerra; Luiza N Lima; Tassia C Souza; Vanessa Mazochi; Francisco J Penna; Andreia M Silva; Jacques R Nicoli; Elizabet V Guimaraes

    2011-01-01

    AIM: To evaluate the treatment off pediatric ffunctional chronic intestinal constipation (FCIC) with a probiotic goat yogurt. METHODS: A crossover double-blind fformula-con- trolled trial was carried out on 59 students (age range: 5-15 years) off a public school in Belo Horizonte, MG, Brazil, presenting a FCIC diagnostic, according to Roma Ⅲ criteria. The students were randomized in two groups to receive a goat yogurt supplemented with 109 colony fforming unit/mL Biffidobacterium longum (B. longum) (probiotic) daily or only the yogurt ffor a period off 5 wk (fformula). Affterwards, the groups were intercrossed another 5 wk. DDeffecation ffrequency, stool consistency and abdominal and deffecation pain were assessed. RESULTS: Both treatment groups demonstrated improvement in deffecation ffrequency compared to baseline. However, the group treated with probiotic showed most significant improvement in the first phase of the study. An inversion was observed affter crossing over, resulting in a reduction in stool when this group was treated by fformula. Probiotic and fformula improved stool consistency in the first phase of treatment, but the improvement obtained with probiotic was signifficantly higher (P = 0.03). In the second phase off treatment, the group initially treated with probiotic showed worseningstool consistency when using fformula. However, the difference was not significant. A significant improvement in abdominal pain and deffecation pain was observed with both probiotic and fformula in the ffirst phase off treatment, but again the improvement was more significant ffor the group treated with B. longum during phase I (P < 0.05). When all data off the crossover study were analyzed, signifficant difffferences were observed between probiotic yogurt and yogurt only ffor deffecation ffrequency (P = 0.012), deffecation pain (P = 0.046) and abdominal pain (P = 0.015). CONCLUSION: An improvement in deffecation ffrequen- cy and abdominal pain was observed using

  16. Neuropsychological functioning in adolescents with anorexia nervosa before and after cognitive remediation therapy: a feasibility trial.

    Science.gov (United States)

    Dahlgren, Camilla Lindvall; Lask, Bryan; Landrø, Nils Inge; Rø, Øyvind

    2013-09-01

    To investigate neuropsychological functioning in adolescents with anorexia nervosa (AN) before and after receiving cognitive remediation therapy (CRT). Twenty young females with AN participated in an individually-delivered CRT treatment program. Neuropsychological and psychiatric assessments were administered before and after treatment. Weight, depression, anxiety, duration of illness, and level of eating disorder psychopathology were considered as covariates in statistical analyses. Significant changes in weight, depression, visio-spatial memory, perceptual disembedding abilities, and verbal fluency were observed. Changes in weight had a significant effect on improvements in visuo-spatial memory and verbal fluency. Results also revealed a significant effect of depressive symptoms on perceptual disembedding abilities. The results suggest improvements on a number of neuropsychological functions during the course of CRT. Future studies should explore the use of additional assessment instruments, and include control groups to assess the effectiveness of the intervention. Copyright © 2013 Wiley Periodicals, Inc.

  17. Functional effects of losartan in hypertrophic cardiomyopathy-a randomised clinical trial.

    Science.gov (United States)

    Axelsson, Anna; Iversen, Kasper; Vejlstrup, Niels; Ho, Carolyn Y; Havndrup, Ole; Kofoed, Klaus F; Norsk, Jakob; Jensen, Morten; Bundgaard, Henning

    2016-02-15

    There is a lack of disease-modifying treatments in hypertrophic cardiomyopathy (HCM). The aim of this randomised, placebo-controlled study was to assess if losartan could improve or ameliorate deterioration of cardiac function and exercise capacity. Echocardiography, exercise test and MRI or CT were performed at baseline and after 12 months in 133 patients (52±13 years, 35% female) randomly allocated to losartan (100 mg/day) or placebo. Losartan had no effect on systolic function compared with placebo (mean difference for left ventricular ejection fraction (LVEF) 0% (95% CI -3% to 4%), p=0.84 or global longitudinal strain 0.7% (95% CI -0.2% to 1.6%), p=0.13). Neither Doppler measures of diastolic function, left atrial volume (mean difference 2 mL/m(2) (95% CI -4 to 8 mL/m(2)) p=0.53) nor exercise capacity (mean difference -0.3 metabolic equivalents (METS) (95% CI -1.0 to 0.3 METS), p=0.28) differed between the treatment groups. At follow-up, there was further progression of disease, with the most prominent impairment being an increase in left atrial volume of 6 mL/m(2) (95% CI 3 to 9 mL/m(2), plosartan had no effect on cardiac function or exercise capacity compared with placebo. Losartan fail to improve myocardial performance and failed to alter the progression of the disease. These findings do not support the use of angiotensin II receptor blockers as disease modifiers in adult patients with overt HCM. NCT01447654-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  18. A multicenter cluster randomized controlled trial of strategies to improve thyroid function testing.

    Science.gov (United States)

    Daucourt, Valentin; Saillour-Glénisson, Florence; Michel, Philippe; Jutand, Marthe-Aline; Abouelfath, Abdelilah

    2003-03-01

    This project aimed to compare the independent and combined effectiveness of two implementation interventions of guidelines for ordering thyroid function tests: a Memorandum Pocket Card (MPC) and a Test Request Form (TRF). Intervention groups were wards. The study used an experimental 2*2 factorial design with matching hospitals according to size and activity and wards according to preintervention appropriateness for test ordering. Four ward groups were established: the dual intervention group, the order form group, the pocket card group and the control group. Physicians in all groups received guidelines and were invited to a local information meeting. The main outcome measure of effectiveness was the Guideline Conformity Rate (GCR). Six hospitals participated in the study (two middle-sized hospitals, two small-sized hospitals and two psychiatric hospitals). A total of 1412 orders for thyroid function tests were collected. GCR was 78% in the dual intervention group, 83% in the order form group, 73% in the pocket card group and 62% in the control group. The interaction between TRF and MPC was not significant (beta = -0.70; P = 0.21). Compared with simple information, TRF was effective in increasing GCR (OR, 2.65; 95% CI, 1.52-4.62), unlike MPC (OR, 1.28; CI, 0.75-2.19). Using a robust design, our study shows the greater effectiveness of TRF than MPC and their association in implementing thyroid function test guidelines.

  19. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction.

    Science.gov (United States)

    Birmingham, Trevor B; Bryant, Dianne M; Giffin, J Robert; Litchfield, Robert B; Kramer, John F; Donner, Allan; Fowler, Peter J

    2008-04-01

    Despite a lack of evidence for their effectiveness, functional knee braces are commonly prescribed to patients after anterior cruciate ligament (ACL) reconstruction. This trial was conducted to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve. Patients using a brace will have superior outcomes than those using a sleeve. Randomized controlled clinical trial; Level of evidence, 1. One hundred fifty patients were randomized to receive a brace (n = 76) or neoprene sleeve (n = 74) at their 6-week postoperative visit after primary ACL reconstruction with hamstring autograft. Patients were assessed preoperatively, then 6 weeks and 6, 12, and 24 months postoperatively. Outcome measures included disease-specific quality of life (Anterior Cruciate Ligament-Quality of Life [ACL-QOL] Questionnaire), anterior tibial translation (KT-1000 arthrometer side-to-side difference), the single-limb forward hop test (limb symmetry index), and Tegner Activity Scale. Outcomes at 1 and 2 years were compared after adjusting for baseline scores. Subjective ratings of how patients felt while using the brace/sleeve were also collected for descriptive purposes using a questionnaire. Four a priori directional subgroup hypotheses were evaluated using tests for interactions. There were no significant differences between brace (n = 62) and sleeve (n = 65) groups for any of the outcomes at 1- and 2-year follow-ups. Adjusted mean differences at 2 years were as follows: -0.94 (95% confidence interval [CI], -7.52 to 5.64) for the ACL-QOL Questionnaire, -0.10 mm (95% CI, -0.99 to 0.81) for KT-1000 arthrometer side-to-side difference, -0.87% (95% CI, -8.89 to 7.12) for hop limb symmetry index, and -0.05 (95% CI, -0.72 to 0.62) for the Tegner Activity Scale. Subjective ratings of confidence in the knee provided by the brace/sleeve were higher for the brace group than the sleeve group. Subgroup findings were minimal. Adverse events were

  20. The ANKLE TRIAL (ANKLE treatment after injuries of the ankle ligaments: what is the benefit of external support devices in the functional treatment of acute ankle sprain? : a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Witjes Suzanne

    2012-02-01

    Full Text Available Abstract Background Acute lateral ankle ligament injuries are very common problems in present health care. Still there is no hard evidence about which treatment strategy is superior. Current evidence supports the view that a functional treatment strategy is preferable, but insufficient data are present to prove the benefit of external support devices in these types of treatment. The hypothesis of our study is that external ankle support devices will not result in better outcome in the treatment of acute ankle sprains, compared to a purely functional treatment strategy. Overall objective is to compare the results of three different strategies of functional treatment for acute ankle sprain, especially to determine the advantages of external support devices in addition to functional treatment strategy, based on balance and coordination exercises. Methods/design This study is designed as a randomised controlled multi-centre trial with one-year follow-up. Adult and healthy patients (N = 180 with acute, single sided and first inversion trauma of the lateral ankle ligaments will be included. They will all follow the same schedule of balancing exercises and will be divided into 3 treatment groups, 1. pressure bandage and tape, 2. pressure bandage and brace and 3. no external support. Primary outcome measure is the Karlsson scoring scale; secondary outcomes are FAOS (subscales, number of recurrent ankle injuries, Visual Analogue Scales of pain and satisfaction and adverse events. They will be measured after one week, 6 weeks, 6 months and 1 year. Discussion The ANKLE TRIAL is a randomized controlled trial in which a purely functional treated control group, without any external support is investigated. Results of this study could lead to other opinions about usefulness of external support devices in the treatment of acute ankle sprain. Trial registration Netherlands Trial Register (NTR: NTR2151

  1. Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: a randomized clinical trial.

    Science.gov (United States)

    Baldon, Rodrigo de Marche; Serrão, Fábio Viadanna; Scattone Silva, Rodrigo; Piva, Sara Regina

    2014-04-01

    Randomized clinical trial. To compare the effects of functional stabilization training (FST) versus standard training on knee pain and function, lower-limb and trunk kinematics, trunk muscle endurance, and eccentric hip and knee muscle strength in women with patellofemoral pain. A combination of hip- and knee-strengthening exercise may be more beneficial than quadriceps strengthening alone to improve pain and function in individuals with patellofemoral pain. However, there is limited evidence of the effectiveness of these exercise programs on the biomechanics of the lower extremity. Thirty-one women were randomized to either the FST group or standard-training group. Patients attended a baseline assessment session, followed by an 8-week intervention, and were reassessed at the end of the intervention and at 3 months after the intervention. Assessment measures were a 10-cm visual analog scale for pain, the Lower Extremity Functional Scale, and the single-leg triple-hop test. A global rating of change scale was used to measure perceived improvement. Kinematics were assessed during the single-leg squat. Outcome measures also included trunk endurance and eccentric hip and knee muscle strength assessment. The patients in the FST group had less pain at the 3-month follow-up and greater global improvement and physical function at the end of the intervention compared to those in the standard-training group. Lesser ipsilateral trunk inclination, pelvis contralateral depression, hip adduction, and knee abduction, along with greater pelvis anteversion and hip flexion movement excursions during the single-leg squat, were only observed in the FST group after the intervention. Only those in the FST group had greater eccentric hip abductor and knee flexor strength, as well as greater endurance of the anterior, posterior, and lateral trunk muscles, after training. An intervention program consisting of hip muscle strengthening and lower-limb and trunk movement control exercises was

  2. Mixed-meal tolerance test versus glucagon stimulation test for the assessment of beta-cell function in therapeutic trials in type 1 diabetes

    DEFF Research Database (Denmark)

    Greenbaum, Carla J; Mandrup-Poulsen, Thomas; McGee, Paula Friedenberg

    2008-01-01

    OBJECTIVE: Beta-cell function in type 1 diabetes clinical trials is commonly measured by C-peptide response to a secretagogue in either a mixed-meal tolerance test (MMTT) or a glucagon stimulation test (GST). The Type 1 Diabetes TrialNet Research Group and the European C-peptide Trial (ECPT) Study...... Group conducted parallel randomized studies to compare the sensitivity, reproducibility, and tolerability of these procedures. RESEARCH DESIGN AND METHODS: In randomized sequences, 148 TrialNet subjects completed 549 tests with up to 2 MMTT and 2 GST tests on separate days, and 118 ECPT subjects...... completed 348 tests (up to 3 each) with either two MMTTs or two GSTs. RESULTS: Among individuals with up to 4 years' duration of type 1 diabetes, >85% had measurable stimulated C-peptide values. The MMTT stimulus produced significantly higher concentrations of C-peptide than the GST. Whereas both tests were...

  3. Symptomatic response to blocked and unblocked pentagastrin stimulation in functional dyspepsia - Comparison of responders and non-responders to omeprazole identified in a single-subject trial model

    DEFF Research Database (Denmark)

    Madsen, L.G.; Bytzer, P.

    2008-01-01

    Background: The role of acid in functional dyspepsia is controversial and drug treatment trials indicate that only a subset of patients has acid-related symptoms. A novel single-subject trial design, the Random Starting Day trial (RSD trial), was developed to identify acid-related symptoms. We...... was expected not to be influenced by gastric acid stimulation or type of treatment. Methods: Nineteen patients were evaluated. Symptomatic response to pentagastrin (6 mu g/kg) was assessed twice in each patient following placebo and omeprazole (40 mg bid) treatment in a randomized, double-blind, cross......-over design. Epigastric pain was assessed every 15 for 90 min after stimulation using a 5-graded Likert scale and a VAS scale. A positive acid provocation test was defined as an increase of the Likert score of epigastric pain by at least one grade after pentagastrin stimulation during placebo treatment...

  4. Internet-delivered cognitive behavior therapy for adolescents with functional gastrointestinal disorders — An open trial

    Directory of Open Access Journals (Sweden)

    Marianne Bonnert

    2014-07-01

    Full Text Available Functional gastrointestinal disorders (FGID, including irritable bowel syndrome, functional dyspepsia and functional abdominal pain, are common in adolescents and are associated with substantially decreased quality of life. Cognitive behavior therapy for children and adolescents with FGID is one of few treatments that have shown effect, but treatment access is limited. In adults with irritable bowel syndrome, exposure-based internet-delivered CBT (ICBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This open pilot aimed to evaluate feasibility and the potential efficacy of an exposure-based ICBT-program for adolescents with pain-predominant FGID. Twenty-nine adolescents (age 13–17, with FGID were included. The ICBT-program lasted for 8 weeks with weekly online therapist support. The protocol for adolescents included exposure to abdominal symptoms, while the protocol for parents aimed at increasing parents' attention to adolescent healthy behaviors. Assessment points were baseline, post-treatment and 6-month follow-up. The primary outcome was the Gastrointestinal Symptoms Rating Scale-IBS (GSRS-IBS. Effect sizes were calculated using Cohen's d in an intent to treat analysis. GSRS-IBS improved significantly from baseline to post-treatment (mean difference 6.48; 95% CI [2.37–10.58] and to follow-up (mean difference 7.82; 95% CI [3.43–12.21], corresponding to moderate effect sizes (within-group Cohen's d = 0.50; 95% CI [0.16–0.84] and d = 0.63; 95% CI [0.24–1.02], respectively. Treatment adherence was high with 22 of 29 (76% adolescents completing the entire treatment period. High adherence indicates acceptability of format and content, while symptomatic improvement suggests potential efficacy for this ICBT intervention in adolescents with FGID.

  5. Effects of combined training vs aerobic training on cognitive functions in COPD: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Aquino G

    2016-04-01

    Full Text Available Giovanna Aquino,1 Enzo Iuliano,1 Alessandra di Cagno,2 Angela Vardaro,3 Giovanni Fiorilli,1 Stefano Moffa,1 Alfonso Di Costanzo,1 Giuseppe De Simone,3 Giuseppe Calcagno1 1Department of Medicine and Health Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, 2Department of Health Science, University ForoItalico, Rome, 3“Villa Margherita”, Benevento, Italy Aim: The aim of this study was to investigate the effects of high-intensity aerobic training (AT and high-intensity aerobic training combined with resistance training (ie, combined training [CT] on cognitive function in patients with COPD. Methods: Twenty-eight Caucasian male patients (68.35±9.64 years; mean ± SD with COPD were recruited and randomized into two groups, AT and CT. Both groups performed physical reconditioning for 4 weeks, with a frequency of five training sessions per week. The CT group completed two daily sessions of 30 minutes: one aerobic session and one strength session, respectively; The AT group performed two 30-minute aerobic endurance exercise sessions on treadmill. Physical and cognitive function tests were performed before and after the training intervention performances. Results: Exercise training improved the following cognitive functions: long-term memory, verbal fluency, attentional capacity, apraxia, and reasoning skills (P<0.01. Moreover, the improvements in the CT group were significantly greater than those in the AT group in long-term memory, apraxia, and reasoning skills (P<0.05. Conclusion: CT may be a possible strategy to prevent cognitive decline and associated comorbidities in male patients with COPD. Keywords: physical training, cognition, resistance training, rehabilitation, respiratory disease

  6. COMPRESSION SOCKS AND FUNCTIONAL RECOVERY FOLLOWING MARATHON RUNNING: A RANDOMISED CONTROLLED TRIAL.

    Science.gov (United States)

    Armstrong, Stuart A; Till, Eloise S; Maloney, Stephen; Harris, Gregory

    2014-09-02

    Compression socks have become a popular recovery aid for distance running athletes. Although some physiological markers have been shown to be influenced by wearing these garments, scant evidence exists on their effects on functional recovery. This research aims to shed light onto whether the wearing of compression socks for 48 hours after marathon running can improve functional recovery, as measured by a timed treadmill test to exhaustion 14 days following marathon running.Athletes (n=33, age = 38.5 ±7.2yrs) participating in the 2012 Melbourne, 2013 Canberra or 2013 Gold Coast marathons were recruited and randomised into the compression sock or placebo group. A graded treadmill test to exhaustion was performed 2 weeks prior and 2 weeks following each marathon. Time to exhaustion, average and maximum heart rates were recorded. Participants were asked to wear their socks for 48 hours immediately after completion of the marathon. The change in treadmill times (seconds) was recorded for each participant.33 participants completed the treadmill protocols. In the compression group average treadmill run to exhaustion time 2 weeks following the marathon increased by 2.6% (52s ±103s). In the placebo group run to exhaustion time decreased by 3.4% (-62s ±130s). P=0.009. This shows a significant beneficial effect of compression socks on recovery compared to placebo.The wearing of below knee compression socks for 48 hours after marathon running has been shown to improve functional recovery as measured by a graduated treadmill test to exhaustion 2 weeks following the event.

  7. Compression socks and functional recovery following marathon running: a randomized controlled trial.

    Science.gov (United States)

    Armstrong, Stuart A; Till, Eloise S; Maloney, Stephen R; Harris, Gregory A

    2015-02-01

    Compression socks have become a popular recovery aid for distance running athletes. Although some physiological markers have been shown to be influenced by wearing these garments, scant evidence exists on their effects on functional recovery. This research aims to shed light onto whether the wearing of compression socks for 48 hours after marathon running can improve functional recovery, as measured by a timed treadmill test to exhaustion 14 days following marathon running. Athletes (n = 33, age, 38.5 ± 7.2 years) participating in the 2012 Melbourne, 2013 Canberra, or 2013 Gold Coast marathons were recruited and randomized into the compression sock or placebo group. A graded treadmill test to exhaustion was performed 2 weeks before and 2 weeks after each marathon. Time to exhaustion, average and maximum heart rates were recorded. Participants were asked to wear their socks for 48 hours immediately after completion of the marathon. The change in treadmill times (seconds) was recorded for each participant. Thirty-three participants completed the treadmill protocols. In the compression group, average treadmill run to exhaustion time 2 weeks after the marathon increased by 2.6% (52 ± 103 seconds). In the placebo group, run to exhaustion time decreased by 3.4% (-62 ± 130 seconds), P = 0.009. This shows a significant beneficial effect of compression socks on recovery compared with placebo. The wearing of below-knee compression socks for 48 hours after marathon running has been shown to improve functional recovery as measured by a graduated treadmill test to exhaustion 2 weeks after the event.

  8. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Soehner, Adriane M; Kaplan, Kate A; Hein, Kerrie; Lee, Jason; Kanady, Jennifer; Li, Descartes; Rabe-Hesketh, Sophia; Ketter, Terence A; Neylan, Thomas C; Buysse, Daniel J

    2015-06-01

    To determine if a treatment for interepisode bipolar disorder I patients with insomnia improves mood state, sleep, and functioning. Alongside psychiatric care, interepisode bipolar disorder I participants with insomnia were randomly allocated to a bipolar disorder-specific modification of cognitive behavior therapy for insomnia (CBTI-BP; n = 30) or psychoeducation (PE; n = 28) as a comparison condition. Outcomes were assessed at baseline, the end of 8 sessions of treatment, and 6 months later. This pilot was conducted to determine initial feasibility and generate effect size estimates. During the 6-month follow-up, the CBTI-BP group had fewer days in a bipolar episode relative to the PE group (3.3 days vs. 25.5 days). The CBTI-BP group also experienced a significantly lower hypomania/mania relapse rate (4.6% vs. 31.6%) and a marginally lower overall mood episode relapse rate (13.6% vs. 42.1%) compared with the PE group. Relative to PE, CBTI-BP reduced insomnia severity and led to higher rates of insomnia remission at posttreatment and marginally higher rates at 6 months. Both CBTI-BP and PE showed statistically significant improvement on selected sleep and functional impairment measures. The effects of treatment were well sustained through follow-up for most outcomes, although some decline on secondary sleep benefits was observed. CBTI-BP was associated with reduced risk of mood episode relapse and improved sleep and functioning on certain outcomes in bipolar disorder. Hence, sleep disturbance appears to be an important pathway contributing to bipolar disorder. The need to develop bipolar disorder-specific sleep diary scoring standards is highlighted. (c) 2015 APA, all rights reserved).

  9. AAB and ABA Renewal as a Function of the Number of Extinction Trials in Conditioned Taste Aversion

    Science.gov (United States)

    Rosas, Juan M.; Garcia-Gutierrez, Ana; Callejas-Aguilera, Jose E.

    2007-01-01

    Three experiments explored renewal in conditioned taste aversion after different amounts of extinction. In Experiment 1, three groups of rats received a single conditioning trial where a saccharin solution was paired with LiCl, followed by 3 extinction trials, and a two-trial test. Groups differed in the context where they received each of the…

  10. Epidermal growth factor receptor (EGFR) and EGFR mutations, function and possible role in clinical trials

    DEFF Research Database (Denmark)

    Voldborg, B R; Damstrup, L; Spang-Thomsen, M

    1997-01-01

    in the intracellular region of the receptor. This tyrosine kinase phosphorylates a number of intracellular substrates that activates pathways leading to cell growth, DNA synthesis and the expression of oncogenes such as fos and jun. EGFR is thought to be involved the development of cancer, as the EGFR gene is often...... amplified, and/or mutated in cancer cells. In this review we will focus on: (I) the structure and function of EGFR, (II) implications of receptor/ligand coexpression and EGFR mutations or overexpression, (III) its effect on cancer cells, (IV) the development of the malignant phenotype and (V) the clinical...

  11. Physical activity, immune function and inflammation in kidney patients (the PINK study): a feasibility trial protocol.

    Science.gov (United States)

    Highton, Patrick James; Neale, Jill; Wilkinson, Thomas J; Bishop, Nicolette C; Smith, Alice C

    2017-05-29

    Patients with chronic kidney disease (CKD) display increased infection-related mortality and elevated cardiovascular risk only partly attributed to traditional risk factors. Patients with CKD also exhibit a pro-inflammatory environment and impaired immune function. Aerobic exercise has the potential to positively impact these detriments, but is under-researched in this patient population. This feasibility study will investigate the effects of acute aerobic exercise on inflammation and immune function in patients with CKD to inform the design of larger studies intended to ultimately influence current exercise recommendations. Patients with CKD, including renal transplant recipients, will visit the laboratory on two occasions, both preceded by appropriate exercise, alcohol and caffeine restrictions. On visit 1, baseline assessments will be completed, comprising anthropometrics, body composition, cardiovascular function and fatigue and leisure time exercise questionnaires. Participants will then undertake an incremental shuttle walk test to estimate predicted peak O 2 consumption (VO 2 peak). On visit 2, participants will complete a 20 min shuttle walk at a constant speed to achieve 85% estimated VO 2 peak. Blood and saliva samples will be taken before, immediately after and 1 hour after this exercise bout. Muscle O 2 saturation will be monitored throughout exercise and recovery. Age and sex-matched non-CKD 'healthy control' participants will complete an identical protocol. Blood and saliva samples will be analysed for markers of inflammation and immune function, using cytometric bead array and flow cytometry techniques. Appropriate statistical tests will be used to analyse the data. A favourable opinion was granted by the East Midlands-Derby Research Ethics Committee on 18 September 2015 (ref 15/EM/0391), and the study was approved and sponsored by University Hospitals of Leicester Research and Innovation (ref 11444). The study was registered with ISRCTN (ref

  12. Ventilatory function during exercise in multiple sclerosis and impact of training intervention: cross-sectional and randomized controlled trial.

    Science.gov (United States)

    Hansen, D; Wens, I; Keytsman, C; Verboven, K; Dendale, P; Eijnde, B O

    2015-10-01

    Patients with MS (pwMS) often experience resting ventilatory anomalies. Ventilatory function during exercise and impact of long-term training intervention remains however uncertain. The aim of this study was to examine the ventilatory function during exercise and impact of a 6-month training intervention in pwMS. Combination of a cross-sectional (part 1) and randomized controlled trial (part 2). University rehabilitation facility. Caucasian patients with MS and healthy controls. In part 1, the ventilatory function during submaximal endurance exercise was compared between pwMS (N.=37) and healthy participants (N.=15). In part 2, pwMS were then randomly assigned to a 6-month training intervention (N.=16) or usual care (N.=11). Following training intervention, ventilatory function during exercise was re-evaluated. Despite comparable relative exercise testing intensities between groups in part 1, significantly elevated steady-state exercise dead space/tidal volume ratio, O2 uptake and CO2 output equivalent, end-tidal O2 pressure, ratings of perceived exertion and lowered end-tidal CO2 pressure and O2 pulse was observed in pwMS (Ptraining intervention, ventilatory dysfunction remained present during endurance exercise (P>0.05). Patients with MS experience a ventilatory dysfunction during endurance exercise, which is related to worse exercise tolerance. This ventilatory anomaly remains present after long-term training intervention. Patients with MS experience ventilatory dysfunction during exercise. This dysfunction is related to exercise tolerance and ratings of perceived exertion. Long-term exercise training did not remediate this ventilatory dysfunction. The systematic examination of the pulmonary/cardiovascular system at rest and during exercise is recommended in MS.

  13. Probiotic Soy Milk Consumption and Renal Function Among Type 2 Diabetic Patients with Nephropathy: a Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Miraghajani, Maryam; Zaghian, Nafiseh; Dehkohneh, Abolfazl; Mirlohi, Maryam; Ghiasvand, Reza

    2017-09-08

    Diabetic nephropathy (DN) is one the most important complications of diabetes leading to end-stage renal disease. Dietary approaches have been considered to control of the kidney function deterioration among these patients. The aim of the present study was to determine the effects of fortified soy milk with Lactobacillus plantarum A7 on renal function biomarkers in type 2 DN patients. Forty-eight DN subjects were attended to this parallel randomized trial study. Participants were randomly assigned to consume a diet containing 200 mL/day probiotic soy milk in intervention group or soy milk in the control condition for 8 weeks. An inflammatory adipokine-Progranulin (PGRN), a cytokine receptor-soluble tumor necrosis factor receptor 1 (sTNFR1), and serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C (Cys-C) as the new renal function biomarkers were measured after 8 weeks of intervention according to the standard protocol. Our analysis showed that consumption of probiotic soy milk resulted in a significant reduction in the Cys-C and PGRN levels compared with the soy milk (P = 0.01) in the final adjusted model. In addition, after adjustment for age, weight, and energy intake, a marginally significant in the NGAL level was seen between two groups (P = 0.05). However, there was no significant differences on the sTNFR1concenteration between two groups (P = 0.06). Overall, intake of probiotic soy milk may have a beneficial effect on the renal function in patients with DN.

  14. Respiratory muscle training on pulmonary and swallowing function in patients with Huntington's disease: a pilot randomised controlled trial.

    Science.gov (United States)

    Reyes, Alvaro; Cruickshank, Travis; Nosaka, Kazunori; Ziman, Mel

    2015-10-01

    To examine the effects of 4-month of respiratory muscle training on pulmonary and swallowing function, exercise capacity and dyspnoea in manifest patients with Huntington's disease. A pilot randomised controlled trial. Home based training program. Eighteen manifest Huntington's disease patients with a positive genetic test and clinically verified disease expression, were randomly assigned to control group (n=9) and training group (n=9). Both groups received home-based inspiratory (5 sets of 5 repetitions) and expiratory (5 sets of 5 repetitions) muscle training 6 times a week for 4 months. The control group used a fixed resistance of 9 centimeters of water, and the training group used a progressively increased resistance from 30% to 75% of each patient's maximum respiratory pressure. Spirometric indices, maximum inspiratory pressure, maximum expiratory pressure, six minutes walk test, dyspnoea, water-swallowing test and swallow quality of life questionnaire were assessed before, at 2 and 4 months after training. The magnitude of increases in maximum inspiratory (d=2.9) and expiratory pressures (d=1.5), forced vital capacity (d=0.8), forced expiratory volume in 1 second (d=0.9) and peak expiratory flow (d=0.8) was substantially greater for the training group in comparison to the control group. Changes in swallowing function, dyspnoea and exercise capacity were small (d ≤ 0.5) for both groups without substantial differences between groups. A home-based respiratory muscle training program appeared to be beneficial to improve pulmonary function in manifest Huntington's disease patients but provided small effects on swallowing function, dyspnoea and exercise capacity. © The Author(s) 2015.

  15. Effect of occupational therapy on functional and emotional outcomes after hip fracture treatment: a randomized controlled trial.

    Science.gov (United States)

    Martín-Martín, Lydia M; Valenza-Demet, Gerald; Jiménez-Moleón, José Juan; Cabrera-Martos, Irene; Revelles-Moyano, Francisco Javier; Valenza, Marie Carmen

    2014-06-01

    To explore whether an occupational therapy intervention combined with physiotherapy rehabilitation improved hip fracture patient outcomes regarding emotional distress, fatigue, independence and function. Randomized controlled trial. Inpatient trauma ward in a rehabilitation and trauma hospital. One hundred and twenty-two patients admitted into hospital for hip fracture. Patients were randomly assigned to a standard care group (SC, n = 61) or a combined treatment group (CT, n = 61). The SC group received conventional hospital care for hip fracture patients and the CT group underwent occupational therapy as well. Patients' emotional distress (GHQ-28), perceived fatigue (the first item of the BASDAI using a 0-100 visual analogue scale scale), level of independence (Modified Barthel Index) and function (Harris Hip Score) were measured at baseline and one, three and six months after the intervention. Patients in the CT group experienced a considerable decrease of emotional distress at three and six months (p = 0.005 and p < 0.001, respectively). A between-group analysis showed significant differences in emotional distress at one, three and six months (p < 0.001). Although fatigue levels decreased in the SC group, the most significant decline was reported by the CT group at six months (p < 0.001, mean difference = 14 points). Regarding independence level, significant differences were found within groups at each stage, but also between groups at one month in favor of the CT group. Function improved in both groups compared with baseline (p < 0.001), but no significant differences were found in functionality between groups. Although both groups reported significant improvements, patients in the CT group had better scores in emotional distress and dependence throughout follow-up and better scores in all measures at six months. © The Author(s) 2013.

  16. Effect of oral appliance therapy on neurobehavioral functioning in obstructive sleep apnea: a randomized controlled trial.

    Science.gov (United States)

    Naismith, Sharon L; Winter, Virginia R; Hickie, Ian B; Cistulli, Peter A

    2005-10-15

    This study aimed to assess the efficacy of a custom-made mandibular advancement splint for the treatment of obstructive sleep apnea with respect to neuropsychological functioning and mood state. A randomized controlled crossover design was used in which 73 participants (mean age = 48.4, SD = 11.0, % men = 80.8) with at least 2 symptoms of obstructive sleep apnea and an apnea hypopnea index > or = 10 per hour underwent treatment with both mandibular advancement splint and an inactive oral device. Polysomnographic, neuropsychological and self-report measures were conducted at baseline and repeated after each of the two 4-week treatment phases. MAS treatment was associated with improvements on the somatic component of the Beck Depression Inventory and the Vigor-Activity and Fatigue-Inertia scales of the Profile of Mood States. While there were no improvements within the neuropsychological domains of attention/working memory, verbal memory, visuospatial or executive functioning, treatment with the mandibular advancement splint was associated with faster performance on a test of vigilance/psychomotor speed. These changes, however, did not correspond to the improved subjective sleepiness or apnea-hypopnea index during treatment. Treatment with the mandibular advancement splint results in improvements in self-reported sleepiness, fatigue/energy levels and vigilance/psychomotor speed in patients with obstructive sleep apnea.

  17. Action observation training for functional activities after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Kim, Jung-Hee; Lee, Byoung-Hee

    2013-01-01

    The objective of this study was to compare the effects of action observation training and motor imagery training on recovery from chronic stroke. Thirty patients who were more than six months post stroke participated in this study and were randomly allocated to three groups. The action observation training group practiced additional action observation training for five 30-minute sessions over a four-week period. The motor imagery training group practiced additional motor imagery training for five 30-minute sessions over a four-week period. The following clinical measures were used for assessment of dynamic balance and gait abilities: Timed Up and Go Test, Functional Reaching Test, Walking Ability Questionnaire, and Functional Ambulation Category. Spatiotemporal gait parameters were also collected using a GAITRite system. Compared with the physical training group, the action observation training group showed significant improvement in the Timed Up and Go test, gait speed, cadence, and single limb support of the affected side. No significant differences in any of the outcome measures were observed between the action observation training group and the motor imagery training group. Action observation training and motor imagery training results in improvement of dynamic balance and gait ability. These results suggest the feasibility and suitability of action observation training for patients with chronic stroke.

  18. Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol.

    Science.gov (United States)

    Oakes, Tina Marie Myers; Myers, Adam L; Marangell, Lauren B; Ahl, Jonna; Prakash, Apurva; Thase, Michael E; Kornstein, Susan G

    2012-01-01

    Return of functional ability is a central goal in the treatment of major depressive disorder. We conducted two trials with the same protocol that was designed to assess functioning after 8 Weeks of treatment with duloxetine. The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities). Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale, and improvement in functioning assessed by the Sheehan Disability Scale (SDS), and the Social Adaptation Self-evaluation Scale (SASS). Patients were randomly assigned to duloxetine 60 mg/day (Trial I, n = 257; Trial II, n = 261) or placebo (Trial I, n = 127; Trial II, n = 131). Changes from baseline were analyzed using a mixed-effects model repeated measures approach. At Week 8, duloxetine was superior to placebo in improving HAMD work/activities (p depressive symptoms compared with placebo, but improvement in HAMD work/activities was inconsistent at 8 weeks. Copyright © 2012 John Wiley & Sons, Ltd.

  19. Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.

    Science.gov (United States)

    Lopez-Villegas, Antonio; Catalan-Matamoros, Daniel; Robles-Musso, Emilio; Peiro, Salvador

    2016-11-01

    The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety. The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed. The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group. The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195. © 2015 Japan Geriatrics Society.

  20. Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala.

    Science.gov (United States)

    Smith-Sivertsen, Tone; Díaz, Esperanza; Pope, Dan; Lie, Rolv T; Díaz, Anaite; McCracken, John; Bakke, Per; Arana, Byron; Smith, Kirk R; Bruce, Nigel

    2009-07-15

    Exposure to household wood smoke from cooking is a risk factor for chronic obstructive lung disease among women in developing countries. The Randomized Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE) is a randomized intervention trial evaluating the respiratory health effects of reducing indoor air pollution from open cooking fires. A total of 504 rural Mayan women in highland Guatemala aged 15-50 years, all using traditional indoor open fires, were randomized to either receive a chimney woodstove (plancha) or continue using the open fire. Assessments of chronic respiratory symptoms and lung function and individual measurements of carbon monoxide exposure were performed at baseline and every 6 months up to 18 months. Use of a plancha significantly reduced carbon monoxide exposure by 61.6%. For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42, 95% confidence interval: 0.25, 0.70). The number of respiratory symptoms reported by the women at each follow-up point was also significantly reduced by the plancha (odds ratio = 0.7, 95% confidence interval: 0.50, 0.97). However, no significant effects on lung function were found after 12-18 months. Reducing indoor air pollution from household biomass burning may relieve symptoms consistent with chronic respiratory tract irritation.

  1. Guided imagery to improve functional outcomes post-anterior cruciate ligament repair: randomized-controlled pilot trial.

    Science.gov (United States)

    Maddison, R; Prapavessis, H; Clatworthy, M; Hall, C; Foley, L; Harper, T; Cupal, D; Brewer, B

    2012-12-01

    Imagery can improve functional outcomes post-anterior cruciate ligament repair (ACLR). Research is needed to investigate potential mechanisms for this effect. The aim of this study was to (a) evaluate the effectiveness of an imagery intervention to improve functional outcomes post-ACLR, and (b) explore potential mechanisms. A randomized-controlled pilot trial was conducted. Participants were randomized to guided imagery and standard rehabilitation or standard rehabilitation alone (control). The primary outcome was knee strength 6-month post-operatively. Secondary outcomes were knee laxity at 6-months, and change in psychological (self-efficacy) and neurohormonal (adrenaline, noradrenaline, dopamine) variables. Participants (n=21; 62% male) were 34.86 (SD 8.84) years. Following the intervention, no statistical differences between groups for knee strength extension at 180°/s (t=-0.43, P=0.67), or at 60°/s (t=-0.72, P=0.48) were found. A statistically significant effect was found for knee laxity, F=4.67, Pimagery intervention improved knee laxity and healing-related neurobiological factors. © 2011 John Wiley & Sons A/S.

  2. Structured functional assessments in general practice increased the use of part-time sick leave: a cluster randomised controlled trial.

    Science.gov (United States)

    Osterås, Nina; Gulbrandsen, Pål; Kann, Inger Cathrine; Brage, Søren

    2010-03-01

    A method for structured functional assessments of persons with long-term sick leave was implemented in a cluster randomised controlled trial in general practice. The aim was to analyse intervention effects on general practitioner (GP) sick-listing practice and patient sick leave. 57 GPs were randomly assigned to an intervention or a control group. The intervention group GPs learned the method at a 1-day workshop including teamwork and role-playing. The control group GPs were requested to assess functional ability as usual during the 8 months intervention period in 2005. Outcome measures included duration of patient sick leave episodes, GP prescription of part-time sick leave, active sick leave, and vocational rehabilitation. This data was extracted from a national register. The GPs in the intervention group prescribed part-time sick leave more often (p part-time and less active sick leave compared to the control group GPs. As a result, more intervention GP patients returned to part-time work compared to control GP patients. No intervention effect was seen on duration of patient sick leave episodes or on prescription of vocational rehabilitation.

  3. Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

    2017-10-01

    This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

  4. Development and clinical trial results of a prototype device for trans-cutaneous monitoring of kidney function

    Science.gov (United States)

    Debreczeny, Martin P.; Dorshow, Richard B.

    2017-02-01

    A prototype medical device for trans-cutaneous monitoring of kidney function has been developed, validated, and used in a clinical trial on 16 healthy subjects having a wide range of skin color types. The fluorescent tracer agent MB-102 was administered intravenously as a bolus that was varied between 0.5 and 4 μmole/kg subject weight. The tracer agent was tracked as a function of time in plasma by blood sampling and trans-cutaneously at four body sites (sternum, forehead, arm, and side) simultaneously. Excitation was performed with a very low level of amplitude-modulated LED light at 450 nm (<50 μW/cm2), and fluorescence emission was synchronously detected at 570 nm. With adjustment of detection gain between subjects, no skin color dependence was observed of the signal-to-noise ratio (SNR) of the transcutaneous measurements. The primary source of measurement noise appeared to be subject motion, likely due to variations in blood content at the skin measurement site. A typical two-compartment pharmacokinetic dependence was observed with equilibration of the fluorescent agent between the vascular space into which it was injected and the extracellular space into which it subsequently diffused. Variation of this equilibration time was observed across body sites, with the sternum providing the shortest and most consistent equilibration. After equilibration, the terminal fluorescence time dependence at the sternum site was found to be highly correlated with tracer agent concentration time dependence sampled from the blood plasma.

  5. Caregiver-mediated intervention can improve physical functional recovery of patients with chronic stroke: a randomized controlled trial.

    Science.gov (United States)

    Wang, Tzu-Chi; Tsai, Alan C; Wang, Jiun-Yi; Lin, Yu-Te; Lin, Ko-Long; Chen, Jiun Jiang; Lin, Bei Yi; Lin, Tai Ching

    2015-01-01

    Background and Purpose. Patients with chronic stroke may benefit from continuing rehabilitation training after hospital discharge. This study examined whether caregiver-mediated, home-based intervention (CHI) could improve physical functioning and social participation in these patients. Methods. A single-blind, randomized, controlled 12-week trial conducted with 51 patients from 3 hospitals in Taiwan who had chronic stroke (>6 months; Brunnstrom recovery stages III-V). Patients and their caregivers in the intervention arm (n = 25) were given weekly personalized CHI trainings designed by a physical therapist. Patients in the control arm (n = 26) received visits from the therapist without intervention. All were evaluated for physical recovery through the Stroke Impact Scale, Berg Balance Scale, 10-Meter Walk Test, 6-Minute Walk Test, and Barthel Index at baseline and endpoint. Caregivers were evaluated with the Caregiver Burden Scale. Results were analyzed through Mann-Whitney U test. Results. CHI significantly improved scores of the Stroke Impact Scale: strength (control vs intervention, respectively: 1.4 vs 15.5; P = .002), mobility (-0.5 vs 13.7; P caregiver burden at endpoint. Conclusion. CHI can improve physical functional recovery and, possibly, social participation in patients with chronic stroke. © The Author(s) 2014.

  6. Delayed effect of Kinesio Taping on neuromuscular performance, balance, and lower limb function in healthy individuals: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Caio A. A. Lins

    2016-01-01

    Full Text Available ABSTRACT Background Kinesio Taping (KT is an elastic bandage that aims to improve neuromuscular performance, although there is no consensus as to its benefits. Objective To analyze the immediate and delayed effects of KT on the neuromuscular performance of the femoral quadriceps, on balance, and lower limb function in healthy subjects. Method This is a randomized controlled trial. Thirty-six women with a mean age of 22.2±3.6 years and BMI of 22.5±2.3 Kg/m2 were divided into three groups: control, with ten minutes of rest (control, n=12, application of Kinesio Taping without tension (placebo, n=12 and with tension (KT, n=12 on the quadriceps. The primary outcome was isokinetic performance, while secondary outcomes were the single-hop test, one-footed static balance, and electromyographic activity. The evaluations were carried out in five stages: 1 before application of KT, 2 immediately after the application of KT, 3 after 24h, 4 after 48h, and 5 after 72h. Mixed ANOVA was used to determine differences between groups. Results There was no change in one-footed static balance, electromyographic activity of the VL in the lower limb function, nor in isokinetic performance between groups. Conclusion KT promotes neither immediate nor delayed changes in neuromuscular performance of the femoral quadriceps in healthy women.

  7. Delayed effect of Kinesio Taping on neuromuscular performance, balance, and lower limb function in healthy individuals: a randomized controlled trial.

    Science.gov (United States)

    Lins, Caio A A; Borges, Daniel T; Macedo, Liane B; Costa, Karinna S A; Brasileiro, Jamilson S

    2016-03-22

    Kinesio Taping (KT) is an elastic bandage that aims to improve neuromuscular performance, although there is no consensus as to its benefits. To analyze the immediate and delayed effects of KT on the neuromuscular performance of the femoral quadriceps, on balance, and lower limb function in healthy subjects. This is a randomized controlled trial. Thirty-six women with a mean age of 22.2±3.6 years and BMI of 22.5±2.3 Kg/m2 were divided into three groups: control, with ten minutes of rest (control, n=12), application of Kinesio Taping without tension (placebo, n=12) and with tension (KT, n=12) on the quadriceps. The primary outcome was isokinetic performance, while secondary outcomes were the single-hop test, one-footed static balance, and electromyographic activity. The evaluations were carried out in five stages: 1) before application of KT, 2) immediately after the application of KT, 3) after 24h, 4) after 48h, and 5) after 72h. Mixed ANOVA was used to determine differences between groups. There was no change in one-footed static balance, electromyographic activity of the VL in the lower limb function, nor in isokinetic performance between groups. KT promotes neither immediate nor delayed changes in neuromuscular performance of the femoral quadriceps in healthy women.

  8. Does selenium supplementation affect thyroid function? Results from a randomized, controlled, double-blinded trial in a Danish population.

    Science.gov (United States)

    Winther, Kristian Hillert; Bonnema, Steen Joop; Cold, Frederik; Debrabant, Birgit; Nybo, Mads; Cold, Søren; Hegedüs, Laszlo

    2015-06-01

    Selenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism. The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function, under conditions of suboptimal dietary selenium intake. The Danish PREvention of Cancer by Intervention with SElenium pilot study (DK-PRECISE) is a randomized, double-blinded, placebo-controlled trial. A total of 491 males and females aged 60-74 years were randomized to 100 μg (n=124), 200 μg (n=122), or 300 μg (n=119) selenium-enriched yeast or matching yeast-based placebo tablets (n=126). A total of 361 participants, equally distributed across treatment groups, completed the 5-year intervention period. Plasma samples were analyzed for selenium and serum samples for TSH, free triiodothyronine (FT3), and free thyroxine (FT4) at baseline, and after 6 months, and 5 years of supplementation. Plasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium (Pselenium supplementation minutely and dose-dependently affects thyroid function, when compared with placebo, by decreasing serum TSH and FT4 concentrations. Based on these findings, selenium supplementation is not warranted under conditions of marginal selenium deficiency. However, a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved. © 2015 European Society of Endocrinology.

  9. Effects of modafinil on attention performance, short-term memory and executive function in university students: a randomized trial.

    Science.gov (United States)

    Fernández, Alejandro; Mascayano, Franco; Lips, Walter; Painel, Andrés; Norambuena, Jonathan; Madrid, Eva

    2015-06-30

    Modafinil is a drug developed and used for the treatment of excessive lethargy. Even though very effective for sleep disorders, it is still controversial whether modafinil can improve performance in high-order cognitive processes such as memory and executive function. This randomized, double-blind, placebo-controlled, crossover trial was designed to evaluate the effect of modafinil (compared to placebo) on the cognitive functions of healthy students. 160 volunteers were recruited and allocated randomly to modafinil or placebo group, and were assessed using the Stroop Test, BCET test and Digit span test. We found a significant difference in favor of modafinil compared to placebo in the proportion of correct answers of Stroop Test in congruent situation. A significant shorter latency of modafinil group in the incongruent situation of Stroop test was also found. No differences were found in Digit Span, or BCET tests. The study demonstrated that modafinil does not enhance the global cognitive performance of healthy non-sleep deprived students, except regarding non-demanding tasks. In particular, this drug does not seem to have positive effects on mental processes that sustain studying tasks in the college population under normal conditions. We expect these findings to demystify the use of this drug and help decision making concerning pharmacological public policies.

  10. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial.

    Science.gov (United States)

    Weinhold, Jan; Hunger, Christina; Bornhäuser, Annette; Link, Leoni; Rochon, Justine; Wild, Beate; Schweitzer, Jochen

    2013-10-01

    The study examined the efficacy of nonrecurring family constellation seminars on psychological health. We conducted a monocentric, single-blind, stratified, and balanced randomized controlled trial (RCT). After choosing their roles for participating in a family constellation seminar as either active participant (AP) or observing participant (OP), 208 adults (M = 48 years, SD = 10; 79% women) from the general population were randomly allocated to the intervention group (IG; 3-day family constellation seminar; 64 AP, 40 OP) or a wait-list control group (WLG; 64 AP, 40 OP). It was predicted that family constellation seminars would improve psychological functioning (Outcome Questionnaire OQ-45.2) at 2-week and 4-month follow-ups. In addition, we assessed the impact of family constellation seminars on psychological distress and motivational incongruence. The IG showed significantly improved psychological functioning (d = 0.45 at 2-week follow-up, p = .003; d = 0.46 at 4-month follow-up, p = .003). Results were confirmed for psychological distress and motivational incongruence. No adverse events were reported. This RCT provides evidence for the efficacy of family constellation in a nonclinical population. The implications of the findings are discussed.

  11. Effect of physical training on function of chronically painful muscles: A randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Lars L; Andersen, Christoffer H; Zebis, Mette K

    2008-01-01

    ) with a clinical diagnosis of trapezius myalgia participated in a 10 week randomized controlled intervention; specific strength training of the neck/shoulder muscles (SST), general fitness training performed as leg-bicycling (GFT), or a reference intervention without physical activity (REF). Torque.......01-0.05). While EMG activity of the unaffected deltoid remained unchanged during the maximal contractions, an increase in EMG amplitude (42-86%, Pmuscle. Correspondingly, torque increased 18-53% (P...Purpose: Pain and tenderness of the upper trapezius muscle is frequent in several occupational groups. The objective of this study is to investigate the effect of three contrasting interventions on muscle function and pain in women with trapezius myalgia. Methods: A group of employed women (n=42...

  12. Efficacy of kinesiotape on functional disability of women with postnatal back pain: A randomized controlled trial.

    Science.gov (United States)

    Mohamed, Eman A; El-Shamy, Fayiz F; Hamed, Hany

    2017-09-22

    Postpartum low back pain harmfully affects all parts of women's life. To investigate the effect of kinesiotape on women with postnatal backache. Thirty participants were randomly allocated to either group (A; n= 15), treated by kinesiotape with exercise program, or the group (B; n= 15), treated by exercise program. Visual analogue scale (VAS) and Back Pain Function Scale (BPFS) were evaluated.at baseline and after 2 weeks of intervention. There were no statistically significant changes between group A and group B for baseline characteristics (p> 0.05). After two-week intervention, within group analyses revealed that VAS decreased (p 0.05) in the two groups. Between group analyses showed that there was significant reduction of VAS (pKinesiotape and postural correction exercises can be recommended as effective treatment methods for women's postnatal back pain with better effect of kinesiotape and postural correction exercises than exercise alone.

  13. Feasible model for prevention of functional decline in older people: municipality-randomized, controlled trial

    DEFF Research Database (Denmark)

    Vass, Mikkel; Avlund, Kirsten; Lauridsen, Jørgen

    2005-01-01

    OBJECTIVES: To investigate the effect of an educational program for preventive healthcare professionals in routine primary care on functional ability, nursing home admissions, and mortality in older adults. DESIGN: A prospective, controlled 3-year follow-up study (1999-2001) in primary care...... asked to participate. Written consent was obtained from 4,060 persons (70.1%), of whom 2,104 were living in 17 intervention municipalities and 1,956 were living in 17 matched control municipalities. INTERVENTION: Intervention municipality visitors received ongoing education, and local general...... practitioners were introduced to a short geriatric assessment program early in the study period. Control municipalities visitors and general practitioners received no education. MEASUREMENTS: At the 3-year follow-up, the outcome measures of mortality and nursing home admissions were obtained from all...

  14. Epidermal growth factor receptor (EGFR) and EGFR mutations, function and possible role in clinical trials.

    Science.gov (United States)

    Voldborg, B R; Damstrup, L; Spang-Thomsen, M; Poulsen, H S

    1997-12-01

    The epidermal growth factor receptor (EGFR) is a growth factor receptor that induces cell differentiation and proliferation upon activation through the binding of one of its ligands. The receptor is located at the cell surface, where the binding of a ligand activates a tyrosine kinase in the intracellular region of the receptor. This tyrosine kinase phosphorylates a number of intracellular substrates that activates pathways leading to cell growth, DNA synthesis and the expression of oncogenes such as fos and jun. EGFR is thought to be involved the development of cancer, as the EGFR gene is often amplified, and/or mutated in cancer cells. In this review we will focus on: (I) the structure and function of EGFR, (II) implications of receptor/ligand coexpression and EGFR mutations or overexpression, (III) its effect on cancer cells, (IV) the development of the malignant phenotype and (V) the clinical aspects of therapeutic targeting of EGFR.

  15. Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function

    Directory of Open Access Journals (Sweden)

    Clarke Margaret

    2010-09-01

    Full Text Available Abstract Background The main hypothesis of this study is that neutral pH, low glucose degradation product (GDP peritoneal dialysis (PD fluid better preserves residual renal function in PD patients over time compared with conventional dialysate. Methods/Design Inclusion criteria are adult PD patients (CAPD or APD aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR ≥ 5 ml/min/1.73 m2, a urine output ≥ 400 ml/day and an ability to understand the nature and requirements of this trial. Pregnant or lactating patients or individuals with an active infection at the time of enrolment, a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded. Patients will be randomized 1:1 to receive either neutral pH, low GDP dialysis solution (Balance® or conventional dialysis solution (Stay.safe® for a period of 2 years. During this 2 year study period, urinary urea and clearance measurements will be performed at 0, 3, 6, 9, 12, 18 and 24 months. The primary outcome measure will be the slope of residual renal function decline, adjusted for centre and presence of diabetic nephropathy. Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria, peritoneal small solute clearance, peritoneal transport status, peritoneal ultrafiltration, technique survival, patient survival, peritonitis rates and adverse events. A total of 185 patients has been recruited into the trial. Discussion This investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients. Trial Registration Australian New Zealand Clinical Trials Registry Number: ACTRN12606000044527

  16. Effect of a Home-Based Exercise Program on Functional Recovery Following Rehabilitation After Hip Fracture A Randomized Clinical Trial

    Science.gov (United States)

    Latham, Nancy K.; Harris, Bette Ann; Bean, Jonathan F.; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M.; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M.

    2015-01-01

    IMPORTANCE For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. OBJECTIVE To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. INTERVENTIONS The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. MAIN OUTCOMES AND MEASURES Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). RESULTS Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58

  17. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial.

    Science.gov (United States)

    Latham, Nancy K; Harris, Bette Ann; Bean, Jonathan F; Heeren, Timothy; Goodyear, Christine; Zawacki, Stacey; Heislein, Diane M; Mustafa, Jabed; Pardasaney, Poonam; Giorgetti, Marie; Holt, Nicole; Goehring, Lori; Jette, Alan M

    2014-02-19

    For many older people, long-term functional limitations persist after a hip fracture. The efficacy of a home exercise program with minimal supervision after formal hip fracture rehabilitation ends has not been established. To determine whether a home exercise program with minimal contact with a physical therapist improved function after formal hip fracture rehabilitation ended. Randomized clinical trial conducted from September 2008 to October 2012 in the homes of 232 functionally limited older adults who had completed traditional rehabilitation after a hip fracture. The intervention group (n = 120) received functionally oriented exercises (such as standing from a chair, climbing a step) taught by a physical therapist and performed independently by the participants in their homes for 6 months. The attention control group (n = 112) received in-home and telephone-based cardiovascular nutrition education. Physical function assessed at baseline, 6 months (ie, at completion of the intervention), and 9 months by blinded assessors. The primary outcome was change in function at 6 months measured by the Short Physical Performance Battery (SPPB; range 0-12, higher score indicates better function) and the Activity Measure for Post-Acute Care (AM-PAC) mobility and daily activity (range, 23-85 and 9-101, higher score indicates better function). Among the 232 randomized patients, 195 were followed up at 6 months and included in the primary analysis. The intervention group (n=100) showed significant improvement relative to the control group (n=95) in functional mobility (mean SPPB scores for intervention group: 6.2 [SD, 2.7] at baseline, 7.2 [SD, 3] at 6 months; control group: 6.0 [SD, 2.8] at baseline, 6.2 [SD, 3] at 6 months; and between-group differences: 0.8 [95% CI, 0.4 to 1.2], P < .001; mean AM-PAC mobility scores for intervention group: 56.2 [SD, 7.3] at baseline, 58.1 [SD, 7.9] at 6 months; control group: 56 [SD, 7.1] at baseline, 56.6 [SD, 8.1] at 6 months

  18. Effect of Uric Acid-Lowering Agents on Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P

    2017-02-01

    Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m 2 and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.

  19. The predictive value of serial changes in diaphragm function during the spontaneous breathing trial for weaning outcome: a study protocol.

    Science.gov (United States)

    Zhou, Pengmin; Zhang, Zhongheng; Hong, Yucai; Cai, Huabo; Zhao, Hui; Xu, Peifeng; Zhao, Yiming; Lin, Shengping; Qin, Xuchang; Guo, JiaWei; Pan, Yun; Dai, Junru

    2017-06-23

    There is a variety of tools being used in clinical practice for the prediction of weaning success from mechanical ventilation. However, their diagnostic performances are less than satisfactory. The purpose of this study is to investigate the value of serial changes in diaphragm function measured by ultrasound during the spontaneous breathing trial (SBT) as a weaning predictor. This is a prospective observational study conducted in a 10-bed medical emergency intensive care unit (EICU) in a university-affiliated hospital. The study will be performed from November 2016 to December 2017. All patients in the EICU who are expected to have mechanical ventilation for more than 48 hours through endotracheal tube are potentially eligible for this study. Patients will be included if they fulfil the criteria for SBT. All enrolled patients will be ventilated with an Evita-4 by using volume assist control mode prior to SBT. Positive end-expiratory pressure (PEEP) will be set to 5 cmH2O and fractional inspired oxygen (FiO2) will be set to a value below 0.5 that guarantees oxygen saturation by pulse oximetry (SpO2) greater than 90%. Enrolled patients will undergo SBT for 2 hours in semirecumbent position. During the SBT, the patients will breathe through the ventilator circuit by using flow triggering (2 L/min) with automatic tube compensation of 100% and 5 cmH2O PEEP. The FiO2 will be set to the same value as used before SBT. If the patients fail to tolerate the SBT, the trial will be discontinued immediately and the ventilation mode will be switched to that used before the trial. Patients who pass the 2-hour SBT will be extubated. Right diaphragm excursion and bilateral diaphragm thickening fraction will be measured by ultrasonography during spontaneous breathing. Images will be obtained immediately prior to the SBT, and at 5, 30, 60, 90 and 120 min after the initiation of SBT. Rapid shallow breathing index will be simultaneously calculated at the bedside by a

  20. Effects of liraglutide on weight, satiation, and gastric functions in obesity: a randomised, placebo-controlled pilot trial.

    Science.gov (United States)

    Halawi, Houssam; Khemani, Disha; Eckert, Deborah; O'Neill, Jessica; Kadouh, Hoda; Grothe, Karen; Clark, Matthew M; Burton, Duane D; Vella, Adrian; Acosta, Andres; Zinsmeister, Alan R; Camilleri, Michael

    2017-12-01

    Liraglutide, a long-acting GLP-1 receptor agonist, is approved for treatment of obesity; however, the mechanisms of action of liraglutide are incompletely understood. We compared effects of liraglutide versus placebo on gastric motor functions, satiation, satiety, and weight in obese individuals over 16 weeks. We did a randomised, double-blind, placebo-controlled pilot trial at a single centre (Mayo Clinic, Rochester, MN, USA). Participants were randomly allocated (1:1) by a computer generated randomisation schedule with no stratification to receive subcutaneous liraglutide (3·0 mg) or placebo, with standardised nutritional and behavioural counselling. Allocation was concealed from participants and study investigators. Otherwise healthy, local residents aged 18-65 years with body-mass index (BMI) 30 kg/m 2 or higher were included. Liraglutide or placebo was escalated by 0·6 mg/day each week for 5 weeks and continued until week 16. The primary outcome was change in gastric emptying (delay relative to baseline) of solids T 1/2 (time taken for half the radiolabelled meal to empty from the stomach), measured at 5 weeks and 16 weeks in all patients who received at least one dose of study drug, with missing data imputed. Secondary outcomes included weight loss at weeks 5 and 16, satiation (volume to fullness and maximum tolerated volume), satiety, and fasting and postprandial gastric volumes at 16 weeks. This trial is registered with ClinicalTrials.gov, number NCT02647944, and is closed to new participants. Between Dec 18, 2015, and Sept 1, 2016, 40 adults were enrolled and randomly allocated (19 to the liraglutide group; 21 to the placebo group). Compared with placebo, liraglutide delayed gastric emptying of solids at 5 weeks (median 70 min [IQR 32 to 151] vs 4 min [-21 to 18]; pEffects of liraglutide on weight loss are associated with delay in gastric emptying of solids; measurement of gastric emptying (eg, at 5 weeks of treatment) may be a biomarker of

  1. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Bartko Johann

    2011-06-01

    Full Text Available Abstract Background Nuclear magnetic resonance (NMR imaging and spectroscopy have been applied to assess skeletal muscle oxidative metabolism. Therefore, in-vivo NMR may enable the characterization of ischemia-reperfusion injury. The goal of this study was to evaluate whether NMR could detect the effects of ischemic preconditioning (IPC in healthy subjects. Methods Twenty-three participants were included in two randomized crossover protocols in which the effects of IPC were measured by NMR and muscle force assessments. Leg ischemia was administered for 20 minutes with or without a subsequent impaired reperfusion for 5 minutes (stenosis model. IPC was administered 4 or 48 hours prior to ischemia. Changes in 31phosphate NMR spectroscopy and blood oxygen level-dependent (BOLD signals were recorded. 3-Tesla NMR data were compared to those obtained for isometric muscular strength. Results The phosphocreatine (PCr signal decreased robustly during ischemia and recovered rapidly during reperfusion. In contrast to PCr, the recovery of muscular strength was slow. During post-ischemic stenosis, PCr increased only slightly. The BOLD signal intensity decreased during ischemia, ischemic exercise and post-ischemic stenosis but increased during hyperemic reperfusion. IPC 4 hours prior to ischemia significantly increased the maximal PCr reperfusion signal and mitigated the peak BOLD signal during reperfusion. Conclusions Ischemic preconditioning positively influenced muscle metabolism during reperfusion; this resulted in an increase in PCr production and higher oxygen consumption, thereby mitigating the peak BOLD signal. In addition, an impairment of energy replenishment during the low-flow reperfusion was detected in this model. Thus, functional NMR is capable of characterizing changes in reperfusion and in therapeutic interventions in vivo. Trial Registration ClinicalTrials.gov: NCT00883467

  2. A randomized trial of two home-based exercise programmes to improve functional walking post-stroke.

    Science.gov (United States)

    Mayo, Nancy E; MacKay-Lyons, Marilyn J; Scott, Susan C; Moriello, Carolina; Brophy, James

    2013-07-01

    To estimate the relative effectiveness in improving walking ability and other mobility and health outcomes post-stroke of two home-based exercise programmes - stationary cycling and an exercise and walking programme. An observer-blinded, randomized, pragmatic, trial with repeated measures. Hospital centers in two Canadian cities. People within 12 months of acute stroke who were able to walk >10 meters independently and healthy enough to engage in exercise. Two dose-equivalent interventions, one involving stationary cycling and the other disability-targeted interventions were tested. Both protocols required daily moderate intensity exercise at home building up to 30 minutes per day. One group exercised on a stationary bicycle, the second group carried out mobility exercises and brisk walking. The primary outcome was walking capacity as measured by the six-minute walk test (6MWT). Secondary outcomes were physical function, role participation, health-related quality of life exercise adherence, and adverse events. The study failed to meet recruitment targets: 87 participants (cycle group, n = 43; exercise group, n = 44) participated. No significant effects of group or time were revealed for the 6MWT, which was approximately 320 m at randomization. A significant effect for role participation was found in favor of the exercise group (global odds ratio (OR) for cycling vs. exercise was 0.51; 95% confidence interval (CI), 0.27-0.95). Change in the 6MWT between highest and lowest adherence categories was statistically significant (p = 0.022). Both programmes were equally effective in maintaining walking capacity after discharge from stroke rehabilitation; or were equally ineffective in improving walking capacity. Clinical Trials Gov number: NCT00786045.

  3. Functional source separation improves the quality of single trial visual evoked potentials recorded during concurrent EEG-fMRI.

    Science.gov (United States)

    Porcaro, Camillo; Ostwald, Dirk; Bagshaw, Andrew P

    2010-03-01

    EEG quality is a crucial issue when acquiring combined EEG-fMRI data, particularly when the focus is on using single trial (ST) variability to integrate the data sets. The most common method for improving EEG data quality following removal of gross MRI artefacts is independent component analysis (ICA), a completely blind source separation technique. In the current study, a different approach is proposed based on the functional source separation (FSS) algorithm. FSS is an extension of ICA that incorporates prior knowledge about the signal of interest into the data decomposition. Since in general the part of the EEG signal that will contain the most relevant information is known beforehand (i.e. evoked potential peaks, spectral bands), FSS separates the signal of interest by exploiting this prior knowledge without renouncing the advantages of using only information contained in the original signal waveforms. A reversing checkerboard stimulus was used to generate visual evoked potentials (VEPs) in healthy control subjects. Gradient and ballistocardiogram artefacts were removed with template subtraction techniques to form the raw data, which were then subjected to ICA denoising and FSS. The resulting EEG data sets were compared using several metrics derived from average and ST data and correlated with fMRI data. In all cases, ICA was an improvement on the raw data, but the most obvious improvement was provided by FSS, which consistently outperformed ICA. The results show the benefit of FSS for the recovery of good quality single trial evoked potentials during concurrent EEG-fMRI recordings. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  4. Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function

    DEFF Research Database (Denmark)

    Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Stylsvig, Mette

    2016-01-01

    trauma, status epilepticus, patients treated with therapeutic hypothermia and patients with severe hypoxia). The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up attempt......BACKGROUND: The effects of non-sedation on cognitive function in critically ill patients on mechanical ventilation are not yet certain. This trial is a substudy of the NONSEDA trial where critically ill patients are randomized to non-sedation or to sedation with a daily wake-up attempt during...... mechanical ventilation in the intensive care unit (ICU). The aim of this substudy is to assess the effects of non-sedation versus sedation with a daily wake-up attempt on long-term cognitive function. METHODS: This is an investigator-initiated, randomized, clinical, parallel-group, superiority trial...

  5. Recovery of hand function with robot-assisted therapy in acute stroke patients: a randomized-controlled trial.

    Science.gov (United States)

    Sale, Patrizio; Mazzoleni, Stefano; Lombardi, Valentina; Galafate, Daniele; Massimiani, Maria P; Posteraro, Federico; Damiani, Carlo; Franceschini, Marco

    2014-09-01

    In the last few years, not many studies on the use of robot-assisted therapy to recover hand function in acute stroke patients have been carried out. This randomized-controlled observer trial is aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in the early recovery phases after stroke with a 3-month follow-up. Twenty acute stroke patients at their first-ever stroke were enrolled and randomized into two groups. The experimental treatment was performed using the Amadeo Robotic System. Control treatment, instead, was carried out using occupational therapy executed by a trained physiotherapist. All participants received 20 sessions of treatment for 4 consecutive weeks (5 days/week). The following clinical scales, Fugl-Meyer Scale (FM), Medical Research Council Scale for Muscle Strength (hand flexor and extensor muscles) (MRC), Motricity Index (MI) and modified Ashworth Scale for wrist and hand muscles (MAS), were performed at baseline (T0), after 20 sessions (end of treatment) (T1) and at the 3-month follow-up (T2). The Barthel Index was assessed only at T0 and T1. Evidence of a significant improvement was shown by the Friedman test for the FM [experimental group (EG): P=0.0039, control group (CG): Phand recovery functions in individuals with acute stroke. The robotic rehabilitation treatment may contribute toward the recovery of hand motor function in acute stroke patients. The positive results obtained through the safe and reliable robotic rehabilitation treatment reinforce the recommendation to extend it to a larger clinical practice.

  6. Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Suzuki Takao

    2012-10-01

    Full Text Available Abstract Background To examine the effects of a multicomponent exercise program on the cognitive function of older adults with amnestic mild cognitive impairment (aMCI. Methods Design: Twelve months, randomized controlled trial; Setting: Community center in Japan; Participants: Fifty older adults (27 men with aMCI ranging in age from 65 to 93 years (mean age, 75 years; Intervention: Subjects were randomized into either a multicomponent exercise (n = 25 or an education control group (n = 25. Subjects in the multicomponent exercise group exercised under the supervision of physiotherapists for 90 min/d, 2 d/wk, for a total of 80 times over 12 months. The exercises included aerobic exercises, muscle strength training, and postural balance retraining, and were conducted using multiple conditions to stimulate cognitive functions. Subjects in the control group attended three education classes regarding health during the 12-month period. Measurements were administered before, after the 6-month, and after the 12-month intervention period; Measurements: The performance measures included the mini-mental state examination, logical memory subtest of the Wechsler memory scale-revised, digit symbol coding test, letter and categorical verbal fluency test, and the Stroop color word test. Results The mean adherence to the exercise program was 79.2%. Improvements of cognitive function following multicomponent exercise were superior at treatment end (group × time interactions for the mini-mental state examination (P = 0.04, logical memory of immediate recall (P = 0.03, and letter verbal fluency test (P = 0.02. The logical memory of delayed recall, digit symbol coding, and Stroop color word test showed main effects of time, although there were no group × time interactions. Conclusions This study indicates that exercise improves or supports, at least partly, cognitive performance in older adults with aMCI.

  7. A single consumption of curry improved postprandial endothelial function in healthy male subjects: a randomized, controlled crossover trial.

    Science.gov (United States)

    Nakayama, Hideki; Tsuge, Nobuaki; Sawada, Hiroshi; Masamura, Noriya; Yamada, Shohei; Satomi, Shigeki; Higashi, Yukihito

    2014-06-28

    Curry, one of the most popular foods in Japan, contains spices that are rich in potentially antioxidative compounds, such as curcumin and eugenol. Oxidative stress is thought to impair endothelial function associated with atherosclerosis, a leading cause of cardiovascular events. The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men. Fourteen healthy male subjects (BMI 23.7 ± 2.7 kg/m2; age 45 ± 9 years) were given a single serving of curry meal or spice-free control meal (180 g of curry or control and 200 g of cooked rice; approximately 500 kcal in total) in a randomized, controlled crossover design. Before and 1 hr after the consumption, fasting and postprandial flow-mediated vasodilation (FMD) responses and other parameters were measured. The consumption of the control meal decreased FMD from 5.8 ± 2.4% to 5.1 ± 2.3% (P = 0.039). On the other hand, the consumption of the curry meal increased FMD from 5.2 ± 2.5% to 6.6 ± 2.0% (P = 0.001), and the postprandial FMD after the curry meal was higher than that after the control meal (P = 0.002). Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics, or any biochemical parameters including oxidative stress markers measured. These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health. UMIN Clinical Trials Registry 000012012.

  8. A RANDOMISED TRIAL OF LIQUID PARAFFIN VERSUS LACTULOSE IN THE TREATMENT OF CHRONIC FUNCTIONAL CONSTIPATION IN CHILDREN

    Directory of Open Access Journals (Sweden)

    F. Farahmand

    2007-07-01

    Full Text Available "nLiquid paraffin has been suggested as a good laxative comparing to lactulose as a treatment option in pediatric constipation. This study was performed to compare liquid paraffin with lactulose in pediatric constipation. A total of 247 patients (127 males and 120 females aged 2-12 years (mean 4.1 ± 2.7 years with chronic functional constipation were included in an 8 week, randomized, controlled trial. After faecal disimpaction, patients received oral liquid paraffin (1-2 cc/kg/day or lactulose (1-2 cc/kg/day. Primary outcome measures were: defecation and encopresis frequency per week and successful treatment after 8 weeks. Success was defined as a defecation frequency ≥ 3 per week and encopresis ≤ 1 every two weeks. Secondary outcome measures were side effects during 8 weeks of treatment. A significant increase in defecation frequency, liquid paraffin group, 3 pre, versus, 12 post treatment per week and lactulose group: 3 pre, versus 8 post, per week was found. A significant decrease in encopresis frequency, liquid paraffin: 10 pre, versus 1 post per week; lactulose: 9 pre, versus 3 post per week, was found in both groups. However success was significantly higher in the liquid paraffin group (85% compared with the lactulose group (29%. Liquid paraffin patients reported less abdominal pain, straining and pain at defecation than children using lactulose. Liquid paraffin is more effective than lactulose in the treatment of chronic functional constipation of childhood. It provided a higher success rate with fewer side effects. Liquid paraffin should be the laxative of first choice in childhood functional constipation.

  9. A randomised controlled trial investigating motor skill training as a function of attentional focus in old age.

    Science.gov (United States)

    de Bruin, Eling D; Swanenburg, Jaap; Betschon, Elsbeth; Murer, Kurt

    2009-05-08

    Motor learning research has had little impact on clinical applications and rarely extended to research about how older adults learn motor skills. There is consistent evidence that motor skill performance and learning can be enhanced by giving learners instructions that direct their attention. The aim of this study was to test whether elderly individuals that receive an external focus instruction during training of dynamic balance skills would learn in a different manner compared to individuals that received an internal focus instruction. This randomised trial included 26 older persons (81 +/- 6 years) that were training functional balance twice a week for the duration of 5 weeks. Learning outcomes were recorded after every training session. Weight shifting score and dynamic balance parameters (Biodex Balance System), components of the Extended Timed-Get-Up-and-Go test, five chair rises, and falls efficacy (FES-I) was assessed at baseline and post-intervention. Participation for training sessions was 94%. No differences between groups were found following 5 weeks of training for weight shifting score, dynamic balance index and dynamic balance time (p Slow down, stop, turnaround, and sit down, p = 0.011 and the Fes-I (p = 0.014) showed improvements for the total group, indicating that function improved compared to baseline. A 5-week balance training improved weight shifting scores and dynamic balance parameters as well as functional abilities. The observed improvements were independent from the type of attentional focus instructions. The findings provide support for the proposition of different motor learning principles in older adults compared to younger adults.

  10. The Acute Effects of Grape Polyphenols Supplementation on Endothelial Function in Adults: Meta-Analyses of Controlled Trials

    Science.gov (United States)

    Li, Shao-Hua; Tian, Hong-Bo; Zhao, Hong-Jin; Chen, Liang-Hua; Cui, Lian-Qun

    2013-01-01

    Background The acute effects of grape polyphenols on endothelial function in adults are inconsistent. Here, we performed meta-analyses to determine these acute effects as measured by flow-mediated dilation (FMD). Methods Trials were searched in PubMed, Embase and the Cochrane Library database. Summary estimates of weighted mean differences (WMDs) and 95% CIs were obtained by using random-effects models. Meta-regression and subgroup analyses were performed to identify the source of heterogeneity. The protocol details of our meta-analysis have been submitted to the PROSPERO register and our registration number is CRD42013004157. Results Nine studies were included in the present meta-analyses. The results showed that the FMD level was significantly increased in the initial 120 min after intake of grape polyphenols as compared with controls. Meta-regression and subgroup analyses were performed and showed that a health status was the main effect modifier of the significant heterogeneity. Subgroups indicated that intake of grape polyphenols could significantly increase FMD in healthy subjects, and the increased FMD appeared to be more obviously in subjects with high cardiovascular risk factors. Moreover, the peak effect of grape polyphenols on FMD in healthy subjects was found 30 min after ingestion, which was different from the effect in subjects with high cardiovascular risk factors, in whom the peak effect was found 60 min after ingestion. Conclusions Endothelial function can be significantly improved in healthy adults in the initial 2 h after intake of grape polyphenols. The acute effect of grape polyphenols on endothelial function may be more significant but the peak effect is delayed in subjects with a smoking history or coronary heart disease as compared with the healthy subjects. PMID:23894543

  11. Minimally Invasive Osteosynthesis with a Bridge Plate Versus a Functional Brace for Humeral Shaft Fractures: A Randomized Controlled Trial.

    Science.gov (United States)

    Matsunaga, Fabio Teruo; Tamaoki, Marcel Jun Sugawara; Matsumoto, Marcelo Hide; Netto, Nicola Archetti; Faloppa, Flavio; Belloti, Joao Carlos

    2017-04-05

    Nonoperative treatment has historically been considered the standard for fractures of the shaft of the humerus. Minimally invasive bridge-plate osteosynthesis for isolated humeral shaft fractures has been proven to be a safe technique, with good and reproducible results. This study was designed to compare clinical and radiographic outcomes between patients who had been treated with bridge plate osteosynthesis and those who had been managed nonoperatively with a functional brace. A prospective randomized trial was designed and included 110 patients allocated to 1 of 2 groups: surgery with a bridge plate or nonoperative treatment with a functional brace. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 6 months. The score on the Short Form-36 (SF-36) life-quality questionnaire, complications of treatment, Constant-Murley score for the shoulder, pain level, and radiographic results were assessed as secondary outcomes. Participants were assessed at 2 weeks; 1, 2, and 6 months; and 1 year after the interventions. The mean DASH score of the bridge plate group was statistically superior to that of the functional brace group (mean scores, 10.9 and 16.9, respectively; p = 0.046) only at 6 months. The bridge plate group also had a significantly more favorable nonunion rate (0% versus 15%) and less mean residual angular displacement seen on the anteroposterior radiograph (2.0° versus 10.5°) (both p bridge plate has a statistically significant advantage, of uncertain clinical benefit, with respect to self-reported outcome (DASH score) at 6 months, nonunion rate, and residual deformity in the coronal plane as seen on radiographs. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  12. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial.

    Science.gov (United States)

    Turolla, Andrea; Dam, Mauro; Ventura, Laura; Tonin, Paolo; Agostini, Michela; Zucconi, Carla; Kiper, Pawel; Cagnin, Annachiara; Piron, Lamberto

    2013-08-01

    Recent evidence has demonstrated the efficacy of Virtual Reality (VR) for stroke rehabilitation nonetheless its benefits and limitations in large population of patients have not yet been studied. To evaluate the effectiveness of non-immersive VR treatment for the restoration of the upper limb motor function and its impact on the activities of daily living capacities in post-stroke patients. A pragmatic clinical trial was conducted among post-stroke patients admitted to our rehabilitation hospital. We enrolled 376 subjects who had a motor arm subscore on the Italian version of the National Institutes of Health Stroke Scale (It-NIHSS) between 1 and 3 and without severe neuropsychological impairments interfering with recovery. Patients were allocated to two treatments groups, receiving combined VR and upper limb conventional (ULC) therapy or ULC therapy alone. The treatment programs consisted of 2 hours of daily therapy, delivered 5 days per week, for 4 weeks. The outcome measures were the Fugl-Meyer Upper Extremity (F-M UE) and Functional Independence Measure (FIM) scales. Both treatments significantly improved F-M UE and FIM scores, but the improvement obtained with VR rehabilitation was significantly greater than that achieved with ULC therapy alone. The estimated effect size of the minimal difference between groups in F-M UE and FIM scores was 2.5 ± 0.5 (P rehabilitation in post-stroke patients seems more effective than conventional interventions in restoring upper limb motor impairments and motor related functional abilities. Italian Ministry of Health IRCCS Research Programme 2590412.

  13. Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Roche-Leboucher, Ghislaine; Petit-Lemanac'h, Audrey; Bontoux, Luc; Dubus-Bausière, Valérie; Parot-Shinkel, Elsa; Fanello, Serge; Penneau-Fontbonne, Dominique; Fouquet, Natacha; Legrand, Erick; Roquelaure, Yves; Richard, Isabelle

    2011-12-15

    Randomized parallel group comparative trial with a 1-year follow-up period. To compare in a population of patients with chronic low back pain, the effectiveness of a functional restoration program (FRP), including intensive physical training and a multidisciplinary approach, with an outpatient active physiotherapy program at 1-year follow-up. Controlled studies conducted in the United States and in Northern Europe showed a benefit of FRPs, especially on return to work. Randomized studies have compared these programs with standard care. A previously reported study presented the effectiveness at 6 months of both functional restoration and active physiotherapy, with a significantly greater reduction of sick-leave days for functional restoration. A total of 132 patients with low back pain were randomized to either FRP (68 patients) or active individual therapy (64 patients). One patient did not complete the FRP; 19 patients were lost to follow-up (4 in the FRP group and 15 in the active individual treatment group). The number of sick-leave days in 2 years before the program was similar in both groups (180 ± 135.1 days in active individual treatment vs. 185 ± 149.8 days in FRP, P = 0.847). In both groups, at 1-year follow-up, intensity of pain, flexibility, trunk muscle endurance, Dallas daily activities and work and leisure scores, and number of sick-leave days were significantly improved compared with baseline. The number of sick-leave days was significantly lower in the FRP group. Both programs are efficient in reducing disability and sick-leave days. The FRP is significantly more effective in reducing sick-leave days. Further analysis is required to determine if this overweighs the difference in costs of both programs.

  14. Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2017-01-01

    While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

  15. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial

    Directory of Open Access Journals (Sweden)

    de Ruiter Marieke A

    2012-12-01

    Full Text Available Abstract Background Neurotoxicity caused by treatment for a brain tumor is a major cause of neurocognitive decline in survivors. Studies have shown that neurofeedback may enhance neurocognitive functioning. This paper describes the protocol of the PRISMA study, a randomized controlled trial to investigate the efficacy of neurofeedback to improve neurocognitive functioning in children treated for a brain tumor. Methods/Design Efficacy of neurofeedback will be compared to placebo training in a randomized controlled double-blind trial. A total of 70 brain tumor survivors in the age range of 8 to 18 years will be recruited. Inclusion also requires caregiver-reported neurocognitive problems and being off treatment for more than two years. A group of 35 healthy siblings will be included as the control group. On the basis of a qEEG patients will be assigned to one of three treatment protocols. Thereafter patients will be randomized to receive either neurofeedback training (n=35 or placebo training (n=35. Neurocognitive tests, and questionnaires administered to the patient, caregivers, and teacher, will be used to evaluate pre- and post-intervention functioning, as well as at 6-month follow-up. Siblings will be administered the same tests and questionnaires once. Discussion If neurofeedback proves to be effective for pediatric brain tumor survivors, this can be a valuable addition to the scarce interventions available to improve neurocognitive and psychosocial functioning. Trial registration ClinicalTrials.gov NCT00961922.

  16. Combined arm stretch positioning and neuromuscular electrical stimulation during rehabilitation does not improve range of motion, shoulder pain or function in patients after stroke: a randomised trial

    NARCIS (Netherlands)

    J. Gerritsen; K. Postema; L.D. de Jong; A.C. Geurts; P.U. Dijkstra

    2013-01-01

    doi: 10.1016/S1836-9553(13)70201-7 QUESTION: Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation (NMES) in the subacute phase after stroke have beneficial effects on basic arm body functions and activities? DESIGN: Multicentre randomised trial with

  17. A randomized trial on the effect of a multimodal intervention on physical capacity, functional performance and quality of life in adult patients undergoing allogeneic SCT

    DEFF Research Database (Denmark)

    Jarden, M; Baadsgaard, M T; Hovgaard, D J

    2009-01-01

    The aim of this randomized controlled trial was to investigate the effect of a 4- to 6-week multimodal program of exercise, relaxation and psychoeducation on physical capacity, functional performance and quality of life (QOL) in allogeneic hematopoietic cell transplantation (allo-HSCT) adult...

  18. Does Tourniquet Use in TKA Affect Recovery of Lower Extremity Strength and Function? A Randomized Trial.

    Science.gov (United States)

    Dennis, Douglas A; Kittelson, Andrew J; Yang, Charlie C; Miner, Todd M; Kim, Raymond H; Stevens-Lapsley, Jennifer E

    2016-01-01

    Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA. The purpose of this study was (1) to determine whether tourniquet use affects recovery of quadriceps strength (primary outcome) during the first 3 postoperative months; and (2) to examine the effects of tourniquet application on secondary outcomes: voluntary quadriceps activation, hamstring strength, unilateral limb balance as well as the effect on operative time and blood loss. Twenty-eight patients (mean age 62 ± 6 years; 16 men) undergoing same-day bilateral TKA (56 lower extremities) were enrolled in a prospective, randomized study. Subjects were randomized to receive a tourniquet-assisted knee arthroplasty on one lower extremity while the contralateral limb underwent knee arthroplasty without extended tourniquet use. In the former group, the tourniquet was inflated just before the incision was made and released after cementation; in the latter group, a tourniquet was not used (10 of 28 [36%]) or inflated only during component cementation (18 of 28 [64%]). The choice of no tourniquet or use just during cementation was based on surgeon choice, because some surgeons felt a tourniquet during cementation was necessary to achieve a dry surgical field to maximize cement fixation. A median parapatellar approach and the identical posterior-stabilized TKA design were used by all four fellowship-trained knee surgeons involved. Isometric quadriceps strength, hamstring strength, voluntary quadriceps activation, and unilateral balance were assessed preoperatively, 3 weeks, and 3 months after bilateral knee arthroplasty. Other factors, including pain, range of motion, and lower extremity girth, were assessed for descriptive purposes at each of these time points as well as on the second postoperative day. Quadriceps strength was

  19. Effect of Probiotic Supplementation on Cognitive Function and Metabolic Status in Alzheimer's Disease: A Randomized, Double-Blind and Controlled Trial

    OpenAIRE

    Akbari, Elmira; Asemi, Zatollah; Daneshvar Kakhaki, Reza; Bahmani, Fereshteh; Kouchaki, Ebrahim; Tamtaji, Omid Reza; Hamidi, Gholam Ali; Salami, Mahmoud

    2016-01-01

    Alzheimer's disease (AD) is associated with severe cognitive impairments as well as some metabolic defects. Scant studies in animal models indicate a link between probiotics and cognitive function. This randomized, double-blind, and controlled clinical trial was conducted among 60 AD patients to assess the effects of probiotic supplementation on cognitive function and metabolic status. The patients were randomly divided into two groups (n = 30 in each group) treating with either milk (control...

  20. Effect of probiotic supplementation on cognitive function and metabolic status in Alzheimer's disease: a randomized, double-blind and controlled trial

    OpenAIRE

    Elmira Akbari; Zatollah Asemi; Reza Daneshvar Kakhaki; Fereshteh Bahmani; Ebrahim Kouchaki; Omid Reza Tamtaji; Gholam Ali Hamidi; Mahmoud Salami

    2016-01-01

    Alzheimer's disease (AD) is associated with severe cognitive impairments as well as some metabolic defects. Scant studies in animal models indicate a link between probiotics and cognitive function. This randomized, double-blind and controlled clinical trial was conducted among 60 AD patients to assess the effects of probiotic supplementation on cognitive function and metabolic status. The patients were randomly divided into two groups (n=30 in each group) treating with either milk (control gr...

  1. Does improved functional performance help to reduce urinary incontinence in institutionalized older women? a multicenter randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Tak Erwin CPM

    2012-09-01

    Full Text Available Abstract Background Urinary incontinence (UI is a major problem in older women. Management is usually restricted to dealing with the consequences instead of treating underlying causes such as bladder dysfunction or reduced mobility. The aim of this multicenter randomized controlled trial was to compare a group-based behavioral exercise program to prevent or reduce UI, with usual care. The exercise program aimed to improve functional performance of pelvic floor muscle (PFM, bladder and physical performance of women living in homes for the elderly. Methods Twenty participating Dutch homes were matched and randomized into intervention or control homes using a random number generator. Homes recruited 6–10 older women, with or without UI, with sufficient cognitive and physical function to participate in the program comprising behavioral aspects of continence and physical exercises to improve PFM, bladder and physical performance. The program consisted of a weekly group training session and homework exercises and ran for 6 months during which time the control group participants received care as usual. Primary outcome measures after 6 months were presence or absence of UI, frequency of episodes (measured by participants and caregivers (not blinded using a 3-day bladder diary and the Physical Performance Test (blinded. Linear and logistic regression analysis based on the Intention to Treat (ITT principle using an imputed data set and per protocol analysis including all participants who completed the study and intervention (minimal attendance of 14 sessions. Results 102 participants were allocated to the program and 90 to care as usual. ITT analysis (n = 85 intervention, n = 70 control showed improvement of physical performance (intervention +8%; control −7% and no differences on other primary and secondary outcome measures. Per protocol analysis (n = 51 intervention, n = 60 control showed a reduction of participants with UI

  2. Efficacy of an Iranian herbal preparation (Lax-Asab in treating functional constipation: A randomized, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Mohammad Hossein Somi

    2015-07-01

    Full Text Available Functional constipation is a common clinical complaint of patients with unsatisfactory treatment outcome. We designed this study to evaluate the efficiency of a traditional herbal preparation (Lax-Asab in treating chronic constipation. In this double-blind, randomized, placebo-controlled clinical trial, participants with chronic constipation (n = 48 were randomly selected to receive either the Lax-Asab powder (n = 24 or placebo (n = 24 on alternative days for 4 weeks. The Lax-Asab powder contains equal amounts of Cassia angustifolia Vahl. (狹葉番瀉葉 xiá yè fān xiè yè, Mentha piperita L. (胡椒薄荷 hú jiāo bò hé, Zingiber officinale Rosc. (生薑 shēng jiāng, Glycyrrhiza glabra L. (甘草 gān cǎo. A total of 40 patients completed the study. We determined the severity of constipation based on defecation frequency (per week and defecation difficulties. Of the total of 48 patients who participated, 40 completed the trial [24 men (60%, mean age, 21.0 ± 4.2 years; 16 women (40%, mean age, 20.1 ± 4.3 years]. The mean of weekly defecation frequency increased in both groups; from 1.8 ± 0.41 to 4.8 ± 1.12 times in patients who received Lax-Asab and from 1.7 ± 0.44 to 2.2 ± 0.61 times in patients who received placebo. A time–treatment interaction showed that this increase was significantly higher in the intervention group. Defecation difficulties improved significantly more in patients who received Lax-Asab than patients who received placebo. There was no statistically significant difference between the two groups with regard to the side effects observed. This study confirms the efficacy and tolerability of an Iranian herbal preparation, Lax-Asab, in treating patients with chronic functional constipation.

  3. Protocol for Fit Bodies, Fine Minds: a randomized controlled trial on the affect of exercise and cognitive training on cognitive functioning in older adults

    Directory of Open Access Journals (Sweden)

    Pachana Nancy A

    2007-10-01

    Full Text Available Abstract Background Declines in cognitive functioning are a normal part of aging that can affect daily functioning and quality of life. This study will examine the impact of an exercise training program, and a combined exercise and cognitive training program, on the cognitive and physical functioning of older adults. Methods/Design Fit Bodies, Fine Minds is a randomized, controlled trial. Community-dwelling adults, aged between 65 and 75 years, are randomly allocated to one of three groups for 16 weeks. The exercise-only group do three 60-minute exercise sessions per week. The exercise and cognitive training group do two 60-minute exercise sessions and one 60-minute cognitive training session per week. A no-training control group is contacted every 4 weeks. Measures of cognitive functioning, physical fitness and psychological well-being are taken at baseline (0 weeks, post-test (16 weeks and 6-month follop (40 weeks. Qualitative responses to the program are taken at post-test. Discussion With an increasingly aged population, interventions to improve the functioning and quality of life of older adults are particularly important. Exercise training, either alone or in combination with cognitive training, may be an effective means of optimizing cognitive functioning in older adults. This study will add to the growing evidence base on the effectiveness of these interventions. Trial Registration Australian Clinical Trials Register: ACTRN012607000151437

  4. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Maddison Ralph

    2010-11-01

    Full Text Available Abstract Background Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Methods/Design Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December. The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades, sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. Discussion This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Trial Registration Number Australian New Zealand Clinical Trials Registry

  5. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial.

    Science.gov (United States)

    Lilja, Gisela; Nielsen, Niklas; Friberg, Hans; Horn, Janneke; Kjaergaard, Jesper; Pellis, Tommaso; Rundgren, Malin; Wetterslev, Jørn; Wise, Matt P; Nilsson, Fredrik; Cronberg, Tobias

    2013-10-12

    Mild to moderate cognitive impairment is common amongst long-term survivors of cardiac arrest. In the Target Temperature Management trial (TTM-trial) comatose survivors were randomized to 33°C or 36°C temperature control for 24 hours after cardiac arrest and the effects on survival and neurological outcome assessed. This protocol describes a sub-study of the TTM-trial investigating cognitive dysfunction and its consequences for patients' and relatives' daily life. Sub-study sites in five European countries included surviving TTM patients 180 days after cardiac arrest. In addition to the instruments for neurological function used in the main trial, sub-study patients were specifically tested for difficulties with memory (Rivermead Behavioural Memory Test), attention (Symbol Digit Modalities Test) and executive function (Frontal Assessment Battery). Cognitive impairments will be related to the patients' degree of participation in society (Mayo-Portland Adaptability Inventory-4), health related quality of life (Short Form Questionnaire-36v2©), and the caregivers' situation (Zarit Burden Interview©). The two intervention groups (33°C and 36°C) will be compared with a group of myocardial infarction controls. This large international sub-study of a randomized controlled trial will focus on mild to moderate cognitive impairment and its consequences for cardiac arrest survivors and their caregivers. By using an additional battery of tests we may be able to detect more subtle differences in cognitive function between the two intervention groups than identified in the main study. The results of the study could be used to develop a relevant screening model for cognitive dysfunction after cardiac arrest. ClinicalTrials.gov: NCT01946932.

  6. Patient-reported functional health and well-being outcomes with drug therapy: a systematic review of randomized trials using the SF-36 health survey.

    Science.gov (United States)

    Frendl, Daniel M; Ware, John E

    2014-05-01

    To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions. We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer's recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions. Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6-4.1; MCS IQR, 0.8-3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold. The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.

  7. Improving Executive Functioning in Children with ADHD: Training Multiple Executive Functions within the Context of a Computer Game. A Randomized Double-Blind Placebo Controlled Trial

    Science.gov (United States)

    Dovis, Sebastiaan; Van der Oord, Saskia; Wiers, Reinout W.; Prins, Pier J. M.

    2015-01-01

    training conditions). As such, in this multiple EF-training, mainly nonspecific treatment factors – as opposed to the specific effects of training EFs—seem related to far transfer effects found on EF and behavior. Trial Registration trialregister.nl NTR2728. Registry name: improving executive functioning in children with ADHD: training executive functions within the context of a computer game; registry number: NTR2728. PMID:25844638

  8. Improvements in gait characteristics after intensive resistance and functional training in people with dementia: a randomised controlled trial.

    Science.gov (United States)

    Schwenk, Michael; Zieschang, Tania; Englert, Stefan; Grewal, Gurtej; Najafi, Bijan; Hauer, Klaus

    2014-06-12

    Preventing and rehabilitating gait disorders in people with dementia during early disease stage is of high importance for staying independent and ambulating safely. However, the evidence gathered in randomized controlled trials (RCTs) on the effectiveness of exercise training for improving spatio-temporal gait parameters in people with dementia is scarce. The aim of the present study was to determine whether a specific, standardized training regimen can improve gait characteristics in people with dementia. Sixty-one individuals (mean age: 81.9 years) with confirmed mild to moderate stage dementia took part in a 3-month double-blinded outpatient RCT. Subjects in the intervention group (IG) received supervised, progressive resistance and functional group training for 3 months (2 times per week for two hours) specifically developed for people with dementia. Subjects in the control group (CG) conducted a low-intensity motor placebo activity program. Gait characteristics were measured before and after the intervention period using a computerized gait analysis system (GAITRite®). Adherence to the intervention was excellent, averaging 91.9% in the IG and 94.4% in the CG. The exercise training significantly improved gait speed (P dementia-adjusted training was feasible and improved clinically meaningful gait variables in people with dementia. The exercise program may represent a model for preventing and rehabilitating gait deficits in the target group. Further research is required for improving specific gait characteristics such as gait variability in people with dementia. ISRCTN49243245.

  9. Plasticity of attentional functions in older adults after non-action video game training: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Julia Mayas

    Full Text Available A major goal of recent research in aging has been to examine cognitive plasticity in older adults and its capacity to counteract cognitive decline. The aim of the present study was to investigate whether older adults could benefit from brain training with video games in a cross-modal oddball task designed to assess distraction and alertness. Twenty-seven healthy older adults participated in the study (15 in the experimental group, 12 in the control group. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the intervention using a cross-modal oddball task measuring alertness and distraction. The results showed a significant reduction of distraction and an increase of alertness in the experimental group and no variation in the control group. These results suggest neurocognitive plasticity in the old human brain as training enhanced cognitive performance on attentional functions.ClinicalTrials.gov NCT02007616.

  10. Very-long-chain ω-3 fatty acid supplements and adipose tissue functions: a randomized controlled trial.

    Science.gov (United States)

    Hames, Kazanna C; Morgan-Bathke, Maria; Harteneck, Debra A; Zhou, Lendia; Port, John D; Lanza, Ian R; Jensen, Michael D

    2017-06-01

    Background: Increased omega-3 (n-3) fatty acid consumption is reported to benefit patients with metabolic syndrome, possibly due to improved adipose tissue function.Objective: We tested the effects of high-dose, very-long-chain ω-3 fatty acids on adipose tissue inflammation and insulin regulation of lipolysis.Design: A double-blind, placebo-controlled study compared 6 mo of 3.9 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)/d (4.2 g total ω-3/d; n = 12) with a placebo (4.2 g oleate/d; n = 9) in insulin-resistant adults. Before and after treatment, the volunteers underwent adipose tissue biopsies to measure the total (CD68+), pro- (CD14+ = M1), and anti- (CD206+ = M2) inflammatory macrophages, crown-like structures, and senescent cells, as well as a 2-step pancreatic clamping with a [U-13C]palmitate infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (IC50(palmitate)f).Results: In the ω-3 group, the EPA and DHA contributions to plasma free fatty acids increased (P = 0.0003 and P = 0.003, respectively), as did the EPA and DHA content in adipose tissue (P insulin-resistant adults. This trial was registered at clinicaltrials.gov as NCT01686568. © 2017 American Society for Nutrition.

  11. A multicenter randomized trial comparing rabeprazole and itopride in patients with functional dyspepsia in Japan: the NAGOYA study.

    Science.gov (United States)

    Kamiya, Takeshi; Shikano, Michiko; Kubota, Eiji; Mizoshita, Tsutomu; Wada, Tsuneya; Tanida, Satoshi; Kataoka, Hiromi; Adachi, Hiroshi; Hirako, Makoto; Okuda, Noriaki; Joh, Takashi

    2017-03-01

    The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day (n = 69) or ITO 150 mg/day (n = 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962).

  12. Ebselen does not improve oxidative stress and vascular function in patients with diabetes: a randomized, crossover trial.

    Science.gov (United States)

    Beckman, Joshua A; Goldfine, Allison B; Leopold, Jane A; Creager, Mark A

    2016-12-01

    Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled, crossover trial was carried out in 26 patients with type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg po twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 wk duration, with a 4-wk washout between treatments. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced to oxidized glutathione. Vascular ultrasound of the brachial artery and plethysmographic measurement of blood flow were used to assess flow-mediated and methacholine-induced endothelium-dependent vasodilation of conduit and resistance vessels, respectively. Ebselen administration did not affect parameters of oxidative stress or conduit artery or forearm arteriolar vascular function compared with placebo treatment. There was no difference in outcome by diabetes type. Ebselen, at the dose and duration evaluated, does not improve the oxidative stress profile, nor does it affect endothelium-dependent vasodilation in patients with diabetes mellitus. Copyright © 2016 the American Physiological Society.

  13. Plasticity of attentional functions in older adults after non-action video game training: a randomized controlled trial.

    Science.gov (United States)

    Mayas, Julia; Parmentier, Fabrice B R; Andrés, Pilar; Ballesteros, Soledad

    2014-01-01

    A major goal of recent research in aging has been to examine cognitive plasticity in older adults and its capacity to counteract cognitive decline. The aim of the present study was to investigate whether older adults could benefit from brain training with video games in a cross-modal oddball task designed to assess distraction and alertness. Twenty-seven healthy older adults participated in the study (15 in the experimental group, 12 in the control group. The experimental group received 20 1-hr video game training sessions using a commercially available brain-training package (Lumosity) involving problem solving, mental calculation, working memory and attention tasks. The control group did not practice this package and, instead, attended meetings with the other members of the study several times along the course of the study. Both groups were evaluated before and after the intervention using a cross-modal oddball task measuring alertness and distraction. The results showed a significant reduction of distraction and an increase of alertness in the experimental group and no variation in the control group. These results suggest neurocognitive plasticity in the old human brain as training enhanced cognitive performance on attentional functions. ClinicalTrials.gov NCT02007616.

  14. Valsartan improves adipose tissue function in humans with impaired glucose metabolism: a randomized placebo-controlled double-blind trial.

    Directory of Open Access Journals (Sweden)

    Gijs H Goossens

    -induced decrease in adipocyte size was associated with reduced expression of macrophage infiltration markers in AT. Our findings suggest that interventions targeting the RAS may improve AT function, thereby contributing to a reduced risk of developing cardiovascular disease and type 2 diabetes. TRIAL REGISTRATION: Trialregister.nl NTR721 (ISRCTN Registry: ISRCTN42786336.

  15. Randomized controlled trial of electro-stimulation therapies to modulate retinal blood flow and visual function in retinitis pigmentosa.

    Science.gov (United States)

    Bittner, Ava K; Seger, Kenneth; Salveson, Rachel; Kayser, Samantha; Morrison, Natalia; Vargas, Patricia; Mendelsohn, Deborah; Han, Jorge; Bi, Hua; Dagnelie, Gislin; Benavente, Alexandra; Ramella-Roman, Jessica

    2017-11-11

    We examined changes in visual function and ocular and retinal blood flow (RBF) among retinitis pigmentosa (RP) participants in a randomized controlled trial of electro-stimulation therapies. Twenty-one RP participants were randomized (1:1:1) to transcorneal electrical stimulation (TES) at 6 weekly half-hour sessions, electro-acupuncture or inactive laser acupuncture (sham control) at 10 half-hour sessions over 2 weeks. Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity (VA), quick contrast sensitivity function, Goldmann visual fields, AdaptDx scotopic sensitivity, spectral flow and colour Doppler imaging of the central retinal artery (CRA), and RBF in macular capillaries were measured twice pre-treatment, after 2 TES sessions, within a week and a month after intervention completion. We measured a significant improvement in retrobulbar CRA mean flow velocity for both the TES (p = 0.038) and electro-acupuncture groups (p = 0.001) on average after 2 weeks of treatment when compared to sham controls. Transcorneal electrical simulation (TES) and electro-acupuncture subjects had significant 55% and 34% greater increases, respectively, in RBF in the macular vessels when compared to sham controls (p < 0.001; p = 0.008) within a week of completing six TES sessions or a month after electro-acupuncture. There was a significant difference in the proportion of eyes that had improved visual function when comparing the three intervention groups (p = 0.038): four of seven TES subjects (57%), two of seven electro-acupuncture subjects (29%) and none of the seven control subjects (0%) had a significant visual improvement outside of typical test-retest variability at two consecutive post-treatment visits. Increased blood flow following electro-stimulation therapies is an objective, physiological change that occurred in addition to visual function improvements in some RP patients. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley

  16. Study of endothelial function response to exercise training in hypertensive individuals (SEFRET): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pedralli, Marinei Lopes; Waclawovsky, Gustavo; Camacho, Augusto; Markoski, Melissa Medeiros; Castro, Iran; Lehnen, Alexandre Machado

    2016-02-13

    Endothelial dysfunction is a hallmark of diabetes mellitus and systemic arterial hypertension (SAH) and an early maker for atherosclerosis. Aerobic exercise training is known to enhance endothelial function, but little is understood about the effects of resistance or combined exercise training on endothelial function. The aim of this study is to investigate the effect of a 12-week aerobic (AT), resistance (RT), or combined (aerobic and resistance, CT) training program on endothelial function and assess associated effects on blood pressure in individuals with SAH. Eighty-one subjects with SAH aged 18 to 70 years will be selected and randomly assigned to three types of exercise training: AT, RT or CT. The study will involve the following procedures and tests: anamnesis, anthropometric assessment, echocardiography, blood pressure measurements through ambulatory blood pressure monitoring, flow-mediated dilation, ergospirometry, one repetition maximum test (1-RM), and blood collection (number of circulating endothelial progenitor cells, number of circulating endothelial microparticles, lipid profile, glucose, glycated hemoglobin, and creatinine). The AT intervention will consist of a 40-min exercise session with progressive intensities ranging from 50 to 75% of heart rate reserve. The RT intervention will consist of a 40-minute session with four sets of six to 12 repetitions with a rest period of 60 to 90 seconds between each set and each type of exercise. Weight loads will be adjusted to 60 to 80% of 1-RM for six types of exercise. The CT intervention will consist of a 20-min aerobic exercise session, followed by an additional 20-min resistance exercise session; each resistance exercise will have two sets less to match the total training volume. The study results are expected evidence of cardiovascular protective effects of different types of exercise training through the modulation of endothelial function in hypertensive individuals. Knowing the magnitude of

  17. Effects of vitamin D supplementation on endothelial function: a systematic review and meta-analysis of randomised clinical trials.

    Science.gov (United States)

    Hussin, Azizah Mat; Ashor, Ammar W; Schoenmakers, Inez; Hill, Tom; Mathers, John C; Siervo, Mario

    2017-04-01

    In addition to regulating calcium homoeostasis and bone health, vitamin D influences vascular and metabolic processes including endothelial function (EF) and insulin signalling. This systematic review and meta-analysis of randomised clinical trials (RCTs) were conducted to investigate the effect of vitamin D supplementation on EF and to examine whether the effect size was modified by health status, study duration, dose, route of vitamin D administration, vitamin D status (baseline and post-intervention), body mass index (BMI), age and type of vitamin D. We searched the Medline, Embase, Cochrane Library and Scopus databases from inception until March 2015 for studies meeting the following criteria: (1) RCT with adult participants, (2) vitamin D administration alone, (3) studies that quantified EF using commonly applied methods including ultrasound, plethysmography, applanation tonometry and laser Doppler. Sixteen articles reporting data for 1177 participants were included. Study duration ranged from 4 to 52 weeks. The effect of vitamin D on EF was not significant (SMD: 0.08, 95 % CI -0.06, 0.22, p = 0.28). Subgroup analysis showed a significant improvement of EF in diabetic subjects (SMD: 0.31, 95 % CI 0.05, 0.57, p = 0.02). A non-significant trend was found for diastolic blood pressure (β = 0.02; p = 0.07) and BMI (β = 0.05; p = 0.06). Vitamin D supplementation did not improve EF. The significant effect of vitamin D in diabetics and a tendency for an association with BMI may indicate a role of excess adiposity and insulin resistance in modulating the effects of vitamin D on vascular function. This remains to be tested in future studies.

  18. No evidence for selection of HIV-1 with enhanced gag-protease or Nef function among breakthrough infections in the CAPRISA 004 tenofovir microbicide trial.

    Directory of Open Access Journals (Sweden)

    Denis R Chopera

    Full Text Available Use of antiretroviral-based microbicides for HIV-1 prophylaxis could introduce a transmission barrier that inadvertently facilitates the selection of fitter viral variants among incident infections. To investigate this, we assessed the in vitro function of gag-protease and nef sequences from participants who acquired HIV-1 during the CAPRISA 004 1% tenofovir microbicide gel trial.We isolated the earliest available gag-protease and nef gene sequences from 83 individuals and examined their in vitro function using recombinant viral replication capacity assays and surface protein downregulation assays, respectively. No major phylogenetic clustering and no significant differences in gag-protease or nef function were observed in participants who received tenofovir gel versus placebo gel prophylaxis.Results indicate that the partial protective effects of 1% tenofovir gel use in the CAPRISA 004 trial were not offset by selection of transmitted/early HIV-1 variants with enhanced Gag-Protease or Nef fitness.

  19. Effect of an education and activation programme on functional limitations and patient-perceived recovery in acute and sub-acute shoulder complaints – a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Goossens Marielle

    2007-11-01

    Full Text Available Abstract Background The education and activation programme (EAP aims at coping with psychosocial determinants to prevent the development of chronic shoulder complaints (SCs. The effect of the EAP on functional limitations and patient-perceived recovery after 6 and 26 weeks is evaluated in a randomised clinical trial. Methods Patients with SCs present at rest or elicited by movement and lasting no longer than 3 months were allocated at random to either EAP as an addition to usual care (UC, or to UC only. Measurements were taken at baseline and after 6 and 26 weeks and were analysed by means of multilevel analysis for the group effect. EAP was administered by GPs or by an ambulant therapist (CDB. Patients in the UC group were given UC by their own GP. Results Multilevel analysis failed to show a significant effect of the EAP on either functional limitations or patient-perceived recovery. Analysis showed coincidentally a relation between catastrophising at baseline and functional limitations. Conclusion The EAP has no significant effect on the outcome of SCs after 6 and 26 weeks. The relation between catastrophising at baseline and functional limitations suggests that an intervention focusing specifically on catastrophising may be more successful in reducing functional limitations in the long term. Further research is however needed to evaluate the effect of catastrophising at baseline on the course of SCs. Trial registration Current Controlled Trials ISRCTN71777817

  20. Visual function after correction of distance refractive error with ready-made and custom spectacles: a randomized clinical trial.

    Science.gov (United States)

    Brady, Christopher J; Villanti, Andrea C; Gandhi, Monica; Friedman, David S; Keay, Lisa

    2012-10-01

    To evaluate patient-reported outcome measures with the use of ready-made spectacles (RMS) and custom spectacles (CS) in an adult population in India with uncorrected refractive error (URE). Prospective, double-masked, randomized trial with 1-month follow-up. A total of 363 adults aged 18 to 45 years with ≥1 diopter (D) of URE (RMS, n = 183; CS, n = 180). All participants received complete refraction and were randomized to receive CS (full sphero-cylindrical correction) or RMS based on the spherical equivalent for the eye with lower refractive error but limited to the powers in the RMS inventory. Visual function and quality of life (VFQoL) instrument and participant satisfaction. Rasch scores for VFQoL increased from 1.14 to 4.37 logits in the RMS group and from 1.11 to 4.72 logits in the CS group: respective mean changes of 3.23 (95% confidence interval [CI], 2.90-3.56) vs. 3.61 (95% CI, 3.34-3.88), respectively. Mean patient satisfaction also increased by 1.83 points (95% CI, 1.60-2.06) on a 5-point Likert scale in the RMS group and by 2.04 points (95% CI, 1.83-2.24) in the CS group. In bivariate analyses, CS was not associated with increased VFQoL or patient satisfaction compared with the RMS group. In the full multivariable linear regression, the CS group had greater improvement when compared with those receiving RMS (+0.45 logits; 95% CI, 0.02-0.88), and subjects with astigmatism >2.00 D had significantly less improvement (-0.99 logits; 95% CI, -1.68 to -0.30) after controlling for demographic and vision-related characteristics. In multivariable analysis, increased change in patient satisfaction was related to demographic and optical characteristics, but not spectacle group. Ready-made spectacles produce large but slightly smaller improvements in VFQoL and similar satisfaction with vision at 1-month follow-up when compared with CS. Ready-made spectacles are suitable for the majority of individuals with URE in our study population, although those with high

  1. Phase I clinical trial of systemically administered TUSC2(FUS1-nanoparticles mediating functional gene transfer in humans.

    Directory of Open Access Journals (Sweden)

    Charles Lu

    Full Text Available Tumor suppressor gene TUSC2/FUS1 (TUSC2 is frequently inactivated early in lung cancer development. TUSC2 mediates apoptosis in cancer cells but not normal cells by upregulation of the intrinsic apoptotic pathway. No drug strategies currently exist targeting loss-of-function genetic abnormalities. We report the first in-human systemic gene therapy clinical trial of tumor suppressor gene TUSC2.Patients with recurrent and/or metastatic lung cancer previously treated with platinum-based chemotherapy were treated with escalating doses of intravenous N-[1-(2,3-dioleoyloxypropyl]-N,N,N-trimethylammonium chloride (DOTAP:cholesterol nanoparticles encapsulating a TUSC2 expression plasmid (DOTAP:chol-TUSC2 every 3 weeks.Thirty-one patients were treated at 6 dose levels (range 0.01 to 0.09 milligrams per kilogram. The MTD was determined to be 0.06 mg/kg. Five patients achieved stable disease (2.6-10.8 months, including 2 minor responses. One patient had a metabolic response on positron emission tomography (PET imaging. RT-PCR analysis detected TUSC2 plasmid expression in 7 of 8 post-treatment tumor specimens but not in pretreatment specimens and peripheral blood lymphocyte controls. Proximity ligation assay, performed on paired biopsies from 3 patients, demonstrated low background TUSC2 protein staining in pretreatment tissues compared with intense (10-25 fold increase TUSC2 protein staining in post-treatment tissues. RT-PCR gene expression profiling analysis of apoptotic pathway genes in two patients with high post-treatment levels of TUSC2 mRNA and protein showed significant post-treatment changes in the intrinsic apoptotic pathway. Twenty-nine genes of the 82 tested in the apoptosis array were identified by Igenuity Pathway Analysis to be significantly altered post-treatment in both patients (Pearson correlation coefficient 0.519; p<0.01.DOTAP:chol-TUSC2 can be safely administered intravenously in lung cancer patients and results in uptake of the gene

  2. The fastest of three trials is recommended for Timed Up & Go testing of functional mobility in an outpatient geriatric setting

    DEFF Research Database (Denmark)

    Bloch, Mette Linding

    , using an armchair if not able to perform without). Repeated measures with Bonferoni corrections for mass significance was used to evaluate differences between TUG trials, T-Tests to evaluate differences between groups,and Pearson’s Correlation coefficient to evaluate association between variables...... trials are needed to produce the best performance. Purpose: To examine if the fastest of three timed TUG trials producesbetter (faster) results than the recording of the second trial in elderly people when following an outpatient geriatric rehabilitation programme. Material and Methods: A total of 32...... elderly people (20 women), at a mean (SD) age of 83.4 (8.6) years were included. All subjects performed three timed TUG trials as fast as safely possible with their normal walking aid (if using). In addition, 30 of the 32 subjects performed the Chair Stand Test (CST) (number of sit to stands in 30 seconds...

  3. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial.

    Science.gov (United States)

    Ni Mhurchu, Cliona; Turley, Maria; Gorton, Delvina; Jiang, Yannan; Michie, Jo; Maddison, Ralph; Hattie, John

    2010-11-29

    Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school) will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December). The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades), sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12609000854235.

  4. Do empowered stroke patients perform better at self-management and functional recovery after a stroke? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sit JW

    2016-10-01

    Full Text Available Janet WH Sit,1 Sek Ying Chair,1 Kai Chow Choi,1 Carmen WH Chan,1 Diana TF Lee,1 Aileen WK Chan,1 Jo LK Cheung,1 Siu Wai Tang,2 Po Shan Chan,2 Ruth E Taylor-Piliae3 1The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, 2Department of Medicine and Rehabilitation, Tung Wah Eastern Hospital, Hong Kong Hospital Authority, Causeway Bay, Hong Kong, People’s Republic of China; 3College of Nursing, The University of Arizona, Tucson, AZ, USA Background: Self-management after a stroke is a challenge because of multifaceted care needs and complex disabling consequences that cause further hindrance to patient participation. A 13-week stroke patient empowerment intervention (Health Empowerment Intervention for Stroke Self-management [HEISS] was developed to enhance patients’ ability to participate in self-management.Purpose: To examine the effects of the empowerment intervention on stroke patients’ self-efficacy, self-management behavior, and functional recovery.Methods: This is a single-blind randomized controlled trial with stroke survivors assigned to either a control group (CG receiving usual ambulatory rehabilitation care or the HEISS in addition to usual care (intervention group [IG]. Outcome data were collected at baseline (T0, 1 week (T1, 3 months (T2, and 6 months (T3 postintervention. Data were analyzed on the intention-to-treat principle. The generalized estimating equation model was used to assess the differential change of self-efficacy in illness management, self-management behaviors (cognitive symptom management, communication with physician, medication adherence, and self-blood pressure monitoring, and functional recovery (Barthel and Lawton indices across time points (baseline = T0, 1 week = T1, 3 months = T2, and 6 months = T3 postintervention between the two groups.Results: A total of 210 (CG =105, IG =105 Hong Kong Chinese stroke survivors (mean age =69 years, 49% women, 72% ischemic

  5. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Fontes-Carvalho, Ricardo; Sampaio, Francisco; Teixeira, Madalena; Gama, Vasco; Leite-Moreira, Adelino F

    2015-03-12

    Exercise training is effective in improving functional capacity and quality of life in patients with coronary artery disease, but its effects on left ventricular systolic and diastolic function are controversial. Diastolic dysfunction is a major determinant of adverse outcome after myocardial infarction and, contrary to systolic function, no therapy or intervention has proved to significantly improve diastolic function. Data from animal studies and from patients with diastolic heart failure has suggested that exercise training can have a positive effect on diastolic function parameters. This trial aims to evaluate if a structured exercise training program can improve resting left ventricular diastolic and systolic function in patients who have had an acute myocardial infarction. This is a phase II, prospective, randomized, open-label, blinded-endpoint trial that will include at least 96 consecutive patients who have had an acute myocardial infarction one month previously. Patients will be randomized (1:1) to an exercise training program or a control group, receiving standard of care. At enrolment, and at the end of the follow-up period, patients will be submitted to an echocardiography (with detailed assessment of diastolic and systolic function using recent consensus guidelines), cardiopulmonary exercise testing, an anthropometric assessment, blood testing, and clinical evaluation. Patients randomized to the intervention group will be submitted to an eight-week outpatient exercise program, combining endurance and resistance training, for three sessions per week. The primary endpoint will be the change in lateral E' velocity immediately after the eight-week exercise training program. Secondary endpoints will include other echocardiographic parameters of left ventricular diastolic and systolic function, cardiac structure, metabolic and inflammation biomarkers (high-sensitivity C-reactive protein and pro-BNP), functional capacity (peak oxygen consumption and

  6. Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Xu, Huajun; Wang, Hui; Guan, Jian; Yi, Hongliang; Qian, Yingjun; Zou, Jianyin; Xia, Yunyan; Fu, Yiqun; Li, Xinyi; Jiao, Xiao; Huang, Hengye; Dong, Pin; Yu, Ziwei; Yang, Jun; Xiang, Mingliang; Li, Jiping; Chen, Yanqing; Wang, Peihua; Sun, Yizhou; Li, Yuehua; Zheng, Xiaojian; Jia, Wei; Yin, Shankai

    2017-05-25

    Many clinical studies have indicated that obstructive sleep apnoea (OSA), the most common chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous positive airway pressure (CPAP) has some neurocognitive protective effects against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture and function remain unclear. Therefore, this multicentre trial was designed to investigate whether and when neurocognitive architecture and function in patients with OSA can be improved by CPAP treatment and to explore the role of gut microbiota in improving neurocognitive function during treatment. This study will be a multicentre, randomised, controlled trial with allocation concealment and assessor blinding. A total of 148 eligible patients with moderate to severe OSA will be enrolled from five sleep centres and randomised to receive CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive function, structure and function of brain regions, gut microbiota, metabolites, biochemical variables, electrocardiography, echocardiography, pulmonary function and arterial stiffness will be assessed at baseline before randomisation and at 3, 6 and 12 months. This study has been approved by the Medical Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (approval number 2015-79). The results from this study will be published in peer-reviewed journals and at relevant conferences. NCT02886156; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Steeds Richard P

    2011-02-01

    Full Text Available Abstract Background Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes arterial stiffening through structural vascular alterations such as medial calcification, which are already apparent in the early stages of chronic kidney disease. Aim To determine the effects of phosphate binding with sevelamer carbonate on left ventricular mass and function together with arterial stiffness in patients with stage 3 chronic kidney disease. Methods/Design A single-centre, prospective, randomised, double-blind, placebo-controlled trial of 120 subjects with stage 3 chronic kidney disease recruited from University Hospitals Birmingham NHS Foundation Trust. Baseline investigations include transthoracic echocardiography and cardiac magnetic resonance imaging to assess ventricular mass, volumes and function, applanation tonometry to determine pulse wave velocity and pulse wave analysis as surrogate measures of arterial stiffness and dual energy x-ray absorptiometry scanning to determine bone density. During an open-label run in phase, subjects will receive 1600 mg sevelamer carbonate with meals for four weeks. They will then be randomised to either continue sevelamer carbonate or receive an identical placebo (60 subjects per arm for the remaining 36 weeks. Four-weekly monitoring of serum electrolytes and bone biochemistry will be performed. All baseline investigations will be repeated at the end of the treatment period. The primary endpoint of the study is a reduction in left ventricular mass after 40 weeks of treatment. Secondary endpoints are: i change in aortic compliance; ii change in arterial stiffness; iii change in arterial elastance; iv change in left ventricular systolic and diastolic elastance; v change in left ventricular function; and vi change in bone density. Trial Registration This trial is

  8. Identifying the concepts contained in outcome measures of clinical trials on breast cancer using the International Classification of Functioning, Disability and Health as a reference.

    Science.gov (United States)

    Brockow, Thomas; Duddeck, Katharina; Geyh, Szilvia; Schwarzkopf, Susanne; Weigl, Martin; Franke, Thomas; Brach, Mirjam

    2004-07-01

    To systematically identify and quantify the concepts contained in outcome measures of clinical breast cancer trials using the International Classification of Functioning, Disability and Health (ICF) as a reference. Randomized controlled trials between 1991 and 2000 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. A total of 640 trials were included. Ninety-four different health status questionnaires were extracted. Three questionnaires were breast cancer-specific and 12 cancer-specific. Of 19,692 extracted concepts, 88% could be linked to the ICF. The most used ICF categories within the components body structures, body functions, and activities and participation were structure of the reproductive system (s630), sensations associated with the digestive system (b535), and looking after one's health (d570) with frequencies of 64%, 46% and 14%, respectively. No category of the environmental factors component reached a frequency of 10%. The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical breast cancer trials. There seems to be a lack of health concepts evaluating specific aspects of disability and participation in breast cancer. Similarly, environmental factors with an impact on individual life of breast cancer survivors seem to be poorly represented.

  9. Effect of the peels of two Citrus fruits on endothelium function in adolescents with excess weight: A triple-masked randomized trial.

    Science.gov (United States)

    Hashemi, Mohammad; Khosravi, Elham; Ghannadi, Alireza; Hashemipour, Mahin; Kelishadi, Roya

    2015-08-01

    Obesity induces endothelial dysfunction even in the pediatric age group. The possible protective effects of fruits and herbal products on the endothelial dysfunction of obese children remain to be determined. This study aims to investigate the effects of lemon and sour orange peels on endothelial function of adolescents with excess weight. This triple-masked, randomized placebo-controlled trial was conducted for 1-month among 90 overweight and obese participants, aged 6-18 years. They were randomly assigned into three groups of equal number receiving daily oral capsules containing lemon or sour orange powder or placebo. Flow-mediated dilatation (FMD) was compared between three groups by using analysis of covariance. Overall, 30 participants in the lemon group, 27 in the sour orange group and 29 in the control group completed the trial. After the trial, mean FMD was significantly (P lemon group (11.99 ± 4.05) and in the sour orange group (12.79 ± 5.47) than in the placebo group (6.45 ± 2.79). FMD percent change was 145.02 ± 24.34 in the lemon group, 142.04 ± 16.11 in the sour orange group, and 46.73 ± 5.16 in controls (P lemon and sour orange peels, which contain plenty amounts of antioxidants, flavonoids, pectin, and vitamin C, might have significant benefits on endothelial function in children and adolescents with excess weight. Trial registry code: IRCT201311201434N10.

  10. Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

    Science.gov (United States)

    Bennell, Kim L; Egerton, Thorlene; Martin, Joel; Abbott, J Haxby; Metcalf, Ben; McManus, Fiona; Sims, Kevin; Pua, Yong-Hao; Wrigley, Tim V; Forbes, Andrew; Smith, Catherine; Harris, Anthony; Buchbinder, Rachelle

    2014-05-21

    There is limited evidence supporting use of physical therapy for hip osteoarthritis. To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score

  11. Individualized Cognition-Action intervention to prevent behavioral disturbances and functional decline in institutionalized older adults: a randomized pilot trial.

    Science.gov (United States)

    Dechamps, Arnaud; Alban, Rigier; Jen, Joanne; Decamps, Arnaud; Traissac, Thalie; Dehail, Patrick

    2010-08-01

    To evaluate the effectiveness of an individualized Cognition-Action (CA) intervention to reduce behavioral disturbances in severely deconditioned institutionalized old adults. 12 weeks randomized pilot trial of either individualized Cognition-Action program (n = 24) or routine medical care as control (C, n = 25). Long-term care (LTC) of the Geriatric Department from the University State Hospital in Bordeaux, France. 49 institutionalized old patients with at least one Neuropsychiatric symptoms > or =4. The CA rationale was a non-preconceived ideas approach over the patient's abilities and discourse. Patients received short bouts of 5-15 min and accumulated 50 min of interaction per week. CA intervention used five standardized exercises as tools to enhance communication and social interactions. CA was compared to usual care. Primary outcomes were the Neuropsychiatric inventory (NPI) total and symptoms scores. Secondary outcomes were the BERG balance scale, the Geriatric Depression Scale (GDS), Quality of life AM-PAC-CAT and Muscle strength. The CA group had a clinically significant NPI total score reduction compared to C, -7, 95%CI [-10.8 to -3], eta2 = 0.24. CA group showed a risk reduction of NPI total score worsening, OR = 0.09, 95%CI [0.02-0.37]. BERG total score was clinically improved in the CA group compared to C, 4.9 95%CI [0.7-9.2], eta2(p)= 0.11. CA patients reduced their GDS score and improved their Quality of life and Strength. The combination of tailored guidance and simple standardized exercises was an effective behavioral management approach for behavioral disturbances reduction and functional autonomy improvement in institutionalized old adult populations.

  12. Which subtype of functional dyspepsia patients responses better to acupuncture? A retrospective analysis of a randomized controlled trial.

    Science.gov (United States)

    Ma, Tingting; Zeng, Fang; Li, Ying; Wang, Chieh-Mei; Tian, Xiaoping; Yu, Shuyuan; Zhao, Ling; Wu, Xi; Yang, Min; Wang, Dejun; Liang, Fanrong

    2015-01-01

    Whether subgroups of functional dyspepsia (FD) should be treated with different approaches is controversially discussed in research. As our previous study has demonstrated the effect of acupuncture in FD treatment, we now further analyze the therapeutic effect of acupuncture in the treatment of postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). A retrospective analysis was conducted in 465 eligible PDS patients and 241 EPS patients. 4 acupuncture groups (group A: specific acupoints along the stomach meridian; group B: non-specific acupoints along the stomach meridian; group C: alarm and transport acupoints; group D: specific acupoints along the gallbladder meridian) were compared with a non-acupoint sham acupuncture group and an itopride group. The patients were treated in 5 consecutive sessions per week for 4 weeks and were followed-up for 12 weeks afterwards. Primary outcome of the study was defined as response rate and symptom improvement as measured by the Symptom Index of Dyspepsia, while secondary outcome was designated as improvement in quality of life (QoL) as determined by the Nepean Dyspepsia Index. Symptoms of dyspepsia and QoL were improved from baseline in all groups. In EPS patients, no statistically significant differences could be observed in response rate (p = 0.239) and symptoms improvement (p = 0.344 for epigastric pain; p = 0.465 for epigastric burning). In contrast, PDS patients of the acupuncture group A showed higher response rate (53.2% vs. 19.7%, pitopride group. FD patients with PDS responded better to the acupuncture therapies, especially at the specific acupoints along the stomach meridian. The positive therapeutic effect of acupuncture on PDS was correlated with the improvement in postprandial fullness. ClinicalTrial.gov NCT00599677. © 2015 S. Karger GmbH, Freiburg.

  13. Factors related to acupuncture response in patients with chronic severe functional constipation: Secondary analysis of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Xingyue Yang

    Full Text Available Acupuncture has been demonstrated to be effective and safe for chronic severe functional constipation (CSFC. However, which patients with CSFC will have a better response to acupuncture remains unclear.To explore factors related to acupuncture response in patients with CSFC.We performed a secondary analysis of a previous multicenter randomized controlled trial consisting of a 2-week run-in period, 8-week treatment, and 12-week follow-up without treatment in which patients with CSFC were randomly allocated to an electroacupuncture group or a sham electroacupuncture group. Responders were defined as participants with an increase of at least one complete spontaneous bowel movement (CSBM in week 20 compared with the baseline period. The CSBM responder rate in both groups was described, and the baseline characteristics of participants potentially related to acupuncture response were mainly analyzed using logistic regression analysis with bootstrapping techniques.A total of 1021 participants were analyzed in this study, of whom 516 (50.5% were classified as responders. The CSBM responder rate in week 20 was significantly greater in the electroacupuncture group than in the sham electroacupuncture group (62.9% vs. 37.9%, respectively; P<0.001. Both age and comorbidity were negatively associated with clinical response: with every one-year increase in age, the likelihood of clinical response was reduced by 1.2% (OR 0.988, 95%CI 0.980 to 0.996; P = 0.005, and patients with comorbidities were approximately 42% less likely to respond to treatment (OR 0.581, 95%CI 0.248 to 0.914; P = 0.001.CSFC patients with increasing age and comorbidity may be less likely to respond to acupuncture. These findings contribute to guiding clinical practice in terms of pretreatment patient selection. Further research is needed to confirm the association.

  14. Pimpinella anisum in modifying the quality of life in patients with functional dyspepsia: A double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    S Ashraffodin Ghoshegir

    2014-01-01

    Full Text Available Background: We aimed to assess the effects of anise on quality of life (QOL of patients with functional dyspepsia (FD in a double-blind randomized clinical trial. Materials and Methods: Of 180 patients attending the gastroenterology clinic, 107 ones with the diagnosis of postprandial distress syndrome according to Rome III criteria were enrolled. They were randomized into two groups, anise and placebo. Anise group involved 47 patients and received anise powders, 3 g after each meal (3 times/day for 4 weeks. Control group had 60 patients who received placebo powders (cornstarch, 3 g after each meal (3 times/day for 4 weeks. The QOL was assessed by short-form (SF-36 questionnaire. Mean scores of eight health domains of the two groups were compared at baseline and at the end of study. Results: The age, sex, body mass index, smoking history, tea and coffee drinking patterns of the two groups were not significantly different. All domains of SF-36 were similar between the two groups at baseline but were significantly different at week 12. At baseline, mean score of physical component summary was 159 in placebo group and 167 in anise group (P = 0.1. At week 12, the score was 141 in placebo group and 251 in anise group (P = 0.0001. Mean baseline score of mental component summary was 172 and 165 in placebo and anise groups, respectively (P = 0.1. At week 12, the score was 135 in placebo group and 233 in anise group (P = 0.0001. Conclusion: The current study revealed the effectiveness of anise in improvement of QOL in patients with FD.

  15. THE EFFICACY OF AN EIGHT-WEEK CORE STABILIZATION PROGRAM ON CORE MUSCLE FUNCTION AND ENDURANCE: A RANDOMIZED TRIAL.

    Science.gov (United States)

    Hoppes, Carrie W; Sperier, Aubrey D; Hopkins, Colleen F; Griffiths, Bridgette D; Principe, Molly F; Schnall, Barri L; Bell, Johanna C; Koppenhaver, Shane L

    2016-08-01

    Body armor is credited with increased survival rates in soldiers but the additional axial load may negatively impact the biomechanics of the spine resulting in low back pain. Multiple studies have found that lumbar stabilization programs are superior to generalized programs for patients with chronic low back pain. It is not known if such programs produce objective changes in trunk muscle function with wear of body armor. An eight-week core stability exercise program would result in a larger improvement in physical endurance and abdominal muscle thickness than a control intervention. The purpose of this study was to assess the effectiveness of an eight-week core stability exercise program on physical endurance and abdominal muscle thickness with and without wear of body armor. Randomized controlled trial. Participants (N = 33) were randomized into either the core strengthening exercise group or the control group. Testing included ultrasound imaging of abdominal muscle thickness in hook-lying and standing with and without body armor and timed measures of endurance. There were statistically significant group by time interactions for transversus abdominis muscle contraction thickness during standing, both with (p = 0.018) and without body armor (p = 0.038). The main effect for hold-time during the horizontal side-support (p = 0.016) indicated improvement over time regardless of group. There was a significant group by time interaction (p = 0.014) for horizontal side-support hold-time when compliance with the exercise protocol was set at 85%, indicating more improvement in the core stabilization group than in the control group. Performing an eight-week core stabilization exercise program significantly improves transversus abdominis muscle activation in standing and standing with body armor. When compliant with the exercises, such a program may increase trunk strength and muscle endurance. Therapy, Level 2b.

  16. Effect of scapular function training on chronic pain in the neck/shoulder region: a randomized controlled trial.

    Science.gov (United States)

    Andersen, Christoffer H; Andersen, Lars L; Zebis, Mette K; Sjøgaard, Gisela

    2014-06-01

    Neck and shoulder complaints are common among employees in occupations characterized by intensive computer use. Treatment has varied from passive rest to active treatments and active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct training of the painful area. Our study investigates the effect of the latter approach. The purpose of this study was in a randomised controlled trial to investigate if intensive scapular function training (SFT)-in terms of training of the lower trapezius and the serratus anterior muscle while minimizing direct training of the upper trapezius-is effective in reducing pain in adults with chronic non-specific pain in the neck/shoulder region. 47 office workers with chronic non-specific pain in the neck/shoulder region were randomized to 10 weeks 3 × 20 min SFT with training supervision or to a control group. At baseline and at follow-up the participants were tested for maximum isometric shoulder strength by a blinded tester. Further, once a week participants reported pain intensity of the neck/shoulder during the previous week. In intention-to-treat analysis neck- and shoulder pain decreased 2.0 (95 % CI 0.35; 3.64) in SFT compared with control group (p Shoulder elevation strength increased 7.7 kg in SFT compared with the control group (p shoulder protraction strength. SFT reduces pain intensity and increases shoulder elevation strength in adults with chronic non-specific pain in the neck/shoulder region. The magnitude of improvement in pain intensity was clinically relevant.

  17. Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the D-Vitaal study, a randomized placebo-controlled clinical trial.

    Science.gov (United States)

    de Koning, Elisa J; van Schoor, Natasja M; Penninx, Brenda W J H; Elders, Petra J M; Heijboer, Annemieke C; Smit, Jan H; Bet, Pierre M; van Tulder, Maurits W; den Heijer, Martin; van Marwijk, Harm W J; Lips, Paul

    2015-11-19

    Depressive symptoms and decreased physical functioning are interrelated conditions and common in older persons, causing significant individual and societal burden. Evidence suggests that vitamin D supplementation may be beneficial for both mental and physical functioning. However, previous randomized controlled trials have yielded inconsistent results and often had suboptimal designs. This study examines the effect of vitamin D supplementation on both depressive symptoms and physical functioning in a high-risk population of older persons with low vitamin D status. The D-Vitaal study is a randomized, double-blind, placebo-controlled trial investigating the effects of a daily dose of 1200 IU vitamin D3 versus placebo for one year on depressive symptoms and physical functioning (primary outcomes) in older adults. Participants (N = 155, age 60-80 years) were recruited from the general population. Eligibility criteria included the presence of depressive symptoms, ≥1 functional limitation and serum 25-hydroxyvitamin D levels between 15 and 50/70 nmol/L (depending on season). Secondary outcomes include incidence of major depressive disorder, anxiety symptoms, health-related quality of life, cognitive function and cost-effectiveness of the intervention. With this study, we aim to elucidate the effects of vitamin D supplementation on depressive symptoms and physical functioning in older persons who are at high risk of developing more substantial mental and physical problems. If effective, vitamin D supplementation can be a preventive intervention strategy that is easy to implement in the primary care setting. Netherlands Trial Register NTR3845. Registered 6 February 2013.

  18. Effect of Kinesio Taping on Pain and Functional Disability in Chronic Nonspecific Low Back Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Al-Shareef, Amal T; Omar, Mohammed T A; Ibrahim, Amal H M

    2016-07-15

    A randomized controlled trial with 2-week Kinesio taping intervention. The aim of the study was to investigate the effectiveness of Kinesio taping application on pain, functional disability, and trunk flexion range of motion (ROM) in patients with chronic nonspecific low back pain (chronic NSLBP). Kinesio taping is a therapeutic tool used for treatment of chronic NSLBP. However, there is little scientific evidence that describes its clinical efficacy. Forty-four patients with chronic NSLBP were randomized into experimental group (n = 21) and placebo group (n = 23). The experimental group was treated with Erector Spinae Taping, whereas the placebo group was treated with placebo taping. The primary endpoint was pain intensity on visual analog scale. Secondary endpoints were functional disability on Arabic version of Oswestry disability index (ODI) and trunk flexion ROM on Modified Schober's test. All measurements were recorded at baseline (W0), after 2-week intervention (W2), and at 4-week (W4) follow-up. Both group were comparable at baseline (P > 0.05). The experimental group had a greater decrease in pain than the placebo group after W2 of intervention (mean between-group difference 2.05 cm, 95% confidence interval [CI] = 1.38-2.71 points). This was maintained to W4 follow-up (2.25 cm, 95% CI = 1.67-2.82 points). At W2, the experimental group had significantly greater improvement in disability, by 3.90 points (95% CI = 1.68-8.54 points). This effect was significant at W4 follow-up (5.6, 95% CI = 2.65-8.54 points). Similarly trunk flexion ROM was significantly better at W2 (-0.71 cm, 95% CI = -0.85 to -0.56) and W4 follow-up (-0.73 cm, 95% CI = -0.88 to -0.58). Kinesio taping reduces pain and disability and improves trunk flexion ROM after 2 weeks of application. However, thesis effects were very small to be considered clinically relevant and meaningful when compared with placebo taping. 2.

  19. Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Witham, Miles D; Band, Margaret M; Littleford, Roberta C; Avenell, Alison; Soiza, Roy L; McMurdo, Marion E T; Sumukadas, Deepa; Ogston, Simon A; Lamb, Edmund J; Hampson, Geeta; McNamee, Paul

    2015-08-01

    Metabolic acidosis is more common with advancing chronic kidney disease, and has been associated with impaired physical function, impaired bone health, accelerated decline in kidney function and increased vascular risk. Although oral sodium bicarbonate is widely used to correct metabolic acidosis, there exist potential risks of therapy including worsening hypertension and fluid overload. Little trial evidence exists to decide whether oral bicarbonate therapy is of net benefit in advanced chronic kidney disease, particularly in older people who are most commonly affected, and in whom physical function, quality of life and vascular health are at least as important outcomes as decline in renal function. BiCARB is a multi-centre, double-blind, placebo controlled, randomised trial evaluating the clinical and cost-effectiveness of oral sodium bicarbonate in the management of older people with chronic kidney disease and severely reduced glomerular filtration rate (GFR) who have a mild degree of metabolic acidosis. The trial will recruit 380 patients from renal, Medicine for the Elderly, and primary care services across centres in the United Kingdom. Male and female patients aged 60 years and older with an estimated glomerular filtration rate of <30 mL/min/1.73 m(2), not on dialysis, and with serum bicarbonate concentrations <22 mmol/L will be eligible for participation. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at 12 months. Secondary outcomes include muscle strength, quality of life measured using the EQ-5D score and KDQoL tools, cost effectiveness, renal function, presence of albuminuria and blood pressure. Markers of bone turnover (25-hydroxyvitamin D, 1,25-hydroxyvitamin D, tartrate-resistant acid phosphatase-5b and bone-specific alkaline phosphatase) and vascular health (B-type natriuretic peptide) will be measured. Participants will receive a total of 24 months of either bicarbonate or

  20. Effect of Reducing Indoor Air Pollution on Women's Respiratory Symptoms and Lung Function: The RESPIRE Randomized Trial, Guatemala

    National Research Council Canada - National Science Library

    Smith-Sivertsen, Tone; Díaz, Esperanza; Pope, Dan; Lie, Rolv T; Díaz, Anaite; McCracken, John; Bakke, Per; Arana, Byron; Smith, Kirk R; Bruce, Nigel

    2009-01-01

    .... The Randomized Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE) is a randomized intervention trial evaluating the respiratory health effects of reducing indoor air pollution from open cooking fires...

  1. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation

    National Research Council Canada - National Science Library

    Gil, Alberto Luiz; Azevedo, Mirela Jobim de; Tomasetto, Giovani Generali; Muniz, Carlos Henrique Gervini; Lavinsky, Jacó

    2011-01-01

    .... The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients...

  2. Contours of a causal feedback mechanism between adaptive personality and psychosocial function in patients with personality disorders: a secondary analysis from a randomized clinical trial.

    Science.gov (United States)

    Klungsøyr, Ole; Antonsen, Bjørnar; Wilberg, Theresa

    2017-06-05

    Patients with personality disorders commonly exhibit impairment in psychosocial function that persists over time even with diagnostic remission. Further causal knowledge may help to identify and assess factors with a potential to alleviate this impairment. Psychosocial function is associated with personality functioning which describes personality disorder severity in DSM-5 (section III) and which can reportedly be improved by therapy. The reciprocal association between personality functioning and psychosocial function was assessed, in 113 patients with different personality disorders, in a secondary longitudinal analysis of data from a randomized clinical trial, over six years. Personality functioning was represented by three domains of the Severity Indices of Personality Problems: Relational Capacity, Identity Integration, and Self-control. Psychosocial function was measured by Global Assessment of Functioning. The marginal structural model was used for estimation of causal effects of the three personality functioning domains on psychosocial function, and vice versa. The attractiveness of this model lies in the ability to assess an effect of a time - varying exposure on an outcome, while adjusting for time - varying confounding. Strong causal effects were found. A hypothetical intervention to increase Relational Capacity by one standard deviation, both at one and two time-points prior to assessment of psychosocial function, would increase psychosocial function by 3.5 standard deviations (95% CI: 2.0, 4.96). Significant effects of Identity Integration and Self-control on psychosocial function, and from psychosocial function on all three domains of personality functioning, although weaker, were also found. This study indicates that persistent impairment in psychosocial function can be addressed through a causal pathway of personality functioning, with interventions of at least 18 months duration.

  3. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: A randomized controlled trial

    OpenAIRE

    Vibe Fersum, K; O?Sullivan, P; Skouen, JS; Smith, A; Kv?le, A

    2012-01-01

    Background: Non-specific chronic low back pain disorders have been proven resistant to change, and there is still a lack of clear evidence for one specific treatment intervention being superior to another. Methods: This randomized controlled trial aimed to investigate the efficacy of a behavioural approach to management, classification-based cognitive functional therapy, compared with traditional manual therapy and exercise. Linear mixed models were used to estimate the group differences in t...

  4. Pre-surgery exercise and post-operative physical function of people undergoing knee replacement surgery: A systematic review and meta-analysis of randomized controlled trials

    OpenAIRE

    Peer, Maria; Rush, Robert; Gallacher, P; Gleeson, Nigel

    2017-01-01

    Objective: To summarize the evidence regarding the effectiveness and dose-response characteristics of pre-operative exercise programmes on post-operative physical function following total knee arthroplasty.\\ud Data sources: CINAHL, Cochrane Library, PubMed, SPORTDiscus and EMBASE.\\ud Study selection: Randomized controlled trials were eligible if they provided full description of physiological stress (i.e. mode, frequency, intensity and duration).\\ud Data extraction: Data extraction and evalua...

  5. Effect of the peels of two Citrus fruits on endothelium function in adolescents with excess weight: A triple-masked randomized trial

    OpenAIRE

    Hashemi, Mohammad; Khosravi, Elham; Ghannadi, Alireza; Hashemipour, Mahin; Kelishadi, Roya

    2015-01-01

    Background: Obesity induces endothelial dysfunction even in the pediatric age group. The possible protective effects of fruits and herbal products on the endothelial dysfunction of obese children remain to be determined. This study aims to investigate the effects of lemon and sour orange peels on endothelial function of adolescents with excess weight. Materials and Methods: This triple-masked, randomized placebo-controlled trial was conducted for 1-month among 90 overweight and obese particip...

  6. Study protocol: a randomised controlled trial of the effects of a multi-modal exercise program on cognition and physical functioning in older women

    Directory of Open Access Journals (Sweden)

    Vaughan Sue

    2012-09-01

    Full Text Available Abstract Background Intervention studies testing the efficacy of cardiorespiratory exercise have shown some promise in terms of improving cognitive function in later life. Recent developments suggest that a multi-modal exercise intervention that includes motor as well as physical training and requires sustained attention and concentration, may better elicit the actual potency of exercise to enhance cognitive performance. This study will test the effect of a multi-modal exercise program, for older women, on cognitive and physical functioning. Methods/design This randomised controlled trial involves community dwelling women, without cognitive impairment, aged 65–75 years. Participants are randomised to exercise intervention or non-exercise control groups, for 16 weeks. The intervention consists of twice weekly, 60 minute, exercise classes incorporating aerobic, strength, balance, flexibility, co-ordination and agility training. Primary outcomes are measures of cognitive function and secondary outcomes include physical functioning and a neurocognitive biomarker (brain derived neurotrophic factor. Measures are taken at baseline and 16 weeks later and qualitative data related to the experience and acceptability of the program are collected from a sub-sample of the intervention group. Discussion If this randomised controlled trial demonstrates that multimodal exercise (that includes motor fitness training can improve cognitive performance in later life, the benefits will be two-fold. First, an inexpensive, effective strategy will have been developed that could ameliorate the increased prevalence of age-related cognitive impairment predicted to accompany population ageing. Second, more robust evidence will have been provided about the mechanisms that link exercise to cognitive improvement allowing future research to be better focused and potentially more productive. Trial registration Australian and New Zealand Clinical Trial Registration Number

  7. Identifying the concepts contained in outcome measures of clinical trials on stroke using the International Classification of Functioning, Disability and Health as a reference.

    Science.gov (United States)

    Geyh, Szilvia; Kurt, Thomas; Brockow, Thomas; Cieza, Alarcos; Ewert, Thomas; Omar, Zaliha; Resch, Karl-Ludwig

    2004-07-01

    To systematically identify and quantify the concepts contained in outcome measures in stroke trials using the International Classification of Functioning, Disability and Health (ICF) as a reference. Randomized controlled trials between 1992 and 2001 were located in MEDLINE and selected according to predefined criteria. Outcome measures were extracted and concepts contained in the outcome measures were linked to the ICF. A random sample of 160 (50%) of 320 eligible studies was included. A total of 148 standardized health status measures were identified. Of 11,283 extracted concepts, 91% could be linked to the ICF. The most used ICF categories for each component were d450 walking (70%) for activities and participation, b525 defecation functions (62%) for body functions, and e399 support and relationships, unspecified (30%) for environmental factors. The ICF provides a useful reference to identify and quantify the concepts contained in outcome measures used in stroke trials. Outcome measurement in stroke refers to an enormous variety of concepts; for comparability of research findings agreement on what should be measured is needed.

  8. Effect of whole soy and purified isoflavone daidzein on renal function--a 6-month randomized controlled trial in equol-producing postmenopausal women with prehypertension.

    Science.gov (United States)

    Liu, Zhao-min; Ho, Suzanne C; Chen, Yu-ming; Tang, Nelson; Woo, Jean

    2014-09-01

    The aim of the study was to examine the long-term effect of commonly used whole soy foods (soy flour) and purified daidzein (one major isoflavone and the precursor of equol) on renal function among prehypertensive postmenopausal women who are also equol producers, a population most likely to benefit from soy intervention. This was a 6-month double-blind, randomized, placebo-controlled trial. Two hundred seventy eligible Chinese women were randomized to either one of the three treatments: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily each for 6 months. Fasting blood and 24-h urine samples were collected at the beginning and end of trial. Serum creatinine, cystatin C, urea, angiotensin-converting enzyme, minerals and 24-h urinary creatinine and minerals were analyzed. Estimated glomerular filtration rate (eGFR) was calculated with the Cockcroft-Gault and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. Two hundred fifty-three subjects completed the study according to the protocol. Urinary isoflavones indicated good compliance of participants. No significant changes were observed in most of renal parameters, however, there was a less decrease in eGFRcockcroft in 6-month change (p=0.044) and %change (p=0.031) with whole soy intake relative to milk placebo. Subgroup analysis among women with lowered renal function suggested whole soy consumption tended to improve markers of renal function relative to control. Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function. Future trials in subjects with more declined renal function are necessary. The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737). Copyright © 2014 The Canadian Society of Clinical Chemists. Published by

  9. Effect of the peels of two Citrus fruits on endothelium function in adolescents with excess weight: A triple-masked randomized trial

    Directory of Open Access Journals (Sweden)

    Mohammad Hashemi

    2015-01-01

    Full Text Available Background: Obesity induces endothelial dysfunction even in the pediatric age group. The possible protective effects of fruits and herbal products on the endothelial dysfunction of obese children remain to be determined. This study aims to investigate the effects of lemon and sour orange peels on endothelial function of adolescents with excess weight. Materials and Methods: This triple-masked, randomized placebo-controlled trial was conducted for 1-month among 90 overweight and obese participants, aged 6-18 years. They were randomly assigned into three groups of equal number receiving daily oral capsules containing lemon or sour orange powder or placebo. Flow-mediated dilatation (FMD was compared between three groups by using analysis of covariance. Results: Overall, 30 participants in the lemon group, 27 in the sour orange group and 29 in the control group completed the trial. After the trial, mean FMD was significantly (P < 0.001 higher in the lemon group (11.99 ± 4.05 and in the sour orange group (12.79 ± 5.47 than in the placebo group (6.45 ± 2.79. FMD percent change was 145.02 ± 24.34 in the lemon group, 142.04 ± 16.11 in the sour orange group, and 46.73 ± 5.16 in controls (P < 0.001. Conclusion: This trial showed that consumption of extracts of lemon and sour orange peels, which contain plenty amounts of antioxidants, flavonoids, pectin, and vitamin C, might have significant benefits on endothelial function in children and adolescents with excess weight. Trial registry code: IRCT201311201434N10.

  10. Azelnidipine plus olmesartan versus amlodipine plus olmesartan on arterial stiffness and cardiac function in hypertensive patients: a randomized trial

    Directory of Open Access Journals (Sweden)

    Takami T

    2013-04-01

    Full Text Available CorrigendumTakami T, Saito Y. Drug Design, Development and Therapy. 2013;7:175–183. On page 177, line 26, heading "Measurement of LVMI and LF diastolic function" should have been "Measurement of LVMI and LV diastolic function". Line 32, "Devereux et al18" should read "Devereux et al19". Line 40, "(E/e’ ratio were measured as previously described.19" should read "(E/e’ ratio were measured as previously described.20". On page 181, line 15, "baPWV with LVMI.20" should read "baPWV with LVMI.21". Line 23, "baPWV and LVMI, E/A ratio.20" should read "baPWV and LVMI, E/A ratio.21,22". Line 28 "diastolic dysfunction.21" should read "diastolic dysfunction.23". Line 38 "is high.22" should read "is high.24". Line 39, "in clinical treatment.23" should read "in clinical treatment.25". Line 57, "A recent cohort study24" should read "A recent cohort study21".On page 182, line 1, "diastolic heart failure.25" should read "diastolic heart failure.26". Line 3, "untreated hypertensive patients.26" should read "untreated hypertensive patients.27". Line 6, "linear regression analysis.27" should read "linear regression analysis.21".On page 183, the references 18 to 27 should be updated as shown below:18. Takami T. Evaluation of arterial stiffness in morning hypertension under high-dose valsartan compared to valsartan plus low-dose diuretic. Hypertens Res. 2009;32:1086–1090.19. Devereux RB, Palmieri V, Sharpe N, et al. Effects of once-daily angiotensin-converting enzyme inhibition and calcium channel blockade-based antihypertensive treatment regimens on left ventricular hypertrophy and diastolic filling in hypertension: the prospective randomized enalapril study evaluating regression of ventricular enlargement (PRESERVE trial. Circulation. 2001;104:1248–1254.20. Ito H, Ishii K, Kihara H, et al. Adding thiazide to a renin-angiotensin blocker improves left ventricular relaxation and improves heart failure in patients with hypertension. Hypertens Res. 2012;35:93

  11. Effects of aerobic exercise therapy and cognitive behavioural therapy on functioning and quality of life in amyotrophic lateral sclerosis: protocol of the FACTS-2-ALS trial

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    van de Weerd Margreet GH

    2011-06-01

    Full Text Available Abstract Background Amyotrophic lateral sclerosis (ALS is a fatal progressive neurodegenerative disorder affecting motor neurons in the spinal cord, brainstem and motor cortex, leading to muscle weakness. Muscle weakness may result in the avoidance of physical activity, which exacerbates disuse weakness and cardiovascular deconditioning. The impact of the grave prognosis may result in depressive symptoms and hopelessness. Since there is no cure for ALS, optimal treatment is based on symptom management and preservation of quality of life (QoL, provided in a multidisciplinary setting. Two distinctly different therapeutic interventions may be effective to improve or preserve daily functioning and QoL at the highest achievable level: aerobic exercise therapy (AET to maintain or enhance functional capacity and cognitive behavioural therapy (CBT to improve coping style and cognitions in patients with ALS. However, evidence to support either approach is still insufficient, and the underlying mechanisms of the approaches remain poorly understood. The primary aim of the FACTS-2-ALS trial is to study the effects of AET and CBT, in addition to usual care, compared to usual care alone, on functioning and QoL in patients with ALS. Methods / Design A multicentre, single-blinded, randomized controlled trial with a postponed information model will be conducted. A sample of 120 patients with ALS (1 month post diagnosis will be recruited from 3 university hospitals and 1 rehabilitation centre. Patients will be randomized to one of three groups i.e. (1 AET + usual care, (2 CBT + usual care, (3 Usual care. AET consists of a 16-week aerobic exercise programme, on 3 days a week. CBT consists of individual psychological support of patients in 5 to 10 sessions over a 16-week period. QoL, functioning and secondary outcome measures will be assessed at baseline, immediately post intervention and at 3- and 6-months follow-up. Discussion The FACTS-2-ALS study is the first

  12. Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sun, Fenghua; Wang, Li-Juan; Wang, Lin

    2015-04-10

    Childhood obesity is one of the most critical public health problems in the world. It is associated with low neuromuscular function and postural deformities. Whether weight loss can improve postural stability and neuromuscular control, benefit daily activities, or prevent injury is unknown. Therefore, this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children. We will conduct a prospective, single-blind, randomized controlled trial with 120 prepubescent obese children. Participants will be randomly assigned to a weight management group or a control group. The weight management group will participate in a dietary and exercise program. The control group will receive health education. After the intervention, participants will be followed for 6 months with no active intervention. The primary and secondary outcomes will be assessed at the baseline, and after 6 months and 12 months. Primary outcome measures will include body weight, body height, body mass index, waist circumference, hip circumference, and body fat percentage. Secondary outcome measures will include three-dimensional functional biomechanics in different tasks, proprioception tests of the knee and ankle, neuromuscular response of the leg muscles, and muscle strength tests of the knee and ankle. Furthermore, adverse events will be recorded and analyzed. An intention-to-treat analysis will be performed if any participants withdraw from the trial. The important features of this trial include the randomization procedures and large sample size. This study attempts to estimate the effect of weight loss intervention on outcomes, including daily life function, postural stability, and neuromuscular control in prepubescent obese children. Therefore, our results can be useful for obese children, medical staff, and healthcare decision makers. Chinese Clinical Trial Registry ChiCTR-IOB-15005874.

  13. Dietary plant stanol ester consumption improves immune function in asthma patients: results of a randomized, double-blind clinical trial.

    Science.gov (United States)

    Brüll, Florence; De Smet, Els; Mensink, Ronald P; Vreugdenhil, Anita; Kerksiek, Anja; Lütjohann, Dieter; Wesseling, Geertjan; Plat, Jogchum

    2016-02-01

    In vitro and ex vivo studies have suggested that plant sterols and stanols can shift the T helper (Th) 1/Th2 balance toward a Th1-type immune response, which may be beneficial in Th2-dominant conditions such as asthma and allergies. We evaluated in vivo whether plant stanol esters affect the immune response in asthma patients. Fifty-eight asthma patients participated in a randomized, double-blind, placebo-controlled intervention study. All subjects started with a 2-wk run-in period in which they consumed 150 mL control soy-based yogurt without added plant stanol esters/d. Next, an 8-wk experimental period was started in which one-half of the participants received plant stanol enriched soy-based yogurts (4.0 g plant stanols/d), whereas the other one-half of subjects continued the consumption of control yogurts. After 4 wk of daily plant stanol consumption, all participants were vaccinated against hepatitis A virus (HAV), and the increase of antibody titres was monitored weekly until 4 wk after vaccination. Asthma patients in the plant stanol ester group showed higher antibody titres against HAV 3 and 4 wk after vaccination [19% (P = 0.037) and 22% (P = 0.030), respectively]. Also, substantial reductions in plasma total immunoglobulin E, interleukin (IL)-1β, and tumor necrosis factor-α were shown in the plant stanol ester group. The increase in serum plant stanol concentrations was correlated significantly with the decrease in IL-13 concentrations and the Th1 switch in the Th1/Th2 balance. However, no absolute differences in cytokine production between the plant stanol ester group and the control group were shown. To the best of our knowledge, we are among the first authors to show that plant stanol ester consumption improves the immune function in vivo in asthma patients. This trial was registered at clinicaltrials.gov as NCT01715675. © 2016 American Society for Nutrition.

  14. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition.

    Science.gov (United States)

    Giangregorio, Lora; Craven, Catharine; Richards, Kieva; Kapadia, Naaz; Hitzig, Sander L; Masani, Kei; Popovic, Milos R

    2012-09-01

    To evaluate the effects of functional electrical stimulation (FES)-assisted walking on body composition, compared to a non-FES exercise program in individuals with a spinal cord injury (SCI). Parallel-group randomized controlled trial. Individuals with chronic (≥ 18 months) incomplete SCI (level C2 to T12, AIS C or D) were recruited and randomized to FES-assisted walking (intervention), or aerobic and resistance training (control) sessions thrice-weekly for 16 weeks. Whole body and leg lean mass and whole body fat mass, measured with dual-energy X-ray absorptiometry, and lower-limb muscle cross-sectional area (CSA) and fat CSA, measured with peripheral computed tomography were assessed at baseline, 4 months, and 12 months. Intention-to-treat analyses using repeated measures general linear models were used to assess between-group differences. Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. There were no significant main effects of FES-assisted walking on body composition variables in intention-to-treat analyses with group means. There was a significant group-by-time interaction for muscle area from baseline to 12 months (P = 0.04). Intention-to-treat analysis of muscle area change scores between baseline and 12 months revealed a significant difference between groups (mean (SD) muscle area change score 212 (517) mm(s) for FES, -136 (268) mm(s) for control, P = 0.026). There were 13 side effects or adverse events deemed related to study participation (7 intervention, 5 control); most were resolved with modifications to the protocol. One fainting episode resulted in a hospital visit and study withdrawal. Thrice-weekly FES-assisted walking exercise over 4 months did not result in a change in body composition in individuals with chronic, motor incomplete C2 to T12 SCI (AIS classification C and D). However, longer-term follow-up revealed that it might maintain muscle area.

  15. Imaging gastric structuring of lipid emulsions and its effect on gastrointestinal function: a randomized trial in healthy subjects.

    Science.gov (United States)

    Steingoetter, Andreas; Radovic, Tijana; Buetikofer, Simon; Curcic, Jelena; Menne, Dieter; Fried, Michael; Schwizer, Werner; Wooster, Tim J

    2015-04-01

    Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine. Both processes also control gastric emptying and gastrointestinal secretions. We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions. Eighteen healthy subjects with normal body mass index (BMI) were studied on 4 separate occasions in a double-blind, randomized, crossover design. Magnetic resonance imaging (MRI) data of the gastrointestinal tract and blood triglycerides were recorded before and for 240 min after the consumption of the following 4 different fat emulsions: lipid emulsion 1 (LE1; acid stable, 0.33 μm), lipid emulsion 2 (LE2; acid stable, 52 μm), lipid emulsion 3 (LE3; acid unstable, solid fat, 0.32 μm), and lipid emulsion 4 (LE4; acid unstable, liquid fat, 0.38 μm). Intragastric emulsion instability was associated with a change in gastric emptying. Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the 2 acid-stable emulsions (P ≤ 0.0001). When combined with solid fat (LE3), different dynamics of postprandial gallbladder volume were induced (P ≤ 0.001). For acid-stable emulsions, a reduction of droplet size by 2 orders of magnitude [LE1 (0.33 μm) compared with LE2 (52 μm)] delayed gastric emptying by 38 min. Although acid-stable (LE1 and LE2) and redispersible (LE4) emulsions caused a constant increase in blood triglycerides, no increase was detectable for LE3 (P emulsions. The acute effects of lipid emulsions on gastric emptying, gallbladder volume, and triglyceride absorption are dependent on microstructural changes undergone during consumption. Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach. This trial was registered at clinicaltrials.gov as NCT01253005. © 2015 American Society for Nutrition.

  16. 'Pharyngocise': Randomized Controlled Trial of Preventative Exercises to Maintain Muscle Structure and Swallowing Function During Head-and-Neck Chemoradiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Carnaby-Mann, Giselle, E-mail: gmann@phhp.ufl.edu [Department of Behavioral Science and Community Health, University of Florida, Gainesville, FL (United States); Crary, Michael A. [Department of Speech Language and Hearing Sciences, University of Florida, Gainesville, FL (United States); Schmalfuss, Ilona [Department of Radiology, North Florida/South Georgia Veterans Health System, Gainesville, FL (Georgia); Amdur, Robert [Department of Radiation Oncology, University of Florida, Gainesville, FL (United States)

    2012-05-01

    Purpose: Dysphagia after chemoradiotherapy is common. The present randomized clinical trial studied the effectiveness of preventative behavioral intervention for dysphagia compared with the 'usual care.' Methods and Materials: A total of 58 head-and-neck cancer patients treated with chemoradiotherapy were randomly assigned to usual care, sham swallowing intervention, or active swallowing exercises (pharyngocise). The intervention arms were treated daily during chemoradiotherapy. The primary outcome measure was muscle size and composition (determined by T{sub 2}-weighted magnetic resonance imaging). The secondary outcomes included functional swallowing ability, dietary intake, chemosensory function, salivation, nutritional status, and the occurrence of dysphagia-related complications. Results: The swallowing musculature (genioglossus, hyoglossuss, and mylohyoid) demonstrated less structural deterioration in the active treatment arm. The functional swallowing, mouth opening, chemosensory acuity, and salivation rate deteriorated less in the pharyngocise group. Conclusion: Patients completing a program of swallowing exercises during cancer treatment demonstrated superior muscle maintenance and functional swallowing ability.

  17. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Gillis, Chelsia; Loiselle, Sarah-Eve; Fiore, Julio F; Awasthi, Rashami; Wykes, Linda; Liberman, A Sender; Stein, Barry; Charlebois, Patrick; Carli, Francesco

    2016-05-01

    A previous comprehensive prehabilitation program, providing nutrition counseling with whey protein supplementation, exercise, and psychological care, initiated 4 weeks before colorectal surgery for cancer, improved functional capacity before surgery and accelerated functional recovery. Those receiving standard of care deteriorated. The specific role of nutritional prehabilitation alone on functional recovery is unknown. This study was undertaken to estimate the impact of nutrition counseling with whey protein on preoperative functional walking capacity and recovery in patients undergoing colorectal resection for cancer. We conducted a double-blinded randomized controlled trial at a single university-affiliated tertiary center located in Montreal, Quebec, Canada. Colon cancer patients (n=48) awaiting elective surgery for nonmetastatic disease were randomized to receive either individualized nutrition counseling with whey protein supplementation to meet protein needs or individualized nutrition counseling with a nonnutritive placebo. Counseling and supplementation began 4 weeks before surgery and continued for 4 weeks after surgery. The primary outcome was change in functional walking capacity as measured with the 6-minute walk test. The distance was recorded at baseline, the day of surgery, and 4 weeks after surgery. A change of 20 m was considered clinically meaningful. The whey group experienced a mean improvement in functional walking capacity before surgery of +20.8 m, with a standard deviation of 42.6 m, and the placebo group improved by +1.2 (65.5) m (P=0.27). Four weeks after surgery, recovery rates were similar between groups (P=0.81). Clinically meaningful improvements in functional walking capacity were achieved before surgery with whey protein supplementation. These pilot results are encouraging and justify larger-scale trials to define the specific role of nutrition prehabilitation on functional recovery after surgery. Copyright © 2016 Academy of

  18. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders

    Science.gov (United States)

    2014-01-01

    Background Different types of exercises can help manage chronic neck pain. Supervised exercise interventions are widely used, but these protocols require substantial resources. The aim of this trial, which focused on adherence, was to evaluate two home exercise interventions. Methods This parallel group randomized controlled trial included 57 women randomly allocated into two groups – a strength training group (STRENGTH, 34 subjects) and a stretching group (STRETCH, 23 subjects). The interventions focused on the neck and shoulder muscles and lasted for 12 months. The STRENGTH group performed weight training and ended each session with stretching exercises. These stretching exercises constituted the entirety of the STRETCH group’s training session. Both groups were instructed to exercise three times per week. All the participants kept an exercise diary. In addition, all participants were offered support via phone and e-mail. The primary outcomes were pain intensity and function. The trial included a four- to six-month and a twelve-month follow-up. A completer in this study exercised at least 1,5 times per week during eight unbroken weeks. A responder in this study reported clinically significant improvements on pain and function. The statistical analyses used the Mann Whitney U-test, Wilcoxon signed-rank test, and X 2 test. Results At four- to six-months, the numbers of completers were 19 in the STRENGTH group and 17 in the STRETCH group. At twelve months, the corresponding numbers were 11 (STRENGTH) and 10 (STRETCH). At four- to six-months, the proportions of subjects reporting clinically important changes (STRENGTH and STRETCH) were for neck pain: 47% and 41%, shoulder pain: 47% and 47%, function: 37% and 29%. At twelve months, the corresponding numbers were for neck pain: 45% and 40%, shoulder pain: 55% and 50%, function: 55% and 20%. Conclusions No differences in the two primary outcomes between the two interventions were found, a finding that may be due to

  19. Lower limb strength training in children with cerebral palsy – a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles

    Directory of Open Access Journals (Sweden)

    Verschuren Olaf

    2008-10-01

    Full Text Available Abstract Background Until recently, strength training in children with cerebral palsy (CP was considered to be inappropriate, because it could lead to increased spasticity or abnormal movement patterns. However, the results of recent studies suggest that progressive strength training can lead to increased strength and improved function, but low methodological quality and incomplete reporting on the training protocols hampers adequate interpretation of the results. This paper describes the design and training protocol of a randomized controlled trial to assess the effects of a school-based progressive functional strength training program for children with CP. Methods/Results Fifty-one children with Gross Motor Function Classification Systems levels I to III, aged of 6 to 13 years, were recruited. Using stratified randomization, each child was assigned to an intervention group (strength training or a control group (usual care. The strength training was given in groups of 4–5 children, 3 times a week, for a period of 12 weeks. Each training session focussed on four exercises out of a 5-exercise circuit. The training load was gradually increased based on the child's maximum level of strength, as determined by the 8 Repetition Maximum (8 RM. To evaluate the effectiveness of the training, all children were evaluated before, during, directly after, and 6 weeks after the intervention period. Primary outcomes in this study were gross motor function (measured with the Gross Motor Function Measure and functional muscle strength tests and walking ability (measured with the 10-meter, the 1-minute and the timed stair test. Secondary outcomes were lower limb muscle strength (measured with a 6 RM test, isometric strength tests, and a sprint capacity test, mobility (measured with a mobility questionnaire, and sport activities (measured with the Children's Assessment of Participation and Enjoyment. Spasticity and range of motion were assessed to evaluate any

  20. Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine.

    Science.gov (United States)

    Chen, Weena J Y; Diamant, Michaela; de Boer, Karin; Harms, Hendrik J; Robbers, Lourens F H J; van Rossum, Albert C; Kramer, Mark H H; Lammertsma, Adriaan A; Knaapen, Paul

    2017-05-19

    Multiple bloodglucose-lowering agents have been linked to cardiovascular events. Preliminary studies showed improvement in left ventricular (LV) function during glucagon-like peptide-1 receptor agonist administration. Underlying mechanisms, however, are unclear. The purpose of this study was to investigate myocardial perfusion and oxidative metabolism in type 2 diabetic (T2DM) patients with LV systolic dysfunction as compared to healthy controls. Furthermore, effects of 26-weeks of exenatide versus insulin glargine administration on cardiac function, perfusion and oxidative metabolism in T2DM patients with LV dysfunction were explored. Twenty-six T2DM patients with LV systolic dysfunction (cardiac magnetic resonance (CMR) derived LV ejection fraction (LVEF) of 47 ± 13%) and 10 controls (LVEF of 59 ± 4%, P efficiency, measured using [ 11 C]acetate PET and CMR derived stroke volume, were not different between the groups. Eleven patients in the exenatide group and 12 patients in the insulin glargine group completed the trial. Systemic metabolic control was improved after both treatments, although, no changes in cardiac function, perfusion and metabolism were seen after exenatide or insulin glargine. T2DM patients with LV systolic dysfunction did not have altered myocardial efficiency as compared to healthy controls. Exenatide or insulin glargine had no effects on cardiac function, perfusion or oxidative metabolism. Trial registration NCT00766857.

  1. Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

    Science.gov (United States)

    Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

    2013-01-01

    Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

  2. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial

    Science.gov (United States)

    Objective: Almonds reduce cardiovascular disease risk via cholesterol reduction, anti-inflammation, glucoregulation, and antioxidation. The objective of this randomized, controlled, cross-over trial was to determine whether the addition of 85 g almonds daily to a National Cholesterol Education Progr...

  3. Does improved functional performance help to reduce urinary incontinence in institutionalized older women? a multicenter randomized clinical trial

    NARCIS (Netherlands)

    Tak, E.C.P.M.; van Hespen, A.; van Dommelen, P.; Hopman-Rock, M.

    2012-01-01

    Background: Urinary incontinence (UI) is a major problem in older women. Management is usually restricted to dealing with the consequences instead of treating underlying causes such as bladder dysfunction or reduced mobility. The aim of this multicenter randomized controlled trial was to compare a

  4. Does improved functional performance help to reduce urinary incontinence in institutionalized older women? a multicenter randomized clinical trial

    NARCIS (Netherlands)

    Tak, E.C.P.M.; Hespen, A. van; Dommelen, P. van; Hopman-Rock, M.

    2012-01-01

    Background Urinary incontinence (UI) is a major problem in older women. Management is usually restricted to dealing with the consequences instead of treating underlying causes such as bladder dysfunction or reduced mobility. The aim of this multicenter randomized controlled trial was to compare a

  5. Upper Limb Evaluation in Duchenne Muscular Dystrophy: Fat-Water Quantification by MRI, Muscle Force and Function Define Endpoints for Clinical Trials.

    Science.gov (United States)

    Ricotti, Valeria; Evans, Matthew R B; Sinclair, Christopher D J; Butler, Jordan W; Ridout, Deborah A; Hogrel, Jean-Yves; Emira, Ahmed; Morrow, Jasper M; Reilly, Mary M; Hanna, Michael G; Janiczek, Robert L; Matthews, Paul M; Yousry, Tarek A; Muntoni, Francesco; Thornton, John S

    2016-01-01

    A number of promising experimental therapies for Duchenne muscular dystrophy (DMD) are emerging. Clinical trials currently rely on invasive biopsies or motivation-dependent functional tests to assess outcome. Quantitative muscle magnetic resonance imaging (MRI) could offer a valuable alternative and permit inclusion of non-ambulant DMD subjects. The aims of our study were to explore the responsiveness of upper-limb MRI muscle-fat measurement as a non-invasive objective endpoint for clinical trials in non-ambulant DMD, and to investigate the relationship of these MRI measures to those of muscle force and function. 15 non-ambulant DMD boys (mean age 13.3 y) and 10 age-gender matched healthy controls (mean age 14.6 y) were recruited. 3-Tesla MRI fat-water quantification was used to measure forearm muscle fat transformation in non-ambulant DMD boys compared with healthy controls. DMD boys were assessed at 4 time-points over 12 months, using 3-point Dixon MRI to measure muscle fat-fraction (f.f.). Images from ten forearm muscles were segmented and mean f.f. and cross-sectional area recorded. DMD subjects also underwent comprehensive upper limb function and force evaluation. Overall mean baseline forearm f.f. was higher in DMD than in healthy controls (pmuscle f.f. as a biomarker to monitor disease progression in the upper limb in non-ambulant DMD, with sensitivity adequate to detect group-level change over time intervals practical for use in clinical trials. Clinical validity is supported by the association of the progressive fat transformation of muscle with loss of muscle force and function.

  6. Lung Volume Reduction Surgery and Improvement of Endothelial Function and Blood Pressure in Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

    Science.gov (United States)

    Clarenbach, Christian F; Sievi, Noriane A; Brock, Matthias; Schneiter, Didier; Weder, Walter; Kohler, Malcolm

    2015-08-01

    Cardiovascular disease is a major cause of morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Preliminary studies have shown that both airflow obstruction and systemic inflammation may contribute to endothelial dysfunction in COPD. Lung volume reduction surgery (LVRS) is a treatment option in selected patients with COPD with emphysema that improves breathing mechanics and lung function. To determine the effect of LVRS on endothelial function and systemic inflammation. We conducted a randomized controlled trial in 30 patients scheduled for LVRS. In the intervention group, immediate LVRS was performed after baseline evaluation followed by reassessment 3 months later. In the control group, reassessment followed 3 months after baseline evaluation, and thereafter LVRS was performed. The primary outcome measures were the treatment effect on endothelial function and systemic inflammation. In the LVRS group 14 patients completed the trial and 13 in the control group. LVRS led to a relative reduction in mean (SD) residual volume/total lung capacity of -12% (12%) and an increase in FEV1 of 29% (27%). Flow-mediated dilatation of the brachial artery increased in the intervention group as compared with the control group (+2.9%; 95% confidence interval, +2.1 to +3.6%; P < 0.001), whereas there was no significant change in systemic inflammation. A significant treatment effect on mean blood pressure was observed (-9.0 mm Hg; 95% confidence interval, -17.5 to -0.5; P = 0.039). Endothelial function and blood pressure are improved 3 months after LVRS in patients with severe COPD and emphysema. LVRS may therefore have beneficial effects on cardiovascular outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT 01020344).

  7. Spinal-flexibility-plus-aerobic versus aerobic-only training: effect of a randomized clinical trial on function in at-risk older adults.

    Science.gov (United States)

    Morey, M C; Schenkman, M; Studenski, S A; Chandler, J M; Crowley, G M; Sullivan, R J; Pieper, C F; Doyle, M E; Higginbotham, M B; Horner, R D; MacAller, H; Puglisi, C M; Morris, K G; Weinberger, M

    1999-07-01

    As exercise is associated with favorable health outcomes, impaired older adults may benefit from specialized exercise interventions to achieve gains in function. The purpose of this study was to determine the added benefit of a spinal flexibility-plus-aerobic exercise intervention versus aerobic-only exercise on function among community-dwelling elders. We employed a randomized clinical trial consisting of 3 months of supervised exercise followed by 6 months of home-based exercise with telephone follow-up. A total of 210 impaired males and females over age 64 enrolled in this study. Of these, 134 were randomly assigned to either spinal flexibility-plus-aerobic exercise or aerobic-only exercise, with 116 individuals completing the study. Primary outcomes obtained at baseline, after 3 months of supervised exercise, and after 6 months of home-based exercise included: axial rotation, maximal oxygen uptake (VO2max); functional reach, timed-bed-mobility; and the Physical Function Scale (PhysFunction) of the Medical Outcomes Study SF-36. Differences between the two interventions were minimal. Overall change scores for both groups combined indicated significant improvement for: axial rotation (p=.001), VO2max (p=.0001), and PhysFunction (p=.0016). Secondary improvements were noted for overall health (p=.0025) and reduced symptoms (p=.0008). Differences between groups were significant only for VO2max (p=.0014) at 3 months with the aerobic-only group improving twice as much in aerobic capacity as the spinal flexibility-plus-aerobic group. Repeated measures indicated both groups improved during the supervised portion of the intervention but tended to return toward baseline following the home-based portion of the trial. Gains in physical functioning and perceived overall health are obtained with moderate aerobic exercise. No differential improvements were noted for the spinal flexibility-plus-aerobic intervention.

  8. Liver Function Assessment Using Technetium 99m-Galactosyl Single-Photon Emission Computed Tomography/CT Fusion Imaging: A Prospective Trial.

    Science.gov (United States)

    Okabayashi, Takehiro; Shima, Yasuo; Morita, Sojiro; Shimada, Yasuhiro; Sumiyoshi, Tatsuaki; Sui, Kenta; Iwata, Jun; Iiyama, Tatsuo

    2017-09-11

    The prediction of postoperative liver function remains a largely subjective practice based on CT volumetric analysis. However, future liver volume after a hepatectomy is not the only factor that contributes to postoperative liver function and outcomes. In this prospective trial, 185 consecutive patients who underwent liver operations between 2014 and 2015 were studied. Volumetric and functional rates of remnant liver were measured using technetium 99m-galactosyl human serum albumin single-photon emission computed tomography/CT fusion imaging to evaluate post-hepatectomy remnant liver function. Remnant indocyanine green clearance rate using galactosyl (KGSA) (KGSA × functional rate) was used to predict future remnant liver function. Hepatectomy was considered safe for patients with remnant KGSA values ≥0.05, and the primary end point was to determine the accuracy and reliability of this criteria. The prediction of the 90-day major complication and mortality rates was assessed. Median hospital stay was 9 days and median ICU stay was 1 day, with only 1 in-hospital death (90-day mortality rate 0.5%). Overall morbidity rate evaluated according to the Clavien-Dindo classification was 9%. For post-hepatectomy liver failure definitions, the International Study Group of Liver Surgery definition was fulfilled in 14 patients (8%), with the majority being grade B (50%), compared with 2 patients (1%) fulfilling the "50-50" criteria, and 0 patients (0%) fulfilling the PeakBili >7 criteria. Results of this study showed that remnant KGSA provided information that allowed us to predict remnant liver function. This information will be important for surgeons when deciding on a treatment plan for patients with liver diseases. (ClinicalTrials.gov ID: NCT02013895). Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Hunter David J

    2007-12-01

    Full Text Available Abstract Background Lower limb strengthening exercises are an important component of the treatment for knee osteoarthritis (OA. Strengthening the hip abductor and adductor muscles may influence joint loading and/or OA-related symptoms, but no study has evaluated these hypotheses directly. The aim of this randomised, single-blind controlled trial is to determine whether hip abductor and adductor muscle strengthening can reduce knee load and improve pain and physical function in people with medial compartment knee OA. Methods/Design 88 participants with painful, radiographically confirmed medial compartment knee OA and varus alignment will be recruited from the community and randomly allocated to a hip strengthening or control group using concealed allocation stratified by disease severity. The hip strengthening group will perform 6 exercises to strengthen the hip abductor and adductor muscles at home 5 times per week for 12 weeks. They will consult with a physiotherapist on 7 occasions to be taught the exercises and progress exercise resistance. The control group will be requested to continue with their usual care. Blinded follow up assessment will be conducted at 12 weeks after randomisation. The primary outcome measure is the change in the peak external knee adduction moment measured during walking. Questionnaires will assess changes in pain and physical function as well as overall perceived rating of change. An intention-to-treat analysis will be performed using linear regression modelling and adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effect of hip strengthening on knee loads and symptoms in people with medial compartment knee OA. If shown to reduce the knee adduction moment, hip strengthening has the potential to slow disease progression. Trial Registration Australia New Zealand Clinical Trials Registry ACTR12607000001493

  10. The effect of Ginkgo biloba on functional outcome of patients with acute ischemic stroke: a double-blind, placebo-controlled, randomized clinical trial.

    Science.gov (United States)

    Oskouei, Darioush Savadi; Rikhtegar, Reza; Hashemilar, Mazyar; Sadeghi-Bazargani, Homayoun; Sharifi-Bonab, Mohsen; Sadeghi-Hokmabadi, Elyar; Zarrintan, Sina; Sharifipour, Ehsan

    2013-11-01

    Acute ischemic stroke is a major cerebrovascular disease with potential morbidity and mortality. Despite the availability of thrombolytic therapy in some centers, risk factor modification and rehabilitation therapy are the mainstays of stroke management. There is supporting evidence that Ginkgo biloba may afford neuroprotection and improve the outcomes of patients with acute ischemic stroke. In a double-blind, placebo-controlled, randomized controlled trial, we assessed the efficacy of G biloba on functional outcome in patients with acute stroke. The National Institutes of Heath Stroke Scale (NIHSS) was used to measure functional outcome. A total of 102 patients with acute ischemic stroke were studied. All patients received either G biloba or placebo tablets for 4 months. This trial was registered to the Iranian Registry of Clinical Trials (www.irct.ir; trial IRCT138804212150N1). There were 52 patients who received G biloba and 50 patients who were in the placebo group. Age, sex distribution, previous medical condition, and laboratory data did not have any significant difference between the 2 groups (P>.05). The mean difference of 4-month follow-up NIHSS scores and NIHSS scores at admission was 4.7±2.7 and 4.1±3.0 in the G biloba and placebo groups, respectively (P>.05). The primary outcome-a 50% reduction in the 4-month follow-up NIHSS score compared to the baseline NIHSS score-was reached in 17 patients (58.6%) and 5 patients (18.5%) in the G biloba and placebo groups, respectively (Pbiloba group compared to the placebo group (Pbiloba may have protective effects in ischemic stroke. Therefore, the administration of G biloba is recommended after acute ischemic stroke. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  11. Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971]1

    National Research Council Canada - National Science Library

    Daksha Trivedi; Michael Kirby; Felicity Norman; Izabela Przybytniak; Shehzad Ali; David M. Wellsted

    2011-01-01

    ... *To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged...

  12. Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Acton, Jennifer H; Molik, Bablin; Binns, Alison; Court, Helen; Margrain, Tom H

    2016-02-24

    Visual Rehabilitation Officers help people with a visual impairment maintain their independence. This intervention adopts a flexible, goal-centred approach, which may include training in mobility, use of optical and non-optical aids, and performance of activities of daily living. Although Visual Rehabilitation Officers are an integral part of the low vision service in the United Kingdom, evidence that they are effective is lacking. The purpose of this exploratory trial is to estimate the impact of a Visual Rehabilitation Officer on self-reported visual function, psychosocial and quality-of-life outcomes in individuals with low vision. In this exploratory, assessor-masked, parallel group, randomised controlled trial, participants will be allocated either to receive home visits from a Visual Rehabilitation Officer (n = 30) or to a waiting list control group (n = 30) in a 1:1 ratio. Adult volunteers with a visual impairment, who have been identified as needing rehabilitation officer input by a social worker, will take part. Those with an urgent need for a Visual Rehabilitation Officer or who have a cognitive impairment will be excluded. The primary outcome measure will be self-reported visual function (48-item Veterans Affairs Low Vision Visual Functioning Questionnaire). Secondary outcome measures will include psychological and quality-of-life metrics: the Patient Health Questionnaire (PHQ-9), the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), the Adjustment to Age-related Visual Loss Scale (AVL-12), the Standardised Health-related Quality of Life Questionnaire (EQ-5D) and the UCLA Loneliness Scale. The interviewer collecting the outcomes will be masked to the group allocations. The analysis will be undertaken on a complete case and intention-to-treat basis. Analysis of covariance (ANCOVA) will be applied to follow-up questionnaire scores, with the baseline score as a covariate. This trial is expected to provide robust effect size estimates of the intervention

  13. Improvement in Renal Function and Reduction in Serum Uric Acid with Intensive Statin Therapy in Older Patients: A Post Hoc Analysis of the SAGE Trial.

    Science.gov (United States)

    Deedwania, Prakash C; Stone, Peter H; Fayyad, Rana S; Laskey, Rachel E; Wilson, Daniel J

    2015-12-01

    Improvement in renal function and decreases in serum uric acid (SUA) have been reported following prolonged high-intensity statin (HMG-CoA reductase inhibitor) therapy. This post hoc analysis of the SAGE trial examined the effect of intensive versus less intensive statin therapy on renal function, safety, and laboratory parameters, including SUA, in elderly coronary artery disease (CAD) patients (65-85 years) with or without chronic kidney disease (CKD). Patients were randomized to atorvastatin 80 mg/day or pravastatin 40 mg/day and treated for 12 months. Patients were stratified using Modification of Diet in Renal Disease (MDRD) estimated glomerular filtration rates (eGFRs) in CKD (eGFR 3 times the upper limit of normal occurred in 4.4% of atorvastatin- and 0.2% of pravastatin-treated patients. Intensive management of dyslipidemia in older patients with stable coronary heart disease may have beneficial effects on renal function and SUA.

  14. A 12-Week Physical and Cognitive Exercise Program Can Improve Cognitive Function and Neural Efficiency in Community-Dwelling Older Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Nishiguchi, Shu; Yamada, Minoru; Tanigawa, Takanori; Sekiyama, Kaoru; Kawagoe, Toshikazu; Suzuki, Maki; Yoshikawa, Sakiko; Abe, Nobuhito; Otsuka, Yuki; Nakai, Ryusuke; Aoyama, Tomoki; Tsuboyama, Tadao

    2015-07-01

    To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults. Randomized controlled trial. Kyoto, Japan. Community-dwelling older adults (N = 48) were randomized into an exercise group (n = 24) and a control group (n = 24). Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase. Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase. The outcome measures were global cognitive function, memory function, executive function, and brain activation (measured using functional magnetic resonance imaging) associated with visual short-term memory. Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group (P brain regions associated with visual short-term memory, including the prefrontal cortex, in the exercise group (P physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults, which is associated with improvements in memory and executive function. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  15. Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Suijker Jacqueline J

    2012-04-01

    Full Text Available Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC score (≥ 2. These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP. The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201

  16. Additional Effects of an Individualized Risk Factor-Based Approach on Pain and the Function of Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Halabchi, Farzin; Mazaheri, Reza; Mansournia, Mohammad Ali; Hamedi, Zahra

    2015-11-01

    To investigate the clinical efficacy of adding risk factor-based approach (including appropriate exercises and orthoses) to routine quadriceps strengthening exercise with respect to pain and function in patients with patellofemoral pain syndrome (PFPS). A parallel group nonblinded randomized controlled trial with 12-week follow-up. An outpatient Sports Medicine Clinic of Tehran University of Medical Sciences, Tehran, Iran. Patients (both sexes, 18-40 years) with clinically diagnosed PFPS of the duration over 2 months. The intervention group received an individualized program, including exercise therapy plus risk factor modification, and was instructed to practice the tailored interventions at home for 12 weeks. The control group received an exercise program, only focusing on quadriceps strengthening. The primary outcomes were pain severity during the activities of daily living (0- to 100-point visual analog scale), and function (0- to 100-point Kujala patellofemoral score) at a 12-week follow-up. A total of 53 participants completed the trial: 26 in the intervention and 27 in the control group. After 12 weeks, both groups showed improvements in pain and function, but the changes were significantly greater in the intervention group with regard to pain [adjusted difference, -14.90; 95% confidence interval (CI), -5.86 to -23.93, P = 0.002], and function (adjusted difference, 6.82; 95% CI, 2.54-11.10, P = 0.002). Assessment and modification of the risk factors may add to the treatment effects on pain and function at a 12-week follow-up in patients with PFPS. These findings may lead to a more comprehensive clinical approach to this very common problem. It seems that incorporating risk factor assessment into our clinical practice may add to treatment effects with regard to pain and function in patients with PFPS.

  17. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement

    Directory of Open Access Journals (Sweden)

    Zheng Hua

    2011-10-01

    Full Text Available Abstract Background Total knee replacement (TKR is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes. Methods/Design This randomized clinical trial (RCT will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score between conditions (standard deviation of 10 at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%. Discussion As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support

  18. Interventions to improve executive functioning and working memory in school-aged children with AD(HD: a randomised controlled trial and stepped-care approach

    Directory of Open Access Journals (Sweden)

    van der Donk Marthe LA

    2013-01-01

    Full Text Available Abstract Background Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD. One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory - and an executive function training applied in a school situation for children with AD(HD, taking individual characteristics, the level of impairment and costs (stepped-care approach into account. Methods/design The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8–12 yrs with AD(HD. Two groups (each n = 50 will be randomly assigned to a well studied computerized working memory training ‘Cogmed’, or to the ‘Paying attention in class’ intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the ‘Paying attention in class’ intervention. School-aged children (8–12 yrs with AD(HD will follow the experimental school-based executive function training ‘Paying attention in class’ (n = 175. Academic performance and neurocognitive functioning (primary outcomes are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. Discussion So far, there is limited but promising evidence that working memory – and other executive function interventions can improve academic performance. Little is know about the

  19. Inpatient rehabilitation improves functional capacity, peripheral muscle strength and quality of life in patients with community-acquired pneumonia: a randomised trial

    Directory of Open Access Journals (Sweden)

    Anderson José

    2016-04-01

    Full Text Available Question: Among people who are hospitalised for community-acquired pneumonia, does an inpatient exercise-based rehabilitation program improve functional outcomes, symptoms, quality of life and length of hospital stay more than a respiratory physiotherapy regimen? Design: Randomised trial with concealed allocation, intention-to-treat analysis and blinding of some outcomes. Participants: Forty-nine adults hospitalised for community-acquired pneumonia. Intervention: The experimental group (n = 32 underwent a physical training program that included warm-up, stretching, peripheral muscle strength training and walking at a controlled speed for 15 minutes. The control group (n = 17 underwent a respiratory physiotherapy regimen that included percussion, vibrocompression, respiratory exercises and free walking. The intervention regimens lasted 8 days. Outcome measures: The primary outcome was the Glittre Activities of Daily Living test, which assesses the time taken to complete a series of functional tasks (eg, rising from a chair, walking, stairs, lifting and bending. Secondary outcomes were distance walked in the incremental shuttle walk test, peripheral muscle strength, quality of life, dyspnoea, lung function, C-reactive protein and length of hospital stay. Measures were taken 1 day before and 1 day after the intervention period. Results: There was greater improvement in the experimental group than in the control group on the Glittre Activities of Daily Living test (mean between-group difference 39 seconds, 95% CI 20 to 59 and the incremental shuttle walk test (mean between-group difference 130 m, 95% CI 77 to 182. There were also significantly greater improvements in quality of life, dyspnoea and peripheral muscle strength in the experimental group than in the control group. There were no between-group differences in lung function, C-reactive protein or length of hospital stay. Conclusion: The improvement in functional outcomes after an

  20. Effect of recombinant alpha interferon on NK and ADCC function in lung cancer patients: results from a phase II trial

    DEFF Research Database (Denmark)

    Hokland, P; Hokland, M; Olesen, B K

    1985-01-01

    -cell antibody. An increase in NK-cell activity could be demonstrated when values before and 24 h after the first injection of IFN were compared, but simultaneously the enhancing effect of IFN-alpha on NK-cells added to in vitro cultures was abolished, probably as a result of preactivation of NK cells in vivo......During a phase II trial of recombinant IFN-alpha given in doses of 50 X 10(6) units/m2 three times per week to lung cancer patients, 13 patients were evaluated longitudinally in NK and ADCC assays and in immunofluorescence tests enumerating the number of cells reactive with the new N901 NK....... These data are discussed in relation to other clinical trials using leukocyte or recombinant IFN-alpha. Udgivelsesdato: 1984 Fall...

  1. Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India.

    Science.gov (United States)

    Wenger, Michael J; Murray-Kolb, Laura E; Nevins, Julie Eh; Venkatramanan, Sudha; Reinhart, Gregory A; Wesley, Annie; Haas, Jere D

    2017-12-01

    Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants ( n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18-55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly ( P mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005. © 2017 American Society for Nutrition.

  2. [Use of itopride in the symptoms of functional dyspepsia in Russia: results of a phase IV prospective open-label multicenter clinical trial].

    Science.gov (United States)

    Kas'ianenko, V I; Denisov, N L; Vasil'ev, Iu V

    2014-01-01

    To evaluate the efficacy and safety of itopride used to treat the symptoms of functional dyspepsia (FD) of the upper gastrointestinal tract. A prospective, open-label, multicenter trial using as a control the placebo response obtained in the previous investigations enrolled 96 adult patients. The diagnosis of FD corresponded to its Rome II criteria. Patients received itopride (Ganaton) oral tablets (50 mg) 3 times daily for 8 weeks. When included into the trial, the patients were orally given itopride (ganaton) tablets (50 mg) thrice daily before meals for 8 weeks. The patients' status was evaluated during (at weeks 4 and 8) and after (at week 12) treatment. Treatment response was assessed using the Global Patient Assessment (GPA) and the Leeds Dyspepsia Questionnaire (LDQ). To evaluate the safety of itopride use, the investigators studied the frequency of adverse events and carried out laboratory tests (renal and liver function tests) and electrocardiography (ECG). The GPA showed that 53.76, 85.71, and 82.22% of the patients achieved a therapeutic effect of itopride at weeks 4, 8, and 12, respectively. The proportion of the patients who achieved the therapeutic effect (86%) at week 8 was higher than the historical placebo controls in the previous studies--45% (86% vs 45%; X2 = 68.868, df = 3; p Itopride is an effective and well-tolerated drug in the treatment of functional dyspepsia in the Russian patients.

  3. Effect of methylphenidate and/or levodopa coupled with physiotherapy on functional and motor recovery after stroke--a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Lokk, J; Salman Roghani, R; Delbari, A

    2011-04-01

    Amphetamine-like drugs are reported to enhance motor recovery and activities of daily living (ADL) in stroke rehabilitation, but results from trials with humans are inconclusive. This study is aimed at investigating whether levodopa (LD) and/or methylphenidate (MPH) in combination with physiotherapy could improve functional motor recovery and ADL in patients with stroke. A randomized, double-blind, placebo-controlled trial with ischemic stroke patients randomly allocated to one of four treatment groups of either MPH, LD or MPH+LD or placebo combined with physiotherapy was performed. Motor function, ADL, and stroke severity were assessed by Fugl-Meyer (FM), Barthel index (BI), and National Institute of Health Stroke Scale (NIHSS) at baseline, 15, 90, and 180 days respectively. All participants showed recovery of motor function and ADL during treatment and at 6-month follow-up. There were slightly but significant differences in BI and NIHSS compared to placebo at the 6-month follow-up. Ischemic chronic stroke patients having MPH and/or LD in combination with physiotherapy showed a slight ADL and stroke severity improvement over time. Future studies should address the issue of the optimal therapeutic window and dosage of medications to identify those patients who would benefit most. © 2010 John Wiley & Sons A/S.

  4. Effects of movement music therapy with a percussion instrument on physical and frontal lobe function in older adults with mild cognitive impairment: a randomized controlled trial.

    Science.gov (United States)

    Shimizu, Nobuko; Umemura, Tomohiro; Matsunaga, Masahiro; Hirai, Takayoshi

    2017-09-22

    We tested the hypothesis that performing a rhythmic physical task accompanied by a cognitive task, such as multitask movement music therapy (MMT) involving repetitive rhythmic movement with a musical instrument (the Naruko clapper), may improve pre-frontal cortex (PFC) function and cognitive performance. Forty-five older adult participants with MCI (74.62 ± 5.05 years) participated in this randomized, controlled, single-blind intervention trial. 35 were assigned to the MMT group and 10 to the control STT group. Before and after the 12-week exercise program, we administered six physical function tests, the Frontal Assessment Battery (FAB), and measured relative oxyhemoglobin concentrations using 45-multichannel functional near-infrared spectroscopy as a reflection of hemodynamic responses in the PFC. We observed significant improvements in FAB scores only in the MMT group. Cerebral blood flow (CBF) in the PFC during the exercise was significantly increased in the MMT group compared with the STT group. The CBF increase was significantly correlated among various channels in the MMT group. The MMT program appeared to stimulate the PFC and improve cognitive performance in our older adult participants with MCI, suggesting that the repetitive, rhythmic movements of MMT can activate the prefrontal area in older adults. Clinical Trial Registry Numbers: R000026130, UMIN000022671 (2016/06/08) [(University Hospital Medical Information Network (UMIN) Center] retrospectively registered.

  5. The effect of electroacupuncture combined with donepezil on cognitive function in Alzheimer's disease patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Peng, Weina; Zhou, Jing; Xu, Min; Feng, Qing; Bin, Lulu; Liu, Zhishun

    2017-07-03

    Alzheimer's disease is a progressive neurodegenerative disease. Although some of the current treatments offer some symptomatic relief, this disease cannot be cured at present. Electroacupuncture may be effective for Alzheimer's disease for cognitive function, but the evidence for its effectiveness is still limited. The aim of this study is to evaluate the add-on effect of electroacupuncture to donepezil for improving the cognitive function of Alzheimer's disease. A total of 334 participants with Alzheimer's disease will be randomly assigned to either an electroacupuncture combined with donepezil group or a donepezil group with a ratio of 1:1. Participants in the electroacupuncture combined with donepezil group will receive electroacupuncture in addition to donepezil for 12 weeks and will keep taking donepezil for the following 24 weeks. Participants in the control group will take donepezil only. The primary outcome is the change from baseline in the total score of the Alzheimer's Disease Assessment Scale-cognition at week 12. A follow-up will be conducted 24 weeks after the treatment. We expect to verify the hypothesis that acupuncture in addition to donepezil is better than donepezil in improving the cognitive function of patients with Alzheimer's disease. This trial has a limitation that participant blinding is impossible. Clinical Trials.gov: ID: NCT02305836 . Registered on 13 November 2014.

  6. Effects of Statin Treatment on Inflammation and Cardiac Function in Heart Failure: An Adjusted Indirect Comparison Meta-Analysis of Randomized Trials.

    Science.gov (United States)

    Bonsu, Kwadwo Osei; Reidpath, Daniel Diamond; Kadirvelu, Amudha

    2015-12-01

    Statins are known to prevent heart failure (HF). However, it is unclear whether statins as class or type (lipophilic or hydrophilic) improve outcomes of established HF. The current meta-analysis was performed to compare the treatment effects of lipophilic and hydrophilic statins on inflammation and cardiac function in HF. Outcomes were indicators of cardiac function [changes in left ventricular ejection fraction (LVEF) and B-type natriuretic peptide (BNP)] and inflammation [changes in highly sensitive C-reactive protein (hsCRP) and interluekin-6 (IL-6)]. We conducted a search of PubMed, EMBASE, and the Cochrane databases until December 31, 2014 for randomized control trials (RCTs) of statin versus placebo in patients with HF. RCTs with their respective extracted information were dichotomized into statin type evaluated and analyzed separately. Outcomes were pooled with random effect approach, producing standardized mean differences (SMD) for each statin type. Using these pooled estimates, we performed adjusted indirect comparisons for each outcome. Data from 6214 patients from 19 trials were analyzed. Lipophilic statin was superior to hydrophilic statin treatment regarding follow-up LVEF (SMD, 4.54; 95% CI, 4.16-4.91; P statin produces greater treatment effects on cardiac function and inflammation compared with hydrophilic statin in patients with HF. Until data from adequately powered head-to-head trial of the statin types are available, our meta-analysis brings clinicians and researchers a step closer to the quest on which statin--lipophilic or hydrophilic--is associated with better outcomes in HF. © 2015 John Wiley & Sons Ltd.

  7. Shoulder function and work disability after decompression surgery for subacromial impingement syndrome: a randomised controlled trial of physiotherapy exercises and occupational medical assistance.

    Science.gov (United States)

    Svendsen, Susanne W; Christiansen, David H; Haahr, Jens Peder; Andrea, Linda C; Frost, Poul

    2014-06-21

    Surgery for subacromial impingement syndrome is often performed in working age and postoperative physiotherapy exercises are widely used to help restore function. A recent Danish study showed that 10% of a nationwide cohort of patients retired prematurely within two years after surgery. Few studies have compared effects of different postoperative exercise programmes on shoulder function, and no studies have evaluated workplace-oriented interventions to reduce postoperative work disability. This study aims to evaluate the effectiveness of physiotherapy exercises and occupational medical assistance compared with usual care in improving shoulder function and reducing postoperative work disability after arthroscopic subacromial decompression. The study is a mainly pragmatic multicentre randomised controlled trial. The trial is embedded in a cohort study of shoulder patients referred to public departments of orthopaedic surgery in Central Denmark Region. Patients aged ≥18-≤63 years, who still have shoulder symptoms 8-12 weeks after surgery, constitute the study population. Around 130 participants are allocated to: 1) physiotherapy exercises, 2) occupational medical assistance, 3) physiotherapy exercises and occupational medical assistance, and 4) usual care. Intervention manuals allow individual tailoring. Primary outcome measures include Oxford Shoulder Score and sickness absence due to symptoms from the operated shoulder. Randomisation is computerised with allocation concealment by randomly permuted block sizes. Statistical analyses will primarily be performed according to the intention-to-treat principle. The paper presents the rationale, design, methods, and operational aspects of the Shoulder Intervention Project (SIP). SIP evaluates a new rehabilitation approach, where physiotherapy and occupational interventions are provided in continuity of surgical episodes of care. If successful, the project may serve as a model for rehabilitation of surgical shoulder

  8. Effects of krill oil on endothelial function and other cardiovascular risk factors in participants with type 2 diabetes, a randomized controlled trial.

    Science.gov (United States)

    Lobraico, Jessika M; DiLello, Lauren C; Butler, Amber D; Cordisco, Marie Elena; Petrini, Joann R; Ahmadi, Ramin

    2015-01-01

    The purpose of this trial was to evaluate the effect of krill oil supplementation, a source of ω-3 fatty acids, on cardiovascular disease risk factors and blood glucose control among participants with type 2 diabetes. A randomized, double-blind controlled cross-over trial was employed. Outcomes assessed were: endothelial function, blood lipids, glucose, glycated hemoglobin, serum antioxidant level, C peptide, and calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores. Participants were randomized to either krill oil or olive oil supplementation for 4 weeks, underwent a 2-week washout period, and then crossed to the other supplementation for 4 weeks. All participants were then offered an additional 17 weeks of krill supplementation. Testing occurred at 3 time points: baseline, after first supplementation, and after second supplementation. Testing also occurred after an optional 17 weeks of krill oil supplementation. Difference scores were calculated for each participant in both sequences (ie, differences in outcome measures in the first and second period of the sequence). The mean and SD of the scores in the 2 sequence groups were used to test for differences between treatment effects at a significance level of pkrill oil for 4 weeks had an improvement in their endothelial function and a reduction in blood C peptide levels and HOMA scores as compared with the olive oil. A total of 34 participants completed the additional 17-week supplementation period. When compared with their respective baseline measures, these participants had a statistically significant improvement in endothelial function and blood high-density lipoprotein (HDL). Krill oil may lead to moderate improvement of cardiovascular risks, specifically endothelial dysfunction and HDL in patients with type 2 diabetes. Registered with ClinicalTrials.gov: NCT02091193.

  9. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial.

    Science.gov (United States)

    Farthmann, Juliane; Mengel, Mathias; Henne, Birgit; Grebe, Markus; Watermann, Dirk; Kaufhold, Jan; Stehle, Margit; Fuenfgeld, Christian

    2016-07-01

    Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year. 289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP(®) Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test. The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up. In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery.

  10. The Effect of Uric Acid Lowering on Albuminuria and Renal Function in Type 1 Diabetes: A Randomized Clinical Trial

    DEFF Research Database (Denmark)

    Pilemann-Lyberg, Sascha; Persson, Frederik; Frystyk, Jan

    . Methods We conducted a randomized, placebo-controlled, double-blinded, cross-over trial enrolling patients with T1D and a plasma uric acid ≥ 4.4 mg/dL, persistent albuminuria (urinary albumin creatinine ration) ≥30 mg/g and an eGFR ≥ 40 ml/min/1.73m2 on stable RAS blocking intervention. The participants...... on albuminuria and slopes of measured GFR....

  11. Effect of glucomannan on functional constipation in children: a systematic review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Han, Yong; Zhang, Lei; Liu, Xiang-Qun; Zhao, Zhi-Jun; Lv, Lu-Xian

    2017-05-01

    Constipation, a common complaint in children, considerably affects the quality of life. This systematic review assessed the treatment effects of glucomannan on children with constipation by summarising evidence from previous randomised controlled trials (RCTs). A comprehensive electronic literature search was conducted for identifying eligible RCTs that evaluated the effectiveness of glucomannan. The results were reported as mean differences (MDs), standardised mean differences (SMDs), and risk ratios (RRs) with 95% confidence intervals (CIs). The primary outcome was the defecation frequency per week; the secondary outcomes were stool consistency and the rate of successful treatment. A metaanalysis was conducted using the random effects model. Three RCTs evaluating 122 participants were identified. Glucomannan use was associated with an increased frequency of defecation (3 trials; MD=1.40; 95% CI: 0.36-2.44, p=0.008); however, there were no significant differences in the outcomes of stool consistency (3 trials; SMD=0.48; 95% CI: -0.44 to 1.40, p=0.300) or the rate of successful treatment (2 trials; RR=1.36; 95% CI: 0.48-3.81, p=0.110). Glucomannan moderately increases the defecation frequency of children with constipation but is not associated with a reduction in stool consistency or overall improvement in the rate of successful treatment. However, these results should be cautiously interpreted because of the small sample size and the risk of products containing glucomannan need to be considered. Additional large-scale and well-designed RCTs are necessary to evaluate the efficacy and long-term safety of glucomannan.

  12. Effect of Scapular Function Training on Chronic Pain in the Neck/Shoulder Region: A Randomized Controlled Trial

    OpenAIRE

    Andersen, Christoffer H.; Andersen, Lars L.; Zebis, Mette K.; Sjøgaard, Gisela

    2013-01-01

    Purpose Neck and shoulder complaints are common among employees in occupations characterized by intensive computer use. Treatment has varied from passive rest to active treatments and active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct training of the painful area. Our study investigates the effect of the latter approach. The purpose of this study was in a randomised controlled trial to investigate if intensive scap...

  13. Effect of tadalafil on blood flow, pain, and function in chronic cold Complex Regional Pain Syndrome: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schasfoort Fabienne C

    2008-10-01

    Full Text Available Abstract Background This double-blind, randomized, controlled trial investigated the effect of the phosphodiesterase-5 inhibitor tadalafil on the microcirculation in patients with cold Complex Regional Pain Syndrome (CRPS in one lower extremity. Methods Twenty-four patients received 20 mg tadalafil or placebo daily for 12 weeks. The patients also participated in a physical therapy program. The primary outcome measure was temperature difference between the CRPS side and the contralateral side, determined by measuring the skin temperature with videothermography. Secondary outcomes were: pain measured on a Visual Analogue Scale, muscle force measured with a MicroFet 2 dynamometer, and level of activity measured with an Activity Monitor (AM and walking tests. Results At the end of the study period, the temperature asymmetry was not significantly reduced in the tadalafil group compared with the placebo group, but there was a significant and clinically relevant reduction of pain in the tadalafil group. Muscle force improved in both treatment groups and the AM revealed small, non-significant improvements in time spent standing, walking, and the number of short walking periods. Conclusion Tadalafil may be a promising new treatment for patients that have chronic cold CRPS due to endothelial dysfunction, and deserves further investigation. Trial Registration The registration number in the Dutch Trial Register is ISRCTN60226869.

  14. Effects of Water Provision and Hydration on Cognitive Function among Primary-School Pupils in Zambia: A Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Victoria Trinies

    Full Text Available There is a well-established link between hydration and improved cognitive performance among adults, with evidence of similar findings among children. No trials have investigated the impact of water provision on cognitive performance among schoolchildren in hot and arid low-resource settings. We conducted a randomized-controlled trial in five schools with limited water access in Chipata district in Eastern province, Zambia, to assess the efficacy of water provision on cognition. Pupils in grades 3-6 were randomly assigned to either receive a bottle of drinking water that they could refill throughout the day (water group, n = 149 or only have access to drinking water that was normally available at the school (control group, n = 143. Hydration was assessed in the morning before provision of water and in the afternoon through urine specific gravity (Usg measured with a portable refractometer. In the afternoon we administered six cognitive tests to assess short-term memory, concentration, visual attention, and visual motor skills. Morning prevalence of dehydration, defined as Usg≥1.020, was 42%. Afternoon dehydration increased to 67% among the control arm and dropped to 10% among the intervention arm. We did not find that provision of water or hydration impacted cognitive test scores, although there were suggestive relationships between both water provision and hydration and increased scores on tests measuring visual attention. We identified key improvements to the study design that are warranted to further investigate this relationship.ClinicalTrials.gov NCT01924546.

  15. Wear, bone density, functional outcome and survival in vitamin E-incorporated polyethylene cups in reversed hybrid total hip arthroplasty: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van der Veen Hugo C

    2012-09-01

    Full Text Available Abstract Background Aseptic loosening of total hip arthroplasties is generally caused by periprosthetic bone resorption due to tissue reactions on polyethylene wear particles. In vitro testing of polyethylene cups incorporated with vitamin E shows increased wear resistance. The objective of this study is to compare vitamin E-stabilized highly cross-linked polyethylene with conventional cross-linked polyethylene in “reversed hybrid” total hip arthroplasties (cemented all-polyethylene cups combined with uncemented femoral stems. We hypothesize that the adjunction of vitamin E leads to a decrease in polyethylene wear in the long-term. We also expect changes in bone mineral density, less osteolysis, equal functional scores and increased implant survival in polyethylene cemented cups incorporated with vitamin E in the long-term. Design A double-blinded randomized controlled trial will be conducted. Patients to be included are aged under 70, suffer from non-inflammatory degenerative joint disease of the hip and are scheduled for a primary total hip arthroplasty. The study group will receive a reversed hybrid total hip arthroplasty with a vitamin E-stabilized highly cross-linked polyethylene cemented cup. The control group will receive a reversed hybrid total hip arthroplasty with a conventional cross-linked polyethylene cemented cup. Radiological follow-up will be assessed at 6 weeks and at 1, 3, 5, 7 and 10 years postoperatively, to determine polyethylene wear and osteolysis. Patient-reported functional status (HOOS, physician-reported functional status (Harris Hip Score and patients’ physical activity behavior (SQUASH will also be assessed at these intervals. Acetabular bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA at 6 weeks and at 1 year and 2 years postoperatively. Implant survival will be determined at 10 years postoperatively. Discussion In vitro results of vitamin E-stabilized polyethylene are promising

  16. Rehabilitation plus OnabotulinumtoxinA Improves Motor Function over OnabotulinumtoxinA Alone in Post-Stroke Upper Limb Spasticity: A Single-Blind, Randomized Trial

    OpenAIRE

    Deidre Devier; JoAnn Harnar; Leandro Lopez; Allison Brashear; Glenn Graham

    2017-01-01

    Background: OnabotulinumtoxinA (BoNT-A) can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. Methods: This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigne...

  17. Usefulness of chewing gum for recovering intestinal function after cesarean delivery: A systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Hua-Ping Huang

    2015-04-01

    Full Text Available Chewing gum has been reported to enhance bowel function. However, the efficacy remains unclear for women undergoing cesarean delivery. The aim of this meta-analysis is to evaluate the efficacy of chewing gum for recovering intestinal function following cesarean delivery in the early postoperative period. Electronic databases including MEDLINE, EMBASE, Cochrane Library were searched to identify English language randomized controlled trials comparing chewing gum with other procedures for promoting the recovery of intestinal function after cesarean delivery. Two of the authors independently extracted data from the eligibility studies, and Review Manager Version 5.2 was used to pool the data. Finally, five randomized controlled trials involving 882 patients were included and all the trials were considered as at high risk of bias. The pooled findings showed that chewing gum after cesarean delivery can significantly shorten the time to first flatus [standardized mean difference (SMD = −0.73; 95% confidence interval (CI = −1.01 to −0.14; p < 0.001]; time to first hearing of normal intestinal sounds (SMD = −0.69; 95% CI = −1.20 to −0.17; p = 0.009; I² = 92%. Time to the first defecation (SMD = −0.53; 95% CI = −1.61 to −0.07; p = 0.07; I² = 92% and length of hospital stay (SMD = −0.59; 95% CI = −1.18 to 0.00; p = 0.05; I² = 93% were also reduced in the chewing gum group; however, these results were not statistically significant. The current evidence suggests that chewing gum has a positive effect on intestinal function recovery following cesarean delivery in the early postoperative period. However, more large-scale and high-quality randomized controlled trials are needed to confirm these results.

  18. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function

    OpenAIRE

    Jovancevic Jelena; Rosano Caterina; Perera Subashan; Erickson Kirk I; Studenski Stephanie

    2012-01-01

    Abstract Background Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not inv...

  19. Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial.

    Science.gov (United States)

    Lechtzin, N; West, N; Allgood, S; Wilhelm, E; Khan, U; Mayer-Hamblett, N; Aitken, M L; Ramsey, B W; Boyle, M P; Mogayzel, P J; Goss, C H

    2013-11-01

    Acute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis (CF). Pulmonary exacerbations lead to impaired lung function, worse quality of life, and shorter survival. We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes. Describe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations. A randomized, non-blinded, multi-center trial in 320 individuals with CF aged 14 years and older. The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation. Participants will be enrolled in the study for 12 months. The primary endpoint is change in FEV1 (L) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV1 measurements. Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation, number of acute pulmonary exacerbations, number of hospitalization days for acute pulmonary exacerbation, time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation, change in health related quality of life, change in treatment burden, change in CF respiratory symptoms, and adherence to the study protocol. This study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations. We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline, reduce respiratory symptoms and improve the quality of life for individuals with CF. © 2013.

  20. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  1. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Science.gov (United States)

    2011-01-01

    Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

  2. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol.

    Science.gov (United States)

    Lohmann-Jensen, Rasmus; Holsgaard-Larsen, Anders; Emmeluth, Claus; Overgaard, Søren; Jensen, Carsten

    2014-03-29

    Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization. A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a

  3. A GO intervention program for enhancing elementary school children's cognitive functions and control abilities of emotion and behavior: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tachibana Yoshiyuki

    2012-01-01

    Full Text Available Abstract Background Executive function is critical for children's healthy development. We propose an intervention program to enhance children's executive function using the game, GO. Many neuroimaging studies have revealed that playing GO is related to executive function. In addition, previous studies also revealed that executive function can be enhanced by training. We will perform a randomized controlled trial to investigate the effectiveness of a GO intervention group and a control group without intervention. Methods/Design 35 elementary school children aged 8 to 10 were recruited from Edogawa elementary school in Tokyo, Japan. They will be randomized into two groups; either the 5-week GO intervention group or no-intervention control group. We will ask the participants of the intervention group to join the GO course which will be held once every week for five weeks (total: six times. In the GO course, the children will be taught GO by the GO masters of the Nihon Ki-in and enjoy it for an hour. Besides the course, the participants will perform GO problems about twenty minutes a day, three times a week during the intervention period. We will use the Stroop task, the digit span, the Raven's colored progressive matrices, the Span-board task, and the Behavioral inhibition/behavioral activation scale for the outcome measures. Outcomes will be measured at a baseline (Assessment 1 and 5 weeks after the intervention program started (Assessment 2. The intervention group will be compared with the control group using one-way analyses of covariance with the difference between Assessment 1 and Assessment 2 measures as dependent variables and pretest scores as covariates. Discussion To our knowledge, this study will be the first RCT to investigate the efficacy of a GO intervention program for elementary school children. If this intervention is effective, we will be able to take the next steps in making an educational program to enhance children's executive

  4. The dose-dependent effect of nesiritide on renal function in patients with acute decompensated heart failure: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xiong, Bo; Wang, Chunbin; Yao, Yuanqing; Huang, Yuwen; Tan, Jie; Cao, Yin; Zou, Yanke; Huang, Jing

    2015-01-01

    Conflicting renal effects of nesiritide have been reported in patients with acute decompensated heart failure. To answer this controversy, we performed a meta-analysis of randomized controlled trials to evaluate the influence of nesiritide on renal function in patients with acute decompensated heart failure. Articles were obtained from PubMed, Medline, Cochrane Library and reference review. Randomized controlled studies that investigated the effects of continuous infusion of nesiritide on renal function in adult patients with acute decompensated heart failure were included and analyzed. Fixed-effect model was used to estimate relative risk (RR) and weight mean difference (WMD). The quality assessment of each study, subgroup, sensitivity, and publication bias analyses were performed. Fifteen randomized controlled trials were eligible for inclusion. Most of included studies had relatively high quality and no publication bias was found. Overall, compared to control therapies, nesiritide might increase the risk of worsening renal function in patients with acute decompensated heart failure (RR 1.08, 95% CI 1.01-1.15, P = 0.023). In subgroup analysis, high-dose nesiritide strongly associated with renal dysfunction (RR 1.54, 95% CI 1.19-2.00, P = 0.001), but no statistical differences were observed in standard-dose (RR 1.04, 95% CI 0.98-1.12, P = 0.213), low-dose groups (RR 1.01, 95% CI 0.74-1.37, P = 0.968) and same results were identified in the subgroup analysis of placebo controlled trials. Peak mean change of serum creatinine from baseline was no significant difference (WMD -2.54, 95% CI -5.76-0.67, P = 0.121). In our meta-analysis, nesiritide may have a dose-dependent effect on renal function in patients with acute decompensated heart failure. High-dose nesiritide is likely to increase the risk of worsening renal function, but standard-dose and low-dose nesiritide probably have no impact on renal function. These findings could be helpful to optimize the use of

  5. Domiciliary VR-Based Therapy for Functional Recovery and Cortical Reorganization: Randomized Controlled Trial in Participants at the Chronic Stage Post Stroke.

    Science.gov (United States)

    Ballester, Belén Rubio; Nirme, Jens; Camacho, Irene; Duarte, Esther; Rodríguez, Susana; Cuxart, Ampar; Duff, Armin; Verschure, Paul F M J

    2017-08-07

    Most stroke survivors continue to experience motor impairments even after hospital discharge. Virtual reality-based techniques have shown potential for rehabilitative training of these motor impairments. Here we assess the impact of at-home VR-based motor training on functional motor recovery, corticospinal excitability and cortical reorganization. The aim of this study was to identify the effects of home-based VR-based motor rehabilitation on (1) cortical reorganization, (2) corticospinal tract, and (3) functional recovery after stroke in comparison to home-based occupational therapy. We conducted a parallel-group, controlled trial to compare the effectiveness of domiciliary VR-based therapy with occupational therapy in inducing motor recovery of the upper extremities. A total of 35 participants with chronic stroke underwent 3 weeks of home-based treatment. A group of subjects was trained using a VR-based system for motor rehabilitation, while the control group followed a conventional therapy. Motor function was evaluated at baseline, after the intervention, and at 12-weeks follow-up. In a subgroup of subjects, we used Navigated Brain Stimulation (NBS) procedures to measure the effect of the interventions on corticospinal excitability and cortical reorganization. Results from the system's recordings and clinical evaluation showed significantly greater functional recovery for the experimental group when compared with the control group (1.53, SD 2.4 in Chedoke Arm and Hand Activity Inventory). However, functional improvements did not reach clinical significance. After the therapy, physiological measures obtained from a subgroup of subjects revealed an increased corticospinal excitability for distal muscles driven by the pathological hemisphere, that is, abductor pollicis brevis. We also observed a displacement of the centroid of the cortical map for each tested muscle in the damaged hemisphere, which strongly correlated with improvements in clinical scales. These

  6. Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial

    Directory of Open Access Journals (Sweden)

    Shuai Yin

    2017-01-01

    Full Text Available Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups: the low-He point group (puncturing at Zusanli (ST36, Mu point group (puncturing at Zhongwan (CV12, and He-Mu point combination group (puncturing at ST36 and CV12. Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the

  7. The effect of bupropion XL and escitalopram on memory and functional outcomes in adults with major depressive disorder: results from a randomized controlled trial.

    Science.gov (United States)

    Soczynska, Joanna K; Ravindran, Lakshmi N; Styra, Rima; McIntyre, Roger S; Cyriac, Anna; Manierka, Marena S; Kennedy, Sidney H

    2014-12-15

    Decrements in cognitive function are a common feature of Major Depressive Disorder (MDD), and whether distinct classes of antidepressants differentially affect memory in these individuals has not been sufficiently evaluated. In this study we sought to determine the effect of escitalopram and bupropion XL on memory and psychosocial