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  1. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  2. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  3. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  4. Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements.

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    Korn, Edward L; Freidlin, Boris

    2017-06-01

    There is a wide range of adaptive elements of clinical trial design (some old and some new), with differing advantages and disadvantages. Classical interim monitoring, which adapts the design based on early evidence of superiority or futility of a treatment arm, has long been known to be extremely useful. A more recent application of interim monitoring is in the use of phase II/III designs, which can be very effective (especially in the setting of multiple experimental treatments and a reliable intermediate end point) but do have the cost of having to commit earlier to the phase III question than if separate phase II and phase III trials were performed. Outcome-adaptive randomization is an older technique that has recently regained attention; it increases trial complexity and duration without offering substantial benefits to the patients in the trial. The use of adaptive trials with biomarkers is new and has great potential for efficiently identifying patients who will be helped most by specific treatments. Master protocols in which trial arms and treatment questions are added to an ongoing trial can be especially efficient in the biomarker setting, where patients are screened for entry into different subtrials based on evolving knowledge about targeted therapies. A discussion of three recent adaptive clinical trials (BATTLE-2, I-SPY 2, and FOCUS4) highlights the issues. Published by Oxford University Press 2017. This work is written by US Government employees and is in the public domain in the US.

  5. Forecasting Sensorimotor Adaptability from Baseline Inter-Trial Correlations

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    Beaton, K. H.; Bloomberg, J. J.

    2014-01-01

    One of the greatest challenges surrounding adaptation to the spaceflight environment is the large variability in symptoms, and corresponding functional impairments, from one crewmember to the next. This renders preflight training and countermeasure development difficult, as a "one-size-fits-all" approach is inappropriate. Therefore, it would be highly advantageous to know ahead of time which crewmembers might have more difficulty adjusting to the novel g-levels inherent to spaceflight. Such knowledge could guide individually customized countermeasures, which would enable more efficient use of crew time, both preflight and inflight, and provide better outcomes. The primary goal of this project is to look for a baseline performance metric that can forecast sensorimotor adaptability without exposure to an adaptive stimulus. We propose a novel hypothesis that considers baseline inter-trial correlations, the trial-to-trial fluctuations in motor performance, as a predictor of individual sensorimotor adaptive capabilities. To-date, a strong relationship has been found between baseline inter-trial correlations and adaptability in two oculomotor systems. For this project, we will explore an analogous predictive mechanism in the locomotion system. METHODS: Baseline Inter-trial Correlations: Inter-trial correlations specify the relationships among repeated trials of a given task that transpire as a consequence of correcting for previous performance errors over multiple timescales. We can quantify the strength of inter-trial correlations by measuring the decay of the autocorrelation function (ACF), which describes how rapidly information from past trials is "forgotten." Processes whose ACFs decay more slowly exhibit longer-term inter-trial correlations (longer memory processes), while processes whose ACFs decay more rapidly exhibit shorterterm inter-trial correlations (shorter memory processes). Longer-term correlations reflect low-frequency activity, which is more easily

  6. Adaptive design methods in clinical trials – a review

    Directory of Open Access Journals (Sweden)

    Chang Mark

    2008-05-01

    Full Text Available Abstract In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc, and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments, challenges in by design (prospective adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed.

  7. Practical considerations for adaptive trial design and implementation

    CERN Document Server

    Pinheiro, José; Kuznetsova, Olga

    2014-01-01

    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...

  8. Can emergency medicine research benefit from adaptive design clinical trials?

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    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. 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/.

  9. An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

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    Marc A Adams

    Full Text Available Physical activity (PA interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible.To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention.Participants (N = 20 were randomized to one of two 6-month treatments: 1 static intervention (SI or 2 adaptive intervention (AI. Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data.A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001 and a group by study phase interaction was observed (p  .017. The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74.The adaptive intervention outperformed the static intervention for increasing

  10. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control

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    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten

    2011-01-01

    When faced with unpredictable environments, the human motor system has been shown to develop optimized adaptation strategies that allow for online adaptation during the control process. Such online adaptation is to be contrasted to slower over-trial learning that corresponds to a trial-by-trial update of the movement plan. Here we investigate the interplay of both processes, i.e., online adaptation and over-trial learning, in a visuomotor experiment performed by macaques. We show that simple non-adaptive control schemes fail to perform in this task, but that a previously suggested adaptive optimal feedback control model can explain the observed behavior. We also show that over-trial learning as seen in learning and aftereffect curves can be explained by learning in a radial basis function network. Our results suggest that both the process of over-trial learning and the process of online adaptation are crucial to understand visuomotor learning. PMID:21720526

  11. Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults’ physical activity

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    Marc A. Adams

    2017-03-01

    Full Text Available Abstract Background Emerging interventions that rely on and harness variability in behavior to adapt to individual performance over time may outperform interventions that prescribe static goals (e.g., 10,000 steps/day. The purpose of this factorial trial was to compare adaptive vs. static goal setting and immediate vs. delayed, non-contingent financial rewards for increasing free-living physical activity (PA. Methods A 4-month 2 × 2 factorial randomized controlled trial tested main effects for goal setting (adaptive vs. static goals and rewards (immediate vs. delayed and interactions between factors to increase steps/day as measured by a Fitbit Zip. Moderate-to-vigorous PA (MVPA minutes/day was examined as a secondary outcome. Results Participants (N = 96 were mainly female (77%, aged 41 ± 9.5 years, and all were insufficiently active and overweight/obese (mean BMI = 34.1 ± 6.2. Participants across all groups increased by 2389 steps/day on average from baseline to intervention phase (p < .001. Participants receiving static goals showed a stronger increase in steps per day from baseline phase to intervention phase (2630 steps/day than those receiving adaptive goals (2149 steps/day; difference = 482 steps/day, p = .095. Participants receiving immediate rewards showed stronger improvement (2762 step/day increase from baseline to intervention phase than those receiving delayed rewards (2016 steps/day increase; difference = 746 steps/day, p = .009. However, the adaptive goals group showed a slower decrease in steps/day from the beginning of the intervention phase to the end of the intervention phase (i.e. less than half the rate compared to the static goals group (−7.7 steps vs. -18.3 steps each day; difference = 10.7 steps/day, p < .001 resulting in better improvements for the adaptive goals group by study end. Rate of change over the intervention phase did not differ between reward groups. Significant goal phase x goal

  12. Dynamic changes in brain activity during prism adaptation.

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    Luauté, Jacques; Schwartz, Sophie; Rossetti, Yves; Spiridon, Mona; Rode, Gilles; Boisson, Dominique; Vuilleumier, Patrik

    2009-01-07

    Prism adaptation does not only induce short-term sensorimotor plasticity, but also longer-term reorganization in the neural representation of space. We used event-related fMRI to study dynamic changes in brain activity during both early and prolonged exposure to visual prisms. Participants performed a pointing task before, during, and after prism exposure. Measures of trial-by-trial pointing errors and corrections allowed parametric analyses of brain activity as a function of performance. We show that during the earliest phase of prism exposure, anterior intraparietal sulcus was primarily implicated in error detection, whereas parieto-occipital sulcus was implicated in error correction. Cerebellum activity showed progressive increases during prism exposure, in accordance with a key role for spatial realignment. This time course further suggests that the cerebellum might promote neural changes in superior temporal cortex, which was selectively activated during the later phase of prism exposure and could mediate the effects of prism adaptation on cognitive spatial representations.

  13. African Development of AIDS Prevention Trials (ADAPT2) | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...

  14. African Development of AIDS Prevention Trials (ADAPT2) | CRDI ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...

  15. Forecasting Sensorimotor Adaptability from Baseline Inter-Trial Correlations

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    Beaton, K. H.; Bloomberg, J. J.

    2016-01-01

    One of the greatest challenges for sensorimotor adaptation to the spaceflight environment is the large variability in symptoms, and corresponding functional impairments, from one crewmember to the next. This renders preflight training and countermeasure development difficult, as a "one-size-fits-all" approach is inappropriate. Therefore, it would be highly advantageous to know ahead of time which crewmembers might have more difficulty adjusting to the novel g-levels inherent to spaceflight. This information could guide individually customized countermeasures, which would enable more efficient use of crew time and provide better outcomes. The principal aim of this work is to look for baseline performance metrics that relate to locomotor adaptability. We propose a novel hypothesis that considers baseline inter-trial correlations, the trial-to-trial fluctuations ("noise") in motor performance, as a predictor of individual adaptive capabilities.

  16. Working memory load-dependent spatio-temporal activity of single-trial P3 response detected with an adaptive wavelet denoiser.

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    Zhang, Qiushi; Yang, Xueqian; Yao, Li; Zhao, Xiaojie

    2017-03-27

    Working memory (WM) refers to the holding and manipulation of information during cognitive tasks. Its underlying neural mechanisms have been explored through both functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Trial-by-trial coupling of simultaneously collected EEG and fMRI signals has become an important and promising approach to study the spatio-temporal dynamics of such cognitive processes. Previous studies have demonstrated a modulation effect of the WM load on both the BOLD response in certain brain areas and the amplitude of P3. However, much remains to be explored regarding the WM load-dependent relationship between the amplitude of ERP components and cortical activities, and the low signal-to-noise ratio (SNR) of the EEG signal still poses a challenge to performing single-trial analyses. In this paper, we investigated the spatio-temporal activities of P3 during an n-back verbal WM task by introducing an adaptive wavelet denoiser into the extraction of single-trial P3 features and using general linear model (GLM) to integrate simultaneously collected EEG and fMRI data. Our results replicated the modulation effect of the WM load on the P3 amplitude. Additionally, the activation of single-trial P3 amplitudes was detected in multiple brain regions, including the insula, the cuneus, the lingual gyrus (LG), and the middle occipital gyrus (MOG). Moreover, we found significant correlations between P3 features and behavioral performance. These findings suggest that the single-trial integration of simultaneous EEG and fMRI signals may provide new insights into classical cognitive functions. Copyright © 2017 IBRO. Published by Elsevier Ltd. All rights reserved.

  17. Disassociation between primary motor cortical activity and movement kinematics during adaptation to reach perturbations.

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    Cai, X; Shimansky, Y P; Weber, D J; He, Jiping

    2004-01-01

    The relationship between movement kinematics and motor cortical activity was studied in monkeys performing a center-out reaching task during their adaptation to force perturbations applied to the wrist. The main feature of adaptive changes in movement kinematics was anticipatory deviation of hand paths in the direction opposite to that of the upcoming perturbation. We identified a group of neurons in the dorsal lateral portion of the primary motor cortex where a gradual buildup of spike activity immediately preceding the actual (in perturbation trials) or the "would-be" (in unperturbed/catch trials) perturbation onset was observed. These neurons were actively involved in the adaptation process, which was evident from the gradual increase in the amplitude of their movement-related modulation of spike activity from virtual zero and development of certain directional tuning pattern (DTP). However, the day-to-day dynamics of the kinematics adaptation was dramatically different from that of the neuronal activity. Hence, the adaptive modification of the motor cortical activity is more likely to reflect the development of the internal model of the perturbation dynamics, rather than motor instructions determining the adaptive behavior.

  18. Group sequential and confirmatory adaptive designs in clinical trials

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    Wassmer, Gernot

    2016-01-01

    This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods...

  19. Online visual feedback during error-free channel trials leads to active unlearning of movement dynamics: evidence for adaptation to trajectory prediction errors.

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    Angel Lago-Rodriguez

    2016-09-01

    Full Text Available Prolonged exposure to movement perturbations leads to creation of motor memories which decay towards previous states when the perturbations are removed. However, it remains unclear whether this decay is due only to a spontaneous and passive recovery of the previous state. It has recently been reported that activation of reinforcement-based learning mechanisms delays the onset of the decay. This raises the question whether other motor learning mechanisms may also contribute to the retention and/or decay of the motor memory. Therefore, we aimed to test whether mechanisms of error-based motor adaptation are active during the decay of the motor memory. Forty-five right-handed participants performed point-to-point reaching movements under an external dynamic perturbation. We measured the expression of the motor memory through error-clamped (EC trials, in which lateral forces constrained movements to a straight line towards the target. We found greater and faster decay of the motor memory for participants who had access to full online visual feedback during these EC trials (Cursor group, when compared with participants who had no EC feedback regarding movement trajectory (Arc group. Importantly, we did not find between-group differences in adaptation to the external perturbation. In addition, we found greater decay of the motor memory when we artificially increased feedback errors through the manipulation of visual feedback (Augmented-Error group. Our results then support the notion of an active decay of the motor memory, suggesting that adaptive mechanisms are involved in correcting for the mismatch between predicted movement trajectories and actual sensory feedback, which leads to greater and faster decay of the motor memory.

  20. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): lessons learned

    International Nuclear Information System (INIS)

    Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

    2013-01-01

    Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated 'help-desk' team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support. (author)

  1. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01: Lessons learned

    Directory of Open Access Journals (Sweden)

    Daniel Pham

    2013-01-01

    Full Text Available Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment. Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%, technical problems (46% while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support.

  2. A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.

    Science.gov (United States)

    Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J; Guetterman, Timothy C; Frederiksen, Shirley; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

    2017-06-01

    Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model. Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.

  3. Mixture-based gatekeeping procedures in adaptive clinical trials.

    Science.gov (United States)

    Kordzakhia, George; Dmitrienko, Alex; Ishida, Eiji

    2018-01-01

    Clinical trials with data-driven decision rules often pursue multiple clinical objectives such as the evaluation of several endpoints or several doses of an experimental treatment. These complex analysis strategies give rise to "multivariate" multiplicity problems with several components or sources of multiplicity. A general framework for defining gatekeeping procedures in clinical trials with adaptive multistage designs is proposed in this paper. The mixture method is applied to build a gatekeeping procedure at each stage and inferences at each decision point (interim or final analysis) are performed using the combination function approach. An advantage of utilizing the mixture method is that it enables powerful gatekeeping procedures applicable to a broad class of settings with complex logical relationships among the hypotheses of interest. Further, the combination function approach supports flexible data-driven decisions such as a decision to increase the sample size or remove a treatment arm. The paper concludes with a clinical trial example that illustrates the methodology by applying it to develop an adaptive two-stage design with a mixture-based gatekeeping procedure.

  4. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of Adaptation and Study Protocol

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    Lee, Christina S.; Colby, Suzanne M.; Magill, Molly; Almeida, Joanna; Tavares, Tonya; Rohsenow, Damaris J.

    2016-01-01

    Background The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult. Objective The CAMI2 (Culturally Adapted Motivational Interviewing) study design and its theoretical model, is described to illustrate how MI adapted to social and cultural factors (CAMI) can be discriminated against non-adapted MI. Methods and Design CAMI2, a large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community (n=257). Outcomes are reductions in heavy drinking days (Time Line Follow-Back) and negative consequences of drinking among Hispanics (Drinkers Inventory of Consequences). A second aim examines perceived acculturation stress as a moderator of treatment outcomes in the CAMI condition. Summary The CAMI2 study design protocol is presented and the theory of adaptation is presented. Findings from the trial described may yield important recommendations on the science of cultural adaptation and improve MI dissemination to Hispanics with alcohol risk. PMID:27565832

  5. The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project.

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    Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

    2017-01-01

    Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key stakeholders from several scientific domains early

  6. Between-Trial Forgetting Due to Interference and Time in Motor Adaptation.

    Directory of Open Access Journals (Sweden)

    Sungshin Kim

    Full Text Available Learning a motor task with temporally spaced presentations or with other tasks intermixed between presentations reduces performance during training, but can enhance retention post training. These two effects are known as the spacing and contextual interference effect, respectively. Here, we aimed at testing a unifying hypothesis of the spacing and contextual interference effects in visuomotor adaptation, according to which forgetting between trials due to either spaced presentations or interference by another task will promote between-trial forgetting, which will depress performance during acquisition, but will promote retention. We first performed an experiment with three visuomotor adaptation conditions: a short inter-trial-interval (ITI condition (SHORT-ITI; a long ITI condition (LONG-ITI; and an alternating condition with two alternated opposite tasks (ALT, with the same single-task ITI as in LONG-ITI. In the SHORT-ITI condition, there was fastest increase in performance during training and largest immediate forgetting in the retention tests. In contrast, in the ALT condition, there was slowest increase in performance during training and little immediate forgetting in the retention tests. Compared to these two conditions, in the LONG-ITI, we found intermediate increase in performance during training and intermediate immediate forgetting. To account for these results, we fitted to the data six possible adaptation models with one or two time scales, and with interference in the fast, or in the slow, or in both time scales. Model comparison confirmed that two time scales and some degree of interferences in either time scale are needed to account for our experimental results. In summary, our results suggest that retention following adaptation is modulated by the degree of between-trial forgetting, which is due to time-based decay in single adaptation task and interferences in multiple adaptation tasks.

  7. Changes in cortical activity associated with adaptive behavior during repeated balance perturbation of unpredictable timing

    Directory of Open Access Journals (Sweden)

    Andreas eMierau

    2015-10-01

    Full Text Available The compensation for a sudden balance perturbation, unpracticed and unpredictable in timing and magnitude is accompanied by pronounced postural instability that is suggested to be causal to falls. However, subsequent presentations of an identical perturbation are characterized by a marked decrease of the amplitude of postural reactions; a phenomenon called adaptation or habituation. This study aimed to identify cortical characteristics associated with adaptive behavior during repetitive balance perturbations based on single-trial analyses of the P1 and N1 perturbation-evoked potentials. Thirty-seven young men were exposed to ten transient balance perturbations while balancing on the dominant leg. 32-channel EEG, surface EMG of the ankle plantar flexor muscles and postural sway (i.e. Euclidean distance of the supporting platform were recorded simultaneously. The P1 and N1 potentials were localized and the amplitude/latency was analyzed trial by trial. The best match sources for P1 and N1 potentials were located in the parietal (Brodmann area 5 and midline fronto-central cortex (Brodmann area 6, respectively. The amplitude and latency of the P1 potential remained unchanged over trials. In contrast, a significant adaptation of the N1 amplitude was observed. Similar adaptation effects were found with regard to postural sway and m. peroneus longus EMG activity of the non-dominant (free leg; an indicator reduced muscular co-contraction and/or less temporary bipedal stance to regain stability. Significant but weak correlations were found between N1 amplitude and postural sway as well as EMG activity. These results highlight the important role of the midline fronto-central cortex for adaptive behavior associated with balance control.

  8. The DIAN-TU Next Generation Alzheimer’s prevention trial: adaptive design and disease progression model

    Science.gov (United States)

    Bateman, Randall J.; Benzinger, Tammie L.; Berry, Scott; Clifford, David B.; Duggan, Cynthia; Fagan, Anne M.; Fanning, Kathleen; Farlow, Martin R.; Hassenstab, Jason; McDade, Eric M.; Mills, Susan; Paumier, Katrina; Quintana, Melanie; Salloway, Stephen P.; Santacruz, Anna; Schneider, Lon S.; Wang, Guoqiao; Xiong, Chengjie

    2016-01-01

    INTRODUCTION The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) trial is an adaptive platform trial testing multiple drugs to slow or prevent the progression of Alzheimer’s disease in autosomal dominant Alzheimer’s disease (ADAD) families. With completion of enrollment of the first two drug arms, the DIAN-TU now plans to add new drugs to the platform, designated as the Next Generation Prevention Trial (NexGen). METHODS In collaboration with ADAD families, philanthropic organizations, academic leaders, the DIAN-TU Pharma Consortium, the NIH, and regulatory colleagues, the DIAN-TU developed innovative clinical study designs for the DIAN-TU NexGen trial. RESULTS Our expanded trials toolbox consists of a Disease Progression Model for ADAD, primary endpoint DIAN-TU cognitive performance composite, biomarker development, self-administered cognitive assessments, adaptive dose adjustments, and blinded data collection through the last participant completion. CONCLUSION These steps represent elements to improve efficacy of the adaptive platform trial and a continued effort to optimize prevention and treatment trials in ADAD. PMID:27583651

  9. Accounting for sequential trial effects in the flanker task: conflict adaptation or associative priming?

    Science.gov (United States)

    Nieuwenhuis, Sander; Stins, John F; Posthuma, Danielle; Polderman, Tinca J C; Boomsma, Dorret I; de Geus, Eco J

    2006-09-01

    The conflict-control loop theory proposes that the detection of conflict in information processing triggers an increase in cognitive control, resulting in improved performance on the subsequent trial. This theory seems consistent with the robust finding that conflict susceptibility is reduced following correct trials associated with high conflict: the conflict adaptation effect. However, despite providing favorable conditions for eliciting and detecting conflict-triggered performance adjustments, none of the five experiments reported here provide unequivocal evidence of such adjustments. Instead, the results corroborate and extend earlier findings by demonstrating that the conflict adaptation effect, at least in the flanker task, is only present for a specific subset of trial sequences that is characterized by a response repetition. This pattern of results provides strong evidence that the conflict adaptation effect reflects associative stimulus-response priming instead of conflict-driven adaptations in cognitive control.

  10. Adaptive clinical trial designs with pre-specified rules for modifying the sample size: understanding efficient types of adaptation.

    Science.gov (United States)

    Levin, Gregory P; Emerson, Sarah C; Emerson, Scott S

    2013-04-15

    Adaptive clinical trial design has been proposed as a promising new approach that may improve the drug discovery process. Proponents of adaptive sample size re-estimation promote its ability to avoid 'up-front' commitment of resources, better address the complicated decisions faced by data monitoring committees, and minimize accrual to studies having delayed ascertainment of outcomes. We investigate aspects of adaptation rules, such as timing of the adaptation analysis and magnitude of sample size adjustment, that lead to greater or lesser statistical efficiency. Owing in part to the recent Food and Drug Administration guidance that promotes the use of pre-specified sampling plans, we evaluate alternative approaches in the context of well-defined, pre-specified adaptation. We quantify the relative costs and benefits of fixed sample, group sequential, and pre-specified adaptive designs with respect to standard operating characteristics such as type I error, maximal sample size, power, and expected sample size under a range of alternatives. Our results build on others' prior research by demonstrating in realistic settings that simple and easily implemented pre-specified adaptive designs provide only very small efficiency gains over group sequential designs with the same number of analyses. In addition, we describe optimal rules for modifying the sample size, providing efficient adaptation boundaries on a variety of scales for the interim test statistic for adaptation analyses occurring at several different stages of the trial. We thus provide insight into what are good and bad choices of adaptive sampling plans when the added flexibility of adaptive designs is desired. Copyright © 2012 John Wiley & Sons, Ltd.

  11. Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study

    Science.gov (United States)

    Touillaud, M; Foucaut, A-M; Berthouze, S E; Reynes, E; Kempf-Lépine, A-S; Carretier, J; Pérol, D; Guillemaut, S; Chabaud, S; Bourne-Branchu, V; Perrier, L; Trédan, O; Fervers, B; Bachmann, P

    2013-01-01

    Introduction After a diagnosis of localised breast cancer, overweight, obesity and weight gain are negatively associated with prognosis. In contrast, maintaining an optimal weight through a balanced diet combined with regular physical activity appears to be effective protective behaviour against comorbidity or mortality after a breast cancer diagnosis. The primary aim of the Programme pour une Alimentation Saine et une Activité Physique Adaptée pour les patientes atteintes d'un cancer du Sein (PASAPAS) randomised controlled trial is to evaluate the feasibility of implementing an intervention of adapted physical activity (APA) for 6 months concomitant with the prescription of a first line of adjuvant chemotherapy. Secondary aims include assessing the acceptability of the intervention, compliance to the programme, process implementation, patients’ satisfaction, evolution of biological parameters and the medicoeconomic impact of the intervention. Methods and analysis The study population consists of 60 women eligible for adjuvant chemotherapy after a diagnosis of localised invasive breast cancer. They will be recruited during a 2-year inclusion period and randomly allocated between an APA intervention arm and a control arm following a 2:1 ratio. All participants should benefit from personalised dietetic counselling and patients allocated to the intervention arm will be offered an APA programme of two to three weekly sessions of Nordic walking and aerobic fitness. During the 6-month intervention and 6-month follow-up, four assessments will be performed including blood draw, anthropometrics and body composition measurements, and questionnaires about physical activity level, diet, lifestyle factors, psychological criteria, satisfaction with the intervention and medical data. Ethics and dissemination The study was approved by the French Ethics Committee (Comité de Protection des Personnes Sud-Est IV) and the national agencies for biomedical studies and for privacy

  12. Walking adaptability therapy after stroke: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Timmermans, Celine; Roerdink, Melvyn; van Ooijen, Marielle W; Meskers, Carel G; Janssen, Thomas W; Beek, Peter J

    2016-08-26

    Walking in everyday life requires the ability to adapt walking to the environment. This adaptability is often impaired after stroke, and this might contribute to the increased fall risk after stroke. To improve safe community ambulation, walking adaptability training might be beneficial after stroke. This study is designed to compare the effects of two interventions for improving walking speed and walking adaptability: treadmill-based C-Mill therapy (therapy with augmented reality) and the overground FALLS program (a conventional therapy program). We hypothesize that C-Mill therapy will result in better outcomes than the FALLS program, owing to its expected greater amount of walking practice. This is a single-center parallel group randomized controlled trial with pre-intervention, post-intervention, retention, and follow-up tests. Forty persons after stroke (≥3 months) with deficits in walking or balance will be included. Participants will be randomly allocated to either C-Mill therapy or the overground FALLS program for 5 weeks. Both interventions will incorporate practice of walking adaptability and will be matched in terms of frequency, duration, and therapist attention. Walking speed, as determined by the 10 Meter Walking Test, will be the primary outcome measure. Secondary outcome measures will pertain to walking adaptability (10 Meter Walking Test with context or cognitive dual-task and Interactive Walkway assessments). Furthermore, commonly used clinical measures to determine walking ability (Timed Up-and-Go test), walking independence (Functional Ambulation Category), balance (Berg Balance Scale), and balance confidence (Activities-specific Balance Confidence scale) will be used, as well as a complementary set of walking-related assessments. The amount of walking practice (the number of steps taken per session) will be registered using the treadmill's inbuilt step counter (C-Mill therapy) and video recordings (FALLS program). This process measure will

  13. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-12-01

    The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools

  14. Physical activity and trial-by-trial adjustments of response conflict.

    Science.gov (United States)

    Kamijo, Keita; Takeda, Yuji

    2013-08-01

    The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

  15. Potential of adaptive clinical trial designs in pharmacogenetic research, A simulation based on the IPASS trial

    NARCIS (Netherlands)

    Van Der Baan, Frederieke H.; Knol, Mirjam J.|info:eu-repo/dai/nl/304820350; Klungel, Olaf H.|info:eu-repo/dai/nl/181447649; Egberts, Toine C.G.|info:eu-repo/dai/nl/162850050; Grobbee, Diederick E.; Roes, Kit C.B.

    2011-01-01

    Background: An adaptive clinical trial design that allows population enrichment after interim analysis can be advantageous in pharmacogenetic research if previous evidence is not strong enough to exclude part of the patient population beforehand.With this design, underpowered studies or unnecessary

  16. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  17. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq.

    Science.gov (United States)

    Magidson, J F; Lejuez, C W; Kamal, T; Blevins, E J; Murray, L K; Bass, J K; Bolton, P; Pagoto, S

    2015-12-01

    Growing evidence supports the use of Western therapies for the treatment of depression, trauma, and stress delivered by community health workers (CHWs) in conflict-affected, resource-limited countries. A recent randomized controlled trial (Bolton et al . 2014 a ) supported the efficacy of two CHW-delivered interventions, cognitive processing therapy (CPT) and brief behavioral activation treatment for depression (BATD), for reducing depressive symptoms and functional impairment among torture survivors in the Kurdish region of Iraq. This study describes the adaptation of the CHW-delivered BATD approach delivered in this trial (Bolton et al .2014 a ), informed by the Assessment-Decision-Administration-Production-Topical experts-Integration-Training-Testing (ADAPT-ITT) framework for intervention adaptation (Wingood & DiClemente, 2008). Cultural modifications, adaptations for low-literacy, and tailored training and supervision for non-specialist CHWs are presented, along with two clinical case examples to illustrate delivery of the adapted intervention in this setting. Eleven CHWs, a study psychiatrist, and the CHW clinical supervisor were trained in BATD. The adaptation process followed the ADAPT-ITT framework and was iterative with significant input from the on-site supervisor and CHWs. Modifications were made to fit Kurdish culture, including culturally relevant analogies, use of stickers for behavior monitoring, cultural modifications to behavioral contracts, and including telephone-delivered sessions to enhance feasibility. BATD was delivered by CHWs in a resource-poor, conflict-affected area in Kurdistan, Iraq, with some important modifications, including low-literacy adaptations, increased cultural relevancy of clinical materials, and tailored training and supervision for CHWs. Barriers to implementation, lessons learned, and recommendations for future efforts to adapt behavioral therapies for resource-limited, conflict-affected areas are discussed.

  18. Interdisciplinarity in Adapted Physical Activity

    Science.gov (United States)

    Bouffard, Marcel; Spencer-Cavaliere, Nancy

    2016-01-01

    It is commonly accepted that inquiry in adapted physical activity involves the use of different disciplines to address questions. It is often advanced today that complex problems of the kind frequently encountered in adapted physical activity require a combination of disciplines for their solution. At the present time, individual research…

  19. Active materials for adaptive architectural envelopes based on plant adaptation principles

    Directory of Open Access Journals (Sweden)

    Marlen Lopez

    2015-06-01

    Full Text Available In this paper, the authors present research into adaptive architectural envelopes that adapt to environmental changes using active materials, as a result of application of biomimetic principles from plants to architecture. Buildings use large amounts of energy in order to maintain their internal comfort, because conventional buildings are designed to provide a static design solution. Most of the current solutions for facades are not designed for optimum adaptation to contextual issues and needs, while biological solutions to adaptation are often complex, multi-functional and highly responsive. We focus on plant adaptations to the environment, as, due to their immobility, they have developed special means of protection against weather changing conditions. Furthermore, recent developments in new technologies are allowing the possibility to transfer these plant adaptation strategies to technical implementation. These technologies include: multi-material 3D printing, advances in materials science and new capabilities in simulation software. Unlike traditional mechanical activation used for dynamic systems in kinetic facades, adaptive architectural envelopes require no complex electronics, sensors, or actuators. The paper proposes a research of the relationship that can be developed between active materials and environmental issues in order to propose innovative and low-tech design strategies to achieve living envelopes according to plant adaptation principles.  

  20. Adaptive trials for tuberculosis: early reflections on theory and practice.

    Science.gov (United States)

    Montgomery, C M

    2016-08-01

    Adaptive designs (ADs) have been proposed for anti-tuberculosis treatment trials. This call for innovation occurs against the backdrop of fundamental changes in the acceptable evidence base in anti-tuberculosis treatment. To contextualise ADs for tuberculosis (TB) and explore early responses from those working in the field. In this qualitative study investigating processes of theoretical and practical change in randomised controlled trials, 24 interviews were conducted with professionals involved in AD trials, half of whom worked in the TB field. Clinical trialists working on AD trials in TB are positive about the efficiency these designs offer, but remain cautious about their suitability. In addition to technical concerns, informants discussed the challenges of implementing AD in developing countries, including limited regulatory capacity to evaluate proposals, investments needed in infrastructure and site capacity, and challenges regarding informed consent. Respondents identified funding, interdisciplinary communication and regulatory and policy responses as additional concerns potentially affecting the success of AD for TB. Empirical research is needed into patient experiences of AD, including informed consent. Further consideration of the contexts of innovation in trial design is needed. These are fundamental to the successful translation of theory into practice.

  1. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    Science.gov (United States)

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

  2. Reducing Reforestation Costs in Lebanon: Adaptive Field Trials

    Directory of Open Access Journals (Sweden)

    Garabet (Garo Haroutunian

    2017-05-01

    Full Text Available Lebanon’s Ministry of Environment initiated a project in 2009 to determine low-cost reforestation techniques for stone pine (Pinus pinea and Lebanon cedar (Cedrus libani for large-scale land rehabilitation activities in the arid Middle East. Irrigation (several techniques vs. no water, planting (8- to 18-month-old seedlings, seeding, and soil preparation methods were evaluated in three sets of adaptive management field trials. The aim was to reduce reforestation costs while still achieving sufficient regeneration. A key result for management was that non-irrigated seed planting of stone pine and possibly of Lebanon cedar showed promise for cost-effective reforestation and could be competitive with seedlings, given correct seed source and planting conditions. Stone pine seeds collected from nearby mother trees and planted without irrigation on sandy soil showed 35% survival for <600 USD/ha; seedlings planted without irrigation cost about 2500 USD/ha and achieved 50–70% survival (costs based on 800 seedlings/ha. Water supplements increased establishment costs over 2 years without concomitant improvements to survival. Future studies should evaluate how soil texture and soil preparation interact with other factors to affect seed germination and survival for each species.

  3. Dynamic adjustments of cognitive control: oscillatory correlates of the conflict adaptation effect.

    Science.gov (United States)

    Pastötter, Bernhard; Dreisbach, Gesine; Bäuml, Karl-Heinz T

    2013-12-01

    It is a prominent idea that cognitive control mediates conflict adaptation, in that response conflict in a previous trial triggers control adjustments that reduce conflict in a current trial. In the present EEG study, we investigated the dynamics of cognitive control in a response-priming task by examining the effects of previous trial conflict on intertrial and current trial oscillatory brain activities, both on the electrode and the source level. Behavioral results showed conflict adaptation effects for RTs and response accuracy. Physiological results showed sustained intertrial effects in left parietal theta power, originating in the left inferior parietal cortex, and midcentral beta power, originating in the left and right (pre)motor cortex. Moreover, physiological analysis revealed a current trial conflict adaptation effect in midfrontal theta power, originating in the ACC. Correlational analyses showed that intertrial effects predicted conflict-induced midfrontal theta power in currently incongruent trials. In addition, conflict adaptation effects in midfrontal theta power and RTs were positively related. Together, these findings point to a dynamic cognitive control system that, as a function of previous trial type, up- and down-regulates attention and preparatory motor activities in anticipation of the next trial.

  4. Influence of Lumbar Muscle Fatigue on Trunk Adaptations during Sudden External Perturbations

    Science.gov (United States)

    Abboud, Jacques; Nougarou, François; Lardon, Arnaud; Dugas, Claude; Descarreaux, Martin

    2016-01-01

    Introduction: When the spine is subjected to perturbations, neuromuscular responses such as reflex muscle contractions contribute to the overall balance control and spinal stabilization mechanisms. These responses are influenced by muscle fatigue, which has been shown to trigger changes in muscle recruitment patterns. Neuromuscular adaptations, e.g., attenuation of reflex activation and/or postural oscillations following repeated unexpected external perturbations, have also been described. However, the characterization of these adaptations still remains unclear. Using high-density electromyography (EMG) may help understand how the nervous system chooses to deal with an unknown perturbation in different physiological and/or mechanical perturbation environments. Aim: To characterize trunk neuromuscular adaptations following repeated sudden external perturbations after a back muscle fatigue task using high-density EMG. Methods: Twenty-five healthy participants experienced a series of 15 sudden external perturbations before and after back muscle fatigue. Erector spinae muscle activity was recorded using high-density EMG. Trunk kinematics during perturbation trials were collected using a 3-D motion analysis system. A two-way repeated measure ANOVA was conducted to assess: (1) the adaptation effect across trials; (2) the fatigue effect; and (3) the interaction effect (fatigue × adaptation) for the baseline activity, the reflex latency, the reflex peak and trunk kinematic variables (flexion angle, velocity and time to peak velocity). Muscle activity spatial distribution before and following the fatigue task was also compared using t-tests for dependent samples. Results: An attenuation of muscle reflex peak was observed across perturbation trials before the fatigue task, but not after. The spatial distribution of muscle activity was significantly higher before the fatigue task compared to post-fatigue trials. Baseline activity showed a trend to higher values after muscle

  5. Influence of lumbar muscle fatigue on trunk adaptations during sudden external perturbations

    Directory of Open Access Journals (Sweden)

    Jacques Abboud

    2016-11-01

    Full Text Available IntroductionWhen the spine is subjected to perturbations, neuromuscular responses such as reflex muscle contractions contribute to the overall balance control and spinal stabilization mechanisms. These responses are influenced by muscle fatigue, which has been shown to trigger changes in muscle recruitment patterns. Neuromuscular adaptations, e.g. attenuation of reflex activation and/or postural oscillations following repeated unexpected external perturbations, have also been described. However, the characterization of these adaptations still remains unclear. Using high-density electromyography (EMG may help understand how the nervous system chooses to deal with an unknown perturbation in different physiological and/or mechanical perturbation environments. AimTo characterize trunk neuromuscular adaptations following repeated sudden external perturbations after a back muscle fatigue task using high-density EMG.MethodsTwenty-five healthy participants experienced a series of 15 sudden external perturbations before and after back muscle fatigue. Erector spinae muscle activity was recorded using high-density EMG. Trunk kinematics during perturbation trials were collected using a 3-D motion analysis system. A two-way repeated measure ANOVA was conducted to assess 1 the adaptation effect across trials, 2 the fatigue effect, and 3 the interaction effect (fatigue x adaptation for the baseline activity, the reflex latency, the reflex peak and trunk kinematic variables (flexion angle, velocity and time to peak velocity. Muscle activity spatial distribution before and following the fatigue task was also compared using t-tests for dependent samples. ResultsAn attenuation of muscle reflex peak was observed across perturbation trials before the fatigue task, but not after. The spatial distribution of muscle activity was significantly higher before the fatigue task compared to post-fatigue trials. Baseline activity showed a trend to higher values after muscle

  6. A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

    Science.gov (United States)

    Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

    2017-07-18

    The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

  7. The interference effects of non-rotated versus counter-rotated trials in visuomotor adaptation.

    Science.gov (United States)

    Hinder, Mark R; Walk, Laura; Woolley, Daniel G; Riek, Stephan; Carson, Richard G

    2007-07-01

    An isometric torque-production task was used to investigate interference and retention in adaptation to multiple visuomotor environments. Subjects produced isometric flexion-extension and pronation-supination elbow torques to move a cursor to acquire targets as quickly as possible. Adaptation to a 30 degrees counter-clockwise (CCW) rotation (task A), was followed by a period of rest (control), trials with no rotation (task B0), or trials with a 60 degrees clockwise (CW) rotation (task B60). For all groups, retention of task A was assessed 5 h later. With initial training, all groups reduced the angular deviation of cursor paths early in the movements, indicating feedforward adaptation. For the control group, performance at commencement of the retest was significantly better than that at the beginning of the initial learning. For the B0 group, performance in the retest of task A was not dissimilar to that at the start of the initial learning, while for the B60 group retest performance in task A was markedly worse than initially observed. Our results indicate that close juxtaposition of two visuomotor environments precludes improved retest performance in the initial environment. Data for the B60 group, specifically larger angular errors upon retest compared with initial exposures, are consistent with the presence of anterograde interference. Furthermore, full interference occurred even when the visuomotor environment encountered in the second task was not rotated (B0). This latter novel result differs from those obtained for force field learning, where interference does not occur when task B does not impose perturbing forces, i.e., when B consists of a null field (Brashers-Krug et al., Nature 382:252-255, 1996). The results are consistent with recent proposals suggesting different interference mechanisms for visuomotor (kinematic) compared to force field (dynamic) adaptations, and have implications for the use of washout trials when studying interference between

  8. Adaptive radiotherapy for head and neck cancer—Dosimetric results from a prospective clinical trial

    International Nuclear Information System (INIS)

    Schwartz, David L.; Garden, Adam S.; Shah, Shalin J.; Chronowski, Gregory; Sejpal, Samir; Rosenthal, David I.; Chen, Yipei; Zhang, Yongbin; Zhang, Lifei; Wong, Pei-Fong; Garcia, John A.; Kian Ang, K.; Dong, Lei

    2013-01-01

    Purpose: To conduct a clinical trial evaluating adaptive head and neck radiotherapy (ART). Methods: Patients with locally advanced oropharyngeal cancer were prospectively enrolled. Daily CT-guided setup and deformable image registration permitted mapping of dose to avoidance structures and CTVs. We compared four planning scenarios: (1) original IMRT plan aligned daily to marked isocenter (BB); (2) original plan aligned daily to bone (IGRT); (3) IGRT with one adaptive replan (ART1); and (4) actual treatment received by each study patient (IGRT with one or two adaptive replans, ART2). Results: All 22 study patients underwent one replan (ART1); eight patients had two replans (ART2). ART1 reduced mean dose to contralateral parotid by 0.6 Gy or 2.8% (paired t-test; p = 0.003) and ipsilateral parotid by 1.3 Gy (3.9%) (p = 0.002) over the IGRT alone. ART2 further reduced the mean contralateral parotid dose by 0.8 Gy or 3.8% (p = 0.026) and ipsilateral parotid by 4.1 Gy or 9% (p = 0.001). ART significantly reduced integral body dose. Conclusions: This pilot trial suggests that head and neck ART dosimetrically outperforms IMRT. IGRT that leverages conventional PTV margins does not improve dosimetry. One properly timed replan delivers the majority of achievable dosimetric improvement. The clinical impact of ART must be confirmed by future trials

  9. Feasibility of the adaptive and automatic presentation of tasks (ADAPT system for rehabilitation of upper extremity function post-stroke

    Directory of Open Access Journals (Sweden)

    Choi Younggeun

    2011-08-01

    Full Text Available Abstract Background Current guidelines for rehabilitation of arm and hand function after stroke recommend that motor training focus on realistic tasks that require reaching and manipulation and engage the patient intensively, actively, and adaptively. Here, we investigated the feasibility of a novel robotic task-practice system, ADAPT, designed in accordance with such guidelines. At each trial, ADAPT selects a functional task according to a training schedule and with difficulty based on previous performance. Once the task is selected, the robot picks up and presents the corresponding tool, simulates the dynamics of the tasks, and the patient interacts with the tool to perform the task. Methods Five participants with chronic stroke with mild to moderate impairments (> 9 months post-stroke; Fugl-Meyer arm score 49.2 ± 5.6 practiced four functional tasks (selected out of six in a pre-test with ADAPT for about one and half hour and 144 trials in a pseudo-random schedule of 3-trial blocks per task. Results No adverse events occurred and ADAPT successfully presented the six functional tasks without human intervention for a total of 900 trials. Qualitative analysis of trajectories showed that ADAPT simulated the desired task dynamics adequately, and participants reported good, although not excellent, task fidelity. During training, the adaptive difficulty algorithm progressively increased task difficulty leading towards an optimal challenge point based on performance; difficulty was then continuously adjusted to keep performance around the challenge point. Furthermore, the time to complete all trained tasks decreased significantly from pretest to one-hour post-test. Finally, post-training questionnaires demonstrated positive patient acceptance of ADAPT. Conclusions ADAPT successfully provided adaptive progressive training for multiple functional tasks based on participant's performance. Our encouraging results establish the feasibility of ADAPT; its

  10. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions.

    Science.gov (United States)

    Klasnja, Predrag; Hekler, Eric B; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A

    2015-12-01

    This article presents an experimental design, the microrandomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals' health behaviors. Microrandomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. The article describes the microrandomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions' effects, enabling creation of more effective JITAIs. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  11. Sensitivity of adaptive enrichment trial designs to accrual rates, time to outcome measurement, and prognostic variables

    Directory of Open Access Journals (Sweden)

    Tianchen Qian

    2017-12-01

    Full Text Available Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions. Through simulation studies, we evaluate the sensitivity of Type I error, power, expected sample size, and trial duration to different design characteristics. Our simulation distributions mimic features of data from the Alzheimer's Disease Neuroimaging Initiative cohort study, and involve two subpopulations based on a genetic marker. We investigate the impact of the following design characteristics: the accrual rate, the time from enrollment to measurement of a short-term outcome and the primary outcome, and the prognostic value of baseline variables and short-term outcomes. To leverage prognostic information in baseline variables and short-term outcomes, we use a semiparametric, locally efficient estimator, and investigate its strengths and limitations compared to standard estimators. We apply information-based monitoring, and evaluate how accurately information can be estimated in an ongoing trial.

  12. Interdisciplinary Best Practices for Adapted Physical Activity

    Science.gov (United States)

    Szostak, Rick

    2016-01-01

    This article provides an introduction to the literature on interdisciplinary research. It then draws lessons from that literature for the field of adapted physical activity. It is argued that adapted physical activity should be a self-consciously interdisciplinary field. It should insist that research be performed according to recognized…

  13. Credentialing of radiotherapy centres for a clinical trial of adaptive radiotherapy for bladder cancer (TROG 10.01)

    International Nuclear Information System (INIS)

    Kron, Tomas; Pham, Daniel; Roxby, Paul; Rolfo, Aldo; Foroudi, Farshad

    2012-01-01

    Background: Daily variations in bladder filling make conformal treatment of bladder cancer challenging. On-line adaptive radiotherapy with a choice of plans has been demonstrated to reduce small bowel irradiation in single institution trials. In order to support a multicentre feasibility clinical trial on adaptive radiotherapy for bladder cancer (TROG 10.01) a credentialing programme was developed for centres wishing to participate. Methods: The credentialing programme entails three components: a facility questionnaire; a planning exercise which tests the ability of centres to create three adaptive plans based on a planning and five cone beam CTs; and a site visit during which image quality, imaging dose and image guidance procedures are assessed. Image quality and decision making were tested using customised inserts for a Perspex phantom (Modus QUASAR) that mimic different bladder sizes. Dose was assessed in the same phantom using thermoluminescence dosimetry (TLD). Results: All 12 centres participating in the full credentialing programme were able to generate appropriate target volumes in the planning exercise and identify the correct target volume and position the bladder phantom in the phantom within 3 mm accuracy. None of the imaging doses exceeded the limit of 5 cGy with a CT on rails system having the lowest overall dose. Conclusion: A phantom mimicking the decision making process for adaptive radiotherapy was found to be well suited during site visits for credentialing of centres participating in a clinical trial of adaptive radiotherapy for bladder cancer. Combined with a planning exercise the site visit allowed testing the ability of centres to create adaptive treatment plans and make appropriate decisions based on the volumetric images acquired at treatment.

  14. The role of affective evaluation in conflict adaptation: An LRP study.

    Science.gov (United States)

    Fröber, Kerstin; Stürmer, Birgit; Frömer, Romy; Dreisbach, Gesine

    2017-08-01

    Conflict between incompatible response tendencies is typically followed by control adjustments aimed at diminishing subsequent conflicts, a phenomenon often called conflict adaptation. Dreisbach and Fischer (2015, 2016) recently proposed that it is not the conflict per se but the aversive quality of a conflict that originally motivates this kind of sequential control adjustment. With the present study we tested the causal role of aversive signals in conflict adaptation in a more direct way. To this end, after each trial of a vertical Simon task participants rated whether they experienced the last trial as rather pleasant or unpleasant. Conflict adaptation was measured via lateralized readiness potentials as a measure of early motor-related activation that were computed on the basis of event-related brain potentials. Results showed the typical suppression of automatic response activation following trials rated as unpleasant, whereas suppression was relaxed following trials rated as pleasant. That is, sequential control adaptation was not based on previous conflict but on the subjective affective experience. This is taken as evidence that negative affect even in the absence of actual conflict triggers subsequent control adjustments. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Cytopathology whole slide images and adaptive tutorials for postgraduate pathology trainees: a randomized crossover trial.

    Science.gov (United States)

    Van Es, Simone L; Kumar, Rakesh K; Pryor, Wendy M; Salisbury, Elizabeth L; Velan, Gary M

    2015-09-01

    To determine whether cytopathology whole slide images and virtual microscopy adaptive tutorials aid learning by postgraduate trainees, we designed a randomized crossover trial to evaluate the quantitative and qualitative impact of whole slide images and virtual microscopy adaptive tutorials compared with traditional glass slide and textbook methods of learning cytopathology. Forty-three anatomical pathology registrars were recruited from Australia, New Zealand, and Malaysia. Online assessments were used to determine efficacy, whereas user experience and perceptions of efficiency were evaluated using online Likert scales and open-ended questions. Outcomes of online assessments indicated that, with respect to performance, learning with whole slide images and virtual microscopy adaptive tutorials was equivalent to using traditional methods. High-impact learning, efficiency, and equity of learning from virtual microscopy adaptive tutorials were strong themes identified in open-ended responses. Participants raised concern about the lack of z-axis capability in the cytopathology whole slide images, suggesting that delivery of z-stacked whole slide images online may be important for future educational development. In this trial, learning cytopathology with whole slide images and virtual microscopy adaptive tutorials was found to be as effective as and perceived as more efficient than learning from glass slides and textbooks. The use of whole slide images and virtual microscopy adaptive tutorials has the potential to provide equitable access to effective learning from teaching material of consistently high quality. It also has broader implications for continuing professional development and maintenance of competence and quality assurance in specialist practice. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial

    Directory of Open Access Journals (Sweden)

    Alison Quinlan

    2017-11-01

    Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform

  17. Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

    Science.gov (United States)

    Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

    2015-01-01

    Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

  18. Disruption of locomotor adaptation with repetitive transcranial magnetic stimulation over the motor cortex

    DEFF Research Database (Denmark)

    Choi, Julia Tsok Lam; Bouyer, Laurent J; Nielsen, Jens Bo

    2015-01-01

    Locomotor patterns are adapted on a trial-and-error basis to account for predictable dynamics. Once a walking pattern is adapted, the new calibration is stored and must be actively de-adapted. Here, we tested the hypothesis that storage of newly acquired ankle adaptation in walking is dependent...

  19. Adaptive Piezoelectric Absorber for Active Vibration Control

    Directory of Open Access Journals (Sweden)

    Sven Herold

    2016-02-01

    Full Text Available Passive vibration control solutions are often limited to working reliably at one design point. Especially applied to lightweight structures, which tend to have unwanted vibration, active vibration control approaches can outperform passive solutions. To generate dynamic forces in a narrow frequency band, passive single-degree-of-freedom oscillators are frequently used as vibration absorbers and neutralizers. In order to respond to changes in system properties and/or the frequency of excitation forces, in this work, adaptive vibration compensation by a tunable piezoelectric vibration absorber is investigated. A special design containing piezoelectric stack actuators is used to cover a large tuning range for the natural frequency of the adaptive vibration absorber, while also the utilization as an active dynamic inertial mass actuator for active control concepts is possible, which can help to implement a broadband vibration control system. An analytical model is set up to derive general design rules for the system. An absorber prototype is set up and validated experimentally for both use cases of an adaptive vibration absorber and inertial mass actuator. Finally, the adaptive vibration control system is installed and tested with a basic truss structure in the laboratory, using both the possibility to adjust the properties of the absorber and active control.

  20. Design of a Bayesian adaptive phase 2 proof-of-concept trial for BAN2401, a putative disease-modifying monoclonal antibody for the treatment of Alzheimer's disease.

    Science.gov (United States)

    Satlin, Andrew; Wang, Jinping; Logovinsky, Veronika; Berry, Scott; Swanson, Chad; Dhadda, Shobha; Berry, Donald A

    2016-01-01

    Recent failures in phase 3 clinical trials in Alzheimer's disease (AD) suggest that novel approaches to drug development are urgently needed. Phase 3 risk can be mitigated by ensuring that clinical efficacy is established before initiating confirmatory trials, but traditional phase 2 trials in AD can be lengthy and costly. We designed a Bayesian adaptive phase 2, proof-of-concept trial with a clinical endpoint to evaluate BAN2401, a monoclonal antibody targeting amyloid protofibrils. The study design used dose response and longitudinal modeling. Simulations were used to refine study design features to achieve optimal operating characteristics. The study design includes five active treatment arms plus placebo, a clinical outcome, 12-month primary endpoint, and a maximum sample size of 800. The average overall probability of success is ≥80% when at least one dose shows a treatment effect that would be considered clinically meaningful. Using frequent interim analyses, the randomization ratios are adapted based on the clinical endpoint, and the trial can be stopped for success or futility before full enrollment. Bayesian statistics can enhance the efficiency of analyzing the study data. The adaptive randomization generates more data on doses that appear to be more efficacious, which can improve dose selection for phase 3. The interim analyses permit stopping as soon as a predefined signal is detected, which can accelerate decision making. Both features can reduce the size and duration of the trial. This study design can mitigate some of the risks associated with advancing to phase 3 in the absence of data demonstrating clinical efficacy. Limitations to the approach are discussed.

  1. Effectiveness of cultural adaptations of interventions aimed at smoking cessation, diet, and/or physical activity in ethnic minorities. a systematic review.

    Directory of Open Access Journals (Sweden)

    Vera Nierkens

    Full Text Available BACKGROUND: The importance of cultural adaptations in behavioral interventions targeting ethnic minorities in high-income societies is widely recognized. Little is known, however, about the effectiveness of specific cultural adaptations in such interventions. AIM: To systematically review the effectiveness of specific cultural adaptations in interventions that target smoking cessation, diet, and/or physical activity and to explore features of such adaptations that may account for their effectiveness. METHODS: Systematic review using MEDLINE, PsycINFO, Embase, and the Cochrane Central Register of Controlled Trials registers (1997-2009. INCLUSION CRITERIA: a effectiveness study of a lifestyle intervention targeted to ethnic minority populations living in a high income society; b interventions included cultural adaptations and a control group that was exposed to the intervention without the cultural adaptation under study; c primary outcome measures included smoking cessation, diet, or physical activity. RESULTS: Out of 44904 hits, we identified 17 studies, all conducted in the United States. In five studies, specific cultural adaptations had a statistically significant effect on primary outcomes. The remaining studies showed no significant effects on primary outcomes, but some presented trends favorable for cultural adaptations. We observed that interventions incorporating a package of cultural adaptations, cultural adaptations that implied higher intensity and those incorporating family values were more likely to report statistically significant effects. Adaptations in smoking cessation interventions seem to be more effective than adaptations in interventions aimed at diet and physical activity. CONCLUSION: This review indicates that culturally targeted behavioral interventions may be more effective if cultural adaptations are implemented as a package of adaptations, the adaptation includes family level, and where the adaptation results in a

  2. Effectiveness of cultural adaptations of interventions aimed at smoking cessation, diet, and/or physical activity in ethnic minorities. a systematic review.

    Science.gov (United States)

    Nierkens, Vera; Hartman, Marieke A; Nicolaou, Mary; Vissenberg, Charlotte; Beune, Erik J A J; Hosper, Karen; van Valkengoed, Irene G; Stronks, Karien

    2013-01-01

    The importance of cultural adaptations in behavioral interventions targeting ethnic minorities in high-income societies is widely recognized. Little is known, however, about the effectiveness of specific cultural adaptations in such interventions. To systematically review the effectiveness of specific cultural adaptations in interventions that target smoking cessation, diet, and/or physical activity and to explore features of such adaptations that may account for their effectiveness. Systematic review using MEDLINE, PsycINFO, Embase, and the Cochrane Central Register of Controlled Trials registers (1997-2009). a) effectiveness study of a lifestyle intervention targeted to ethnic minority populations living in a high income society; b) interventions included cultural adaptations and a control group that was exposed to the intervention without the cultural adaptation under study; c) primary outcome measures included smoking cessation, diet, or physical activity. Out of 44904 hits, we identified 17 studies, all conducted in the United States. In five studies, specific cultural adaptations had a statistically significant effect on primary outcomes. The remaining studies showed no significant effects on primary outcomes, but some presented trends favorable for cultural adaptations. We observed that interventions incorporating a package of cultural adaptations, cultural adaptations that implied higher intensity and those incorporating family values were more likely to report statistically significant effects. Adaptations in smoking cessation interventions seem to be more effective than adaptations in interventions aimed at diet and physical activity. This review indicates that culturally targeted behavioral interventions may be more effective if cultural adaptations are implemented as a package of adaptations, the adaptation includes family level, and where the adaptation results in a higher intensity of the intervention. More systematic experiments are needed in which

  3. Applications of adaptive filters in active noise control

    Science.gov (United States)

    Darlington, Paul

    The active reduction of acoustic noise is achieved by the addition of a cancelling acoustic signal to the unwanted sound. Successful definition of the cancelling signal amounts to a system identification problem. Recent advances in adaptive signal processing have allowed this problem to be tackled using adaptive filters, which offer significant advantages over conventional solutions. The extension of adaptive noise cancelling techniques, which were developed in the electrical signal conditioning context, to the control of acoustic systems is studied. An analysis is presented of the behavior of the Widrow-Hoff LMS adaptive noise canceller with a linear filter in its control loop. The active control of plane waves propagating axially in a hardwalled duct is used as a motivating model problem. The model problem also motivates the study of the effects of feedback around an LMS adaptive filter. An alternative stochastic gradient algorithm for controlling adaptive filters in the presence of feedback is presented.

  4. HMM Adaptation for Improving a Human Activity Recognition System

    Directory of Open Access Journals (Sweden)

    Rubén San-Segundo

    2016-09-01

    Full Text Available When developing a fully automatic system for evaluating motor activities performed by a person, it is necessary to segment and recognize the different activities in order to focus the analysis. This process must be carried out by a Human Activity Recognition (HAR system. This paper proposes a user adaptation technique for improving a HAR system based on Hidden Markov Models (HMMs. This system segments and recognizes six different physical activities (walking, walking upstairs, walking downstairs, sitting, standing and lying down using inertial signals from a smartphone. The system is composed of a feature extractor for obtaining the most relevant characteristics from the inertial signals, a module for training the six HMMs (one per activity, and the last module for segmenting new activity sequences using these models. The user adaptation technique consists of a Maximum A Posteriori (MAP approach that adapts the activity HMMs to the user, using some activity examples from this specific user. The main results on a public dataset have reported a significant relative error rate reduction of more than 30%. In conclusion, adapting a HAR system to the user who is performing the physical activities provides significant improvement in the system’s performance.

  5. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

    2017-11-09

    Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

  6. Adaptation and psychometric properties of the ISPCAN Child Abuse Screening Tool for use in trials (ICAST-Trial) among South African adolescents and their primary caregivers.

    Science.gov (United States)

    Meinck, Franziska; Boyes, Mark E; Cluver, Lucie; Ward, Catherine L; Schmidt, Peter; DeStone, Sachin; Dunne, Michael P

    2018-05-31

    Child abuse prevention research has been hampered by a lack of validated multi-dimensional non-proprietary instruments, sensitive enough to measure change in abuse victimization or behavior. This study aimed to adapt the ICAST child abuse self-report measure (parent and child) for use in intervention studies and to investigate the psychometric properties of this substantially modified tool in a South African sample. First, cross-cultural and sensitivity adaptation of the original ICAST tools resulted in two preliminary measures (ICAST-Trial adolescents: 27 items, ICAST-Trial caregivers: 19 items). Second, ICAST-Trial data from a cluster randomized trial of a parenting intervention for families with adolescents (N = 1104, 552 caregiver-adolescent dyads) was analyzed. Confirmatory factor analysis established the hypothesized 6-factor (adolescents) and 4-factor (caregivers) structure. Removal of two items for adolescents and five for caregivers resulted in adequate model fit. Concurrent criterion validity analysis confirmed hypothesized relationships between child abuse and adolescent and caregiver mental health, adolescent behavior, discipline techniques and caregiver childhood abuse history. The resulting ICAST-Trial measures have 25 (adolescent) and 14 (caregiver) items respectively and measure physical, emotional and contact sexual abuse, neglect (both versions), and witnessing intimate partner violence and sexual harassment (adolescent version). The study established that both tools are sensitive to measuring change over time in response to a parenting intervention. The ICAST-Trial should have utility for evaluating the effectiveness of child abuse prevention efforts in similar socioeconomic contexts. Further research is needed to replicate these findings and examine cultural appropriateness, barriers for disclosure, and willingness to engage in child abuse research. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Impact of adaptation algorithm, timing, and stopping boundaries on the performance of Bayesian response adaptive randomization in confirmative trials with a binary endpoint.

    Science.gov (United States)

    Jiang, Yunyun; Zhao, Wenle; Durkalski-Mauldin, Valerie

    2017-11-01

    Despite the concerns of time trend in subject profiles, the use of Bayesian response adaptive randomization (BRAR) in large multicenter phase 3 confirmative trials has been reported in recent years, motivated by the potential benefits in subject ethics and/or trial efficiency. However three issues remain unclear to investigators: 1) among several BRAR algorithms, how to choose one for the specific trial setting; 2) when to start and how frequently to update the allocation ratio; and 3) how to choose the interim analyses stopping boundaries to preserve the type 1 error. In this paper, three commonly used BRAR algorithms are evaluated based on type 1 error, power, sample size, the proportion of subjects assigned to the better performing arm, and the total number of failures, under two specific trial settings and different allocation ratio update timing and frequencies. Simulation studies show that for two-arm superiority trials, none of the three BRAR algorithms has predominant benefits in both patient ethics and trial efficiency when compared to fixed equal allocation design. For a specific trial aiming to identify the best or the worst among three treatments, a properly selected BRAR algorithm and its implementation parameters are able to gain ethical and efficiency benefits simultaneously. Although the simulation results come from a specific trial setting, the methods described in this paper are generally applicable to other trials. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Activating clinical trials: a process improvement approach.

    Science.gov (United States)

    Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

    2016-02-24

    The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

  9. Defining Adapted Physical Activity: International Perspectives

    Science.gov (United States)

    Hutzler, Yeshayahu; Sherrill, Claudine

    2007-01-01

    The purpose of this study was to describe international perspectives concerning terms, definitions, and meanings of adapted physical activity (APA) as (a) activities or service delivery, (b) a profession, and (c) an academic field of study. Gergen's social constructionism, our theory, guided analysis of multiple sources of data via qualitative…

  10. Detection of User Independent Single Trial ERPs in Brain Computer Interfaces: An Adaptive Spatial Filtering Approach

    DEFF Research Database (Denmark)

    Leza, Cristina; Puthusserypady, Sadasivan

    2017-01-01

    Brain Computer Interfaces (BCIs) use brain signals to communicate with the external world. The main challenges to address are speed, accuracy and adaptability. Here, a novel algorithm for P300 based BCI spelling system is presented, specifically suited for single-trial detection of Event...

  11. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    Science.gov (United States)

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmö): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saha, Sanjib; Leijon, Matti; Gerdtham, Ulf; Sundquist, Kristina; Sundquist, Jan; Arvidsson, Daniel; Bennet, Louise

    2013-09-03

    Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. However, research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. The aim was to design a culturally adapted lifestyle intervention for an immigrant population and to evaluate its effectiveness and cost-effectiveness. In this randomized controlled trial, 308 participants (born in Iraq, living in Malmö, Sweden and at high risk of type 2 diabetes) will be allocated to either a culturally adapted intervention or a control group. The intervention will consist of 10 group counseling sessions focusing on diet, physical activity and behavioral change over 6 months, and the offer of exercise sessions. Cultural adaptation includes gender-specific exercise sessions, and counseling by a health coach community member. The control group will receive the information about healthy lifestyle habits provided by the primary health care center. The primary outcome is change in fasting glucose level. Secondary outcomes are changes in body mass index, insulin sensitivity, physical activity, food habits and health-related quality of life. Measurements will be taken at baseline, after 3 and 6 months. Data will be analyzed by the intention-to-treat approach. The cost-effectiveness during the trial period and over the longer term will be assessed by simulation modeling from patient, health care and societal perspectives. This study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will also assess its cost-effectiveness. Results from this trial may help health care providers and policy makers to adapt and implement lifestyle interventions suitable for this population group that can be conducted in the community. ClinicalTrials

  13. Effects of Yoga on Stress, Stress Adaption, and Heart Rate Variability Among Mental Health Professionals--A Randomized Controlled Trial.

    Science.gov (United States)

    Lin, Shu-Ling; Huang, Ching-Ya; Shiu, Shau-Ping; Yeh, Shu-Hui

    2015-08-01

    Mental health professionals experiencing work-related stress may experience burn out, leading to a negative impact on their organization and patients. The aim of this study was to examine the effects of yoga classes on work-related stress, stress adaptation, and autonomic nerve activity among mental health professionals. A randomized controlled trial was used, which compared the outcomes between the experimental (e.g., yoga program) and the control groups (e.g., no yoga exercise) for 12 weeks. Work-related stress and stress adaptation were assessed before and after the program. Heart rate variability (HRV) was measured at baseline, midpoint through the weekly yoga classes (6 weeks), and postintervention (after 12 weeks of yoga classes). The results showed that the mental health professionals in the yoga group experienced a significant reduction in work-related stress (t = -6.225, p control group revealed no significant changes. Comparing the mean differences in pre- and posttest scores between yoga and control groups, we found the yoga group significantly decreased work-related stress (t = -3.216, p = .002), but there was no significant change in stress adaptation (p = .084). While controlling for the pretest scores of work-related stress, participants in yoga, but not the control group, revealed a significant increase in autonomic nerve activity at midpoint (6 weeks) test (t = -2.799, p = .007), and at posttest (12 weeks; t = -2.099, p = .040). Because mental health professionals experienced a reduction in work-related stress and an increase in autonomic nerve activity in a weekly yoga program for 12 weeks, clinicians, administrators, and educators should offer yoga classes as a strategy to help health professionals reduce their work-related stress and balance autonomic nerve activities. © 2015 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Society for Worldviews on Evidence-Based Nursing.

  14. SOCIO-PSYCHOLOGICAL ADAPTATION TO PROFESSIONAL ACTIVITY

    Directory of Open Access Journals (Sweden)

    V. Ivanov

    2016-01-01

    Full Text Available The article analyzes the factors of successful adaptation of employees to professional work in the new environment. Under the new conditions of professional development and employee having professional experience and young professional may encounter, with the presentation not only new professional requirements and tasks, but also new working conditions, the system of building relationships in the team, discovering with some discrepancies between obtained them in the learning process theoretical knowledge and skills available to the real practice of professional activities. At the level of interpersonal relations of the process of social cognition, is account of the special knowledge of the process of social facilities and construction of social reality, such an important parameter defi nes as "emotional intelligence" – construct is proposed for study in 1990 by American psychologists Peter Salovey and John Mayer. Initially, the concept of "emotional intelligence" was linked to the notion of social intelligence. The effectiveness of social and psychological adaptation to the professional activity can be enhanced through the development of emotional intelligence. Implementation of the basic functions of emotional intelligence improves communication efficiency, optimization of interpersonal relationships, social and psychological adaptation of personality.

  15. Adaptive ILC with an adaptive iterative learnign gain

    International Nuclear Information System (INIS)

    Ashraf, S.; Muhammad, E.

    2008-01-01

    This paper describes the design of an adaptive ILC (Iterative Learning Controller) with an iterative learning gain. The basic idea behind ILC is that the information obtained from one trial can be used to improve the control input for the next trial. This proposed scheme extends the idea further and suggests that the information obtained from one trial could also be used to improve control algorithm parameters (gain matrices). The scheme converges faster than the conventional ILC. This convergence and hence number of iterations has always been an issue with ILC. This scheme because of its simple mathematical structure can easily be implemented with lower memory and simpler hardware as opposed to other such adaptive schemes which are computationally expensive. (author)

  16. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...

  17. Middle-Range Theory: Coping and Adaptation with Active Aging.

    Science.gov (United States)

    Salazar-Barajas, Martha Elba; Salazar-González, Bertha Cecilia; Gallegos-Cabriales, Esther Carlota

    2017-10-01

    Various disciplines focus on a multiplicity of aspects of aging: lifestyles, personal biological factors, psychological conditions, health conditions, physical environment, and social and economic factors. The aforementioned are all related to the determinants of active aging. The aim is to describe the development of a middle-range theory based on coping and adaptation with active aging. Concepts and relationships derived from Roy's model of adaptation are included. The proposed concepts are hope, health habits, coping with aging, social relations, and active aging.

  18. Inferior parietal and right frontal contributions to trial-by-trial adaptations of attention to memory.

    Science.gov (United States)

    Kizilirmak, Jasmin M; Rösler, Frank; Bien, Siegfried; Khader, Patrick H

    2015-07-21

    The attention to memory theory (AtoM) proposes that the same brain regions might be involved in selective processing of perceived stimuli (selective attention) and memory representations (selective retrieval). Although this idea is compelling, given consistently found neural overlap between perceiving and remembering stimuli, recent comparisons brought evidence for overlap as well as considerable differences. Here, we present a paradigm that enables the investigation of the AtoM hypothesis from a novel perspective to gain further insight into the neural resources involved in AtoM. Selective attention in perception is often investigated as a control process that shows lingering effects on immediately following trials. Here, we employed a paradigm capable of modulating selective retrieval in a similarly dynamic manner as in such selective-attention paradigms by inducing trial-to-trial shifts between relevant and irrelevant memory representations as well as changes of the width of the internal focus on memory. We found evidence for an involvement of bilateral inferior parietal lobe and right inferior frontal gyrus in reorienting the attentional focus on previously accessed memory representations. Moreover, we could dissociate the right inferior from the parietal activation in separate contrasts, suggesting that the right inferior frontal gyrus plays a role in facilitating attentional reorienting to memory representations when competing representations have been activated in the preceding trial, potentially by resolving this competition. Our results support the AtoM theory, i.e. that ventral frontal and parietal regions are involved in automatic attentional reorienting in memory, and highlight the importance of further investigations of the overlap and differences between regions involved in internal (memory) and external (perceptual) attentional selection. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Meditation-induced cognitive-control states regulate response-conflict adaptation: Evidence from trial-to-trial adjustments in the Simon task.

    Science.gov (United States)

    Colzato, Lorenza S; Sellaro, Roberta; Samara, Iliana; Hommel, Bernhard

    2015-09-01

    Here we consider the possibility that meditation has an immediate impact on information processing. Moreover, we were interested to see whether this impact affects attentional input control, as previous observations suggest, or the handling of response conflict. Healthy adults underwent a brief single session of either focused attention meditation (FAM), which is assumed to increase top-down control, or open monitoring meditation (OMM), which is assumed to weaken top-down control, before performing a Simon task-which assesses conflict-resolution efficiency. While the size of the Simon effect (reflecting the efficiency of handling response conflict) was unaffected by type of meditation, the amount of dynamic behavioral adjustments (i.e., trial-to-trial variability of the Simon effect: the Gratton effect) was considerably smaller after OMM than after FAM. Our findings suggest that engaging in meditation instantly creates a cognitive-control state that has a specific impact on conflict-driven control adaptations. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Adaptation to conflict via context-driven anticipatory signals in the dorsomedial prefrontal cortex.

    Science.gov (United States)

    Horga, Guillermo; Maia, Tiago V; Wang, Pengwei; Wang, Zhishun; Marsh, Rachel; Peterson, Bradley S

    2011-11-09

    Behavioral interference elicited by competing response tendencies adapts to contextual changes. Recent nonhuman primate research suggests a key mnemonic role of distinct prefrontal cells in supporting such context-driven behavioral adjustments by maintaining conflict information across trials, but corresponding prefrontal functions have yet to be probed in humans. Using event-related functional magnetic resonance imaging, we investigated the human neural substrates of contextual adaptations to conflict. We found that a neural system comprising the rostral dorsomedial prefrontal cortex and portions of the dorsolateral prefrontal cortex specifically encodes the history of previously experienced conflict and influences subsequent adaptation to conflict on a trial-by-trial basis. This neural system became active in anticipation of stimulus onsets during preparatory periods and interacted with a second neural system engaged during the processing of conflict. Our findings suggest that a dynamic interaction between a system that represents conflict history and a system that resolves conflict underlies the contextual adaptation to conflict.

  1. Preventing academic difficulties in preterm children: a randomised controlled trial of an adaptive working memory training intervention - IMPRINT study.

    Science.gov (United States)

    Pascoe, Leona; Roberts, Gehan; Doyle, Lex W; Lee, Katherine J; Thompson, Deanne K; Seal, Marc L; Josev, Elisha K; Nosarti, Chiara; Gathercole, Susan; Anderson, Peter J

    2013-09-16

    Very preterm children exhibit difficulties in working memory, a key cognitive ability vital to learning information and the development of academic skills. Previous research suggests that an adaptive working memory training intervention (Cogmed) may improve working memory and other cognitive and behavioural domains, although further randomised controlled trials employing long-term outcomes are needed, and with populations at risk for working memory deficits, such as children born preterm.In a cohort of extremely preterm (memory and attention 2 weeks', 12 months' and 24 months' post-intervention, and to investigate training related neuroplasticity in working memory neural networks 2 weeks' post-intervention. This double-blind, placebo-controlled, randomised controlled trial aims to recruit 126 extremely preterm/extremely low birthweight 7-year-old children. Children attending mainstream school without major intellectual, sensory or physical impairments will be eligible. Participating children will undergo an extensive baseline cognitive assessment before being randomised to either an adaptive or placebo (non-adaptive) version of Cogmed. Cogmed is a computerised working memory training program consisting of 25 sessions completed over a 5 to 7 week period. Each training session takes approximately 35 minutes and will be completed in the child's home. Structural, diffusion and functional Magnetic Resonance Imaging, which is optional for participants, will be completed prior to and 2 weeks following the training period. Follow-up assessments focusing on academic skills (primary outcome), working memory and attention (secondary outcomes) will be conducted at 2 weeks', 12 months' and 24 months' post-intervention. To our knowledge, this study will be the first randomised controlled trial to (a) assess the effectiveness of Cogmed in school-aged extremely preterm/extremely low birthweight children, while incorporating advanced imaging techniques to investigate neural changes

  2. Framing Cross-Cultural Ethical Practice in Adapt[ive] Physical Activity

    Science.gov (United States)

    Goodwin, Donna; Howe, P. David

    2016-01-01

    Academics and practitioners are often at a loss when it comes to understanding the ethical socio-political and cultural contexts that invade the world of adapted physical activity. Ethical practice is situated in the local and the specific. In this article we highlight the reality that both academics and practitioners need to be ever mindful that…

  3. Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

    Science.gov (United States)

    Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

    2017-03-15

    Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

  4. Wearable activity monitors in oncology trials: Current use of an emerging technology.

    Science.gov (United States)

    Gresham, Gillian; Schrack, Jennifer; Gresham, Louise M; Shinde, Arvind M; Hendifar, Andrew E; Tuli, Richard; Rimel, B J; Figlin, Robert; Meinert, Curtis L; Piantadosi, Steven

    2018-01-01

    Physical activity is an important outcome in oncology trials. Physical activity is commonly assessed using self-reported questionnaires, which are limited by recall and response biases. Recent advancements in wearable technology have provided oncologists with new opportunities to obtain real-time, objective physical activity data. The purpose of this review was to describe current uses of wearable activity monitors in oncology trials. We searched Pubmed, Embase, and the Cochrane Central Register of Controlled Trials for oncology trials involving wearable activity monitors published between 2005 and 2016. We extracted details on study design, types of activity monitors used, and purpose for their use. We summarized activity monitor metrics including step counts, sleep and sedentary time, and time spent in moderate-to-vigorous activity. We identified 41 trials of which 26 (63%) involved cancer survivors (post-treatment) and 15 trials (37%) involved patients with active cancer. Most trials (65%) involved breast cancer patients. Wearable activity monitors were commonly used in exercise (54%) or behavioral (29%) trials. Cancer survivors take between 4660 and 11,000 steps/day and those undergoing treatment take 2885 to 8300steps/day. Wearable activity monitors are increasingly being used to obtain objective measures of physical activity in oncology trials. There is potential for their use to expand to evaluate and predict clinical outcomes such as survival, quality of life, and treatment tolerance in future studies. Currently, there remains a lack of standardization in the types of monitors being used and how their data are being collected, analyzed, and interpreted. Recent advancements in wearable activity monitor technology have provided oncologists with new opportunities to monitor their patients' daily activity in real-world settings. The integration of wearable activity monitors into cancer care will help increase our understanding of the associations between

  5. Adaptation to Recent Conflict in the Classical Color-Word Stroop-Task Mainly Involves Facilitation of Processing of Task-Relevant Information

    Directory of Open Access Journals (Sweden)

    Sascha ePurmann

    2015-03-01

    Full Text Available To process information selectively and to continuously fine-tune selectivity of information processing are important abilities for successful goal-directed behavior. One phenomenon thought to represent this fine-tuning are conflict adaptation effects in interference tasks, i.e. reduction of interference after an incompatible trial and when incompatible trials are frequent. The neurocognitive mechanisms of these effects are currently only partly understood and results from brainimaging studies so far are mixed. In our study we validate and extend recent findings by examining adaption to recent conflict in the classical Stroop task using functional magnetic resonance imaging. Consistent with previous research we found increased activity in a fronto-parietal network comprising the medial prefrontal cortex, ventro-lateral prefrontal cortex, and posterior parietal cortex when contrasting incompatible with compatible trials. These areas have been associated with attentional processes and might reflect increased cognitive conflict and resolution thereof during incompatible trials. While carefully controlling for non-attentional sequential effects we found smaller Stroop interference after an incompatible trial (conflict adaptation effect. These behavioral conflict adaptation effects were accompanied by changes in activity in visual color-selective areas (V4, V4α, while there was no modulation by previous trial compatibility in a visual word-selective area (VWFA. Our results provide further evidence for the notion, that adaptation to recent conflict seems to be based mainly on enhancement of processing of the task-relevant information.

  6. Adaptation to recent conflict in the classical color-word Stroop-task mainly involves facilitation of processing of task-relevant information.

    Science.gov (United States)

    Purmann, Sascha; Pollmann, Stefan

    2015-01-01

    To process information selectively and to continuously fine-tune selectivity of information processing are important abilities for successful goal-directed behavior. One phenomenon thought to represent this fine-tuning are conflict adaptation effects in interference tasks, i.e., reduction of interference after an incompatible trial and when incompatible trials are frequent. The neurocognitive mechanisms of these effects are currently only partly understood and results from brainimaging studies so far are mixed. In our study we validate and extend recent findings by examining adaption to recent conflict in the classical Stroop task using functional magnetic resonance imaging. Consistent with previous research we found increased activity in a fronto-parietal network comprising the medial prefrontal cortex, ventro-lateral prefrontal cortex, and posterior parietal cortex when contrasting incompatible with compatible trials. These areas have been associated with attentional processes and might reflect increased cognitive conflict and resolution thereof during incompatible trials. While carefully controlling for non-attentional sequential effects we found smaller Stroop interference after an incompatible trial (conflict adaptation effect). These behavioral conflict adaptation effects were accompanied by changes in activity in visual color-selective areas (V4, V4α), while there was no modulation by previous trial compatibility in a visual word-selective area (VWFA). Our results provide further evidence for the notion, that adaptation to recent conflict seems to be based mainly on enhancement of processing of the task-relevant information.

  7. Adenylate cyclase activity in fish gills in relation to salt adaptation

    International Nuclear Information System (INIS)

    Guibbolini, M.E.; Lahlou, B.

    1987-01-01

    The influence of salt adaptation on specific adenylate cyclase activity (measured by conversion of [α- 32 P] - ATP into [α- 32 P] - cAMP) was investigated in gill plasma membranes of rainbow trout (Salmo gairdneri) adapted to various salinities (deionized water, DW; fresh water, FW; 3/4 sea water, 3/4 SW; sea water, SW) and in sea water adapted- mullet (Mugil sp.). Basal activity declined by a factor of 2 in trout with increasing external salinity (pmoles cAMP/mg protein/10 min: 530 in DW, 440 in FW, 340 in 3/4 SW; 250 in SW) and was very low in SW adapted-mullet: 35. The Km for ATP was similar (0.5 mM) in both FW adapted- and SW adapted- trout in either the absence (basal activity) or in the presence of stimulating agents (isoproterenol; NaF) while the Vm varied. Analysis of stimulation ratios with respect to basal levels of the enzyme showed that hormones and pharmacological substances (isoproterenol, NaF) display a greater potency in high salt than in low salt adapted- fish gills. In contrast, salt adaptation did not have any effect on the regulation of adenylate cyclase by PGE 1 . These results are interpreted in relation to the general process of osmoregulation. 27 references, 6 figures

  8. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

    Science.gov (United States)

    Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

    2014-09-30

    Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

  9. Adapting Activity and Participation (The ADAPT intervention program)

    DEFF Research Database (Denmark)

    von Bülow, Cecilie

    Præsentation af et ergoterapeutisk gruppebaseret program, ADAPT programmet. ADAPT programmet er designet på baggrund af evidens samt understøttet af ergoterapeutiske teorier og modeller......Præsentation af et ergoterapeutisk gruppebaseret program, ADAPT programmet. ADAPT programmet er designet på baggrund af evidens samt understøttet af ergoterapeutiske teorier og modeller...

  10. Active Recovery After High-Intensity Interval-Training Does Not Attenuate Training Adaptation

    Directory of Open Access Journals (Sweden)

    Thimo Wiewelhove

    2018-04-01

    Full Text Available Objective: High-intensity interval training (HIIT can be extremely demanding and can consequently produce high blood lactate levels. Previous studies have shown that lactate is a potent metabolic stimulus, which is important for adaptation. Active recovery (ACT after intensive exercise, however, enhances blood lactate removal in comparison with passive recovery (PAS and, consequently, may attenuate endurance performance improvements. Therefore, the aim of this study was to examine the influence of regular ACT on training adaptations during a HIIT mesocycle.Methods: Twenty-six well-trained male intermittent sport athletes (age: 23.5 ± 2.5 years; O2max: 55.36 ± 3.69 ml min kg-1 participated in a randomized controlled trial consisting of 4 weeks of a running-based HIIT mesocycle with a total of 12 HIIT sessions. After each training session, participants completed 15 min of either moderate jogging (ACT or PAS. Subjects were matched to the ACT or PAS groups according to age and performance. Before the HIIT program and 1 week after the last training session, the athletes performed a progressive incremental exercise test on a motor-driven treadmill to determine O2max, maximum running velocity (vmax, the running velocity at which O2max occurs (vO2max, and anaerobic lactate threshold (AT. Furthermore, repeated sprint ability (RSA were determined.Results: In the whole group the HIIT mesocycle induced significant or small to moderate changes in vmax (p < 0.001, effect size [ES] = 0.65,, vO2max (p < 0.001, ES = 0.62, and AT (p < 0.001, ES = 0.56 compared with the values before the intervention. O2max and RSA remained unchanged throughout the study. In addition, no significant differences in the changes were noted in any of the parameters between ACT and PAS except for AT (p < 0.05, ES = 0.57.Conclusion: Regular use of individualized ACT did not attenuate training adaptations during a HIIT mesocycle compared to PAS. Interestingly, we found that the ACT

  11. Paradigms for adaptive statistical information designs: practical experiences and strategies.

    Science.gov (United States)

    Wang, Sue-Jane; Hung, H M James; O'Neill, Robert

    2012-11-10

    In the last decade or so, interest in adaptive design clinical trials has gradually been directed towards their use in regulatory submissions by pharmaceutical drug sponsors to evaluate investigational new drugs. Methodological advances of adaptive designs are abundant in the statistical literature since the 1970s. The adaptive design paradigm has been enthusiastically perceived to increase the efficiency and to be more cost-effective than the fixed design paradigm for drug development. Much interest in adaptive designs is in those studies with two-stages, where stage 1 is exploratory and stage 2 depends upon stage 1 results, but where the data of both stages will be combined to yield statistical evidence for use as that of a pivotal registration trial. It was not until the recent release of the US Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics (2010) that the boundaries of flexibility for adaptive designs were specifically considered for regulatory purposes, including what are exploratory goals, and what are the goals of adequate and well-controlled (A&WC) trials (2002). The guidance carefully described these distinctions in an attempt to minimize the confusion between the goals of preliminary learning phases of drug development, which are inherently substantially uncertain, and the definitive inference-based phases of drug development. In this paper, in addition to discussing some aspects of adaptive designs in a confirmatory study setting, we underscore the value of adaptive designs when used in exploratory trials to improve planning of subsequent A&WC trials. One type of adaptation that is receiving attention is the re-estimation of the sample size during the course of the trial. We refer to this type of adaptation as an adaptive statistical information design. Specifically, a case example is used to illustrate how challenging it is to plan a confirmatory adaptive statistical information

  12. Adapting the Wii Fit Balance Board to Enable Active Video Game Play by Wheelchair Users: User-Centered Design and Usability Evaluation.

    Science.gov (United States)

    Thirumalai, Mohanraj; Kirkland, William B; Misko, Samuel R; Padalabalanarayanan, Sangeetha; Malone, Laurie A

    2018-03-06

    of the controller, enabling stable and safe game play; and (3) included a sensitivity control feature, allowing users to fine-tune the controller to match the users' range of COB motion. More than half the sample could not use the OTS version of the Wii Fit Balance Board, while all participants were able to use the adapted version. All participants rated the adapted Wii Fit Balance Board at a minimum as "good," while those who could not use the OTS Wii Fit Balance Board rated the adapted Wii Fit Balance Board as "excellent." We found a significant negative correlation between lower-extremity function and differences between OTS and adapted SUS scores, indicating that as lower-extremity function decreased, participants perceived the adapted Wii Fit Balance Board as more usable. This study demonstrated a successful adaptation of a widely used AVG controller. The adapted controller's potential to increase physical activity levels among people with mobility impairments will be evaluated in a subsequent trial. ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6xWTyiJWf). ©Mohanraj Thirumalai, William B Kirkland, Samuel R Misko, Sangeetha Padalabalanarayanan, Laurie A Malone. Originally published in JMIR Rehabilitation and Assistive Technology (http://rehab.jmir.org), 06.03.2018.

  13. Engaging Axiology: Enabling MeaningfulTransdisciplinary Collaboration in Adapted Physical Activity.

    Science.gov (United States)

    Peers, Danielle

    2018-07-01

    In this article, I explore the concept of axiology in the context of adapted physical activity research and analyze its connection to the more commonly discussed paradigmatic assumptions of epistemology and ontology. Following methodological scholars, I argue for an acknowledgment of the pivotal role that axiology already plays in adapted physical activity research and for the potential interdisciplinary and transdisciplinary opportunities that could be enabled by engaging with axiology in more explicit ways. I discuss a number of potential axiological gaps between the field of adapted physical activity and disability communities, arguing that such differences may undermine attempts at doing meaningful transdisciplinary research with such communities. I offer strategies for bridging these axiological gaps, encouraging us to work together in axiologically reflexive ways in order to increase meaningful opportunities for more people with disabilities to be engaged in the movement-based activities and communities of their choice.

  14. Adapted physical activity is beneficial on balance, functional mobility, quality of life and fall risk in community-dwelling older women: a randomized single-blinded controlled trial.

    Science.gov (United States)

    Kovács, E; Prókai, L; Mészáros, L; Gondos, T

    2013-06-01

    Exercise programmes have important role in prevention of falls, but to date, we have little knowledge about the effects of Adapted Physical Activity programme on balance of older women. The aim of this study was to investigate the effects of an Adapted Physical Activity programme on balance, risk of falls and quality of life in community-dwelling older women. This was a randomized controlled study. Community, in a local sport centre. Older women aged over 60 years. Seventy-six women were randomised to an exercise group providing Adapted Physical Activity programme for 25 weeks or a control group (in which they did not participate in any exercise programme). The one-leg stance test, Timed Up and Go test, incidence of fall and the quality of life (SF-36V2) were measured at baseline and after 25 weeks. The one-leg stance test and the Timed Up and Go test in the exercise group was significantly better than in the control group after the intervention period (P=0.005; P=0.001, respectively). The Physical Functioning, Vitality and General Health subdomains of quality of life were also significantly better in the exercise group compared to the control group (P=0.004; P=0.005; P=0.038, respectively). Relative risk was 0.40 (90% CI 0.174 to 0.920) and the number needed to treat was 5 (95% CI 2.3 to 23.3). This 25-week Adapted Physical Activity programme improves static balance, functional mobility, as well as Physical Functioning, Vitality and General Health subdomains of quality of life. Based on our results, the Adapted Physical Activity programme may be a promising fall prevention exercise programme improving static balance and functional mobility for community-dwelling older women.

  15. Adaptation of the international physical activity questionnarie for the elderly

    Directory of Open Access Journals (Sweden)

    Tânia R. Bertoldo Benedetti

    2010-09-01

    Full Text Available The International Physical Activity Questionnaire (IPAQ estimates the weekly energy expenditure for physical activities (PA. This instrument was validated for use with Brazilian older adults. The need to adapt the structure and application of the IPAQ arose from the difficulties of older adults to correctly measure the number of days, time and intensity of PA (domains during a normal week and the difficulties encountered by the interviewers in field research. The adapted IPAQ consists of five domains and 15 questions and is applied by interview because of the low educational level of Brazilian older adults. The instrument is applied in its long form to permit better discrimination of PA in each domain and refers to a normal week to help recall morning, afternoon and evening activities. In addition, it includes details about mild, moderate and vigorous intensity. The training of the interviewers is fundamental. The report of the IPAQ adapted for older adults should be delivered in minutes per week and should use the classification active (≤ 150 min/week. The IPAQ adapted for older adults is an international instrument that is valid for the Brazilian elderly population. The instrument is a noninvasive easily applied method of low cost that reaches large population groups, among other advantages.

  16. Adaptive Value Normalization in the Prefrontal Cortex Is Reduced by Memory Load

    Science.gov (United States)

    Burke, C. J.; Seifritz, E.; Tobler, P. N.

    2017-01-01

    Abstract Adaptation facilitates neural representation of a wide range of diverse inputs, including reward values. Adaptive value coding typically relies on contextual information either obtained from the environment or retrieved from and maintained in memory. However, it is unknown whether having to retrieve and maintain context information modulates the brain’s capacity for value adaptation. To address this issue, we measured hemodynamic responses of the prefrontal cortex (PFC) in two studies on risky decision-making. In each trial, healthy human subjects chose between a risky and a safe alternative; half of the participants had to remember the risky alternatives, whereas for the other half they were presented visually. The value of safe alternatives varied across trials. PFC responses adapted to contextual risk information, with steeper coding of safe alternative value in lower-risk contexts. Importantly, this adaptation depended on working memory load, such that response functions relating PFC activity to safe values were steeper with presented versus remembered risk. An independent second study replicated the findings of the first study and showed that similar slope reductions also arose when memory maintenance demands were increased with a secondary working memory task. Formal model comparison showed that a divisive normalization model fitted effects of both risk context and working memory demands on PFC activity better than alternative models of value adaptation, and revealed that reduced suppression of background activity was the critical parameter impairing normalization with increased memory maintenance demand. Our findings suggest that mnemonic processes can constrain normalization of neural value representations. PMID:28462394

  17. Dynamics of adaptive and innate immunity in patients treated during primary human immunodeficiency virus infection: results from Maraviroc in HIV Acute Infection (MAIN) randomized clinical trial.

    Science.gov (United States)

    Ripa, M; Pogliaghi, M; Chiappetta, S; Galli, L; Pensieroso, S; Cavarelli, M; Scarlatti, G; De Biasi, S; Cossarizza, A; De Battista, D; Malnati, M; Lazzarin, A; Nozza, S; Tambussi, G

    2015-09-01

    We evaluated the dynamics of innate and adaptive immunity in patients treated with combined antiretroviral therapy (cART) during primary human immunodeficiency virus infection (PHI), enrolled in a prospective randomized trial (MAIN, EUDRACT 2008-007004-29). After 48 weeks of cART, we documented a reduction in activated B cells and CD8(+) T cells. Natural killer cell and dendritic cell frequencies were measured and a decrease in CD16(+) CD56(dim) with a reciprocal rise in CD56(high) natural killer cells and an increase in myeloid and plasmacytoid dendritic cells were recorded. In conclusion, 48 weeks of cART during PHI showed significant benefits for both innate and adaptive immunity. Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  18. Adaptive active vibration isolation – A control perspective

    Directory of Open Access Journals (Sweden)

    Landau Ioan Doré

    2015-01-01

    The paper will review a number of recent developments for adaptive feedback compensation of multiple unknown and time-varying narrow band disturbances and for adaptive feedforward compensation of broad band disturbances in the presence of the inherent internal positive feedback caused by the coupling between the compensator system and the measurement of the image of the disturbance. Some experimental results obtained on a relevant active vibration control system will illustrate the performance of the various algorithms presented.

  19. Health Activities Project (HAP), Trial Edition III.

    Science.gov (United States)

    Buller, Dave; And Others

    Contained within this Health Activities Project (HAP) trial edition (set III) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into an Overview, Health Background, Materials, Setting Up, and…

  20. Health Activities Project (HAP), Trial Edition II.

    Science.gov (United States)

    Buller, Dave; And Others

    Contained within this Health Activities Project (HAP) trial edition (set II) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into a Synopsis, Health Background, Materials, Setting Up, and Activities…

  1. Adaptive Behaviour Assessment System: Indigenous Australian Adaptation Model (ABAS: IAAM)

    Science.gov (United States)

    du Plessis, Santie

    2015-01-01

    The study objectives were to develop, trial and evaluate a cross-cultural adaptation of the Adaptive Behavior Assessment System-Second Edition Teacher Form (ABAS-II TF) ages 5-21 for use with Indigenous Australian students ages 5-14. This study introduced a multiphase mixed-method design with semi-structured and informal interviews, school…

  2. Adaptive piezoelectric sensoriactuators for active structural acoustic control

    Science.gov (United States)

    Vipperman, Jeffrey Stuart

    1997-09-01

    A new transducer technology with application to active control systems, modal analysis, and autonomous system health monitoring, is brought to fruition in this work. It has the advantages of being lightweight, potentially cost-effective, self-tuning, has negligible dynamics, and most importantly (from a robustness perspective), it provides a colocated sensor/actuator pair. The transducer consists of a piezoceramic element which serves as both an actuator and a sensor and will be referred to in this work as a sensoriactuator. Simple, adaptive signal processing in conjunction with a voltage controlled amplifier, reference capacitor, and a common-mode rejection circuit extract the mechanical response from the total response of the piezoelectric sensoriactuator for sensing. The digital portion of the adaptive piezoelectric sensoriactuator merely serves to tune the circuit, avoiding the potentially destabilizing effects of introducing a digital delay in the signal path, when used for feedback control applications. Adaptive compensation of the sensoriactuator is necessary since the signal to noise ratio is typically greater than 40 dB, making it prohibitive to tune the circuit manually. In addition, the constitutive properties of piezoceramics vary with time and environment, necessitating that the circuit be periodically re-tuned. The analog portion of the hardware is based upon op-amp circuits and an AD632 analog multiplier chip, which serves as both a voltage controlled amplifier (VCA) and a common mode rejection (CMR) circuit. A single coefficient least-mean square (LMS) adaptive filter continuously adjusts the gain of the VCA circuit as necessary. Nonideal behavior of piezoceramics is discussed along with methods to counter the consequential deterioration in circuit performance. A multiple input multiple output (MIMO) implementation of the adaptive piezoelectric sensoriactuator is developed using orthogonal white noise training signals for each sensoriactuator. Two

  3. The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

    Science.gov (United States)

    Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

    2014-07-01

    The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design

  4. Novel strategies in feedforward adaptation to a position-dependent perturbation.

    Science.gov (United States)

    Hinder, Mark R; Milner, Theodore E

    2005-08-01

    To investigate the control mechanisms used in adapting to position-dependent forces, subjects performed 150 horizontal reaching movements over 25 cm in the presence of a position-dependent parabolic force field (PF). The PF acted only over the first 10 cm of the movement. On every fifth trial, a virtual mechanical guide (double wall) constrained subjects to move along a straight-line path between the start and target positions. Its purpose was to register lateral force to track formation of an internal model of the force field, and to look for evidence of possible alternative adaptive strategies. The force field produced a force to the right, which initially caused subjects to deviate in that direction. They reacted by producing deviations to the left, "into" the force field, as early as the second trial. Further adaptation resulted in rapid exponential reduction of kinematic error in the latter portion of the movement, where the greatest perturbation to the handpath was initially observed, whereas there was little modification of the handpath in the region where the PF was active. Significant force directed to counteract the PF was measured on the first guided trial, and was modified during the first half of the learning set. The total force impulse in the region of the PF increased throughout the learning trials, but it always remained less than that produced by the PF. The force profile did not resemble a mirror image of the PF in that it tended to be more trapezoidal than parabolic in shape. As in previous studies of force-field adaptation, we found that changes in muscle activation involved a general increase in the activity of all muscles, which increased arm stiffness, and selectively-greater increases in the activation of muscles which counteracted the PF. With training, activation was exponentially reduced, albeit more slowly than kinematic error. Progressive changes in kinematics and EMG occurred predominantly in the region of the workspace beyond the

  5. Using assistive technology adaptations to include students with learning disabilities in cooperative learning activities.

    Science.gov (United States)

    Bryant, D P; Bryant, B R

    1998-01-01

    Cooperative learning (CL) is a common instructional arrangement that is used by classroom teachers to foster academic achievement and social acceptance of students with and without learning disabilities. Cooperative learning is appealing to classroom teachers because it can provide an opportunity for more instruction and feedback by peers than can be provided by teachers to individual students who require extra assistance. Recent studies suggest that students with LD may need adaptations during cooperative learning activities. The use of assistive technology adaptations may be necessary to help some students with LD compensate for their specific learning difficulties so that they can engage more readily in cooperative learning activities. A process for integrating technology adaptations into cooperative learning activities is discussed in terms of three components: selecting adaptations, monitoring the use of the adaptations during cooperative learning activities, and evaluating the adaptations' effectiveness. The article concludes with comments regarding barriers to and support systems for technology integration, technology and effective instructional practices, and the need to consider technology adaptations for students who have learning disabilities.

  6. Normal tissue sparing in a phase II trial on daily adaptive plan selection in radiotherapy for urinary bladder cancer.

    Science.gov (United States)

    Vestergaard, Anne; Muren, Ludvig P; Lindberg, Henriette; Jakobsen, Kirsten L; Petersen, Jørgen B B; Elstrøm, Ulrik V; Agerbæk, Mads; Høyer, Morten

    2014-08-01

    Background: Patients with urinary bladder cancer often display large changes in the shape and size of their bladder target during a course of radiotherapy (RT), making adaptive RT (ART) appealing for this tumour site. We are conducting a clinical phase II trial of daily plan selection-based ART for bladder cancer and here report dose-volume data from the first 20 patients treated in the trial. All patients received 60 Gy in 30 fractions to the bladder; in 13 of the patients the pelvic lymph nodes were simultaneously treated to 48 Gy. Daily patient set-up was by use of cone beam computed tomography (CBCT) guidance. The first 5 fractions were delivered with large, population-based (non-adaptive) margins. The bladder contours from the CBCTs acquired in the first 4 fractions were used to create a patient-specific library of three plans, corresponding to a small, medium and large size bladder. From fraction 6, daily online plan selection was performed, where the smallest plan covering the bladder was selected prior to each treatment delivery. A total of 600 treatment fractions in the 20 patients were evaluated. Small, medium and large size plans were used almost equally often, with an average of 10, 9 and 11 fractions, respectively. The median volume ratio of the course-averaged PTV (PTV-ART) relative to the non-adaptive PTV was 0.70 (range: 0.46-0.89). A linear regression analysis showed a 183 cm(3) (CI 143-223 cm(3)) reduction in PTV-ART compared to the non-adaptive PTV (R(2) = 0.94). Daily adaptive plan selection in RT of bladder cancer results in a considerable normal tissue sparing, of a magnitude that we expect will translate into a clinically significant reduction of the treatment-related morbidity.

  7. Effect of visuomotor-map uncertainty on visuomotor adaptation.

    Science.gov (United States)

    Saijo, Naoki; Gomi, Hiroaki

    2012-03-01

    Vision and proprioception contribute to generating hand movement. If a conflict between the visual and proprioceptive feedback of hand position is given, reaching movement is disturbed initially but recovers after training. Although previous studies have predominantly investigated the adaptive change in the motor output, it is unclear whether the contributions of visual and proprioceptive feedback controls to the reaching movement are modified by visuomotor adaptation. To investigate this, we focused on the change in proprioceptive feedback control associated with visuomotor adaptation. After the adaptation to gradually introduce visuomotor rotation, the hand reached the shifted position of the visual target to move the cursor to the visual target correctly. When the cursor feedback was occasionally eliminated (probe trial), the end point of the hand movement was biased in the visual-target direction, while the movement was initiated in the adapted direction, suggesting the incomplete adaptation of proprioceptive feedback control. Moreover, after the learning of uncertain visuomotor rotation, in which the rotation angle was randomly fluctuated on a trial-by-trial basis, the end-point bias in the probe trial increased, but the initial movement direction was not affected, suggesting a reduction in the adaptation level of proprioceptive feedback control. These results suggest that the change in the relative contribution of visual and proprioceptive feedback controls to the reaching movement in response to the visuomotor-map uncertainty is involved in visuomotor adaptation, whereas feedforward control might adapt in a manner different from that of the feedback control.

  8. Invasion of the Zebra Mussels: A Mock Trial Activity

    Science.gov (United States)

    Beck, Judy A.; Czerniak, Charlene M.

    2005-01-01

    In this activity, students learn about the important topic of invasive species, specifically Zebra Mussels. Students role-play different characters in a real-life situation: the trial of the Zebra Mussel for unlawful disruption of the Great Lakes ecosystem. Students will also learn about jurisprudential inquiry by examining the trial process. This…

  9. The brain dynamics of rapid perceptual adaptation to adverse listening conditions.

    Science.gov (United States)

    Erb, Julia; Henry, Molly J; Eisner, Frank; Obleser, Jonas

    2013-06-26

    Listeners show a remarkable ability to quickly adjust to degraded speech input. Here, we aimed to identify the neural mechanisms of such short-term perceptual adaptation. In a sparse-sampling, cardiac-gated functional magnetic resonance imaging (fMRI) acquisition, human listeners heard and repeated back 4-band-vocoded sentences (in which the temporal envelope of the acoustic signal is preserved, while spectral information is highly degraded). Clear-speech trials were included as baseline. An additional fMRI experiment on amplitude modulation rate discrimination quantified the convergence of neural mechanisms that subserve coping with challenging listening conditions for speech and non-speech. First, the degraded speech task revealed an "executive" network (comprising the anterior insula and anterior cingulate cortex), parts of which were also activated in the non-speech discrimination task. Second, trial-by-trial fluctuations in successful comprehension of degraded speech drove hemodynamic signal change in classic "language" areas (bilateral temporal cortices). Third, as listeners perceptually adapted to degraded speech, downregulation in a cortico-striato-thalamo-cortical circuit was observable. The present data highlight differential upregulation and downregulation in auditory-language and executive networks, respectively, with important subcortical contributions when successfully adapting to a challenging listening situation.

  10. [Exercise-referral to a specialist in adapted physical activity (APA) : a pilot project].

    Science.gov (United States)

    Brugnerotto, Adeline; Cardinaux, Regula; Ueltschi, Yan; Bauwens, Marine; Nanchen, David; Cornuz, Jacques; Bize, Raphaël; Auer, Reto

    2016-11-02

    Family physicians have a key role in the promotion of physical activity, in particular in identifying and counseling persons who have a sedentary lifestyle. Some patients could benefit from intensive individual counseling. Physicians are often not aware of all physical activity promotion activities in the community that they could recommend their patients. In a pilot study, we have tested and adapted the referral of patients from family physicians to specialists in adapted physical activity (APAs). APAs are trained to assess and guide persons towards physical activities adapted to their needs and pathologies and thus towards an increase in physical activity. Pilot data suggest that, while few patients were oriented to the APAs in the pilot project, family physicians appreciate the possibility of collaborating with the APAs.

  11. Adaptive Intervention Design in Mobile Health: Intervention Design and Development in the Cell Phone Intervention for You (CITY) Trial

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-01-01

    Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to

  12. Unconsciously triggered conflict adaptation.

    Science.gov (United States)

    van Gaal, Simon; Lamme, Victor A F; Ridderinkhof, K Richard

    2010-07-09

    In conflict tasks such as the Stroop, the Eriksen flanker or the Simon task, it is generally observed that the detection of conflict in the current trial reduces the impact of conflicting information in the subsequent trial; a phenomenon termed conflict adaptation. This higher-order cognitive control function has been assumed to be restricted to cases where conflict is experienced consciously. In the present experiment we manipulated the awareness of conflict-inducing stimuli in a metacontrast masking paradigm to directly test this assumption. Conflicting response tendencies were elicited either consciously (through primes that were weakly masked) or unconsciously (strongly masked primes). We demonstrate trial-by-trial conflict adaptation effects after conscious as well as unconscious conflict, which could not be explained by direct stimulus/response repetitions. These findings show that unconscious information can have a longer-lasting influence on our behavior than previously thought and further stretch the functional boundaries of unconscious cognition.

  13. Unconsciously triggered conflict adaptation.

    Directory of Open Access Journals (Sweden)

    Simon van Gaal

    Full Text Available In conflict tasks such as the Stroop, the Eriksen flanker or the Simon task, it is generally observed that the detection of conflict in the current trial reduces the impact of conflicting information in the subsequent trial; a phenomenon termed conflict adaptation. This higher-order cognitive control function has been assumed to be restricted to cases where conflict is experienced consciously. In the present experiment we manipulated the awareness of conflict-inducing stimuli in a metacontrast masking paradigm to directly test this assumption. Conflicting response tendencies were elicited either consciously (through primes that were weakly masked or unconsciously (strongly masked primes. We demonstrate trial-by-trial conflict adaptation effects after conscious as well as unconscious conflict, which could not be explained by direct stimulus/response repetitions. These findings show that unconscious information can have a longer-lasting influence on our behavior than previously thought and further stretch the functional boundaries of unconscious cognition.

  14. Adaptive Rationality, Adaptive Behavior and Institutions

    Directory of Open Access Journals (Sweden)

    Volchik Vyacheslav, V.

    2015-12-01

    Full Text Available The economic literature focused on understanding decision-making and choice processes reveals a vast collection of approaches to human rationality. Theorists’ attention has moved from absolutely rational, utility-maximizing individuals to boundedly rational and adaptive ones. A number of economists have criticized the concepts of adaptive rationality and adaptive behavior. One of the recent trends in the economic literature is to consider humans irrational. This paper offers an approach which examines adaptive behavior in the context of existing institutions and constantly changing institutional environment. It is assumed that adaptive behavior is a process of evolutionary adjustment to fundamental uncertainty. We emphasize the importance of actors’ engagement in trial and error learning, since if they are involved in this process, they obtain experience and are able to adapt to existing and new institutions. The paper aims at identifying relevant institutions, adaptive mechanisms, informal working rules and practices that influence actors’ behavior in the field of Higher Education in Russia (Rostov Region education services market has been taken as an example. The paper emphasizes the application of qualitative interpretative methods (interviews and discourse analysis in examining actors’ behavior.

  15. Adaptive genetic variability and differentiation of Croatian and Austrian Quercus robur L. populations at a drought prone field trial

    Directory of Open Access Journals (Sweden)

    Saša Bogdan

    2017-07-01

    Full Text Available Provenance trials, where populations of different geographical origin are tested in a common environment (common garden test, are a tool suited to allow the study of intraspecific adaptive genetic variation. Research of pedunculate oak (Quercus robur L. adaptive genetic variability through analyses of populations in common garden tests has a long tradition. However, pedunculated oak populations originating south-eastern from the Alps have been scarcely studied in this way. This study addresses the adaptive genetic variability and differentiation of pedunculate oak populations originating from Austria and Croatia in a provenance/progeny field trial. Studied plants were six years old and were growing at the trial for three years. After two years of unusually low precipitations height and survival were analysed. The total mean height of all plants in the trial was 137.8 cm and ranged from 123.0 cm to 151.8 cm. The overall mean survival rate was rather high (0.85. Mean population survival ranged from 0.64 to 0.94. Individual narrow-sense heritabilities (hi2, family mean heritabilities (hf2, the coefficients of additive genetic variation (CVA and quantitative genetic differentiation coefficients (QST were calculated. A multivariate regression tree (MRT analysis was used to determine the pattern of genetic differentiation of the populations. Individual heritabilities for height ranged between 0.00 and 0.39. Family mean heritabilities for height were rather low in most populations as well (<0.5. Family mean heritabilities for survival were higher than for height (ranging between 0.00 and 0.77. Calculated QST coefficients (0.25 for height and 0.14 for survival indicated between-population genetic differentiation. The populations were separated into two clusters by MRT analysis regarding a climatic variable, namely Hargreaves’ reference evapotranspiration. Populations originating from comparatively more humid habitats were grouped in the first

  16. Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials.

    Science.gov (United States)

    Koopmeiners, Joseph S; Hobbs, Brian P

    2018-05-01

    Randomized, placebo-controlled clinical trials are the gold standard for evaluating a novel therapeutic agent. In some instances, it may not be considered ethical or desirable to complete a placebo-controlled clinical trial and, instead, the placebo is replaced by an active comparator with the objective of showing either superiority or non-inferiority to the active comparator. In a non-inferiority trial, the experimental treatment is considered non-inferior if it retains a pre-specified proportion of the effect of the active comparator as represented by the non-inferiority margin. A key assumption required for valid inference in the non-inferiority setting is the constancy assumption, which requires that the effect of the active comparator in the non-inferiority trial is consistent with the effect that was observed in previous trials. It has been shown that violations of the constancy assumption can result in a dramatic increase in the rate of incorrectly concluding non-inferiority in the presence of ineffective or even harmful treatment. In this paper, we illustrate how Bayesian hierarchical modeling can be used to facilitate multi-source smoothing of the data from the current trial with the data from historical studies, enabling direct probabilistic evaluation of the constancy assumption. We then show how this result can be used to adapt the non-inferiority margin when the constancy assumption is violated and present simulation results illustrating that our method controls the type-I error rate when the constancy assumption is violated, while retaining the power of the standard approach when the constancy assumption holds. We illustrate our adaptive procedure using a non-inferiority trial of raltegravir, an antiretroviral drug for the treatment of HIV.

  17. Methodological issues for designing and conducting a multicenter, international clinical trial in Acute Stroke: Experience from ARTSS-2 trial.

    Science.gov (United States)

    Rahbar, Mohammad H; Dickerson, Aisha S; Cai, Chunyan; Pedroza, Claudia; Hessabi, Manouchehr; Shen, Loren; Pandurengan, Renganayaki; Jacobs, Amber Nicole M; Indupuru, Hari; Sline, Melvin R; Delgado, Rigoberto I; Macdonald, Claire; Ford, Gary A; Grotta, James C; Barreto, Andrew D

    2015-09-01

    We describe innovations in the study design and the efficient data coordination of a randomized multicenter trial of Argatroban in Combination with Recombinant Tissue Plasminogen Activator for Acute Stroke (ARTSS-2). ARTSS-2 is a 3-arm, multisite/multiregional randomized controlled trials (RCTs) of two doses of Argatroban injection (low, high) in combination with recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients and rt-PA alone. We developed a covariate adaptive randomization program that balanced the study arms with respect to study site as well as hemorrhage after thrombolysis (HAT) score and presence of distal internal carotid artery occlusion (DICAO). We used simulation studies to validate performance of the randomization program before making any adaptations during the trial. For the first 90 patients enrolled in ARTSS-2, we evaluated performance of our randomization program using chi-square tests of homogeneity or extended Fisher's exact test. We also designed a four-step partly Bayesian safety stopping rule for low and high dose Argatroban arms. Homogeneity of the study arms was confirmed with respect to distribution of study site (UK sites vs. US sites, P=0.98), HAT score (0-2 vs. 3-5, P=1.0), and DICAO (N/A vs. No vs. Yes, P=0.97). Our stopping thresholds for safety of low and high dose Argatroban were not crossed. Despite challenges, data quality was assured. We recommend adaptive designs for randomization and Bayesian safety stopping rules for multisite Phase I/II RCTs for maintaining additional flexibility. Efficient data coordination could lead to improved data quality. Copyright © 2015. Published by Elsevier Inc.

  18. A new approach to physical activity maintenance: Rationale, design, and baseline data from the Keep Active Minnesota trial

    Directory of Open Access Journals (Sweden)

    Crain A Lauren

    2008-07-01

    Full Text Available Abstract Background Since many individuals who initiate physical activity programs are highly likely to return to a sedentary lifestyle, innovative strategies to efforts to increase the number of physically active older adults who successfully maintain beneficial levels of PA for a substantial length of time are needed. Methods/Design The Keep Active Minnesota Trial is a randomized controlled trial of an interactive phone- and mail-based intervention to help 50–70 year old adults who have recently increased their physical activity level, maintain that activity level over a 24-month period in comparison to usual care. Baseline, 6, 12, and 24 month measurement occurred via phone surveys with kilocalories expended per week in total and moderate-to-vigorous physical activity (CHAMPS Questionnaire as the primary outcome measures. Secondary outcomes include hypothesized mediators of physical activity change (e.g., physical activity enjoyment, self-efficacy, physical activity self-concept, body mass index, and depression. Seven day accelerometry data were collected on a sub-sample of participants at baseline and 24-month follow-up. Discussion The Keep Active Minnesota study offers an innovative approach to the perennial problem of physical activity relapse; by focusing explicitly on physical activity maintenance, the intervention holds considerable promise for modifying the typical relapse curve. Moreover, if shown to be efficacious, the use of phone- and mail-based intervention delivery offers potential for widespread dissemination. Trial registration ClinicalTrials.gov Identifier: NCT00283452.

  19. Transcultural adaptation and psychometric properties of Spanish version of Pregnancy Physical Activity Questionnaire: the PregnActive project.

    Science.gov (United States)

    Oviedo-Caro, Miguel Ángel; Bueno-Antequera, Javier; Munguía-Izquierdo, Diego

    2018-03-19

    To transculturally adapt the Spanish version of Pregnancy Physical Activity Questionnaire (PPAQ) analyzing its psychometric properties. The PPAQ was transculturally adapted into Spanish. Test-retest reliability was evaluated in a subsample of 109 pregnant women. The validity was evaluated in a sample of 208 pregnant women who answered the questionnaire and wore the multi-sensor monitor for 7 valid days. The reliability (intraclass correlation coefficient), concordance (concordance correlation coefficient), correlation (Pearson correlation coefficient), agreement (Bland-Altman plots) and relative activity levels (Jonckheere-Terpstra test) between both administrations and methods were examined. Intraclass correlation coefficients between both administrations were good for all categories except transportation. A low but significant correlation was found for total activity (light and above) whereas no correlation was found for other intensities between both methods. Relative activity levels analysis showed a significant linear trend for increased total activity between both methods. Spanish version of PPAQ is a brief and easily interpretable questionnaire with good reliability and ability to rank individuals, and poor validity compared with multi-sensor monitor. The use of PPAQ provides information of pregnancy-specific activities in order to establish physical activity levels of pregnant women and adapt health promotion interventions. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Incoherent feedforward control governs adaptation of activated ras in a eukaryotic chemotaxis pathway.

    Science.gov (United States)

    Takeda, Kosuke; Shao, Danying; Adler, Micha; Charest, Pascale G; Loomis, William F; Levine, Herbert; Groisman, Alex; Rappel, Wouter-Jan; Firtel, Richard A

    2012-01-03

    Adaptation in signaling systems, during which the output returns to a fixed baseline after a change in the input, often involves negative feedback loops and plays a crucial role in eukaryotic chemotaxis. We determined the dynamical response to a uniform change in chemoattractant concentration of a eukaryotic chemotaxis pathway immediately downstream from G protein-coupled receptors. The response of an activated Ras showed near-perfect adaptation, leading us to attempt to fit the results using mathematical models for the two possible simple network topologies that can provide perfect adaptation. Only the incoherent feedforward network accurately described the experimental results. This analysis revealed that adaptation in this Ras pathway is achieved through the proportional activation of upstream components and not through negative feedback loops. Furthermore, these results are consistent with a local excitation, global inhibition mechanism for gradient sensing, possibly with a Ras guanosine triphosphatase-activating protein acting as a global inhibitor.

  1. Adaptation to walking with an exoskeleton that assists ankle extension.

    Science.gov (United States)

    Galle, S; Malcolm, P; Derave, W; De Clercq, D

    2013-07-01

    The goal of this study was to investigate adaptation to walking with bilateral ankle-foot exoskeletons with kinematic control that assisted ankle extension during push-off. We hypothesized that subjects would show a neuromotor and metabolic adaptation during a 24min walking trial with a powered exoskeleton. Nine female subjects walked on a treadmill at 1.36±0.04ms(-1) during 24min with a powered exoskeleton and 4min with an unpowered exoskeleton. Subjects showed a metabolic adaptation after 18.5±5.0min, followed by an adapted period. Metabolic cost, electromyography and kinematics were compared between the unpowered condition, the beginning of the adaptation and the adapted period. In the beginning of the adaptation (4min), a reduction in metabolic cost of 9% was found compared to the unpowered condition. This reduction was accompanied by reduced muscular activity in the plantarflexor muscles, as the powered exoskeleton delivered part of the necessary ankle extension moment. During the adaptation this metabolic reduction further increased to 16%, notwithstanding a constant exoskeleton assistance. This increased reduction is the result of a neuromotor adaptation in which subjects adapt to walking with the exoskeleton, thereby reducing muscular activity in all leg muscles. Because of the fast adaptation and the significant reductions in metabolic cost we want to highlight the potential of an ankle-foot exoskeleton with kinematic control that assists ankle extension during push-off. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. [Adapted physical activity in the prevention and therapy of osteoporosis].

    Science.gov (United States)

    Bosković, Ksenija; Gava, Branka Protić; Grajić, Mirko; Madić, Dejan; Obradović, Borislav; Todorović, Snezana Tomasević

    2013-01-01

    Osteoporosis, a disease characterized by the progressive loss of bone tissue, is one of the most common complications of aging. According to some calculations, there were 25% of women and 4% of men older than 50 years with osteoporosis in the world in 2010. It is assumed that the number of patients with osteoporosis will increase by 30% in every 10 years in the 21st century. There are many reasons for that: the world's population is growing older, diet is getting poorer in vitamins and minerals and physical activity is decreasing. THE QUALITY AND QUANTITY OF BONE TISSUE: Developing bones are much more responsive to mechanical loading and physical activity than mature bones. This suggests that training in early childhood may be an important factor in the prevention of osteoporosis in later life. It is important to note that the quality of bone achieved by training at younger age cannot be maintained permanently if it is not supported by physical activity later in life. Adapted physical activity represents physical activity individually tailored according to the psychosomatic capabilities of a person and the goal to be achieved. It can be applied at any age in order to maintain strong bones and reduce the risk of fracture. Adapted physical activity is different for men and women, for different age, as well as for the individuals. Aerobic exercises, which lead to an acceleration of breathing, increased heart rate and mild perspiration, as well as resistance exercises and exercises against resistance done by stretching elastic bands, for hands, legs and torso have been proven to increase bone density and improve bone strength. Coordination and balance exercises are important in an individual workout program. An explanation of the action of adapted physical activity is the basis for the theory of control and modulation of bone loss, muscle strength, coordination and balance. Physical activity is very effective in reducing sclerostin, which is known to inhibit bone

  3. Adaptive Control of a Wearable Exoskeleton for Upper-Extremity Neurorehabilitation

    Directory of Open Access Journals (Sweden)

    Sivakumar Balasubramanian

    2012-01-01

    Full Text Available The paper describes the implementation and testing of two adaptive controllers developed for a wearable, underactuated upper extremity therapy robot – RUPERT (Robotic Upper Extremity Repetitive Trainer. The controllers developed in this study were used to implement two adaptive robotic therapy modes – the adaptive co-operative mode and the adaptive active-assist mode – that are based on two different approaches for providing robotic assistance for task practice. The adaptive active-assist mode completes therapy tasks when a subject is unable to do so voluntarily. This robotic therapy mode is a novel implementation of the idea of an active-assist therapy mode; it utilizes the measure of a subject’s motor ability, along with their real-time movement kinematics to initiate robotic assistance at the appropriate time during a movement trial. The adaptive co-operative mode, on the other hand, is based on the idea of enabling task completion instead of completing the task for the subject. Both these therapy modes were designed to adapt to a stroke subject's motor ability, and thus encourage voluntary participation from the stroke subject. The two controllers were tested on three stroke subjects practicing robot-assisted reaching movements. The results from this testing demonstrate that an underactuated wearable exoskeleton, such as RUPERT, can be used for administering robot-assisted therapy, in a manner that encourages voluntary participation from the subject undergoing therapy.

  4. Individual differences in response conflict adaptations

    Directory of Open Access Journals (Sweden)

    Doris eKeye

    2013-12-01

    Full Text Available Conflict-monitoring theory argues for a general cognitive mechanism that monitors for con-flicts in information-processing. If that mechanism detects conflict, it engages cognitive con-trol to resolve it. A slow-down in response to incongruent trials (conflict effect, and a modu-lation of the conflict effect by the congruence of the preceding trial (Gratton or context effect have been taken as indicators of such a monitoring system. The present study (N = 157 investigated individual differences in the conflict and the context effect in a horizontal and a vertical Simon task, and their correlation with working memory capacity. Strength of conflict was varied by proportion of congruent trials. Coherent factors could be formed representing individual differences in speeded performance, conflict adaptation, and context adaptation. Conflict and context factors were not associated with each other. Contrary to theories assuming a close relation between working memory and cognitive control, working memory capacity showed no relation with any factors representing adaptation to conflict.

  5. Adapting Animal-Assisted Therapy Trials to Prison-Based Animal Programs.

    Science.gov (United States)

    Allison, Molly; Ramaswamy, Megha

    2016-09-01

    Prison-based animal programs have shown promise when it comes to increased sociability, responsibility, and levels of patience for inmates who participate in these programs. Yet there remains a dearth of scientific research that demonstrates the impact of prison-based animal programs on inmates' physical and mental health. Trials of animal-assisted therapy interventions, a form of human-animal interaction therapy most often used with populations affected by depression/anxiety, mental illness, and trauma, may provide models of how prison-based animal program research can have widespread implementation in jail and prison settings, whose populations have high rates of mental health problems. This paper reviews the components of prison-based animal programs most commonly practiced in prisons today, presents five animal-assisted therapy case studies, evaluates them based on their adaptability to prison-based animal programs, and discusses the institutional constraints that act as barriers for rigorous prison-based animal program research implementation. This paper can serve to inform the development of a research approach to animal-assisted therapy that nurses and other public health researchers can use in working with correctional populations. © 2016 Wiley Periodicals, Inc.

  6. A new adaptive videogame for training attention and executive functions: design principles and initial validation.

    Science.gov (United States)

    Montani, Veronica; De Filippo De Grazia, Michele; Zorzi, Marco

    2014-01-01

    A growing body of evidence suggests that action videogames could enhance a variety of cognitive skills and more specifically attention skills. The aim of this study was to develop a novel adaptive videogame to support the rehabilitation of the most common consequences of traumatic brain injury (TBI), that is the impairment of attention and executive functions. TBI patients can be affected by psychomotor slowness and by difficulties in dealing with distraction, maintain a cognitive set for a long time, processing different simultaneously presented stimuli, and planning purposeful behavior. Accordingly, we designed a videogame that was specifically conceived to activate those functions. Playing involves visuospatial planning and selective attention, active maintenance of the cognitive set representing the goal, and error monitoring. Moreover, different game trials require to alternate between two tasks (i.e., task switching) or to perform the two tasks simultaneously (i.e., divided attention/dual-tasking). The videogame is controlled by a multidimensional adaptive algorithm that calibrates task difficulty on-line based on a model of user performance that is updated on a trial-by-trial basis. We report simulations of user performance designed to test the adaptive game as well as a validation study with healthy participants engaged in a training protocol. The results confirmed the involvement of the cognitive abilities that the game is supposed to enhance and suggested that training improved attentional control during play.

  7. A new adaptive videogame for training attention and executive functions: design principles and initial validation

    Science.gov (United States)

    Montani, Veronica; De Filippo De Grazia, Michele; Zorzi, Marco

    2014-01-01

    A growing body of evidence suggests that action videogames could enhance a variety of cognitive skills and more specifically attention skills. The aim of this study was to develop a novel adaptive videogame to support the rehabilitation of the most common consequences of traumatic brain injury (TBI), that is the impairment of attention and executive functions. TBI patients can be affected by psychomotor slowness and by difficulties in dealing with distraction, maintain a cognitive set for a long time, processing different simultaneously presented stimuli, and planning purposeful behavior. Accordingly, we designed a videogame that was specifically conceived to activate those functions. Playing involves visuospatial planning and selective attention, active maintenance of the cognitive set representing the goal, and error monitoring. Moreover, different game trials require to alternate between two tasks (i.e., task switching) or to perform the two tasks simultaneously (i.e., divided attention/dual-tasking). The videogame is controlled by a multidimensional adaptive algorithm that calibrates task difficulty on-line based on a model of user performance that is updated on a trial-by-trial basis. We report simulations of user performance designed to test the adaptive game as well as a validation study with healthy participants engaged in a training protocol. The results confirmed the involvement of the cognitive abilities that the game is supposed to enhance and suggested that training improved attentional control during play. PMID:24860529

  8. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... companies to manufacture pharmaceuticals, 24 to carry out quality control and ... represents a 3% real growth from 2004/2005, it represents a slight decline from ... manufacturer for the pharmas, or can it leverage strengths in medical ... increased clinical trials activity, R&D investment is too low to make it a ...

  9. Bayesian selective response-adaptive design using the historical control.

    Science.gov (United States)

    Kim, Mi-Ok; Harun, Nusrat; Liu, Chunyan; Khoury, Jane C; Broderick, Joseph P

    2018-06-13

    High quality historical control data, if incorporated, may reduce sample size, trial cost, and duration. A too optimistic use of the data, however, may result in bias under prior-data conflict. Motivated by well-publicized two-arm comparative trials in stroke, we propose a Bayesian design that both adaptively incorporates historical control data and selectively adapt the treatment allocation ratios within an ongoing trial responsively to the relative treatment effects. The proposed design differs from existing designs that borrow from historical controls. As opposed to reducing the number of subjects assigned to the control arm blindly, this design does so adaptively to the relative treatment effects only if evaluation of cumulated current trial data combined with the historical control suggests the superiority of the intervention arm. We used the effective historical sample size approach to quantify borrowed information on the control arm and modified the treatment allocation rules of the doubly adaptive biased coin design to incorporate the quantity. The modified allocation rules were then implemented under the Bayesian framework with commensurate priors addressing prior-data conflict. Trials were also more frequently concluded earlier in line with the underlying truth, reducing trial cost, and duration and yielded parameter estimates with smaller standard errors. © 2018 The Authors. Statistics in Medicine Published by John Wiley & Sons, Ltd.

  10. Adapted yoga to improve physical function and health-related quality of life in physically-inactive older adults: a randomised controlled pilot trial.

    Science.gov (United States)

    Tew, Garry A; Howsam, Jenny; Hardy, Matthew; Bissell, Laura

    2017-06-23

    Yoga is a holistic therapy of expanding popularity, which has the potential to produce a range of physical, mental and social benefits. This trial evaluated the feasibility and effects of an adapted yoga programme on physical function and health-related quality of life in physically-inactive older adults. In this randomised controlled pilot trial, 52 older adults (90% female; mean age 74.8 years, SD 7.2) were randomised 1:1 to a yoga programme or wait-list control. The yoga group (n = 25) received a physical activity education booklet and were invited to attend ten yoga sessions during a 12-week period. The control group (n = 27) received the education booklet only. Measures of physical function (e.g., Short Physical Performance Battery; SPPB), health status (EQ-5D) and mental well-being (Warwick-Edinburgh Mental Well-being Scale; WEMWBS) were assessed at baseline and 3 months. Feasibility was assessed using course attendance and adverse event data, and participant interviews. Forty-seven participants completed follow-up assessments. Median class attendance was 8 (range 3 to 10). At the 3-month follow-up, the yoga group had a higher SPPB total score compared with the control group (mean difference 0.9, 95% confidence interval [CI] -0.3 to 2.0), a faster time to rise from a chair five times (mean difference - 1.73 s, 95% CI -4.08 to 0.62), and better performance on the chair sit-and-reach lower-limb flexibility test (mean difference 5 cm, 95% CI 0 to 10). The yoga group also had superior health status and mental well-being (vs. control) at 3 months, with mean differences in EQ-5D and WEMWBS scores of 0.12 (95% CI, 0.03 to 0.21) and 6 (95% CI, 1 to 11), respectively. The interviews indicated that participants valued attending the yoga programme, and that they experienced a range of benefits. The adapted yoga programme appeared to be feasible and potentially beneficial in terms of improving mental and social well-being and aspects of physical function in

  11. Cognitive control and conflict adaptation in youth with high-functioning autism.

    Science.gov (United States)

    Larson, Michael J; South, Mikle; Clayson, Peter E; Clawson, Ann

    2012-04-01

      Youth diagnosed with autism spectrum disorders (ASD) often show deficits in cognitive control processes, potentially contributing to characteristic difficulties monitoring and regulating behavior. Modification of performance following conflict can be measured by examining conflict adaptation, the adjustment of cognitive resources based on previous-trial conflict. The electrophysiological correlates of these processes can be measured using the N2, a stimulus-locked component of the event-related potential (ERP).   High-density ERPs and behavioral data [i.e. response times (RTs) and error rates] were acquired while 28 youth with ASD and 36 typically developing controls completed a modified Eriksen flanker task.   Behaviorally, groups showed similar conflict adaptation effects; youth with ASD showed larger RT slowing on switch trials. For electrophysiology, controls demonstrated larger N2 amplitudes for incongruent (high-conflict) trials following congruent (low-conflict) trials than for incongruent trials following incongruent trials. Importantly, youth with ASD showed no such differences in N2 amplitude based on previous-trial conflict.   Lack of electrophysiological conflict adaptation effects in youth with ASD indicates irregular neural processing associated with conflict adaptation. Individuals with ASD show declines in level of conflict evaluation and adaptation. Future research is necessary to accurately characterize and understand the behavioral implications of these cognitive control deficits relative to diagnostic severity, anxiety, and personality. © 2011 The Authors. Journal of Child Psychology and Psychiatry © 2011 Association for Child and Adolescent Mental Health.

  12. ADAPTATION OF THE FIRST FORM PUPILS TO EDUCATIONAL ACTIVITY IN PRIMARY SCHOOL

    Directory of Open Access Journals (Sweden)

    Микола Прозар

    2015-05-01

    Full Text Available The article presents the results of a study of adaptive possibilities (social and psychological of pupils of the first form to the educational activities in secondary schools. Using the research methods, an one-year experiment was conducted: the pupils of the first forms of Kamjanets-Podilsky secondary schools  № 13 and № 14 (73 boys and 87 girls were selected by the method of random sample. The study found that the living conditions of the 6-year-olds (due to the beginning of education in secondary school do not assist formation of adequate adaptation: at the beginning, the social and psychological adaptation correspond to the average level, and in the end – to the lowest one. Obtained results give reason to conclude that the learning activities in the first year of study negatively affects the adaptive possibilities of the first form pupils; it results in poor mental capacity and health of pupils.

  13. Brain serotonergic activation in growth-stunted farmed salmon: adaption versus pathology

    DEFF Research Database (Denmark)

    Vindas, Marco A.; Johansen, Ida B.; Folkedal, Ole

    2016-01-01

    Signalling systems activated under stress are highly conserved, suggesting adaptive effects of their function. Pathologies arising from continued activation of such systems may represent a mismatch between evolutionary programming and current environments. Here, we use Atlantic salmon (Salmo salar...

  14. Adaptive designs for dose-finding in non-cancer phase II trials: influence of early unexpected outcomes.

    Science.gov (United States)

    Resche-Rigon, Matthieu; Zohar, Sarah; Chevret, Sylvie

    2008-01-01

    In non-cancer phase II trials, dose-finding trials are usually carried out using fixed designs, in which several doses including a placebo are randomly distributed to patients. However, in certain vulnerable populations, such as neonates or infants, there is an heightened requirement for safety, precluding randomization. To estimate the minimum effective dose of a new drug from a non-cancer phase II trial, we propose the use of adaptive designs like the Continual Reassessment Method (CRM). This approach estimates the dose closest to some target response, and has been shown to be unbiased and efficient in cancer phase I trials. Based on a motivating example, we point out the individual influence of first outliers in this setting. A weighted version of the CRM is proposed as a theoretical benchmark to control for these outliers. Using simulations, we illustrate how this approach provides further insight into the behavior of the CRM. When dealing with low targets like a 10% failure rate, the CRM appears unable to rapidly overcome an early unexpected outcome. This behavior persisted despite changing the inference (Bayesian or likelihood), underlying dose-response model (though slightly improved using the power model), and the number of patients enrolled at each dose level. The choices for initial guesses of failure rates, the vague prior for the model parameter, and the log-log shape of weights can appear somewhat arbitrary. In phase II dose-finding studies in which failure targets are below 20%, the CRM appears quite sensitive to first unexpected outcomes. Using a power model for dose-response improves some behavior if the trial is started at the first dose level and includes at least three to five patients at the starting dose before applying the CRM allocation rule.

  15. Adaptive optimization for active queue management supporting TCP flows

    NARCIS (Netherlands)

    Baldi, S.; Kosmatopoulos, Elias B.; Pitsillides, Andreas; Lestas, Marios; Ioannou, Petros A.; Wan, Y.; Chiu, George; Johnson, Katie; Abramovitch, Danny

    2016-01-01

    An adaptive decentralized strategy for active queue management of TCP flows over communication networks is presented. The proposed strategy solves locally, at each link, an optimal control problem, minimizing a cost composed of residual capacity and buffer queue size. The solution of the optimal

  16. The influence of catch trials on the consolidation of motor memory in force field adaptation tasks

    Directory of Open Access Journals (Sweden)

    Anne eFocke

    2013-07-01

    Full Text Available In computational neuroscience it is generally accepted that human motor memory contains neural representations of the physics of the musculoskeletal system and the objects in the environment. These representations are called internal models. Force field studies, in which subjects have to adapt to dynamic perturbations induced by a robotic manipulandum, are an established tool to analyze the characteristics of such internal models. The aim of the current study was to investigate whether catch trials during force field learning could influence the consolidation of motor memory in more complex tasks. Thereby, the force field was more than double the force field of previous studies (35 Ns/m. Moreover, the arm of the subjects was not supported. A total of forty-six subjects participated in this study and performed center-out movements at a robotic manipulandum in two different force fields. Two control groups learned force field A on day 1 and were retested in the same force field on day 3 (AA. Two test groups additionally learned an interfering force field B (=-A on day 2 (ABA. The difference between the two test and control groups, respectively, was the absence (0% or presence (19% of catch trials, in which the force field was turned off suddenly. The results showed consolidation of force field A on day 3 for both control groups. Test groups showed no consolidation of force field A (19% catch trials and even poorer performance on day 3 (0% catch trials. In conclusion, it can be stated that catch trials seem to have a positive effect on the performance on day 3 but do not trigger a consolidation process as shown in previous studies that used a lower force field viscosity with supported arm. These findings indicate that the results of previous studies in which less complex tasks were analyzed, cannot be fully transferred to more complex tasks. Moreover, the effects of catch trials in these situations are insufficiently understood and further research

  17. Some challenges with statistical inference in adaptive designs.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling

    2014-01-01

    Adaptive designs have generated a great deal of attention to clinical trial communities. The literature contains many statistical methods to deal with added statistical uncertainties concerning the adaptations. Increasingly encountered in regulatory applications are adaptive statistical information designs that allow modification of sample size or related statistical information and adaptive selection designs that allow selection of doses or patient populations during the course of a clinical trial. For adaptive statistical information designs, a few statistical testing methods are mathematically equivalent, as a number of articles have stipulated, but arguably there are large differences in their practical ramifications. We pinpoint some undesirable features of these methods in this work. For adaptive selection designs, the selection based on biomarker data for testing the correlated clinical endpoints may increase statistical uncertainty in terms of type I error probability, and most importantly the increased statistical uncertainty may be impossible to assess.

  18. Family planning to promote physical activity: a randomized controlled trial protocol.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Blanchard, Chris M; Naylor, Patti-Jean; Warburton, Darren E R

    2015-10-05

    Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines. A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families. This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families. This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the

  19. Active learning and adaptive sampling for non-parametric inference

    NARCIS (Netherlands)

    Castro, R.M.

    2007-01-01

    This thesis presents a general discussion of active learning and adaptive sampling. In many practical scenarios it is possible to use information gleaned from previous observations to focus the sampling process, in the spirit of the "twenty-questions" game. As more samples are collected one can

  20. Global adaptation patterns of Australian and CIMMYT spring bread wheat.

    Science.gov (United States)

    Mathews, Ky L; Chapman, Scott C; Trethowan, Richard; Pfeiffer, Wolfgang; van Ginkel, Maarten; Crossa, Jose; Payne, Thomas; Delacy, Ian; Fox, Paul N; Cooper, Mark

    2007-10-01

    The International Adaptation Trial (IAT) is a special purpose nursery designed to investigate the genotype-by-environment interactions and worldwide adaptation for grain yield of Australian and CIMMYT spring bread wheat (Triticum aestivum L.) and durum wheat (T. turgidum L. var. durum). The IAT contains lines representing Australian and CIMMYT wheat breeding programs and was distributed to 91 countries between 2000 and 2004. Yield data of 41 reference lines from 106 trials were analysed. A multiplicative mixed model accounted for trial variance heterogeneity and inter-trial correlations characteristic of multi-environment trials. A factor analytic model explained 48% of the genetic variance for the reference lines. Pedigree information was then incorporated to partition the genetic line effects into additive and non-additive components. This model explained 67 and 56% of the additive by environment and non-additive by environment genetic variances, respectively. Australian and CIMMYT germplasm showed good adaptation to their respective target production environments. In general, Australian lines performed well in south and west Australia, South America, southern Africa, Iran and high latitude European and Canadian locations. CIMMYT lines performed well at CIMMYT's key yield testing location in Mexico (CIANO), north-eastern Australia, the Indo-Gangetic plains, West Asia North Africa and locations in Europe and Canada. Maturity explained some of the global adaptation patterns. In general, southern Australian germplasm were later maturing than CIMMYT material. While CIANO continues to provide adapted lines to northern Australia, selecting for yield among later maturing CIMMYT material in CIANO may identify lines adapted to southern and western Australian environments.

  1. Gender-specific effects of physical activity on children's academic performance: The Active Smarter Kids cluster randomized controlled trial.

    Science.gov (United States)

    Resaland, G K; Moe, V F; Bartholomew, J B; Andersen, L B; McKay, H A; Anderssen, S A; Aadland, E

    2018-01-01

    Active learning combines academic content with physical activity (PA) to increase child PA and academic performance, but the impact of active learning is mixed. It may be that this is a moderated relationship in which active learning is beneficial for only some children. This paper examine the impact of baseline academic performance and gender as moderators for the effects of active learning on children's academic performance. In the ASK-study, 1129 fifth-graders from 57 Norwegian elementary schools were randomized by school to intervention or control in a physical activity intervention between November 2014 and June 2015. Academic performance in numeracy, reading, and English was measured and a composite score was calculated. Children were split into low, middle and high academic performing tertiles. 3-way-interactions for group (intervention, control)∗gender (boys, girls)∗academic performance (tertiles) were investigated using mixed model regression. There was a significant, 3-way-interaction (p=0.044). Both boys (ES=0.11) and girls (ES=0.18) in the low performing tertile had a similar beneficial trend. In contrast, middle (ES=0.03) and high performing boys (ES=0.09) responded with small beneficial trends, while middle (ES=-0.11) and high performing girls (ES=-0.06) responded with negative trends. ASK was associated with a significant increase in academic performance for low performing children. It is likely that active learning benefited children most in need of adapted education but it may have a null or negative effect for those girls who are already performing well in the sedentary classroom. Differences in gendered responses are discussed as a possible explanation for these results. Clinicaltrials.gov registry, trial registration number: NCT02132494. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Familiar Sports and Activities Adapted for Multiply Impaired Persons.

    Science.gov (United States)

    Schilling, Mary Lou, Ed.

    1984-01-01

    Means of adapting some familiar and popular physical activities for multiply impaired persons are described. Games reviewed are dice baseball, one base baseball, in-house bowling, wheelchair bowling, ramp bowling, swing-ball bowling, table tennis, shuffleboard, beanbag bingo and tic-tac-toe, balloon basketball, circle football, and wheelchair…

  3. Methodological issues in systematic reviews of headache trials: adapting historical diagnostic classifications and outcome measures to present-day standards.

    Science.gov (United States)

    McCrory, Douglas C; Gray, Rebecca N; Tfelt-Hansen, Peer; Steiner, Timothy J; Taylor, Frederick R

    2005-05-01

    Recent efforts to make headache diagnostic classification and clinical trial methodology more consistent provide valuable advice to trialists generating new evidence on effectiveness of treatments for headache; however, interpreting older trials that do not conform to new standards remains problematic. Systematic reviewers seeking to utilize historical data can adapt currently recommended diagnostic classification and clinical trial methodological approaches to interpret all available data relative to current standards. In evaluating study populations, systematic reviewers can: (i) use available data to attempt to map study populations to diagnoses in the new International Classification of Headache Disorders; and (ii) stratify analyses based on the extent to which study populations are precisely specified. In evaluating outcome measures, systematic reviewers can: (i) summarize prevention studies using headache frequency, incorporating headache index in a stratified analysis if headache frequency is not available; (ii) summarize acute treatment studies using pain-free response as reported in directly measured headache improvement or headache severity outcomes; and (iii) avoid analysis of recurrence or relapse data not conforming to the sustained pain-free response definition.

  4. A new adaptive videogame for training attention and executive functions: Design principles and initial validation

    Directory of Open Access Journals (Sweden)

    Veronica eMontani

    2014-05-01

    Full Text Available A growing body of evidence suggests that action videogames could enhance a variety of cognitive skills and more specifically attention skills. The aim of this study was to develop a novel adaptive videogame to support the rehabilitation of the most common consequences of traumatic brain injury (TBI, that is the impairment of attention and executive functions. TBI patients can be affected by psychomotor slowness and by difficulties in dealing with distraction, maintain a cognitive set for a long time, processing different simultaneously presented stimuli, and planning purposeful behaviour. Accordingly, we designed a videogame that was specifically conceived to activate those functions. Playing involves visuospatial planning and selective attention, active maintenance of the cognitive set representing the goal, and error monitoring. Moreover, different game trials require to alternate between two tasks (i.e., task switching or to perform the two tasks simultaneously (i.e., divided attention / dual-tasking. The videogame is controlled by a multidimensional adaptive algorithm that calibrates task difficulty on-line based on a model of user performance that is updated on a trial-by-trial basis. We report simulations of user performance designed to test the adaptive game as well as a validation study with healthy participants engaged in a training protocol. The results confirmed the involvement of the cognitive abilities that the game is supposed to enhance and suggested that training improved attentional control during play.

  5. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol.

    Science.gov (United States)

    Malone, Laurie A; Padalabalanarayanan, Sangeetha; McCroskey, Justin; Thirumalai, Mohanraj

    2017-06-16

    Individuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity. Our aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat. Participants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were

  6. Financial motivation undermines potential enjoyment in an intensive diet and activity intervention.

    Science.gov (United States)

    Moller, Arlen C; Buscemi, Joanna; McFadden, H Gene; Hedeker, Donald; Spring, Bonnie

    2014-10-01

    The use of material incentives in healthy lifestyle interventions is becoming widespread. However, self-determination theory (SDT) posits that when material incentives are perceived as controlling, they undermine intrinsic motivation. We analyzed data from the Make Better Choices trial-a trial testing strategies for improving four risk behaviors: low fruit-vegetable intake, high saturated fat intake, low physical activity, and high sedentary activity. At baseline, participants reported the degree to which financial incentives were an important motivator (financial motivation); self-reported enjoyment of each behavior was assessed before and after the 3-week incentivization phase. Consistent with SDT, after controlling for general motivation and group assignment, lower financial motivation predicted more adaptive changes in enjoyment. Whereas participants low in financial motivation experienced adaptive changes, adaptive changes were suppressed among those high in financial motivation.

  7. Myocardial adaption to HI(R)T in previously untrained men with a randomized, longitudinal cardiac MR imaging study (Physical adaptions in Untrained on Strength and Heart trial, PUSH-trial).

    Science.gov (United States)

    Scharf, Michael; Oezdemir, Derya; Schmid, Axel; Kemmler, Wolfgang; von Stengel, Simon; May, Matthias S; Uder, Michael; Lell, Michael M

    2017-01-01

    Although musculoskeletal effects in resistance training are well described, little is known about structural and functional cardiac adaption in formerly untrained subjects. We prospectively evaluated whether short term high intensity (resistance) training (HI(R)T) induces detectable morphologic cardiac changes in previously untrained men in a randomized controlled magnetic resonance imaging (MRI) study. 80 untrained middle-aged men were randomly assigned to a HI(R)T-group (n = 40; 43.5±5.9 years) or an inactive control group (n = 40; 42.0±6.3 years). HI(R)T comprised 22 weeks of training focusing on a single-set to failure protocol in 2-3 sessions/week, each with 10-13 exercises addressing main muscle groups. Repetitions were decreased from 8-10 to 3-5 during study period. Before and after HI(R)T all subjects underwent physiologic examination and cardiac MRI (cine imaging, tagging). Indexed left (LV) and right ventricular (RV) volume (LV: 76.8±15.6 to 78.7±14.8 ml/m2; RV: 77.0±15.5 to 78.7±15.1 ml/m2) and mass (LV: 55.5±9.7 to 57.0±8.8 g/m2; RV: 14.6±3.0 to 15.0±2.9 g/m2) significantly increased with HI(R)T (all pHI(R)T-group did not alter with training (0.73g/mL and 0.19g/mL, respectively [p = 0.96 and p = 0.87]), indicating balanced cardiac adaption. Indexed LV (48.4±11.1 to 50.8±11.0 ml/m2) and RV (48.5±11.0 to 50.6±10.7 ml/m2) stroke volume significantly increased with HI(R)T (pHI(R)T (36.2±7.9 to 37.0±8.4 ml/m2, p = 0.411), the ratio to end-diastolic LV volume at baseline and post-training was unchanged (0.47 vs. 0.47, p = 0.79). 22 weeks of HI(R)T lead to measurable, physiological changes in cardiac atrial and ventricular morphologic characteristics and function in previously untrained men. The PUSH-trial is registered at the US National Institutes of Health (ClinicalTrials.gov), NCT01766791.

  8. Cognitive and adaptive measurement endpoints for clinical trials in mucopolysaccharidoses types I, II, and III: A review of the literature.

    Science.gov (United States)

    Janzen, Darren; Delaney, Kathleen A; Shapiro, Elsa G

    2017-06-01

    Sensitive, reliable measurement instruments are critical for the evaluation of disease progression and new treatments that affect the brain in the mucopolysaccharidoses (MPS). MPS I, II, and III have early onset clinical phenotypes that affect the brain during development and result in devastating cognitive decline and ultimately death without treatment. Comparisons of outcomes are hindered by diverse protocols and approaches to assessment including applicability to international trials necessary in rare diseases. We review both cognitive and adaptive measures with the goal of providing evidence to a Delphi panel to come to a consensus about recommendations for clinical trials for various age groups. The results of the consensus panel are reported in an accompanying article. The following data were gathered (from internet resources and from test manuals) for each measure and summarized in the discussion: reliability, validity, date and adequacy of normative data, applicability of the measure's metrics, cross cultural validity including translations and adaptations, feasibility in the MPS population, familiarity to sites, sensitivity to change, and interpretability. If, resulting from this consensus, standard protocols are used for both natural history and treatment studies, patients, their families, and health care providers will benefit from the ability to compare study outcomes. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  9. Adaptive/Nonadaptive Proton Radiation Planning and Outcomes in a Phase II Trial for Locally Advanced Non-small Cell Lung Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Koay, Eugene J.; Lege, David [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Mohan, Radhe [Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Komaki, Ritsuko; Cox, James D. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Chang, Joe Y., E-mail: jychang@mdanderson.org [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2012-12-01

    Purpose: To analyze dosimetric variables and outcomes after adaptive replanning of radiation therapy during concurrent high-dose protons and chemotherapy for locally advanced non-small cell lung cancer (NSCLC). Methods and Materials: Nine of 44 patients with stage III NSCLC in a prospective phase II trial of concurrent paclitaxel/carboplatin with proton radiation [74 Gy(RBE) in 37 fractions] had modifications to their original treatment plans after re-evaluation revealed changes that would compromise coverage of the target volume or violate dose constraints; plans for the other 35 patients were not changed. We compared patients with adaptive plans with those with nonadaptive plans in terms of dosimetry and outcomes. Results: At a median follow-up of 21.2 months (median overall survival, 29.6 months), no differences were found in local, regional, or distant failure or overall survival between groups. Adaptive planning was used more often for large tumors that shrank to a greater extent (median, 107.1 cm{sup 3} adaptive and 86.4 cm{sup 3} nonadaptive; median changes in volume, 25.3% adaptive and 1.2% nonadaptive; P<.01). The median number of fractions delivered using adaptive planning was 13 (range, 4-22). Adaptive planning generally improved sparing of the esophagus (median absolute decrease in V{sub 70}, 1.8%; range, 0%-22.9%) and spinal cord (median absolute change in maximum dose, 3.7 Gy; range, 0-13.8 Gy). Without adaptive replanning, target coverage would have been compromised in 2 cases (57% and 82% coverage without adaptation vs 100% for both with adaptation); neither patient experienced local failure. Radiation-related grade 3 toxicity rates were similar between groups. Conclusions: Adaptive planning can reduce normal tissue doses and prevent target misses, particularly for patients with large tumors that shrink substantially during therapy. Adaptive plans seem to have acceptable toxicity and achieve similar local, regional, and distant control and overall

  10. Maximum tolerated dose in a phase I trial on adaptive dose painting by numbers for head and neck cancer

    International Nuclear Information System (INIS)

    Madani, Indira; Duprez, Fréderic; Boterberg, Tom; Van de Wiele, Christophe; Bonte, Katrien; Deron, Philippe; De Gersem, Werner; Coghe, Marc; De Neve, Wilfried

    2011-01-01

    Purpose: To determine the maximum tolerated dose (MTD) in a phase I trial on adaptive dose-painting-by-numbers (DPBN) for non-metastatic head and neck cancer. Materials and methods: Adaptive intensity-modulated radiotherapy was based on voxel intensity of pre-treatment and per-treatment [ 18 F]fluoro-2-deoxy-D-glucose positron emission tomography ( 18 F-FDG-PET) scans. Dose was escalated to a median total dose of 80.9 Gy in the high-dose clinical target volume (dose level I) and 85.9 Gy in the gross tumor volume (dose level II). The MTD would be reached, if ⩾33% of patients developed any grade ⩾4 toxicity (DLT) up to 3 months follow-up. Results: Between February 2007 and August 2009, seven patients at dose level I and 14 at dose level II were treated. All patients completed treatment without interruption. At a median follow-up for surviving patients of 38 (dose level I) and 22 months (dose level II) there was no grade ⩾4 toxicity during treatment and follow-up but six cases of mucosal ulcers at latency of 4–10 months, of which five (36%) were observed at dose level II. Mucosal ulcers healed spontaneously in four patients. Conclusions: Considering late mucosal ulcers as DLT, the MTD of a median dose of 80.9 Gy has been reached in our trial.

  11. Periodic activations of behaviours and emotional adaptation in behaviour-based robotics

    Science.gov (United States)

    Burattini, Ernesto; Rossi, Silvia

    2010-09-01

    The possible modulatory influence of motivations and emotions is of great interest in designing robotic adaptive systems. In this paper, an attempt is made to connect the concept of periodic behaviour activations to emotional modulation, in order to link the variability of behaviours to the circumstances in which they are activated. The impact of emotion is studied, described as timed controlled structures, on simple but conflicting reactive behaviours. Through this approach it is shown that the introduction of such asynchronies in the robot control system may lead to an adaptation in the emergent behaviour without having an explicit action selection mechanism. The emergent behaviours of a simple robot designed with both a parallel and a hierarchical architecture are evaluated and compared.

  12. Perspectives on the Contribution of Social Science to Adapted Physical Activity: Looking Forward, Looking Back

    Science.gov (United States)

    Causgrove Dunn, Janice; Cairney, John; Zimmer, Chantelle

    2016-01-01

    In this article, we reflect on the contributions of the social sciences to the field of adapted physical activity by examining the theories and methods that have been adopted from the social science disciplines. To broaden our perspective on adapted physical activity and provide new avenues for theoretical and empirical exploration, we discuss and…

  13. Driving Meaningful Adaptation Action through an Adaptation Market Mechanism

    Energy Technology Data Exchange (ETDEWEB)

    Butzengeiger-Geyer, Sonja; Koehler, Michel; Michaelowa, Axel

    2011-07-01

    Approaches and criteria for allocating adaptation funds vary significantly among current sources - UN-backed funds and bilateral cooperation - and to some extent lack transparency and consistency. Such funding risks being spent in a haphazard way that repeats many of the mistakes made in development assistance over the past decades. An Adaptation Market Mechanism (AMM) could contribute to efficient allocation of adaptation funds, promote adaptation activities by private and public actors through additional financial incentives, and raise additional and reliable adaptation money. This would help to avoid future public criticism of the effectiveness and efficiency of spending adaptation funding.The proposed AMM would specify mandatory adaptation targets, on international, regional or domestic level. Participants who achieve their targets either by generating adaptation units or by buying them in the market would incentivize private, commercial and institutional actors to develop adaptation projects that create verified adaptation units. A universally accepted and verifiable trading unit applicable to all types of adaptation activities would help to maximize the cost reduction potential for the AMM. We suggest applying net present value (NPV) for property saved; Disability Adjusted Life Years Saved (DALYS) for health benefits; and potentially a separate unit to consider the environmental benefits of an adaptation activity.(Author)

  14. Physical activity stimulation program for children with cerebral palsy did not improve physical activity: a randomised trial

    NARCIS (Netherlands)

    van Wely, L.; Balemans, A.C.J.; Becher, J.G.; Dallmeijer, A.J.

    2014-01-01

    Question: In children with cerebral palsy, does a 6-month physical activity stimulation program improve physical activity, mobility capacity, fitness, fatigue and attitude towards sports more than usual paediatric physiotherapy? Design: Multicentre randomised controlled trial with concealed

  15. A Feasibility Trial of Mental Health First Aid First Nations: Acceptability, Cultural Adaptation, and Preliminary Outcomes.

    Science.gov (United States)

    Crooks, Claire V; Lapp, Andrea; Auger, Monique; van der Woerd, Kim; Snowshoe, Angela; Rogers, Billie Jo; Tsuruda, Samantha; Caron, Cassidy

    2018-03-25

    The Mental Health First Aid First Nations course was adapted from Mental Health First Aid Basic to create a community-based, culturally safe and relevant approach to promoting mental health literacy in First Nations contexts. Over 2.5 days, the course aims to build community capacity by teaching individuals to recognize and respond to mental health crises. This feasibility trial utilized mixed methods to evaluate the acceptability, cultural adaptation, and preliminary effectiveness of MHFAFN. Our approach was grounded in community-based participatory research principles, emphasizing relationship-driven procedures to collecting data and choice for how participants shared their voices. Data included participant interviews (n = 89), and surveys (n = 91) from 10 groups in four provinces. Surveys contained open-ended questions, retrospective pre-post ratings, and a scenario. We utilized data from nine facilitator interviews and 24 facilitator implementation surveys. The different lines of evidence converged to highlight strong acceptability, mixed reactions to the cultural adaptation, and gains in participants' knowledge, mental health first aid skill application, awareness, and self-efficacy, and reductions in stigma beliefs. Beyond promoting individual gains, the course served as a community-wide prevention approach by situating mental health in a colonial context and highlighting local resources and cultural strengths for promoting mental well-being. © 2018 The Authors American Journal of Community Psychology published by Wiley Periodicals, Inc. on behalf of Society for Community Research and Action.

  16. A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial.

    Science.gov (United States)

    Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory

    2017-10-01

    Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  18. Muscle, functional and cognitive adaptations after flywheel resistance training in stroke patients: a pilot randomized controlled trial.

    Science.gov (United States)

    Fernandez-Gonzalo, Rodrigo; Fernandez-Gonzalo, Sol; Turon, Marc; Prieto, Cristina; Tesch, Per A; García-Carreira, Maria del Carmen

    2016-04-06

    Resistance exercise (RE) improves neuromuscular function and physical performance after stroke. Yet, the effects of RE emphasizing eccentric (ECC; lengthening) actions on muscle hypertrophy and cognitive function in stroke patients are currently unknown. Thus, this study explored the effects of ECC-overload RE training on skeletal muscle size and function, and cognitive performance in individuals with stroke. Thirty-two individuals with chronic stroke (≥6 months post-stroke) were randomly assigned into a training group (TG; n = 16) performing ECC-overload flywheel RE of the more-affected lower limb (12 weeks, 2 times/week; 4 sets of 7 maximal closed-chain knee extensions; trained (48.2 %), and the less-affected, untrained limb (28.1 %) increased after training. TG showed enhanced balance (8.9 %), gait performance (10.6 %), dual-task performance, executive functions (working memory, verbal fluency tasks), attention, and speed of information processing. CG showed no changes. ECC-overload flywheel resistance exercise comprising 4 min of contractile activity per week offers a powerful aid to regain muscle mass and function, and functional performance in individuals with stroke. While the current intervention improved cognitive functions, the cause-effect relationship, if any, with the concomitant neuromuscular adaptations remains to be explored. Clinical Trials NCT02120846.

  19. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  20. The neural dynamics of conflict adaptation within a look-to-do transition.

    Directory of Open Access Journals (Sweden)

    Dandan Tang

    Full Text Available BACKGROUND: For optimal performance in conflict situations, conflict adaptation (conflict detection and adjustment is necessary. However, the neural dynamics of conflict adaptation is still unclear. METHODS: In the present study, behavioral and electroencephalography (EEG data were recorded from seventeen healthy participants during performance of a color-word Stroop task with a novel look-to-do transition. Within this transition, participants looked at the Stroop stimuli but no responses were required in the 'look' trials; or made manual responses to the Stroop stimuli in the 'do' trials. RESULTS: In the 'look' trials, the amplitude modulation of N450 occurred exclusively in the right-frontal region. Subsequently, the amplitude modulation of sustained potential (SP emerged in the posterior parietal and right-frontal regions. A significantly positive correlation between the modulation of reconfiguration in the 'look' trials and the behavioral conflict adaptation in the 'do' trials was observed. Specially, a stronger information flow from right-frontal region to posterior parietal region in the beta band was observed for incongruent condition than for congruent condition. In the 'do' trials, the conflict of 'look' trials enhanced the amplitude modulations of N450 in the right-frontal and posterior parietal regions, but decreased the amplitude modulations of SP in these regions. Uniquely, a stronger information flow from centro-parietal region to right-frontal region in the theta band was observed for iI condition than for cI condition. CONCLUSION: All these findings showed that top-down conflict adaptation is implemented by: (1 enhancing the sensitivity to conflict detection and the adaptation to conflict resolution; (2 modulating the effective connectivity between parietal region and right-frontal region.

  1. Adding methylphenidate to prism-adaptation improves outcome in neglect patients. A randomized clinical trial.

    Science.gov (United States)

    Luauté, Jacques; Villeneuve, Laurent; Roux, Adeline; Nash, Stuart; Bar, Jean-Yves; Chabanat, Eric; Cotton, François; Ciancia, Sophie; Sancho, Pierre-Olivier; Hovantruc, Patrick; Quelard, François; Sarraf, Thierry; Cojan, Yann; Hadj-Bouziane, Fadila; Farné, Alessandro; Janoly-Dumenil, Audrey; Boisson, Dominique; Jacquin-Courtois, Sophie; Rode, Gilles; Rossetti, Yves

    2018-04-04

    Spatial neglect is one of the main predictors of poor functional recovery after stroke. Many therapeutic interventions have been developed to alleviate this condition, but to date the evidence of their effectiveness is still scarce. The purpose of this study was to test whether combining prism adaptation (PA) and methylphenidate (MP) could enhance the recovery of neglect patients at a functional level. RITAPRISM is a multicentre, randomized, double-blind, placebo-controlled study comparing PA plus placebo (control) versus PA plus MP. 24 patients were prospectively enrolled (10 in the placebo group and 14 in the MP group). The main result is a long-term functional improvement (on the functional independence measure (FIM) and on Bergego's scale) induced by MP combined with PA. No serious adverse event occurred. The long-term benefit on activities of daily living (ADL) obtained in this randomized controlled trial set this intervention apart from previous attempts and supports with a high level of evidence the value of combining PA and MP in order to improve the autonomy of neglect patients. Further studies will be needed to clarify the mechanism of this improvement. Although not specifically assessed at this stage, a part of the improvement in ADL might be related to the collateral effect of MP on mood, executive functions or fatigue, and/or the combined effect of PA and MP on motor intentional bias of neglect patients. This study provides Class I evidence that adding MP to PA improves the functional outcome of neglect patients. EUCTR2008-000325-20-FR. Copyright © 2018 Elsevier Ltd. All rights reserved.

  2. Application of Avco data analysis and prediction techniques (ADAPT) to prediction of sunspot activity

    Science.gov (United States)

    Hunter, H. E.; Amato, R. A.

    1972-01-01

    The results are presented of the application of Avco Data Analysis and Prediction Techniques (ADAPT) to derivation of new algorithms for the prediction of future sunspot activity. The ADAPT derived algorithms show a factor of 2 to 3 reduction in the expected 2-sigma errors in the estimates of the 81-day running average of the Zurich sunspot numbers. The report presents: (1) the best estimates for sunspot cycles 20 and 21, (2) a comparison of the ADAPT performance with conventional techniques, and (3) specific approaches to further reduction in the errors of estimated sunspot activity and to recovery of earlier sunspot historical data. The ADAPT programs are used both to derive regression algorithm for prediction of the entire 11-year sunspot cycle from the preceding two cycles and to derive extrapolation algorithms for extrapolating a given sunspot cycle based on any available portion of the cycle.

  3. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    Science.gov (United States)

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  4. Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.

    Science.gov (United States)

    Meinzer, Caitlyn; Martin, Renee; Suarez, Jose I

    2017-09-08

    In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size. To balance these challenges, a novel placebo-controlled design is presented in which a restricted Bayesian response adaptive randomization (RAR) is used to allocate a majority of subjects to the optimal dose of active drug, defined as the dose with the lowest probability of poor outcome. However, the allocation between subjects who receive active drug or placebo is held constant to retain the maximum possible power for a hypothesis test of overall efficacy comparing the optimal dose to placebo. The design properties and optimization of the design are presented in the context of a phase II trial for subarachnoid hemorrhage. For a fixed total sample size, a trade-off exists between the ability to select the optimal dose and the probability of rejecting the null hypothesis. This relationship is modified by the allocation ratio between active and control subjects, the choice of RAR algorithm, and the number of subjects allocated to an initial fixed allocation period. While a responsive RAR algorithm improves the ability to select the correct dose, there is an increased risk of assigning more subjects to a worse arm as a function of ephemeral trends in the data. A subarachnoid treatment trial is used to illustrate how this design can be customized for specific objectives and available data. Bayesian adaptive designs are a flexible approach to addressing multiple questions surrounding the optimal dose for treatment efficacy

  5. Challenges in introduction of artificial intelligence in medical practice – a review of clinical trials concerning adaptation of artificial intelligence in medicine

    OpenAIRE

    Mielnik, Pawel Franciszek; Fojcik, Marcin; Kulbacki, Marek; Segen, Jakub

    2016-01-01

    An interest in Artificial Intelligence [AI] as science is growing in the last years. It has become gradually more used in the medicine. Methodology of development and testing of AI algorithms is generally well established. Use of AI in medicine requires elaboration of standards of its validation in clinical settings. This paper is a review of literature concerning clinical trials on AI adaptation in medicine

  6. Active Inference, homeostatic regulation and adaptive behavioural control.

    Science.gov (United States)

    Pezzulo, Giovanni; Rigoli, Francesco; Friston, Karl

    2015-11-01

    We review a theory of homeostatic regulation and adaptive behavioural control within the Active Inference framework. Our aim is to connect two research streams that are usually considered independently; namely, Active Inference and associative learning theories of animal behaviour. The former uses a probabilistic (Bayesian) formulation of perception and action, while the latter calls on multiple (Pavlovian, habitual, goal-directed) processes for homeostatic and behavioural control. We offer a synthesis these classical processes and cast them as successive hierarchical contextualisations of sensorimotor constructs, using the generative models that underpin Active Inference. This dissolves any apparent mechanistic distinction between the optimization processes that mediate classical control or learning. Furthermore, we generalize the scope of Active Inference by emphasizing interoceptive inference and homeostatic regulation. The ensuing homeostatic (or allostatic) perspective provides an intuitive explanation for how priors act as drives or goals to enslave action, and emphasises the embodied nature of inference. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Re-estimating sample size in cluster randomized trials with active recruitment within clusters

    NARCIS (Netherlands)

    van Schie, Sander; Moerbeek, Mirjam

    2014-01-01

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster

  8. Older adults learn less, but still reduce metabolic cost, during motor adaptation

    Science.gov (United States)

    Huang, Helen J.

    2013-01-01

    The ability to learn new movements and dynamics is important for maintaining independence with advancing age. Age-related sensorimotor changes and increased muscle coactivation likely alter the trial-and-error-based process of adapting to new movement demands (motor adaptation). Here, we asked, to what extent is motor adaptation to novel dynamics maintained in older adults (≥65 yr)? We hypothesized that older adults would adapt to the novel dynamics less well than young adults. Because older adults often use muscle coactivation, we expected older adults to use greater muscle coactivation during motor adaptation than young adults. Nevertheless, we predicted that older adults would reduce muscle activity and metabolic cost with motor adaptation, similar to young adults. Seated older (n = 11, 73.8 ± 5.6 yr) and young (n = 15, 23.8 ± 4.7 yr) adults made targeted reaching movements while grasping a robotic arm. We measured their metabolic rate continuously via expired gas analysis. A force field was used to add novel dynamics. Older adults had greater movement deviations and compensated for just 65% of the novel dynamics compared with 84% in young adults. As expected, older adults used greater muscle coactivation than young adults. Last, older adults reduced muscle activity with motor adaptation and had consistent reductions in metabolic cost later during motor adaptation, similar to young adults. These results suggest that despite increased muscle coactivation, older adults can adapt to the novel dynamics, albeit less accurately. These results also suggest that reductions in metabolic cost may be a fundamental feature of motor adaptation. PMID:24133222

  9. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up.

    Science.gov (United States)

    Kauhanen, Lotta; Järvelä, Liisa; Lähteenmäki, Päivi M; Arola, Mikko; Heinonen, Olli J; Axelin, Anna; Lilius, Johan; Vahlberg, Tero; Salanterä, Sanna

    2014-04-05

    Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children's cancer treatment. The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children's perceptions of the most enjoyable activation methods are explored through an interview at 2 months. This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012).

  10. Clinical Marginal and Internal Adaptation of Maxillary Anterior Single All-Ceramic Crowns and 2-year Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Akın, Aslı; Toksavul, Suna; Toman, Muhittin

    2015-07-01

    The aims of this randomized-controlled clinical trial were to compare marginal and internal adaptation of all-ceramic crowns fabricated with CAD/CAM and heat-pressed (HP) techniques before luting and to evaluate the clinical outcomes at baseline and at 6, 12, and 24 months after luting. Fifteen CAD/CAM (CC) and 15 HP all-ceramic crowns were placed in 15 patients. A silicone replica was obtained to measure marginal and internal adaptation of each all-ceramic crown before luting, and they were sectioned buccolingually and mesiodistally. Marginal and internal adaptations were measured using computerized light microscope at 40× magnification. Clinical evaluations took place at baseline (2 days after luting) and at 6, 12, and 24 months after luting. Replica scores were analyzed with Mann-Whitney U and Student's t-test (α = 0.05). Survival rate of crowns was determined using Kaplan-Meier statistical analysis. The median marginal gap for the CC group was 132.2 μm and was 130.2 μm for the HP group. The mean internal adaptation for the CC group was 220.3 ± 51.3 μm and 210.5 ± 31 μm for the HP group. There were no statistically significant differences with respect to marginal opening (Mann-Whitney U test; p = 0.95) and internal adaptation (Student's t-test; p = 0.535) between the 2 groups. Based on modified Ryge criteria, 100% of the crowns were rated satisfactory during the 2-year period. In this in vivo study, CAD/CAM and HP all-ceramic crowns exhibited similar marginal and internal adaptations. A 100% success rate was recorded for the 15 CAD/CAM and for the 15 HP all-ceramic crowns during the 2-year period. © 2014 by the American College of Prosthodontists.

  11. Rapid, generalized adaptation to asynchronous audiovisual speech.

    Science.gov (United States)

    Van der Burg, Erik; Goodbourn, Patrick T

    2015-04-07

    The brain is adaptive. The speed of propagation through air, and of low-level sensory processing, differs markedly between auditory and visual stimuli; yet the brain can adapt to compensate for the resulting cross-modal delays. Studies investigating temporal recalibration to audiovisual speech have used prolonged adaptation procedures, suggesting that adaptation is sluggish. Here, we show that adaptation to asynchronous audiovisual speech occurs rapidly. Participants viewed a brief clip of an actor pronouncing a single syllable. The voice was either advanced or delayed relative to the corresponding lip movements, and participants were asked to make a synchrony judgement. Although we did not use an explicit adaptation procedure, we demonstrate rapid recalibration based on a single audiovisual event. We find that the point of subjective simultaneity on each trial is highly contingent upon the modality order of the preceding trial. We find compelling evidence that rapid recalibration generalizes across different stimuli, and different actors. Finally, we demonstrate that rapid recalibration occurs even when auditory and visual events clearly belong to different actors. These results suggest that rapid temporal recalibration to audiovisual speech is primarily mediated by basic temporal factors, rather than higher-order factors such as perceived simultaneity and source identity. © 2015 The Author(s) Published by the Royal Society. All rights reserved.

  12. Early Behavioral Intervention Is Associated with Normalized Brain Activity in Young Children with Autism

    Science.gov (United States)

    Dawson, Geraldine; Jones, Emily J. H.; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J.; Webb, Sara J.

    2012-01-01

    Objective: A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Method:…

  13. Fast adaptation of the internal model of gravity for manual interceptions: evidence for event-dependent learning.

    Science.gov (United States)

    Zago, Myrka; Bosco, Gianfranco; Maffei, Vincenzo; Iosa, Marco; Ivanenko, Yuri P; Lacquaniti, Francesco

    2005-02-01

    We studied how subjects learn to deal with two conflicting sensory environments as a function of the probability of each environment and the temporal distance between repeated events. Subjects were asked to intercept a visual target moving downward on a screen with randomized laws of motion. We compared five protocols that differed in the probability of constant speed (0g) targets and accelerated (1g) targets. Probability ranged from 9 to 100%, and the time interval between consecutive repetitions of the same target ranged from about 1 to 20 min. We found that subjects systematically timed their responses consistent with the assumption of gravity effects, for both 1 and 0g trials. With training, subjects rapidly adapted to 0g targets by shifting the time of motor activation. Surprisingly, the adaptation rate was independent of both the probability of 0g targets and their temporal distance. Very few 0g trials sporadically interspersed as catch trials during immersive practice with 1g trials were sufficient for learning and consolidation in long-term memory, as verified by retesting after 24 h. We argue that the memory store for adapted states of the internal gravity model is triggered by individual events and can be sustained for prolonged periods of time separating sporadic repetitions. This form of event-related learning could depend on multiple-stage memory, with exponential rise and decay in the initial stages followed by a sample-and-hold module.

  14. Hot Water Bathing Impairs Training Adaptation in Elite Teen Archers.

    Science.gov (United States)

    Hung, Ta-Cheng; Liao, Yi-Hung; Tsai, Yung-Shen; Ferguson-Stegall, Lisa; Kuo, Chia-Hua; Chen, Chung-Yu

    2018-04-30

    Despite heat imposes considerable physiological stress to human body, hot water immersion remains as a popular relaxation modality for athletes. Here we examined the lingering effect of hot tub relaxation after training on performance-associated measures and dehydroepiandrosterone sulfate (DHEA-S) in junior archers. Ten national level archers, aged 16.6 ± 0.3 years (M = 8, F = 2), participated in a randomized counter-balanced crossover study after baseline measurements. In particular, half participants were assigned to the hot water immersion (HOT) group, whereas another halves were assigned to the untreated control (CON) group. Crossover trial was conducted following a 2-week washout period. During the HOT trial, participants immersed in hot water for 30 min at 40°C, 1 h after training, twice a week (every 3 days) for 2 weeks. Participants during CON trial sat at the same environment without hot water after training. Performance-associated measures and salivary DHEA-S were determined 3 days after the last HOT session. We found that the HOT intervention significantly decreased shooting performance (CON: -4%; HOT: -22%, P HOT: -16%, P HOT: -60%, P < 0.05) of archers, compared with untreated CON trial. No group differences were found in motor unit recruitment (root mean square electromyography, RMS EMG) of arm muscles during aiming, autonomic nervous activity (sympathetic and vagal powers of heart rate variability, HRV), and plasma cortisol levels after treatments. Our data suggest that physiological adaptation against heat exposure takes away the sources needed for normal training adaptation specific to shooting performance in archers.

  15. Probability differently modulating the effects of reward and punishment on visuomotor adaptation.

    Science.gov (United States)

    Song, Yanlong; Smiley-Oyen, Ann L

    2017-12-01

    Recent human motor learning studies revealed that punishment seemingly accelerated motor learning but reward enhanced consolidation of motor memory. It is not evident how intrinsic properties of reward and punishment modulate the potentially dissociable effects of reward and punishment on motor learning and motor memory. It is also not clear what causes the dissociation of the effects of reward and punishment. By manipulating probability of distribution, a critical property of reward and punishment, the present study demonstrated that probability had distinct modulation on the effects of reward and punishment in adapting to a sudden visual rotation and consolidation of the adaptation memory. Specifically, two probabilities of monetary reward and punishment distribution, 50 and 100%, were applied during young adult participants adapting to a sudden visual rotation. Punishment and reward showed distinct effects on motor adaptation and motor memory. The group that received punishments in 100% of the adaptation trials adapted significantly faster than the other three groups, but the group that received rewards in 100% of the adaptation trials showed marked savings in re-adapting to the same rotation. In addition, the group that received punishments in 50% of the adaptation trials that were randomly selected also had savings in re-adapting to the same rotation. Sensitivity to sensory prediction error or difference in explicit process induced by reward and punishment may likely contribute to the distinct effects of reward and punishment.

  16. Physical activity and nutrition program for seniors (PANS: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lee Andy

    2010-12-01

    Full Text Available Abstract Background Along with reduced levels of physical activity, older Australian's mean energy consumption has increased. Now over 60% of older Australians are considered overweight or obese. This study aims to confirm if a low-cost, accessible physical activity and nutrition program can improve levels of physical activity and diet of insufficiently active 60-70 year-olds. Methods/Design This 12-month home-based randomised controlled trial (RCT will consist of a nutrition and physical activity intervention for insufficiently active people aged 60 to 70 years from low to medium socio-economic areas. Six-hundred participants will be recruited from the Australian Federal Electoral Role and randomly assigned to the intervention (n = 300 and control (n = 300 groups. The study is based on the Social Cognitive Theory and Precede-Proceed Model, incorporating voluntary cooperation and self-efficacy. The intervention includes a specially designed booklet that provides participants with information and encourages dietary and physical activity goal setting. The booklet will be supported by an exercise chart, calendar, bi-monthly newsletters, resistance bands and pedometers, along with phone and email contact. Data will be collected over three time points: pre-intervention, immediately post-intervention and 6-months post-study. Discussion This trial will provide valuable information for community-based strategies to improve older adults' physical activity and dietary intake. The project will provide guidelines for appropriate sample recruitment, and the development, implementation and evaluation of a minimal intervention program, as well as information on minimising barriers to participation in similar programs. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12609000735257

  17. Active Team” a social and gamified app-based physical activity intervention: randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Sarah Edney

    2017-11-01

    Full Text Available Abstract Background Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app. Methods The study is a three-group, cluster-RCT. Four hundred and forty (440 inactive Australian adults who use Facebook at least weekly will be recruited in clusters of three to eight existing Facebook friends. Participant clusters will be randomly allocated to one of three conditions: (1 waitlist control condition, (2 basic experimental condition (pedometer plus basic app with no social and gamification features, or (3 socially-enhanced experimental condition (pedometer plus app with social and gamification features. Participants will undertake assessments at baseline, three and nine months. The primary outcome is change in total daily minutes of moderate-to-vigorous physical activity at three months measured objectively using GENEActive accelerometers [Activeinsights Ltd., UK]. Secondary outcomes include self-reported physical activity, depression and anxiety, wellbeing, quality of life, social-cognitive theory constructs and app usage and engagement. Discussion The current study will incorporate novel social and gamification elements in order to examine whether the inclusion of these components increases the efficacy of app-based physical activity interventions. The findings will be used to guide the development

  18. A randomised controlled trial investigating the benefits of adaptive working memory training for working memory capacity and attentional control in high worriers.

    Science.gov (United States)

    Hotton, Matthew; Derakshan, Nazanin; Fox, Elaine

    2018-01-01

    The process of worry has been associated with reductions in working memory capacity and availability of resources necessary for efficient attentional control. This, in turn, can lead to escalating worry. Recent investigations into working memory training have shown improvements in attentional control and cognitive performance in high trait-anxious individuals and individuals with sub-clinical depression. The current randomised controlled trial investigated the effects of 15 days of adaptive n-back working memory training, or an active control task, on working memory capacity, attentional control and worry in a sample of high worriers. Pre-training, post-training and one-month follow-up measures of working memory capacity were assessed using a Change Detection task, while a Flanker task was used to assess attentional control. A breathing focus task was used as a behavioural measure of worry in addition to a number of self-report assessments of worry and anxiety. Overall there was no difference between the active training and the active control condition with both groups demonstrating similar improvements in working memory capacity and worry, post-training and at follow-up. However, training-related improvements on the n-back task were associated with gains in working memory capacity and reductions in worry symptoms in the active training condition. These results highlight the need for further research investigating the role of individual differences in working memory training. Copyright © 2017. Published by Elsevier Ltd.

  19. Supporting Adaptive and Adaptable Hypermedia Presentation Semantics

    NARCIS (Netherlands)

    D.C.A. Bulterman (Dick); L. Rutledge (Lloyd); L. Hardman (Lynda); J.R. van Ossenbruggen (Jacco)

    1999-01-01

    textabstractHaving the content of a presentation adapt to the needs, resources and prior activities of a user can be an important benefit of electronic documents. While part of this adaptation is related to the encodings of individual data streams, much of the adaptation can/should be guided by the

  20. Cerebellar transcranial direct current stimulation improves adaptive postural control.

    Science.gov (United States)

    Poortvliet, Peter; Hsieh, Billie; Cresswell, Andrew; Au, Jacky; Meinzer, Marcus

    2018-01-01

    Rehabilitation interventions contribute to recovery of impaired postural control, but it remains a priority to optimize their effectiveness. A promising strategy may involve transcranial direct current stimulation (tDCS) of brain areas involved in fine-tuning of motor adaptation. This study explored the effects of cerebellar tDCS (ctDCS) on postural recovery from disturbance by Achilles tendon vibration. Twenty-eight healthy volunteers participated in this sham-ctDCS controlled study. Standing blindfolded on a force platform, four trials were completed: 60 s quiet standing followed by 20 min active (anodal-tDCS, 1 mA, 20 min, N = 14) or sham-ctDCS (40 s, N = 14) tDCS; three quiet standing trials with 15 s of Achilles tendon vibration and 25 s of postural recovery. Postural steadiness was quantified as displacement, standard deviation and path derived from the center of pressure (COP). Baseline demographics and quiet standing postural steadiness, and backwards displacement during vibration were comparable between groups. However, active-tDCS significantly improved postural steadiness during vibration and reduced forward displacement and variability in COP derivatives during recovery. We demonstrate that ctDCS results in short-term improvement of postural adaptation in healthy individuals. Future studies need to investigate if multisession ctDCS combined with training or rehabilitation interventions can induce prolonged improvement of postural balance. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

  1. Metabolic adaptation to intermittent fasting is independent of peroxisome proliferator-activated receptor alpha

    Directory of Open Access Journals (Sweden)

    Guolin Li

    2018-01-01

    Full Text Available Background: Peroxisome proliferator-activated receptor alpha (PPARA is a major regulator of fatty acid oxidation and severe hepatic steatosis occurs during acute fasting in Ppara-null mice. Thus, PPARA is considered an important mediator of the fasting response; however, its role in other fasting regiments such as every-other-day fasting (EODF has not been investigated. Methods: Mice were pre-conditioned using either a diet containing the potent PPARA agonist Wy-14643 or an EODF regimen prior to acute fasting. Ppara-null mice were used to assess the contribution of PPARA activation during the metabolic response to EODF. Livers were collected for histological, biochemical, qRT-PCR, and Western blot analysis. Results: Acute fasting activated PPARA and led to steatosis, whereas EODF protected against fasting-induced hepatic steatosis without affecting PPARA signaling. In contrast, pretreatment with Wy-14,643 did activate PPARA signaling but did not ameliorate acute fasting-induced steatosis and unexpectedly promoted liver injury. Ppara ablation exacerbated acute fasting-induced hypoglycemia, hepatic steatosis, and liver injury in mice, whereas these detrimental effects were absent in response to EODF, which promoted PPARA-independent fatty acid metabolism and normalized serum lipids. Conclusions: These findings indicate that PPARA activation prior to acute fasting cannot ameliorate fasting-induced hepatic steatosis, whereas EODF induced metabolic adaptations to protect against fasting-induced steatosis without altering PPARA signaling. Therefore, PPARA activation does not mediate the metabolic adaptation to fasting, at least in preventing acute fasting-induced steatosis. Keywords: PPARA, PPARalpha, Intermittent fasting, Every-other-day fasting, Steatosis, Adaptive fasting response

  2. Root locus analysis and design of the adaptation process in active noise control.

    Science.gov (United States)

    Tabatabaei Ardekani, Iman; Abdulla, Waleed H

    2012-10-01

    This paper applies root locus theory to develop a graphical tool for the analysis and design of adaptive active noise control systems. It is shown that the poles of the adaptation process performed in these systems move on typical trajectories in the z-plane as the adaptation step-size varies. Based on this finding, the dominant root of the adaptation process and its trajectory can be determined. The first contribution of this paper is formulating parameters of the adaptation process root locus. The next contribution is introducing a mechanism for modifying the trajectory of the dominant root in the root locus. This mechanism creates a single open loop zero in the original root locus. It is shown that appropriate localization of this zero can cause the dominant root of the locus to be pushed toward the origin, and thereby the adaptation process becomes faster. The validity of the theoretical findings is confirmed in an experimental setup which is implemented using real-time multi-threading and multi-core processing techniques.

  3. A New Approach to Teaching Biomechanics Through Active, Adaptive, and Experiential Learning.

    Science.gov (United States)

    Singh, Anita

    2017-07-01

    Demand of biomedical engineers continues to rise to meet the needs of healthcare industry. Current training of bioengineers follows the traditional and dominant model of theory-focused curricula. However, the unmet needs of the healthcare industry warrant newer skill sets in these engineers. Translational training strategies such as solving real world problems through active, adaptive, and experiential learning hold promise. In this paper, we report our findings of adding a real-world 4-week problem-based learning unit into a biomechanics capstone course for engineering students. Surveys assessed student perceptions of the activity and learning experience. While students, across three cohorts, felt challenged to solve a real-world problem identified during the simulation lab visit, they felt more confident in utilizing knowledge learned in the biomechanics course and self-directed research. Instructor evaluations indicated that the active and experiential learning approach fostered their technical knowledge and life-long learning skills while exposing them to the components of adaptive learning and innovation.

  4. Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study.

    Science.gov (United States)

    Brosteanu, Oana; Schwarz, Gabriele; Houben, Peggy; Paulus, Ursula; Strenge-Hesse, Anke; Zettelmeyer, Ulrike; Schneider, Anja; Hasenclever, Dirk

    2017-12-01

    Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%-99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is -0.04 on the logit scale with two-sided 95

  5. Nonlinear attractor dynamics in the fundamental and extended prism adaptation paradigm

    International Nuclear Information System (INIS)

    Frank, T.D.; Blau, Julia J.C.; Turvey, M.T.

    2009-01-01

    Adaptation and re-adaptation processes are studied in terms of dynamic attractors that evolve and devolve. In doing so, a theoretical account is given for the fundamental observation that adaptation and re-adaptation processes do not exhibit one-trial learning. Moreover, the emergence of the latent aftereffect in the extended prism paradigm is addressed

  6. Adaptive semi-active control of buildings under seismic solicitations

    International Nuclear Information System (INIS)

    Roberti, V.; Jezequel, L.

    1993-01-01

    This paper describes an adaptive semi-active control method whereby nonlinear distributed systems are identified by their dynamical response. Approximate procedures are proposed which take into account the nonlinear behavior of the dynamic system considered. It is shown that only slight knowledge of nonlinearities is needed to apply feedback and feedforward control laws. The method is implemented to a simple example of a building with three degrees of freedom and the numerical results are analyzed

  7. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy

    DEFF Research Database (Denmark)

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen

    2017-01-01

    AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled...... trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting...... as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60...

  8. Active children through individual vouchers – evaluation (ACTIVE: protocol for a mixed method randomised control trial to increase physical activity levels in teenagers

    Directory of Open Access Journals (Sweden)

    Michaela James

    2017-07-01

    Full Text Available Abstract Background Many teenagers are insufficiently active despite the health benefits of physical activity (PA. There is strong evidence to show that inactivity and low fitness levels increase the risk of non-communicable diseases such as coronary heart disease (CHD, type 2 diabetes and breast and colon cancers (Lee et al. Lancet 380:219–29, 2012. A major barrier facing adolescents is accessibility (e.g. cost and lack of local facilities. The ACTIVE project aims to tackle this barrier through a multi-faceted intervention, giving teenagers vouchers to spend on activities of their choice and empowering young people to improve their fitness and PA levels. Design ACTIVE is a mixed methods randomised control trial in 7 secondary schools in Swansea, South Wales. Quantitative and qualitative measures including PA (cooper run test (CRT, accelerometery over 7 days, cardiovascular (CV measures (blood pressure, pulse wave analysis and focus groups will be undertaken at 4 separate time points (baseline, 6 months,12 months and follow-up at 18 months. Intervention schools will receive a multi-component intervention involving 12 months of £20 vouchers to spend on physical activities of their choice, a peer mentor scheme and opportunities to attend advocacy meetings. Control schools are encouraged to continue usual practice. The primary aim is to examine the effect of the intervention in improving cardiovascular fitness. Discussion This paper describes the protocol for the ACTIVE randomised control trial, which aims to increase fitness, physical activity and socialisation of teenagers in Swansea, UK via a voucher scheme combined with peer mentoring. Results can contribute to the evidence base on teenage physical activity and, if effective, the intervention has the potential to inform future physical activity interventions and policy. Trial registration ISRCTN75594310 (Assigned 06/03/2017.

  9. Adaptive tracking control for active suspension systems with non-ideal actuators

    Science.gov (United States)

    Pan, Huihui; Sun, Weichao; Jing, Xingjian; Gao, Huijun; Yao, Jianyong

    2017-07-01

    As a critical component of transportation vehicles, active suspension systems are instrumental in the improvement of ride comfort and maneuverability. However, practical active suspensions commonly suffer from parameter uncertainties (e.g., the variations of payload mass and suspension component parameters), external disturbances and especially the unknown non-ideal actuators (i.e., dead-zone and hysteresis nonlinearities), which always significantly deteriorate the control performance in practice. To overcome these issues, this paper synthesizes an adaptive tracking control strategy for vehicle suspension systems to achieve suspension performance improvements. The proposed control algorithm is formulated by developing a unified framework of non-ideal actuators rather than a separate way, which is a simple yet effective approach to remove the unexpected nonlinear effects. From the perspective of practical implementation, the advantages of the presented controller for active suspensions include that the assumptions on the measurable actuator outputs, the prior knowledge of nonlinear actuator parameters and the uncertain parameters within a known compact set are not required. Furthermore, the stability of the closed-loop suspension system is theoretically guaranteed by rigorous mathematical analysis. Finally, the effectiveness of the presented adaptive control scheme is confirmed using comparative numerical simulation validations.

  10. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

    Directory of Open Access Journals (Sweden)

    Guallar Eliseo

    2010-12-01

    Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

  11. The influence of negative stimulus features on conflict adaption:Evidence from fluency of processing

    Directory of Open Access Journals (Sweden)

    Julia eFritz

    2015-02-01

    Full Text Available Cognitive control enables adaptive behavior in a dynamically changing environment. In this context, one prominent adaptation effect is the sequential conflict adjustment, i.e. the observation of reduced response interference on trials following conflict trials. Increasing evidence suggests that such response conflicts are registered as aversive signals. So far, however, the functional role of this aversive signal for conflict adaptation to occur has not been put to test directly. In two experiments, the affective valence of conflict stimuli was manipulated by fluency of processing (stimulus contrast. Experiment 1 used a flanker interference task, Experiment 2 a color-word Stroop task. In both experiments, conflict adaptation effects were only present in fluent, but absent in disfluent trials. Results thus speak against the simple idea that any aversive stimulus feature is suited to promote specific conflict adjustments. Two alternative but not mutually exclusive accounts, namely resource competition and adaptation-by-motivation, will be discussed.

  12. A single-rate context-dependent learning process underlies rapid adaptation to familiar object dynamics.

    Science.gov (United States)

    Ingram, James N; Howard, Ian S; Flanagan, J Randall; Wolpert, Daniel M

    2011-09-01

    Motor learning has been extensively studied using dynamic (force-field) perturbations. These induce movement errors that result in adaptive changes to the motor commands. Several state-space models have been developed to explain how trial-by-trial errors drive the progressive adaptation observed in such studies. These models have been applied to adaptation involving novel dynamics, which typically occurs over tens to hundreds of trials, and which appears to be mediated by a dual-rate adaptation process. In contrast, when manipulating objects with familiar dynamics, subjects adapt rapidly within a few trials. Here, we apply state-space models to familiar dynamics, asking whether adaptation is mediated by a single-rate or dual-rate process. Previously, we reported a task in which subjects rotate an object with known dynamics. By presenting the object at different visual orientations, adaptation was shown to be context-specific, with limited generalization to novel orientations. Here we show that a multiple-context state-space model, with a generalization function tuned to visual object orientation, can reproduce the time-course of adaptation and de-adaptation as well as the observed context-dependent behavior. In contrast to the dual-rate process associated with novel dynamics, we show that a single-rate process mediates adaptation to familiar object dynamics. The model predicts that during exposure to the object across multiple orientations, there will be a degree of independence for adaptation and de-adaptation within each context, and that the states associated with all contexts will slowly de-adapt during exposure in one particular context. We confirm these predictions in two new experiments. Results of the current study thus highlight similarities and differences in the processes engaged during exposure to novel versus familiar dynamics. In both cases, adaptation is mediated by multiple context-specific representations. In the case of familiar object dynamics

  13. A single-rate context-dependent learning process underlies rapid adaptation to familiar object dynamics.

    Directory of Open Access Journals (Sweden)

    James N Ingram

    2011-09-01

    Full Text Available Motor learning has been extensively studied using dynamic (force-field perturbations. These induce movement errors that result in adaptive changes to the motor commands. Several state-space models have been developed to explain how trial-by-trial errors drive the progressive adaptation observed in such studies. These models have been applied to adaptation involving novel dynamics, which typically occurs over tens to hundreds of trials, and which appears to be mediated by a dual-rate adaptation process. In contrast, when manipulating objects with familiar dynamics, subjects adapt rapidly within a few trials. Here, we apply state-space models to familiar dynamics, asking whether adaptation is mediated by a single-rate or dual-rate process. Previously, we reported a task in which subjects rotate an object with known dynamics. By presenting the object at different visual orientations, adaptation was shown to be context-specific, with limited generalization to novel orientations. Here we show that a multiple-context state-space model, with a generalization function tuned to visual object orientation, can reproduce the time-course of adaptation and de-adaptation as well as the observed context-dependent behavior. In contrast to the dual-rate process associated with novel dynamics, we show that a single-rate process mediates adaptation to familiar object dynamics. The model predicts that during exposure to the object across multiple orientations, there will be a degree of independence for adaptation and de-adaptation within each context, and that the states associated with all contexts will slowly de-adapt during exposure in one particular context. We confirm these predictions in two new experiments. Results of the current study thus highlight similarities and differences in the processes engaged during exposure to novel versus familiar dynamics. In both cases, adaptation is mediated by multiple context-specific representations. In the case of familiar

  14. Adaptation of My Classroom Activities Scale to Turkish Culture: Validity and Reliability Study

    Directory of Open Access Journals (Sweden)

    Kaan Zülfikar DENİZ

    2017-06-01

    Full Text Available Student interest in class activities, their enjoyment of activity topics, their ability to make choices about the activity topics, and opportunities for students to challenge themselves during activities are among basic components that support their higher level learning. Properties of educational activities that make them interesting, enjoyable, and challenging while allowing students with choices are also among properties that are known to be necessary in all educational content, processes, and products within educational systems of the 21st century. Consequently, measuring these properties is also of great importance. The goal of this study is to perform the Turkish adaptation of the My Class Activities Scale, developed by Gentry and Gable (2001 in the United States and subsequently adapted to the Korean, Chinese, and Arabic languages. To this end, data was collected from 214 students attending 3rd, 4th, 5th, 6th, 7th, and 8th grades during the 2015-2016 academic year. As part of the validity study for the scale, the factor structure obtained from the original development of the scale was tested using the Confirmatory Factor Analysis (CFA method. Moreover, item-total correlation and inter-dimensional correlation analyses were also performed as part of the validity study. In studying the reliability of the scale, the Cronbach-Alpha reliability coefficients were estimated (Cronbach alpha values ranged between 0.82-0.90. Based on the results, the factor structure of the scale was verified in parallel with the original development work for the scale. In conclusion, the validity and reliability of using the scale in Turkey was established, contributing a new scale adaptation to the Turkish literature for use in different studies.

  15. Adaptability and Prediction of Anticipatory Muscular Activity Parameters to Different Movements in the Sitting Position.

    Science.gov (United States)

    Chikh, Soufien; Watelain, Eric; Faupin, Arnaud; Pinti, Antonio; Jarraya, Mohamed; Garnier, Cyril

    2016-08-01

    Voluntary movement often causes postural perturbation that requires an anticipatory postural adjustment to minimize perturbation and increase the efficiency and coordination during execution. This systematic review focuses specifically on the relationship between the parameters of anticipatory muscular activities and movement finality in sitting position among adults, to study the adaptability and predictability of anticipatory muscular activities parameters to different movements and conditions in sitting position in adults. A systematic literature search was performed using PubMed, Science Direct, Web of Science, Springer-Link, Engineering Village, and EbscoHost. Inclusion and exclusion criteria were applied to retain the most rigorous and specific studies, yielding 76 articles, Seventeen articles were excluded at first reading, and after the application of inclusion and exclusion criteria, 23 were retained. In a sitting position, central nervous system activity precedes movement by diverse anticipatory muscular activities and shows the ability to adapt anticipatory muscular activity parameters to the movement direction, postural stability, or charge weight. In addition, these parameters could be adapted to the speed of execution, as found for the standing position. Parameters of anticipatory muscular activities (duration, order, and amplitude of muscle contractions constituting the anticipatory muscular activity) could be used as a predictive indicator of forthcoming movement. In addition, this systematic review may improve methodology in empirical studies and assistive technology for people with disabilities. © The Author(s) 2016.

  16. Cognitive performance and electrophysiological indices of cognitive control: a validation study of conflict adaptation.

    Science.gov (United States)

    Clayson, Peter E; Larson, Michael J

    2012-05-01

    Psychiatric and neurologic disorders are associated with deficits in the postconflict recruitment of cognitive control. The primary aim of this study was to validate the relationship between cognitive functioning and indices of conflict adaptation. Event-related potentials were obtained from 89 healthy individuals who completed an Eriksen flanker task. Neuropsychological domains tested included memory, verbal fluency, and attention/executive functioning. Behavioral measures and N2 amplitudes showed significant conflict adaptation (i.e., previous-trial congruencies influenced current-trial measures). Higher scores on the attention/executive functioning and verbal fluency domains were associated with larger incongruent-trial N2 conflict adaptation; measures of cognitive functioning were not related to behavioral indices. This study provides initial validation of N2 conflict adaptation effects as cognitive function-related aspects of cognitive control. Copyright © 2012 Society for Psychophysiological Research.

  17. A culturally adapted survivorship programme for Asian early stage breast cancer patients in Singapore: A randomized, controlled trial.

    Science.gov (United States)

    Chan, Alexandre; Gan, Yan Xiang; Oh, Suan Kai; Ng, Terence; Shwe, Maung; Chan, Raymond; Ng, Raymond; Goh, Brandon; Tan, Yee Pin; Fan, Gilbert

    2017-10-01

    As cancer mortality rates improve in Singapore, there is an increasing need to improve the transition to posttreatment survivorship care. This study aimed to evaluate the effectiveness of a psychoeducation group (PEG) intervention program compared with usual care to reduce distress for physical symptom and psychological aspects in Asian breast cancer survivors who have completed adjuvant chemotherapy. This was a randomized, controlled trial comprising 72 Asian early stage breast cancer survivors who were randomized into the PEG (n = 34) or the control (n = 38) arm. The participants in the PEG arm underwent a weekly multidisciplinary PEG program delivered in a group format over 3 weeks coupled with cultural adaptation. Both arms were assessed at baseline and 2 months after intervention using the Rotterdam Symptom Checklist, Beck Anxiety Inventory, and EORTC QLQ-C30. A satisfaction questionnaire was also conducted among those survivors who have participated in the PEG program. Effective sizes were calculated using Cohen d. The mean age ± SD of all participants was 53.0 ± 8.9 years, with the majority being Chinese (84.7%) and Malay (6.9%), and clinical characteristics were well balanced in both arms. Compared to the control arm, the PEG arm showed a significantly greater reduction in physical symptom distress (d = 0.76, P = .01) and fatigue (d = 0.49, P = .04). The 82.4% of the participants in the intervention group responded to the satisfaction questionnaire, and the majority (92.9%) agreed that the overall duration of the PEG intervention program was appropriate. A culturally adapted PEG program was effective in reducing physical symptom distress in Asian breast cancer survivors. (ClinicalTrials.gov: NCT02600299). Copyright © 2016 John Wiley & Sons, Ltd.

  18. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rejeski W Jack

    2011-05-01

    Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

  19. The modulatory effect of adaptive deep brain stimulation on beta bursts in Parkinson's disease.

    Science.gov (United States)

    Tinkhauser, Gerd; Pogosyan, Alek; Little, Simon; Beudel, Martijn; Herz, Damian M; Tan, Huiling; Brown, Peter

    2017-04-01

    Adaptive deep brain stimulation uses feedback about the state of neural circuits to control stimulation rather than delivering fixed stimulation all the time, as currently performed. In patients with Parkinson's disease, elevations in beta activity (13-35 Hz) in the subthalamic nucleus have been demonstrated to correlate with clinical impairment and have provided the basis for feedback control in trials of adaptive deep brain stimulation. These pilot studies have suggested that adaptive deep brain stimulation may potentially be more effective, efficient and selective than conventional deep brain stimulation, implying mechanistic differences between the two approaches. Here we test the hypothesis that such differences arise through differential effects on the temporal dynamics of beta activity. The latter is not constantly increased in Parkinson's disease, but comes in bursts of different durations and amplitudes. We demonstrate that the amplitude of beta activity in the subthalamic nucleus increases in proportion to burst duration, consistent with progressively increasing synchronization. Effective adaptive deep brain stimulation truncated long beta bursts shifting the distribution of burst duration away from long duration with large amplitude towards short duration, lower amplitude bursts. Critically, bursts with shorter duration are negatively and bursts with longer duration positively correlated with the motor impairment off stimulation. Conventional deep brain stimulation did not change the distribution of burst durations. Although both adaptive and conventional deep brain stimulation suppressed mean beta activity amplitude compared to the unstimulated state, this was achieved by a selective effect on burst duration during adaptive deep brain stimulation, whereas conventional deep brain stimulation globally suppressed beta activity. We posit that the relatively selective effect of adaptive deep brain stimulation provides a rationale for why this approach could

  20. Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

    Science.gov (United States)

    Lin, Ja-An; He, Pei

    2015-06-01

    Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  1. Aero-Effected Distributed Adaptive Control of Flexible Aircraft Using Active Bleed, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed research focuses on the development of a new adaptive control methodology for active control of wing aerodynamic shape to effect distributed aerodynamic...

  2. Effects of active video games on body composition: a randomized controlled trial.

    Science.gov (United States)

    Maddison, Ralph; Foley, Louise; Ni Mhurchu, Cliona; Jiang, Yannan; Jull, Andrew; Prapavessis, Harry; Hohepa, Maea; Rodgers, Anthony

    2011-07-01

    Sedentary activities such as video gaming are independently associated with obesity. Active video games, in which players physically interact with images on screen, may help increase physical activity and improve body composition. The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight, body composition, physical activity, and physical fitness. We conducted a 2-arm, parallel, randomized controlled trial in Auckland, New Zealand. A total of 322 overweight and obese children aged 10-14 y, who were current users of sedentary video games, were randomly assigned at a 1:1 ratio to receive either an active video game upgrade package (intervention, n = 160) or to have no change (control group, n = 162). The primary outcome was the change from baseline in body mass index (BMI; in kg/m(2)). Secondary outcomes were changes in percentage body fat, physical activity, cardiorespiratory fitness, video game play, and food snacking. At 24 wk, the treatment effect on BMI (-0.24; 95% CI: -0.44, -0.05; P = 0.02) favored the intervention group. The change (±SE) in BMI from baseline increased in the control group (0.34 ± 0.08) but remained the same in the intervention group (0.09 ± 0.08). There was also evidence of a reduction in body fat in the intervention group (-0.83%; 95% CI: -1.54%, -0.12%; P = 0.02). The change in daily time spent playing active video games at 24 wk increased (10.03 min; 95% CI: 6.26, 13.81 min; P video games (-9.39 min; 95% CI: -19.38, 0.59 min; P = 0.06). An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children. This trial was registered in the Australian New Zealand Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493.

  3. Energy transfer in light-adapted photosynthetic membranes: from active to saturated photosynthesis.

    Science.gov (United States)

    Fassioli, Francesca; Olaya-Castro, Alexandra; Scheuring, Simon; Sturgis, James N; Johnson, Neil F

    2009-11-04

    In bacterial photosynthesis light-harvesting complexes, LH2 and LH1 absorb sunlight energy and deliver it to reaction centers (RCs) with extraordinarily high efficiency. Submolecular resolution images have revealed that both the LH2:LH1 ratio, and the architecture of the photosynthetic membrane itself, adapt to light intensity. We investigate the functional implications of structural adaptations in the energy transfer performance in natural in vivo low- and high-light-adapted membrane architectures of Rhodospirillum photometricum. A model is presented to describe excitation migration across the full range of light intensities that cover states from active photosynthesis, where all RCs are available for charge separation, to saturated photosynthesis where all RCs are unavailable. Our study outlines three key findings. First, there is a critical light-energy density, below which the low-light adapted membrane is more efficient at absorbing photons and generating a charge separation at RCs, than the high-light-adapted membrane. Second, connectivity of core complexes is similar in both membranes, suggesting that, despite different growth conditions, a preferred transfer pathway is through core-core contacts. Third, there may be minimal subareas on the membrane which, containing the same LH2:LH1 ratio, behave as minimal functional units as far as excitation transfer efficiency is concerned.

  4. A cluster-randomised controlled trial to promote physical activity in adolescents: the Raising Awareness of Physical Activity (RAW-PA Study

    Directory of Open Access Journals (Sweden)

    Nicola D. Ridgers

    2017-01-01

    Full Text Available Abstract Background Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents’ daily physical activity levels. Methods/Design RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13–14 years. Participants’ moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity will also be collected. Discussion To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents’ physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy. Trial registration Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016.

  5. Local adaptation of the National Physical Activity Plan: creation of the Active Living Plan for a Healthier San Antonio.

    Science.gov (United States)

    Esparza, Laura A; Velasquez, Katherine S; Zaharoff, Annette M

    2014-03-01

    Physical inactivity and related health consequences are serious public health threats. Effective strategies to facilitate and support active-living opportunities must be implemented at national, state, and local levels. San Antonio, Texas, health department officials launched the Active Living Council of San Antonio (ALCSA) to engage the community in developing a 3- to 5-year plan to promote active living. A steering committee set preliminary ALCSA aims and established a multisector membership structure modeled after the US National Physical Activity Plan (NPAP). ALCSA adopted governance standards, increased knowledge of physical activity and health, and engaged in an 18-month collaborative master plan writing process. ALCSA selected overarching strategies and evidence-based strategies for each societal sector and adapted strategies to the local context, including tactics, measures of success, and timelines. Community and expert engagement led to a localized plan reflecting national recommendations, the Active Living Plan for a Healthier San Antonio. Multisector collaborations among governmental agencies and community organizations, which were successfully developed in this case to produce the first-ever local adaptation of the NPAP, require clearly defined expectations. Lessons learned in ALCSA's organizational and plan development can serve as a model for future community-driven efforts to increase active living.

  6. Learning-induced Dependence of Neuronal Activity in Primary Motor Cortex on Motor Task Condition.

    Science.gov (United States)

    Cai, X; Shimansky, Y; He, Jiping

    2005-01-01

    A brain-computer interface (BCI) system such as a cortically controlled robotic arm must have a capacity of adjusting its function to a specific environmental condition. We studied this capacity in non-human primates based on chronic multi-electrode recording from the primary motor cortex of a monkey during the animal's performance of a center-out 3D reaching task and adaptation to external force perturbations. The main condition-related feature of motor cortical activity observed before the onset of force perturbation was a phasic raise of activity immediately before the perturbation onset. This feature was observed during a series of perturbation trials, but were absent under no perturbations. After adaptation has been completed, it usually was taking the subject only one trial to recognize a change in the condition to switch the neuronal activity accordingly. These condition-dependent features of neuronal activity can be used by a BCI for recognizing a change in the environmental condition and making corresponding adjustments, which requires that the BCI-based control system possess such advanced properties of the neural motor control system as capacity to learn and adapt.

  7. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

  8. Genotype x Environmental Interactions and Adaptation Abilities of Chickpea (Cicer arietinum L.) in Cukurova Conditions

    OpenAIRE

    MART, Dürdane

    2015-01-01

    During the study, at which genotype x environmental interactions and adaptation capacity of 18 chickpea varieties that took place at yield trials conducted in years 2001, 2002 and 2003 at two different locations (Doğankent, Taşçı) in Çukurova region were studied, it has been observed that studied characteristics are significantly affected from trial locations. Chickpea varieties used in the yield trial, demonstrated different adaptation capacities to different environmental conditions in term...

  9. Inactive experiments for advanced separation processes prior to high activity trials in ATALANTE

    International Nuclear Information System (INIS)

    Duhamet, Jean; Lanoe, Jean-Yves; Rivalier, Patrick; Borda, Gilles

    2008-01-01

    Many trials have been performed in ATALANTE's shielded cells to demonstrate the technical feasibility of processes involving minor actinide separation. They required developments of new extractors as well as a step by step procedure have been used to lower the risks of malfunction during high active operation. The design of the extractors developed by Cea has included shielded cells restrictions, miniaturization to lower the quantity of high active material and wastes and the care for being representative of industrial equipment. After individual shake down inactive tests, with actual phases, each process experiment scheduled in ATALANTE has been tested at G1 Facility in Marcoule. The objective was to reproduce as much as possible all the equipment chosen for active tests. This procedure has demonstrated its efficiency to detect many problems that would have heavy impact if they have been discovered during active trials. It was also used for operators'training. (authors)

  10. Vitamin C and E supplementation hampers cellular adaptation to endurance training in humans: a double-blind, randomised, controlled trial.

    Science.gov (United States)

    Paulsen, Gøran; Cumming, Kristoffer T; Holden, Geir; Hallén, Jostein; Rønnestad, Bent Ronny; Sveen, Ole; Skaug, Arne; Paur, Ingvild; Bastani, Nasser E; Østgaard, Hege Nymo; Buer, Charlotte; Midttun, Magnus; Freuchen, Fredrik; Wiig, Havard; Ulseth, Elisabeth Tallaksen; Garthe, Ina; Blomhoff, Rune; Benestad, Haakon B; Raastad, Truls

    2014-04-15

    In this double-blind, randomised, controlled trial, we investigated the effects of vitamin C and E supplementation on endurance training adaptations in humans. Fifty-four young men and women were randomly allocated to receive either 1000 mg of vitamin C and 235 mg of vitamin E or a placebo daily for 11 weeks. During supplementation, the participants completed an endurance training programme consisting of three to four sessions per week (primarily of running), divided into high-intensity interval sessions [4-6 × 4-6 min; >90% of maximal heart rate (HRmax)] and steady state continuous sessions (30-60 min; 70-90% of HRmax). Maximal oxygen uptake (VO2 max ), submaximal running and a 20 m shuttle run test were assessed and blood samples and muscle biopsies were collected, before and after the intervention. Participants in the vitamin C and E group increased their VO2 max (mean ± s.d.: 8 ± 5%) and performance in the 20 m shuttle test (10 ± 11%) to the same degree as those in the placebo group (mean ± s.d.: 8 ± 5% and 14 ± 17%, respectively). However, the mitochondrial marker cytochrome c oxidase subunit IV (COX4) and cytosolic peroxisome proliferator-activated receptor-γ coactivator 1 α (PGC-1α) increased in the m. vastus lateralis in the placebo group by 59 ± 97% and 19 ± 51%, respectively, but not in the vitamin C and E group (COX4: -13 ± 54%; PGC-1α: -13 ± 29%; P ≤ 0.03, between groups). Furthermore, mRNA levels of CDC42 and mitogen-activated protein kinase 1 (MAPK1) in the trained muscle were lower in the vitamin C and E group than in the placebo group (P ≤ 0.05). Daily vitamin C and E supplementation attenuated increases in markers of mitochondrial biogenesis following endurance training. However, no clear interactions were detected for improvements in VO2 max and running performance. Consequently, vitamin C and E supplementation hampered cellular adaptations in the exercised muscles, and although this did not translate to the performance tests

  11. Modern dose-finding designs for cancer phase I trials drug combinations and molecularly targeted agents

    CERN Document Server

    Hirakawa, Akihiro; Daimon, Takashi; Matsui, Shigeyuki

    2018-01-01

    This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of tw...

  12. Say what you mean: rethinking disability language in Adapted Physical Activity Quarterly.

    Science.gov (United States)

    Peers, Danielle; Spencer-Cavaliere, Nancy; Eales, Lindsay

    2014-07-01

    Adapted Physical Activity Quarterly (APAQ) currently mandates that authors use person-first language in their publications. In this viewpoint article, we argue that although this policy is well intentioned, it betrays a very particular cultural and disciplinary approach to disability: one that is inappropriate given the international and multidisciplinary mandate of the journal. Further, we contend that APAQ's current language policy may serve to delimit the range of high-quality articles submitted and to encourage both theoretical inconsistency and the erasure of the ways in which research participants self-identify. The article begins with narrative accounts of each of our negotiations with disability terminology in adapted physical activity research and practice. We then provide historical and theoretical contexts for person-first language, as well as various other widely circulated alternative English-language disability terminology. We close with four suggested revisions to APAQ's language policy.

  13. Uncertainty of feedback and state estimation determines the speed of motor adaptation

    Directory of Open Access Journals (Sweden)

    Kunlin Wei

    2010-05-01

    Full Text Available Humans can adapt their motor behaviors to deal with ongoing changes. To achieve this, the nervous system needs to estimate central variables for our movement based on past knowledge and new feedback, both of which are uncertain. In the Bayesian framework, rates of adaptation characterize how noisy feedback is in comparison to the uncertainty of the state estimate. The predictions of Bayesian models are intuitive: the nervous system should adapt slower when sensory feedback is more noisy and faster when its state estimate is more uncertain. Here we want to quantitatively understand how uncertainty in these two factors affects motor adaptation. In a hand reaching experiment we measured trial-by-trial adaptation to a randomly changing visual perturbation to characterize the way the nervous system handles uncertainty in state estimation and feedback. We found both qualitative predictions of Bayesian models confirmed. Our study provides evidence that the nervous system represents and uses uncertainty in state estimate and feedback during motor adaptation.

  14. "Active Team" a social and gamified app-based physical activity intervention: randomised controlled trial study protocol.

    Science.gov (United States)

    Edney, Sarah; Plotnikoff, Ronald; Vandelanotte, Corneel; Olds, Tim; De Bourdeaudhuij, Ilse; Ryan, Jillian; Maher, Carol

    2017-11-02

    Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app. The study is a three-group, cluster-RCT. Four hundred and forty (440) inactive Australian adults who use Facebook at least weekly will be recruited in clusters of three to eight existing Facebook friends. Participant clusters will be randomly allocated to one of three conditions: (1) waitlist control condition, (2) basic experimental condition (pedometer plus basic app with no social and gamification features), or (3) socially-enhanced experimental condition (pedometer plus app with social and gamification features). Participants will undertake assessments at baseline, three and nine months. The primary outcome is change in total daily minutes of moderate-to-vigorous physical activity at three months measured objectively using GENEActive accelerometers [Activeinsights Ltd., UK]. Secondary outcomes include self-reported physical activity, depression and anxiety, wellbeing, quality of life, social-cognitive theory constructs and app usage and engagement. The current study will incorporate novel social and gamification elements in order to examine whether the inclusion of these components increases the efficacy of app-based physical activity interventions. The findings will be used to guide the development and increase the effectiveness of future health

  15. From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

    Science.gov (United States)

    Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

    2011-01-01

    Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

  16. Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

    Science.gov (United States)

    Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

    2016-03-01

    Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Adaptive neural networks control for camera stabilization with active suspension system

    Directory of Open Access Journals (Sweden)

    Feng Zhao

    2015-08-01

    Full Text Available The camera always suffers from image instability on the moving vehicle due to unintentional vibrations caused by road roughness. This article presents an adaptive neural network approach mixed with linear quadratic regulator control for a quarter-car active suspension system to stabilize the image captured area of the camera. An active suspension system provides extra force through the actuator which allows it to suppress vertical vibration of sprung mass. First, to deal with the road disturbance and the system uncertainties, radial basis function neural network is proposed to construct the map between the state error and the compensation component, which can correct the optimal state-feedback control law. The weights matrix of radial basis function neural network is adaptively tuned online. Then, the closed-loop stability and asymptotic convergence performance is guaranteed by Lyapunov analysis. Finally, the simulation results demonstrate that the proposed controller effectively suppresses the vibration of the camera and enhances the stabilization of the entire camera, where different excitations are considered to validate the system performance.

  18. Adaptation of feedforward movement control is abnormal in patients with cervical dystonia and tremor.

    Science.gov (United States)

    Avanzino, Laura; Ravaschio, Andrea; Lagravinese, Giovanna; Bonassi, Gaia; Abbruzzese, Giovanni; Pelosin, Elisa

    2018-01-01

    It is under debate whether the cerebellum plays a role in dystonia pathophysiology and in the expression of clinical phenotypes. We investigated a typical cerebellar function (anticipatory movement control) in patients with cervical dystonia (CD) with and without tremor. Twenty patients with CD, with and without tremor, and 17 healthy controls were required to catch balls of different load: 15 trials with a light ball, 25 trials with a heavy ball (adaptation) and 15 trials with a light ball (post-adaptation). Arm movements were recorded using a motion capture system. We evaluated: (i) the anticipatory adjustment (just before the impact); (ii) the extent and rate of the adaptation (at the impact) and (iii) the aftereffect in the post-adaptation phase. The anticipatory adjustment was reduced during adaptation in CD patients with tremor respect to CD patients without tremor and controls. The extent and rate of adaptation and the aftereffect in the post-adaptation phase were smaller in CD with tremor than in controls and CD without tremor. Patients with cervical dystonia and tremor display an abnormal predictive movement control. Our findings point to a possible role of cerebellum in the expression of a clinical phenotype in dystonia. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

  19. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial.

    Science.gov (United States)

    Rovniak, Liza S; Kong, Lan; Hovell, Melbourne F; Ding, Ding; Sallis, James F; Ray, Chester A; Kraschnewski, Jennifer L; Matthews, Stephen A; Kiser, Elizabeth; Chinchilli, Vernon M; George, Daniel R; Sciamanna, Christopher N

    2016-12-01

    Social networks can influence physical activity, but little is known about how best to engineer online and in-person social networks to increase activity. The purpose of this study was to conduct a randomized trial based on the Social Networks for Activity Promotion model to assess the incremental contributions of different procedures for building social networks on objectively measured outcomes. Physically inactive adults (n = 308, age, 50.3 (SD = 8.3) years, 38.3 % male, 83.4 % overweight/obese) were randomized to one of three groups. The Promotion group evaluated the effects of weekly emailed tips emphasizing social network interactions for walking (e.g., encouragement, informational support); the Activity group evaluated the incremental effect of adding an evidence-based online fitness walking intervention to the weekly tips; and the Social Networks group evaluated the additional incremental effect of providing access to an online networking site for walking as well as prompting walking/activity across diverse settings. The primary outcome was mean change in accelerometer-measured moderate-to-vigorous physical activity (MVPA), assessed at 3 and 9 months from baseline. Participants increased their MVPA by 21.0 min/week, 95 % CI [5.9, 36.1], p = .005, at 3 months, and this change was sustained at 9 months, with no between-group differences. Although the structure of procedures for targeting social networks varied across intervention groups, the functional effect of these procedures on physical activity was similar. Future research should evaluate if more powerful reinforcers improve the effects of social network interventions. The trial was registered with the ClinicalTrials.gov (NCT01142804).

  20. Stepping strategies for regulating gait adaptability and stability.

    Science.gov (United States)

    Hak, Laura; Houdijk, Han; Steenbrink, Frans; Mert, Agali; van der Wurff, Peter; Beek, Peter J; van Dieën, Jaap H

    2013-03-15

    Besides a stable gait pattern, gait in daily life requires the capability to adapt this pattern in response to environmental conditions. The purpose of this study was to elucidate the anticipatory strategies used by able-bodied people to attain an adaptive gait pattern, and how these strategies interact with strategies used to maintain gait stability. Ten healthy subjects walked in a Computer Assisted Rehabilitation ENvironment (CAREN). To provoke an adaptive gait pattern, subjects had to hit virtual targets, with markers guided by their knees, while walking on a self-paced treadmill. The effects of walking with and without this task on walking speed, step length, step frequency, step width and the margins of stability (MoS) were assessed. Furthermore, these trials were performed with and without additional continuous ML platform translations. When an adaptive gait pattern was required, subjects decreased step length (padaptations resulted in the preservation of equal MoS between trials, despite the disturbing influence of the gait adaptability task. When the gait adaptability task was combined with the balance perturbation subjects further decreased step length, as evidenced by a significant interaction between both manipulations (p=0.012). In conclusion, able-bodied people reduce step length and increase step width during walking conditions requiring a high level of both stability and adaptability. Although an increase in step frequency has previously been found to enhance stability, a faster movement, which would coincide with a higher step frequency, hampers accuracy and may consequently limit gait adaptability. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Increasing girls’ physical activity during an organised youth sport basketball program: a randomised controlled trial protocol

    Science.gov (United States)

    2014-01-01

    Background Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples’ moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players’ MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. Methods/design A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players’ MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players’ perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. Discussion The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study’s findings will

  2. A cluster-randomized controlled trial of strategies to increase adolescents’ physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP trial

    Directory of Open Access Journals (Sweden)

    Rosenkranz Richard R

    2012-10-01

    Full Text Available Abstract Background The physical activity (PA levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children’s motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT, on PA levels, and their hypothesized antecedents, during year 8 PE lessons. Methods/design This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16 and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1 explaining the relevance of activities; (2 providing choice from PA options selected by the teacher; (3 providing equipment and free choice of activities; or (4 usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested

  3. The Pupillary Orienting Response Predicts Adaptive Behavioral Adjustment after Errors.

    Directory of Open Access Journals (Sweden)

    Peter R Murphy

    Full Text Available Reaction time (RT is commonly observed to slow down after an error. This post-error slowing (PES has been thought to arise from the strategic adoption of a more cautious response mode following deployment of cognitive control. Recently, an alternative account has suggested that PES results from interference due to an error-evoked orienting response. We investigated whether error-related orienting may in fact be a pre-cursor to adaptive post-error behavioral adjustment when the orienting response resolves before subsequent trial onset. We measured pupil dilation, a prototypical measure of autonomic orienting, during performance of a choice RT task with long inter-stimulus intervals, and found that the trial-by-trial magnitude of the error-evoked pupil response positively predicted both PES magnitude and the likelihood that the following response would be correct. These combined findings suggest that the magnitude of the error-related orienting response predicts an adaptive change of response strategy following errors, and thereby promote a reconciliation of the orienting and adaptive control accounts of PES.

  4. Active Hearing Mechanisms Inspire Adaptive Amplification in an Acoustic Sensor System.

    Science.gov (United States)

    Guerreiro, Jose; Reid, Andrew; Jackson, Joseph C; Windmill, James F C

    2018-06-01

    Over many millions of years of evolution, nature has developed some of the most adaptable sensors and sensory systems possible, capable of sensing, conditioning and processing signals in a very power- and size-effective manner. By looking into biological sensors and systems as a source of inspiration, this paper presents the study of a bioinspired concept of signal processing at the sensor level. By exploiting a feedback control mechanism between a front-end acoustic receiver and back-end neuronal based computation, a nonlinear amplification with hysteretic behavior is created. Moreover, the transient response of the front-end acoustic receiver can also be controlled and enhanced. A theoretical model is proposed and the concept is prototyped experimentally through an embedded system setup that can provide dynamic adaptations of a sensory system comprising a MEMS microphone placed in a closed-loop feedback system. It faithfully mimics the mosquito's active hearing response as a function of the input sound intensity. This is an adaptive acoustic sensor system concept that can be exploited by sensor and system designers within acoustics and ultrasonic engineering fields.

  5. Materials learning from life: concepts for active, adaptive and autonomous molecular systems.

    Science.gov (United States)

    Merindol, Rémi; Walther, Andreas

    2017-09-18

    Bioinspired out-of-equilibrium systems will set the scene for the next generation of molecular materials with active, adaptive, autonomous, emergent and intelligent behavior. Indeed life provides the best demonstrations of complex and functional out-of-equilibrium systems: cells keep track of time, communicate, move, adapt, evolve and replicate continuously. Stirred by the understanding of biological principles, artificial out-of-equilibrium systems are emerging in many fields of soft matter science. Here we put in perspective the molecular mechanisms driving biological functions with the ones driving synthetic molecular systems. Focusing on principles that enable new levels of functionalities (temporal control, autonomous structures, motion and work generation, information processing) rather than on specific material classes, we outline key cross-disciplinary concepts that emerge in this challenging field. Ultimately, the goal is to inspire and support new generations of autonomous and adaptive molecular devices fueled by self-regulating chemistry.

  6. Physical activity as a treatment for depression: the TREAD randomised trial protocol

    Directory of Open Access Journals (Sweden)

    Lawlor Debbie A

    2010-11-01

    Full Text Available Abstract Background Depression is one of the most common reasons for consulting a General Practitioner (GP within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R, a Beck Depression Inventory (BDI score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT basis and will use linear and logistic regression models to compare treatments. Discussion The results of

  7. Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain.

    Science.gov (United States)

    Gao, Jingjing; Nangia, Narinder; Jia, Jia; Bolognese, James; Bhattacharyya, Jaydeep; Patel, Nitin

    2017-06-01

    In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Requirements Elicitation in a Telemedicine Pain-treatment Trial

    NARCIS (Netherlands)

    Widya, I.A.; Bults, Richard G.A.; van Beijnum, Bernhard J.F.; Sandsjö, L.; Schaake, L.; Huis in 't Veld, M.H.A.; Jones, Valerie M.; Hermens, Hermanus J.; Ryan, K.; Robinson, W.

    2009-01-01

    This paper presents the early phase requirements elicitation for a work-related neck-shoulder pain teletreatment trial and the assessment of those requirements in respect of their importance to the trial and the feasibility of the needed software adaptations of the telemedicine system within the

  9. Glucose pathways adaptation supports acquisition of activated microglia phenotype.

    Science.gov (United States)

    Gimeno-Bayón, J; López-López, A; Rodríguez, M J; Mahy, N

    2014-06-01

    With its capacity to survey the environment and phagocyte debris, microglia assume a diversity of phenotypes to respond specifically through neurotrophic and toxic effects. Although these roles are well accepted, the underlying energetic mechanisms associated with microglial activation remain largely unclear. This study investigates microglia metabolic adaptation to ATP, NADPH, H(+) , and reactive oxygen species production. To this end, in vitro studies were performed with BV-2 cells before and after activation with lipopolysaccharide + interferon-γ. Nitric oxide (NO) was measured as a marker of cell activation. Our results show that microglial activation triggers a metabolic reprogramming based on an increased glucose uptake and a strengthening of anaerobic glycolysis, as well as of the pentose pathway oxidative branch, while retaining the mitochondrial activity. Based on this energy commitment, microglial defense capacity increases rapidly as well as ribose-5-phosphate and nucleic acid formation for gene transcription, essential to ensure the newly acquired functions demanded by central nervous system signaling. We also review the role of NO in this microglial energy commitment that positions cytotoxic microglia within the energetics of the astrocyte-neuron lactate shuttle. Copyright © 2014 Wiley Periodicals, Inc.

  10. Glycoside hydrolase activities of thermophilic bacterial consortia adapted to switchgrass.

    Science.gov (United States)

    Gladden, John M; Allgaier, Martin; Miller, Christopher S; Hazen, Terry C; VanderGheynst, Jean S; Hugenholtz, Philip; Simmons, Blake A; Singer, Steven W

    2011-08-15

    Industrial-scale biofuel production requires robust enzymatic cocktails to produce fermentable sugars from lignocellulosic biomass. Thermophilic bacterial consortia are a potential source of cellulases and hemicellulases adapted to harsher reaction conditions than commercial fungal enzymes. Compost-derived microbial consortia were adapted to switchgrass at 60°C to develop thermophilic biomass-degrading consortia for detailed studies. Microbial community analysis using small-subunit rRNA gene amplicon pyrosequencing and short-read metagenomic sequencing demonstrated that thermophilic adaptation to switchgrass resulted in low-diversity bacterial consortia with a high abundance of bacteria related to thermophilic paenibacilli, Rhodothermus marinus, and Thermus thermophilus. At lower abundance, thermophilic Chloroflexi and an uncultivated lineage of the Gemmatimonadetes phylum were observed. Supernatants isolated from these consortia had high levels of xylanase and endoglucanase activities. Compared to commercial enzyme preparations, the endoglucanase enzymes had a higher thermotolerance and were more stable in the presence of 1-ethyl-3-methylimidazolium acetate ([C2mim][OAc]), an ionic liquid used for biomass pretreatment. The supernatants were used to saccharify [C2mim][OAc]-pretreated switchgrass at elevated temperatures (up to 80°C), demonstrating that these consortia are an excellent source of enzymes for the development of enzymatic cocktails tailored to more extreme reaction conditions.

  11. The Potential of Adaptive Design in Animal Studies

    Directory of Open Access Journals (Sweden)

    Arshad Majid

    2015-10-01

    Full Text Available Clinical trials are the backbone of medical research, and are often the last step in the development of new therapies for use in patients. Prior to human testing, however, preclinical studies using animal subjects are usually performed in order to provide initial data on the safety and effectiveness of prospective treatments. These studies can be costly and time consuming, and may also raise concerns about the ethical treatment of animals when potentially harmful procedures are involved. Adaptive design is a process by which the methods used in a study may be altered while it is being conducted in response to preliminary data or other new information. Adaptive design has been shown to be useful in reducing the time and costs associated with clinical trials, and may provide similar benefits in preclinical animal studies. The purpose of this review is to summarize various aspects of adaptive design and evaluate its potential for use in preclinical research.

  12. The Potential of Adaptive Design in Animal Studies.

    Science.gov (United States)

    Majid, Arshad; Bae, Ok-Nam; Redgrave, Jessica; Teare, Dawn; Ali, Ali; Zemke, Daniel

    2015-10-12

    Clinical trials are the backbone of medical research, and are often the last step in the development of new therapies for use in patients. Prior to human testing, however, preclinical studies using animal subjects are usually performed in order to provide initial data on the safety and effectiveness of prospective treatments. These studies can be costly and time consuming, and may also raise concerns about the ethical treatment of animals when potentially harmful procedures are involved. Adaptive design is a process by which the methods used in a study may be altered while it is being conducted in response to preliminary data or other new information. Adaptive design has been shown to be useful in reducing the time and costs associated with clinical trials, and may provide similar benefits in preclinical animal studies. The purpose of this review is to summarize various aspects of adaptive design and evaluate its potential for use in preclinical research.

  13. Sweat chloride as a biomarker of CFTR activity: proof of concept and ivacaftor clinical trial data.

    Science.gov (United States)

    Accurso, Frank J; Van Goor, Fredrick; Zha, Jiuhong; Stone, Anne J; Dong, Qunming; Ordonez, Claudia L; Rowe, Steven M; Clancy, John Paul; Konstan, Michael W; Hoch, Heather E; Heltshe, Sonya L; Ramsey, Bonnie W; Campbell, Preston W; Ashlock, Melissa A

    2014-03-01

    We examined data from a Phase 2 trial {NCT00457821} of ivacaftor, a CFTR potentiator, in cystic fibrosis (CF) patients with aG551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference (NPD) to estimate CFTR activity. Sweat chloride and NPD were secondary endpoints in this placebo-controlled, multicenter trial. Standardization of sweat collection, processing,and analysis was employed for the first time. Sweat chloride and chloride ion transport (NPD) were integrated into a model of CFTR activity. Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects. Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40% of normal. Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators.

  14. Age-related changes in gait adaptability in response to unpredictable obstacles and stepping targets.

    Science.gov (United States)

    Caetano, Maria Joana D; Lord, Stephen R; Schoene, Daniel; Pelicioni, Paulo H S; Sturnieks, Daina L; Menant, Jasmine C

    2016-05-01

    A large proportion of falls in older people occur when walking. Limitations in gait adaptability might contribute to tripping; a frequently reported cause of falls in this group. To evaluate age-related changes in gait adaptability in response to obstacles or stepping targets presented at short notice, i.e.: approximately two steps ahead. Fifty older adults (aged 74±7 years; 34 females) and 21 young adults (aged 26±4 years; 12 females) completed 3 usual gait speed (baseline) trials. They then completed the following randomly presented gait adaptability trials: obstacle avoidance, short stepping target, long stepping target and no target/obstacle (3 trials of each). Compared with the young, the older adults slowed significantly in no target/obstacle trials compared with the baseline trials. They took more steps and spent more time in double support while approaching the obstacle and stepping targets, demonstrated poorer stepping accuracy and made more stepping errors (failed to hit the stepping targets/avoid the obstacle). The older adults also reduced velocity of the two preceding steps and shortened the previous step in the long stepping target condition and in the obstacle avoidance condition. Compared with their younger counterparts, the older adults exhibited a more conservative adaptation strategy characterised by slow, short and multiple steps with longer time in double support. Even so, they demonstrated poorer stepping accuracy and made more stepping errors. This reduced gait adaptability may place older adults at increased risk of falling when negotiating unexpected hazards. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. A Modified Active Appearance Model Based on an Adaptive Artificial Bee Colony

    Science.gov (United States)

    Othman, Zulaiha Ali

    2014-01-01

    Active appearance model (AAM) is one of the most popular model-based approaches that have been extensively used to extract features by highly accurate modeling of human faces under various physical and environmental circumstances. However, in such active appearance model, fitting the model with original image is a challenging task. State of the art shows that optimization method is applicable to resolve this problem. However, another common problem is applying optimization. Hence, in this paper we propose an AAM based face recognition technique, which is capable of resolving the fitting problem of AAM by introducing a new adaptive ABC algorithm. The adaptation increases the efficiency of fitting as against the conventional ABC algorithm. We have used three datasets: CASIA dataset, property 2.5D face dataset, and UBIRIS v1 images dataset in our experiments. The results have revealed that the proposed face recognition technique has performed effectively, in terms of accuracy of face recognition. PMID:25165748

  16. Sympathetic nervous system activity measured by skin conductance quantifies the challenge of walking adaptability tasks after stroke.

    Science.gov (United States)

    Clark, David J; Chatterjee, Sudeshna A; McGuirk, Theresa E; Porges, Eric C; Fox, Emily J; Balasubramanian, Chitralakshmi K

    2018-02-01

    Walking adaptability tasks are challenging for people with motor impairments. The construct of perceived challenge is typically measured by self-report assessments, which are susceptible to subjective measurement error. The development of an objective physiologically-based measure of challenge may help to improve the ability to assess this important aspect of mobility function. The objective of this study to investigate the use of sympathetic nervous system (SNS) activity measured by skin conductance to gauge the physiological stress response to challenging walking adaptability tasks in people post-stroke. Thirty adults with chronic post-stroke hemiparesis performed a battery of seventeen walking adaptability tasks. SNS activity was measured by skin conductance from the palmar surface of each hand. The primary outcome variable was the percent change in skin conductance level (ΔSCL) between the baseline resting and walking phases of each task. Task difficulty was measured by performance speed and by physical therapist scoring of performance. Walking function and balance confidence were measured by preferred walking speed and the Activities-specific Balance Confidence Scale, respectively. There was a statistically significant negative association between ΔSCL and task performance speed and between ΔSCL and clinical score, indicating that tasks with greater SNS activity had slower performance speed and poorer clinical scores. ΔSCL was significantly greater for low functioning participants versus high functioning participants, particularly during the most challenging walking adaptability tasks. This study supports the use of SNS activity measured by skin conductance as a valuable approach for objectively quantifying the perceived challenge of walking adaptability tasks in people post-stroke. Published by Elsevier B.V.

  17. Adaptation to emotional conflict: evidence from a novel face emotion paradigm.

    Science.gov (United States)

    Clayson, Peter E; Larson, Michael J

    2013-01-01

    The preponderance of research on trial-by-trial recruitment of affective control (e.g., conflict adaptation) relies on stimuli wherein lexical word information conflicts with facial affective stimulus properties (e.g., the face-Stroop paradigm where an emotional word is overlaid on a facial expression). Several studies, however, indicate different neural time course and properties for processing of affective lexical stimuli versus affective facial stimuli. The current investigation used a novel task to examine control processes implemented following conflicting emotional stimuli with conflict-inducing affective face stimuli in the absence of affective words. Forty-one individuals completed a task wherein the affective-valence of the eyes and mouth were either congruent (happy eyes, happy mouth) or incongruent (happy eyes, angry mouth) while high-density event-related potentials (ERPs) were recorded. There was a significant congruency effect and significant conflict adaptation effects for error rates. Although response times (RTs) showed a significant congruency effect, the effect of previous-trial congruency on current-trial RTs was only present for current congruent trials. Temporospatial principal components analysis showed a P3-like ERP source localized using FieldTrip software to the medial cingulate gyrus that was smaller on incongruent than congruent trials and was significantly influenced by the recruitment of control processes following previous-trial emotional conflict (i.e., there was significant conflict adaptation in the ERPs). Results show that a face-only paradigm may be sufficient to elicit emotional conflict and suggest a system for rapidly detecting conflicting emotional stimuli and subsequently adjusting control resources, similar to cognitive conflict detection processes, when using conflicting facial expressions without words.

  18. Adaptation to emotional conflict: evidence from a novel face emotion paradigm.

    Directory of Open Access Journals (Sweden)

    Peter E Clayson

    Full Text Available The preponderance of research on trial-by-trial recruitment of affective control (e.g., conflict adaptation relies on stimuli wherein lexical word information conflicts with facial affective stimulus properties (e.g., the face-Stroop paradigm where an emotional word is overlaid on a facial expression. Several studies, however, indicate different neural time course and properties for processing of affective lexical stimuli versus affective facial stimuli. The current investigation used a novel task to examine control processes implemented following conflicting emotional stimuli with conflict-inducing affective face stimuli in the absence of affective words. Forty-one individuals completed a task wherein the affective-valence of the eyes and mouth were either congruent (happy eyes, happy mouth or incongruent (happy eyes, angry mouth while high-density event-related potentials (ERPs were recorded. There was a significant congruency effect and significant conflict adaptation effects for error rates. Although response times (RTs showed a significant congruency effect, the effect of previous-trial congruency on current-trial RTs was only present for current congruent trials. Temporospatial principal components analysis showed a P3-like ERP source localized using FieldTrip software to the medial cingulate gyrus that was smaller on incongruent than congruent trials and was significantly influenced by the recruitment of control processes following previous-trial emotional conflict (i.e., there was significant conflict adaptation in the ERPs. Results show that a face-only paradigm may be sufficient to elicit emotional conflict and suggest a system for rapidly detecting conflicting emotional stimuli and subsequently adjusting control resources, similar to cognitive conflict detection processes, when using conflicting facial expressions without words.

  19. An open trial assessment of "The Number Race", an adaptive computer game for remediation of dyscalculia

    Directory of Open Access Journals (Sweden)

    Cohen Laurent

    2006-05-01

    Full Text Available Abstract Background In a companion article 1, we described the development and evaluation of software designed to remediate dyscalculia. This software is based on the hypothesis that dyscalculia is due to a "core deficit" in number sense or in its access via symbolic information. Here we review the evidence for this hypothesis, and present results from an initial open-trial test of the software in a sample of nine 7–9 year old children with mathematical difficulties. Methods Children completed adaptive training on numerical comparison for half an hour a day, four days a week over a period of five-weeks. They were tested before and after intervention on their performance in core numerical tasks: counting, transcoding, base-10 comprehension, enumeration, addition, subtraction, and symbolic and non-symbolic numerical comparison. Results Children showed specific increases in performance on core number sense tasks. Speed of subitizing and numerical comparison increased by several hundred msec. Subtraction accuracy increased by an average of 23%. Performance on addition and base-10 comprehension tasks did not improve over the period of the study. Conclusion Initial open-trial testing showed promising results, and suggested that the software was successful in increasing number sense over the short period of the study. However these results need to be followed up with larger, controlled studies. The issues of transfer to higher-level tasks, and of the best developmental time window for intervention also need to be addressed.

  20. An open trial assessment of "The Number Race", an adaptive computer game for remediation of dyscalculia

    Science.gov (United States)

    Wilson, Anna J; Revkin, Susannah K; Cohen, David; Cohen, Laurent; Dehaene, Stanislas

    2006-01-01

    Background In a companion article [1], we described the development and evaluation of software designed to remediate dyscalculia. This software is based on the hypothesis that dyscalculia is due to a "core deficit" in number sense or in its access via symbolic information. Here we review the evidence for this hypothesis, and present results from an initial open-trial test of the software in a sample of nine 7–9 year old children with mathematical difficulties. Methods Children completed adaptive training on numerical comparison for half an hour a day, four days a week over a period of five-weeks. They were tested before and after intervention on their performance in core numerical tasks: counting, transcoding, base-10 comprehension, enumeration, addition, subtraction, and symbolic and non-symbolic numerical comparison. Results Children showed specific increases in performance on core number sense tasks. Speed of subitizing and numerical comparison increased by several hundred msec. Subtraction accuracy increased by an average of 23%. Performance on addition and base-10 comprehension tasks did not improve over the period of the study. Conclusion Initial open-trial testing showed promising results, and suggested that the software was successful in increasing number sense over the short period of the study. However these results need to be followed up with larger, controlled studies. The issues of transfer to higher-level tasks, and of the best developmental time window for intervention also need to be addressed. PMID:16734906

  1. Operational Challenges and Solutions with Implementation of an Adaptive Seamless Phase 2/3 Study

    Science.gov (United States)

    Spencer, Kimberly; Colvin, Kelly; Braunecker, Brad; Brackman, Marcia; Ripley, Joyce; Hines, Paul; Skrivanek, Zachary; Gaydos, Brenda; Geiger, Mary Jane

    2012-01-01

    A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional coordination. The existing infrastructure necessitated greater flexibility to meet the needs of the adaptive design. Rapid data acquisition, analysis, and reporting were essential to support the successful implementation of the adaptive algorithm. Drug supply for nine treatment arms had to be carefully managed across many sites worldwide. Details regarding these key operational challenges and others will be discussed along with resolutions taken to enable successful implementation of this adaptive, seamless trial. PMID:23294774

  2. Linking inter-individual differences in the conflict adaptation effect to spontaneous brain activity.

    Science.gov (United States)

    Wang, Ting; Chen, Zhencai; Zhao, Guang; Hitchman, Glenn; Liu, Congcong; Zhao, Xiaoyue; Liu, Yijun; Chen, Antao

    2014-04-15

    Conflict adaptation has been widely researched in normal and clinical populations. There are large individual differences in conflict adaptation, and it has been linked to the schizotypal trait. However, no study to date has examined how individual differences in spontaneous brain activity are related to behavioral conflict adaptation (performance). Resting-state functional magnetic resonance imaging (RS-fMRI) is a promising tool to investigate this issue. The present study evaluated the regional homogeneity (ReHo) of RS-fMRI signals in order to explore the neural basis of individual differences in conflict adaptation across two independent samples comprising a total of 67 normal subjects. A partial correlation analysis was carried out to examine the relationship between ReHo and behavioral conflict adaptation, while controlling for reaction time, standard deviation and flanker interference effects. This analysis was conducted on 39 subjects' data (sample 1); the results showed significant positive correlations in the left dorsolateral prefrontal cortex (DLPFC) and left ventrolateral prefrontal cortex. We then conducted a test-validation procedure on the remaining 28 subjects' data (sample 2) to examine the reliability of the results. Regions of interest were defined based on the correlation results. Regression analysis showed that variability in ReHo values in the DLPFC accounted for 48% of the individual differences in the conflict adaptation effect in sample 2. The present findings provide further support for the importance of the DLPFC in the conflict adaptation process. More importantly, we demonstrated that ReHo of RS-fMRI signals in the DLPFC can predict behavioral performance in conflict adaptation, which provides potential biomarkers for the early detection of cognitive control deterioration. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Effect of physical activity on frailty and associated negative outcomes: the LIFE randomized trial

    Science.gov (United States)

    Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large, long-term, randomized trials are lacking. Objective: To determine whether a long-term structured moderate-intensity physical activity (PA) p...

  4. Virtual Reality as a Medium for Sensorimotor Adaptation Training and Spaceflight Countermeasures

    Science.gov (United States)

    Madansingh, S.; Bloomberg, J. J.

    2014-01-01

    Astronauts experience a profound sensorimotor adaptation during transition to and from the microgravity environment of space. With the upcoming shift to extra-long duration missions (upwards of 1 year) aboard the International Space Station, the immediate risks to astronauts during these transitory periods become more important than ever to understand and prepare for. Recent advances in virtual reality technology enable everyday adoption of these tools for entertainment and use in training. Embedding an individual in a virtual environment (VE) allows the ability to change the perception of visual flow, elicit automatic motor behavior and produce sensorimotor adaptation, not unlike those required during long duration microgravity exposure. The overall goal of this study is to determine the feasibility of present head mounted display technology (HMD) to produce reliable visual flow information and the expected adaptation associated with virtual environment manipulation to be used in future sensorimotor adaptability countermeasures. To further understand the influence of visual flow on gait adaptation during treadmill walking, a series of discordant visual flow manipulations in a virtual environment are proposed. Six healthy participants (3 male and 3 female) will observe visual flow information via HMD (Oculus Rift DK2) while walking on an instrumented treadmill at their preferred walking speed. Participants will be immersed in a series of VE's resembling infinite hallways with different visual characteristics: an office hallway, a hallway with pillars and the hallway of a fictional spacecraft. Participants will perform three trials of 10 min. each, which include walking on the treadmill while receiving congruent or incongruent visual information via the HMD. In the first trial, participants will experience congruent visual information (baseline) where the hallway is perceived to move at the same rate as their walking speed. The final two trials will be randomized

  5. Robustness of muscle synergies during visuomotor adaptation

    Directory of Open Access Journals (Sweden)

    Reinhard eGentner

    2013-09-01

    Full Text Available During visuomotor adaptation a novel mapping between visual targets and motor commands is gradually acquired. How muscle activation patterns are affected by this process is an open question. We tested whether the structure of muscle synergies is preserved during adaptation to a visuomotor rotation. Eight subjects applied targeted isometric forces on a handle instrumented with a force transducer while electromyographic (EMG activity was recorded from 13 shoulder and elbow muscles. The recorded forces were mapped into horizontal displacements of a virtual sphere with simulated mass, elasticity, and damping. The task consisted of moving the sphere to a target at one of eight equally spaced directions. Subjects performed three baseline blocks of 32 trials, followed by six blocks with a 45° CW rotation applied to the planar force, and finally three wash-out blocks without the perturbation. The sphere position at 100 ms after movement onset revealed significant directional error at the beginning of the rotation, a gradual learning in subsequent blocks, and aftereffects at the beginning of the wash-out. The change in initial force direction was closely related to the change in directional tuning of the initial EMG activity of most muscles. Throughout the experiment muscle synergies extracted using a non-negative matrix factorization algorithm from the muscle patterns recorded during the baseline blocks could reconstruct the muscle patterns of all other blocks with an accuracy significantly higher than chance indicating structural robustness. In addition, the synergies extracted from individual blocks remained similar to the baseline synergies throughout the experiment. Thus synergy structure is robust during visuomotor adaptation suggesting that changes in muscle patterns are obtained by rotating the directional tuning of the synergy recruitment.

  6. Reducing barriers to healthy weight: Planned and responsive adaptations to a lifestyle intervention to serve people with impaired mobility.

    Science.gov (United States)

    Betts, Andrea C; Froehlich-Grobe, Katherine; Driver, Simon; Carlton, Danielle; Kramer, M Kaye

    2018-04-01

    People with impaired mobility (IM) disabilities have a higher prevalence of obesity and obesity-related chronic conditions; however, lifestyle interventions that address the unique needs of people with IM are lacking. This paper describes an adapted evidence-based lifestyle intervention developed through community-based participatory research (CBPR). Individuals with IM, health professionals, disability group representatives, and researchers formed an advisory board to guide the process of thoroughly adapting the Diabetes Prevention Program Group Lifestyle Balance (DPP GLB) intervention after a successful pilot in people with IM. The process involved two phases: 1) planned adaptations to DPP GLB content and delivery, and 2) responsive adaptations to address issues that emerged during intervention delivery. Planned adaptations included combining in-person sessions with conference calls, providing arm-based activity trackers, and adding content on adaptive cooking, adaptive physical activity, injury prevention, unique health considerations, self-advocacy, and caregiver support. During the intervention, participants encountered numerous barriers, including health and mental health issues, transportation, caregivers, employment, adjusting to disability, and functional limitations. We addressed barriers with responsive adaptations, such as supporting electronic self-monitoring, offering make up sessions, and adding content and activities on goal setting, problem solving, planning, peer support, reflection, and motivation. Given the lack of evidence on lifestyle change in people with disabilities, it is critical to involve the community in intervention planning and respond to real-time barriers as participants engage in change. A randomized controlled trial (RCT) is underway to examine the usability, feasibility, and preliminary effectiveness of the adapted intervention. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. 18F-Fdg-PET-guided Planning and Re-Planning (Adaptive) Radiotherapy in Head and Neck Cancer: Current State of Art.

    Science.gov (United States)

    Farina, Eleonora; Ferioli, Martina; Castellucci, Paolo; Farina, Arianna; Zanirato Rambaldi, Giuseppe; Cilla, Savino; Cammelli, Silvia; Fanti, Stefano; Morganti, Alessio G

    2017-12-01

    A review of the literature is proposed as a contribution to current knowledge on technical, physical, and clinical issues about PET-guided planning and re-planning radiotherapy (RT) in head and neck cancer. PubMed and Scopus electronic databases were searched for articles including clinical trials. Search terms were "gross tumor volume (GTV) delineation", "head and neck cancer", "radiotherapy", "adaptive radiotherapy" in combination with "PET". A 18 F-FDG-PET and CT-scan comparison in GTV definition for RT planning of head and neck cancer was shown in twenty-seven clinical trials with a total of 712 patients. Only two clinical trials focused on PET-guided adaptive radiotherapy (ART) with a total of 31 patients. 18 F-FDG-PET is able to achieve an accurate and precise definition of GTV boundaries during RT planning, especially in combination with CT-scan. ART strategies are proposed to evaluate tumor volume changes, plan boost irradiation on metabolically active residual neoplasm and protect organs at risk (OaRs). Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  8. Adaptive Tutorials Versus Web-Based Resources in Radiology: A Mixed Methods Comparison of Efficacy and Student Engagement.

    Science.gov (United States)

    Wong, Vincent; Smith, Ariella J; Hawkins, Nicholas J; Kumar, Rakesh K; Young, Noel; Kyaw, Merribel; Velan, Gary M

    2015-10-01

    Diagnostic imaging is under-represented in medical curricula globally. Adaptive tutorials, online intelligent tutoring systems that provide a personalized learning experience, have the potential to bridge this gap. However, there is limited evidence of their effectiveness for learning about diagnostic imaging. We performed a randomized mixed methods crossover trial to determine the impact of adaptive tutorials on perceived engagement and understanding of the appropriate use and interpretation of common diagnostic imaging investigations. Although concurrently engaged in disparate blocks of study, 99 volunteer medical students (from years 1-4 of the 6-year program) were randomly allocated to one of two groups. In the first arm of the trial on chest X-rays, one group received access to an adaptive tutorial, whereas the other received links to an existing peer-reviewed Web resource. These two groups crossed over in the second arm of the trial, which focused on computed tomography scans of the head, chest, and abdomen. At the conclusion of each arm of the trial, both groups completed an examination-style assessment, comprising questions both related and unrelated to the topics covered by the relevant adaptive tutorial. Online questionnaires were used to evaluate student perceptions of both learning resources. In both arms of the trial, the group using adaptive tutorials obtained significantly higher assessment scores than controls. This was because of higher assessment scores by senior students in the adaptive tutorial group when answering questions related to topics covered in those tutorials. Furthermore, students indicated significantly better engagement with adaptive tutorials than the Web resource and rated the tutorials as a significantly more valuable tool for learning. Medical students overwhelmingly accept adaptive tutorials for diagnostic imaging. The tutorials significantly improve the understanding of diagnostic imaging by senior students. Crown Copyright

  9. Difference, Adapted Physical Activity and Human Development: Potential Contribution of Capabilities Approach

    Science.gov (United States)

    Silva, Carla Filomena; Howe, P. David

    2012-01-01

    This paper is a call to Adapted Physical Activity (APA) professionals to increase the reflexive nature of their practice. Drawing upon Foucault's concept of governmentality (1977) APA action may work against its own publicized goals of empowerment and self-determination. To highlight these inconsistencies, we will draw upon historical and social…

  10. Influence of neural adaptation on dynamics and equilibrium state of neural activities in a ring neural network

    Science.gov (United States)

    Takiyama, Ken

    2017-12-01

    How neural adaptation affects neural information processing (i.e. the dynamics and equilibrium state of neural activities) is a central question in computational neuroscience. In my previous works, I analytically clarified the dynamics and equilibrium state of neural activities in a ring-type neural network model that is widely used to model the visual cortex, motor cortex, and several other brain regions. The neural dynamics and the equilibrium state in the neural network model corresponded to a Bayesian computation and statistically optimal multiple information integration, respectively, under a biologically inspired condition. These results were revealed in an analytically tractable manner; however, adaptation effects were not considered. Here, I analytically reveal how the dynamics and equilibrium state of neural activities in a ring neural network are influenced by spike-frequency adaptation (SFA). SFA is an adaptation that causes gradual inhibition of neural activity when a sustained stimulus is applied, and the strength of this inhibition depends on neural activities. I reveal that SFA plays three roles: (1) SFA amplifies the influence of external input in neural dynamics; (2) SFA allows the history of the external input to affect neural dynamics; and (3) the equilibrium state corresponds to the statistically optimal multiple information integration independent of the existence of SFA. In addition, the equilibrium state in a ring neural network model corresponds to the statistically optimal integration of multiple information sources under biologically inspired conditions, independent of the existence of SFA.

  11. Dietary resources shape the adaptive changes of cyanide detoxification function in giant panda (Ailuropoda melanoleuca)

    OpenAIRE

    He Huang; Shangmian Yie; Yuliang Liu; Chengdong Wang; Zhigang Cai; Wenping Zhang; Jingchao Lan; Xiangming Huang; Li Luo; Kailai Cai; Rong Hou; Zhihe Zhang

    2016-01-01

    The functional adaptive changes in cyanide detoxification in giant panda appear to be response to dietary transition from typical carnivore to herbivorous bear. We tested the absorption of cyanide contained in bamboo/bamboo shoots with a feeding trial in 20 adult giant pandas. We determined total cyanide content in bamboo shoots and giant panda?s feces, levels of urinary thiocyanate and tissue rhodanese activity using color reactions with a spectrophotometer. Rhodanese expression in liver and...

  12. An adaptive synchronization strategy based on active control for demodulating message hidden in chaotic signals

    International Nuclear Information System (INIS)

    Tang Fang

    2008-01-01

    In the field of secure communication, it is very important to demodulate the message hidden in chaotic signals. In this paper, an adaptive synchronization strategy based on active control is proposed, which is used to design an active controller and an appropriate adaptive demodulator at the receiver to recover the transmitted message hidden in chaotic signals of a drive system. Based on Lyapunov stability theory, it is shown that the transmitted message can be theoretically recovered by using the proposed strategy. Numerical simulations based on the Chua's circuit are also presented to verify the effectiveness of the proposed strategy. In addition, it is shown via simulations that, by increasing the gain of the active controller the message error caused by the external noise and the discontinuous property of the message can be reduced

  13. Testing a workplace physical activity intervention: a cluster randomized controlled trial.

    Science.gov (United States)

    McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

    2011-04-11

    Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.

  14. Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial.

    Science.gov (United States)

    Mehta, Shivan J; Feingold, Jordyn; Vandertuyn, Matthew; Niewood, Tess; Cox, Catherine; Doubeni, Chyke A; Volpp, Kevin G; Asch, David A

    2017-11-01

    Behavioral economic approaches could increase uptake for colorectal cancer screening. We performed a randomized controlled trial of 2245 employees to determine whether an email containing a phone number for scheduling (control), an email with the active choice to opt in or opt out (active choice), or the active choice email plus a $100 incentive (financial incentive) increased colonoscopy completion within 3 months. Higher proportions of participants in the financial incentive group underwent screening (3.7%) than in the control (1.6%) or active choice groups (1.5%) (P = .01 and P < .01). We found no difference in uptake of screening between the active choice and control groups (P = .88). The $100 conditional incentive modestly but significantly increased colonoscopy use. ClinicalTrials.gov no: NCT02660671. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  15. A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Ekstam, Lisa; Carlsson, Gunilla; Chiatti, Carlos; Nilsson, Maria H; Malmgren Fänge, Agneta

    2014-11-29

    The primary aim of this paper is to describe the design of a project evaluating the effects of using a research-based strategy for managing housing adaptations (HAs). The evaluation targets clients' perspectives in terms of activity, participation, usability, fear of falling, fall incidence, use of mobility devices, and health-related quality of life, and determines the societal effects of HAs in terms of costs. Additional aims of the project are to explore and describe this strategy in relation to experiences and expectations (a) among clients and cohabitants and (b) occupational therapists in ordinary practice. This study is a quasi-experimental trial applying a multiphase design, combining quantitative and qualitative data. At the experimental sites, the occupational therapists (OTs) apply the intervention, i.e. a standardized research-based strategy for HA case management. At the control site, the occupational therapists are following their regular routine in relation to HA. Three municipalities in south Sweden will be included based on their population, their geographical dispersion, and their similar organizational structures for HA administration. Identical data on outcomes is being collected at all the sites at the same four time points: before the HA and then 3, 6, and 12 months after the HA. The data-collection methods are semi-structured qualitative interviews, observations, clinical assessments, and certificates related to each client's HA. The intervention in this study has been developed and tested through many years of research and in collaboration with practitioners. This process includes methodological development and testing research aimed at identifying the most important outcomes and research targeting current HA case-management procedures in Swedish municipalities. When the study is completed, the results will be used for further optimization of the practice strategy for HA, in close collaboration with the data-collecting OTs. No: NCT01960582.

  16. Terrorists on Trial: A Performative Perspective

    Directory of Open Access Journals (Sweden)

    Beatrice de Graaf

    2011-03-01

    Full Text Available On 30 March 2011, ICCT organised an Expert Meeting entitled “Terrorism Trials as Theatre: A Performative Perspective”. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group, the Mumbai 2008 Terrorist Attack Trial and the Guantanamo Military Tribunals. As such, the Expert Meeting did not concentrate solely on the immediate judicial performance of the magistrates and/or the defence; instead, the trials were put in their wider sociological context, adopting notions of social drama and communication sciences. This Expert Meeting Paper is a further adaptation of the Discussion Paper that was used as basis for debate during the Meeting.

  17. The Effects of Reflective Activities on Skill Adaptation in a Work-Related Instrumental Learning Setting

    Science.gov (United States)

    Roessger, Kevin M.

    2014-01-01

    In work-related instrumental learning contexts, the role of reflective activities is unclear. Kolb's experiential learning theory and Mezirow's transformative learning theory predict skill adaptation as an outcome. This prediction was tested by manipulating reflective activities and assessing participants' response and error rates during novel…

  18. Effects of Adaptation on Discrimination of Whisker Deflection Velocity and Angular Direction in a Model of the Barrel Cortex

    Directory of Open Access Journals (Sweden)

    Mainak J. Patel

    2018-06-01

    Full Text Available Two important stimulus features represented within the rodent barrel cortex are velocity and angular direction of whisker deflection. Each cortical barrel receives information from thalamocortical (TC cells that relay information from a single whisker, and TC input is decoded by barrel regular-spiking (RS cells through a feedforward inhibitory architecture (with inhibition delivered by cortical fast-spiking or FS cells. TC cells encode deflection velocity through population synchrony, while deflection direction is encoded through the distribution of spike counts across the TC population. Barrel RS cells encode both deflection direction and velocity with spike rate, and are divided into functional domains by direction preference. Following repetitive whisker stimulation, system adaptation causes a weakening of synaptic inputs to RS cells and diminishes RS cell spike responses, though evidence suggests that stimulus discrimination may improve following adaptation. In this work, I construct a model of the TC, FS, and RS cells comprising a single barrel system—the model incorporates realistic synaptic connectivity and dynamics and simulates both angular direction (through the spatial pattern of TC activation and velocity (through synchrony of the TC population spikes of a deflection of the primary whisker, and I use the model to examine direction and velocity selectivity of barrel RS cells before and after adaptation. I find that velocity and direction selectivity of individual RS cells (measured over multiple trials sharpens following adaptation, but stimulus discrimination using a simple linear classifier by the RS population response during a single trial (a more biologically meaningful measure than single cell discrimination over multiple trials exhibits strikingly different behavior—velocity discrimination is similar both before and after adaptation, while direction classification improves substantially following adaptation. This is the

  19. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial.

    Science.gov (United States)

    Maher, Carol; Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-07-13

    Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers ("Active Team" Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, Plife or mental health quality of life at either time point. High levels of engagement with the intervention, and particularly the self-monitoring features, were observed. An online, social networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Australian New Zealand

  20. Leg muscle activation during gait in Parkinson's disease : Adaptation and interlimb coordination

    NARCIS (Netherlands)

    Dietz, [No Value; Zijlstra, W; Prokop, T; Berger, W

    1995-01-01

    Adaptation in leg muscle activity and coordination between lower limbs were studied during walking on a treadmill with split belts in one group of parkinsonian patients and one of age-matched healthy subjects. Four different belt speeds (0.25/0.5/0.75/1.0 m/sec) were applied in selected combinations

  1. Implementation of an anonymisation tool for clinical trials using a clinical trial processor integrated with an existing trial patient data information system

    NARCIS (Netherlands)

    Aryanto, Kadek Y. E.; Broekema, Andre; Oudkerk, Matthijs; van Ooijen, Peter M. A.

    To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two

  2. Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

    Science.gov (United States)

    Poslawsky, Irina E; Naber, Fabiënne Ba; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-07-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners. © The Author(s) 2014.

  3. Adaptive Programming Improves Outcomes in Drug Court: An Experimental Trial.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Croft, Jason R

    2012-04-01

    Prior studies in Drug Courts reported improved outcomes when participants were matched to schedules of judicial status hearings based on their criminological risk level. The current experiment determined whether incremental efficacy could be gained by periodically adjusting the schedule of status hearings and clinical case-management sessions in response to participants' ensuing performance in the program. The adjustments were made pursuant to a priori criteria specified in an adaptive algorithm. Results confirmed that participants in the full adaptive condition (n = 62) were more than twice as likely as those assigned to baseline-matching only (n = 63) to be drug-abstinent during the first 18 weeks of the program; however, graduation rates and the average time to case resolution were not significantly different. The positive effects of the adaptive program appear to have stemmed from holding noncompliant participants more accountable for meeting their attendance obligations in the program. Directions for future research and practice implications are discussed.

  4. Towards psychologically adaptive brain-computer interfaces

    Science.gov (United States)

    Myrden, A.; Chau, T.

    2016-12-01

    Objective. Brain-computer interface (BCI) performance is sensitive to short-term changes in psychological states such as fatigue, frustration, and attention. This paper explores the design of a BCI that can adapt to these short-term changes. Approach. Eleven able-bodied individuals participated in a study during which they used a mental task-based EEG-BCI to play a simple maze navigation game while self-reporting their perceived levels of fatigue, frustration, and attention. In an offline analysis, a regression algorithm was trained to predict changes in these states, yielding Pearson correlation coefficients in excess of 0.45 between the self-reported and predicted states. Two means of fusing the resultant mental state predictions with mental task classification were investigated. First, single-trial mental state predictions were used to predict correct classification by the BCI during each trial. Second, an adaptive BCI was designed that retrained a new classifier for each testing sample using only those training samples for which predicted mental state was similar to that predicted for the current testing sample. Main results. Mental state-based prediction of BCI reliability exceeded chance levels. The adaptive BCI exhibited significant, but practically modest, increases in classification accuracy for five of 11 participants and no significant difference for the remaining six despite a smaller average training set size. Significance. Collectively, these findings indicate that adaptation to psychological state may allow the design of more accurate BCIs.

  5. Optimizing trial design in pharmacogenetics research: comparing a fixed parallel group, group sequential, and adaptive selection design on sample size requirements.

    Science.gov (United States)

    Boessen, Ruud; van der Baan, Frederieke; Groenwold, Rolf; Egberts, Antoine; Klungel, Olaf; Grobbee, Diederick; Knol, Mirjam; Roes, Kit

    2013-01-01

    Two-stage clinical trial designs may be efficient in pharmacogenetics research when there is some but inconclusive evidence of effect modification by a genomic marker. Two-stage designs allow to stop early for efficacy or futility and can offer the additional opportunity to enrich the study population to a specific patient subgroup after an interim analysis. This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family-wise type I error rate. The designs were evaluated across scenarios that defined the effect sizes in the marker positive and marker negative subgroups and the prevalence of marker positive patients in the overall study population. Effect sizes were chosen to reflect realistic planning scenarios, where at least some effect is present in the marker negative subgroup. In addition, scenarios were considered in which the assumed 'true' subgroup effects (i.e., the postulated effects) differed from those hypothesized at the planning stage. As expected, both two-stage designs generally required fewer patients than a fixed parallel group design, and the advantage increased as the difference between subgroups increased. The adaptive selection design added little further reduction in sample size, as compared with the group sequential design, when the postulated effect sizes were equal to those hypothesized at the planning stage. However, when the postulated effects deviated strongly in favor of enrichment, the comparative advantage of the adaptive selection design increased, which precisely reflects the adaptive nature of the design. Copyright © 2013 John Wiley & Sons, Ltd.

  6. Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

    Science.gov (United States)

    Hölzel, Lars P; Ries, Zivile; Kriston, Levente; Dirmaier, Jörg; Zill, Jördis M; Rummel-Kluge, Christine; Niebling, Wilhelm; Bermejo, Isaac; Härter, Martin

    2016-11-23

    To evaluate the usefulness of culture-sensitive patient information material compared with standard translated material. Multicentre, double-blind randomised controlled trial. 37 primary care practices. 435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin. Intervention group: provision of culture-sensitive adapted material. provision of standard translated material. Primary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points. Usefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005). Cultural adaptation of patient information material provides benefits over high quality

  7. Adaptation of reach-to-grasp movement in response to force perturbations.

    Science.gov (United States)

    Rand, M K; Shimansky, Y; Stelmach, G E; Bloedel, J R

    2004-01-01

    This study examined how reach-to-grasp movements are modified during adaptation to external force perturbations applied on the arm during reach. Specifically, we examined whether the organization of these movements was dependent upon the condition under which the perturbation was applied. In response to an auditory signal, all subjects were asked to reach for a vertical dowel, grasp it between the index finger and thumb, and lift it a short distance off the table. The subjects were instructed to do the task as fast as possible. The perturbation was an elastic load acting on the wrist at an angle of 105 deg lateral to the reaching direction. The condition was modified by changing the predictability with which the perturbation was applied in a given trial. After recording unperturbed control trials, perturbations were applied first on successive trials (predictable perturbations) and then were applied randomly (unpredictable perturbations). In the early predictable perturbation trials, reach path length became longer and reaching duration increased. As more predictable perturbations were applied, the reach path length gradually decreased and became similar to that of control trials. Reaching duration also decreased gradually as the subjects adapted by exerting force against the perturbation. In addition, the amplitude of peak grip aperture during arm transport initially increased in response to repeated perturbations. During the course of learning, it reached its maximum and thereafter slightly decreased. However, it did not return to the normal level. The subjects also adapted to the unpredictable perturbations through changes in both arm transport and grasping components, indicating that they can compensate even when the occurrence of the perturbation cannot be predicted during the inter-trial interval. Throughout random perturbation trials, large grip aperture values were observed, suggesting that a conservative aperture level is set regardless of whether the

  8. Regulation of pH in human skeletal muscle: adaptations to physical activity

    DEFF Research Database (Denmark)

    Juel, C

    2008-01-01

    -transport) and describes the contribution of each transport system in pH regulation at rest and during muscle activity. It is reported that the mechanisms involved in pH regulation can undergo adaptational changes in association with physical activity and that these changes are of functional importance....... resonance technique to exercise experiments including blood sampling and muscle biopsies. The present review characterizes the cellular buffering system as well as the most important membrane transport systems involved (Na(+)/H(+) exchange, Na-bicarbonate co-transport and lactate/H(+) co...

  9. Adaptive process triage system cannot identify patients with gastrointestinal perforation

    DEFF Research Database (Denmark)

    Bohm, Aske Mathias; Tolstrup, Mai-Britt; Gögenur, Ismail

    2017-01-01

    INTRODUCTION: Adaptive process triage (ADAPT) is a triage tool developed to assess the severity and address the priority of emergency patients. In 2009-2011, ADAPT was the most frequently used triage system in Denmark. Until now, no Danish triage system has been evaluated based on a selective group...... triaged as green or yellow had a GIP that was not identified by the triage system. CONCLUSION: ADAPT is incapable of identifying one of the most critically ill patient groups in need of emergency abdominal surgery. FUNDING: none. TRIAL REGISTRATION: HEH-2013-034 I-Suite: 02336....

  10. Metabolic adaptation to intermittent fasting is independent of peroxisome proliferator-activated receptor alpha.

    Science.gov (United States)

    Li, Guolin; Brocker, Chad N; Yan, Tingting; Xie, Cen; Krausz, Kristopher W; Xiang, Rong; Gonzalez, Frank J

    2018-01-01

    Peroxisome proliferator-activated receptor alpha (PPARA) is a major regulator of fatty acid oxidation and severe hepatic steatosis occurs during acute fasting in Ppara-null mice. Thus, PPARA is considered an important mediator of the fasting response; however, its role in other fasting regiments such as every-other-day fasting (EODF) has not been investigated. Mice were pre-conditioned using either a diet containing the potent PPARA agonist Wy-14643 or an EODF regimen prior to acute fasting. Ppara-null mice were used to assess the contribution of PPARA activation during the metabolic response to EODF. Livers were collected for histological, biochemical, qRT-PCR, and Western blot analysis. Acute fasting activated PPARA and led to steatosis, whereas EODF protected against fasting-induced hepatic steatosis without affecting PPARA signaling. In contrast, pretreatment with Wy-14,643 did activate PPARA signaling but did not ameliorate acute fasting-induced steatosis and unexpectedly promoted liver injury. Ppara ablation exacerbated acute fasting-induced hypoglycemia, hepatic steatosis, and liver injury in mice, whereas these detrimental effects were absent in response to EODF, which promoted PPARA-independent fatty acid metabolism and normalized serum lipids. These findings indicate that PPARA activation prior to acute fasting cannot ameliorate fasting-induced hepatic steatosis, whereas EODF induced metabolic adaptations to protect against fasting-induced steatosis without altering PPARA signaling. Therefore, PPARA activation does not mediate the metabolic adaptation to fasting, at least in preventing acute fasting-induced steatosis. Published by Elsevier GmbH.

  11. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials.

    Science.gov (United States)

    Hindryckx, Pieter; Levesque, Barrett G; Holvoet, Tom; Durand, Serina; Tang, Ceen-Ming; Parker, Claire; Khanna, Reena; Shackelton, Lisa M; D'Haens, Geert; Sandborn, William J; Feagan, Brian G; Lebwohl, Benjamin; Leffler, Daniel A; Jairath, Vipul

    2018-01-01

    Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted measure of disease activity used in clinical trials. We conducted a systematic review of coeliac disease activity indices to evaluate their operating properties and potential as outcome measures in registration trials. MEDLINE, EMBASE and the Cochrane central library were searched from 1966 to 2015 for eligible studies in adult and/or paediatric patients with coeliac disease that included coeliac disease activity markers in their outcome measures. The operating characteristics of histological indices, patient-reported outcomes (PROs) and endoscopic indices were evaluated for content and construct validity, reliability, responsiveness and feasibility using guidelines proposed by the US Food and Drug Administration (FDA). Of 19 123 citations, 286 studies were eligible, including 24 randomised-controlled trials. Three of five PROs identified met most key evaluative criteria but only the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient-Reported Outcome (CeD PRO) have been approved by the FDA. All histological and endoscopic scores identified lacked content validity. Quantitative morphometric histological analysis had better reliability and responsiveness compared with qualitative scales. Endoscopic indices were infrequently used, and only one index demonstrated responsiveness to effective therapy. Current best evidence suggests that the CDSD and the CeD PRO are appropriate for use in the definition of primary end points in coeliac disease registration trials. Morphometric histology should be included as a key secondary or co-primary end point. Further work is needed to optimise end point configuration to inform efficient drug development. 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/.

  12. Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

  13. A User-Adaptive Algorithm for Activity Recognition Based on K-Means Clustering, Local Outlier Factor, and Multivariate Gaussian Distribution

    Directory of Open Access Journals (Sweden)

    Shizhen Zhao

    2018-06-01

    Full Text Available Mobile activity recognition is significant to the development of human-centric pervasive applications including elderly care, personalized recommendations, etc. Nevertheless, the distribution of inertial sensor data can be influenced to a great extent by varying users. This means that the performance of an activity recognition classifier trained by one user’s dataset will degenerate when transferred to others. In this study, we focus on building a personalized classifier to detect four categories of human activities: light intensity activity, moderate intensity activity, vigorous intensity activity, and fall. In order to solve the problem caused by different distributions of inertial sensor signals, a user-adaptive algorithm based on K-Means clustering, local outlier factor (LOF, and multivariate Gaussian distribution (MGD is proposed. To automatically cluster and annotate a specific user’s activity data, an improved K-Means algorithm with a novel initialization method is designed. By quantifying the samples’ informative degree in a labeled individual dataset, the most profitable samples can be selected for activity recognition model adaption. Through experiments, we conclude that our proposed models can adapt to new users with good recognition performance.

  14. A comparison of two adaptive algorithms for the control of active engine mounts

    Science.gov (United States)

    Hillis, A. J.; Harrison, A. J. L.; Stoten, D. P.

    2005-08-01

    This paper describes work conducted in order to control automotive active engine mounts, consisting of a conventional passive mount and an internal electromagnetic actuator. Active engine mounts seek to cancel the oscillatory forces generated by the rotation of out-of-balance masses within the engine. The actuator generates a force dependent on a control signal from an algorithm implemented with a real-time DSP. The filtered-x least-mean-square (FXLMS) adaptive filter is used as a benchmark for comparison with a new implementation of the error-driven minimal controller synthesis (Er-MCSI) adaptive controller. Both algorithms are applied to an active mount fitted to a saloon car equipped with a four-cylinder turbo-diesel engine, and have no a priori knowledge of the system dynamics. The steady-state and transient performance of the two algorithms are compared and the relative merits of the two approaches are discussed. The Er-MCSI strategy offers significant computational advantages as it requires no cancellation path modelling. The Er-MCSI controller is found to perform in a fashion similar to the FXLMS filter—typically reducing chassis vibration by 50-90% under normal driving conditions.

  15. Culturally adapting a physical activity intervention for Somali women: the need for theory and innovation to promote equity.

    Science.gov (United States)

    Murray, Kate E; Ermias, Azieb; Lung, Amber; Mohamed, Amina Sheik; Ellis, B Heidi; Linke, Sarah; Kerr, Jacqueline; Bowen, Deborah J; Marcus, Bess H

    2017-03-01

    There is pressing need for innovation in clinical research to more effectively recruit, engage, retain, and promote health among diverse populations overburdened by health disparities. The purpose of this study is to provide a detailed illustration of the cultural adaptation of an evidence-based intervention to bolster translational research with currently underserved communities. The cultural adaptation heuristic framework described by Barrera and colleagues is applied to the adaptation of a physical activity evidence-based intervention with adult Somali women. Widespread changes were required to ensure program feasibility and acceptability, including the reduction of assessment protocols and changes discordant with current trends in physical activity research. The cultural adaptation of evidence-based interventions offers an important mechanism for reducing health disparities. Improved reporting standards, assessment of features relevant to underserved communities, and greater funding requirements to ensure better representation are needed to promote more widespread access for all people.

  16. Contingency-based emotional resilience: effort-based reward training and flexible coping lead to adaptive responses to uncertainty in male rats.

    Science.gov (United States)

    Lambert, Kelly G; Hyer, Molly M; Rzucidlo, Amanda A; Bergeron, Timothy; Landis, Timothy; Bardi, Massimo

    2014-01-01

    Emotional resilience enhances an animal's ability to maintain physiological allostasis and adaptive responses in the midst of challenges ranging from cognitive uncertainty to chronic stress. In the current study, neurobiological factors related to strategic responses to uncertainty produced by prediction errors were investigated by initially profiling male rats as passive, active or flexible copers (n = 12 each group) and assigning to either a contingency-trained or non-contingency trained group. Animals were subsequently trained in a spatial learning task so that problem solving strategies in the final probe task, as well-various biomarkers of brain activation and plasticity in brain areas associated with cognition and emotional regulation, could be assessed. Additionally, fecal samples were collected to further determine markers of stress responsivity and emotional resilience. Results indicated that contingency-trained rats exhibited more adaptive responses in the probe trial (e.g., fewer interrupted grooming sequences and more targeted search strategies) than the noncontingent-trained rats; additionally, increased DHEA/CORT ratios were observed in the contingent-trained animals. Diminished activation of the habenula (i.e., fos-immunoreactivity) was correlated with resilience factors such as increased levels of DHEA metabolites during cognitive training. Of the three coping profiles, flexible copers exhibited enhanced neuroplasticity (i.e., increased dentate gyrus doublecortin-immunoreactivity) compared to the more consistently responding active and passive copers. Thus, in the current study, contingency training via effort-based reward (EBR) training, enhanced by a flexible coping style, provided neurobiological resilience and adaptive responses to prediction errors in the final probe trial. These findings have implications for psychiatric illnesses that are influenced by altered stress responses and decision-making abilities (e.g., depression).

  17. Contingency-based emotional resilience: Effort-based reward training and flexible coping lead to adaptive responses to uncertainty in male rats

    Directory of Open Access Journals (Sweden)

    Kelly G Lambert

    2014-04-01

    Full Text Available Emotional resilience enhances an animal’s ability to maintain physiological allostasis and adaptive responses in the midst of challenges ranging from cognitive uncertainty to chronic stress. In the current study, neurobiological factors related to strategic responses to uncertainty produced by prediction errors were investigated by initially profiling male rats as passive, active or flexible copers (n=12 each group and assigning to either a contingency-trained or non-contingency trained group. Animals were subsequently trained in a spatial learning task so that problem solving strategies in the final probe task, as well various biomarkers of brain activation and plasticity in brain areas associated with cognition and emotional regulation, could be assessed. Additionally, fecal samples were collected to further determine markers of stress responsivity and emotional resilience. Results indicated that contingency-trained rats exhibited more adaptive responses in the probe trial (e.g., fewer interrupted grooming sequences and more targeted search strategies than the noncontingent-trained rats; additionally, increased DHEA/CORT ratios were observed in the contingent-trained animals. Diminished activation of the habenula (i.e., fos-immunoreactivity was correlated with resilience factors such as increased levels of DHEA metabolites during cognitive training. Of the three coping profiles, flexible copers exhibited enhanced neuroplasticity (i.e., increased dentate gyrus doublecortin-immunoreactivity compared to the more consistently responding active and passive copers. Thus, in the current study, contingency training via effort-based reward training, enhanced by a flexible coping style, provided neurobiological resilience and adaptive responses to prediction errors in the final probe trial. These findings have implications for psychiatric illnesses that are influenced by altered stress responses and decision-making abilities (e.g., depression.

  18. Comparison of trial participants and open access users of a web-based physical activity intervention regarding adherence, attrition, and repeated participation.

    Science.gov (United States)

    Wanner, Miriam; Martin-Diener, Eva; Bauer, Georg; Braun-Fahrländer, Charlotte; Martin, Brian W

    2010-02-10

    Web-based interventions are popular for promoting healthy lifestyles such as physical activity. However, little is known about user characteristics, adherence, attrition, and predictors of repeated participation on open access physical activity websites. The focus of this study was Active-online, a Web-based individually tailored physical activity intervention. The aims were (1) to assess and compare user characteristics and adherence to the website (a) in the open access context over time from 2003 to 2009, and (b) between trial participants and open access users; and (2) to analyze attrition and predictors of repeated use among participants in a randomized controlled trial compared with registered open access users. Data routinely recorded in the Active-online user database were used. Adherence was defined as: the number of pages viewed, the proportion of visits during which a tailored module was begun, the proportion of visits during which tailored feedback was received, and the time spent in the tailored modules. Adherence was analyzed according to six one-year periods (2003-2009) and according to the context (trial or open access) based on first visits and longest visits. Attrition and predictors of repeated participation were compared between trial participants and open access users. The number of recorded visits per year on Active-online decreased from 42,626 in 2003-2004 to 8343 in 2008-2009 (each of six one-year time periods ran from April 23 to April 22 of the following year). The mean age of users was between 38.4 and 43.1 years in all time periods and both contexts. The proportion of women increased from 49.5% in 2003-2004 to 61.3% in 2008-2009 (Popen access users. For open access users, adherence was similar during the first and the longest visits; for trial participants, adherence was lower during the first visits and higher during the longest visits. Of registered open access users and trial participants, 25.8% and 67.3% respectively visited Active

  19. Comparison between paricalcitol and active non-selective vitamin D receptor activator for secondary hyperparathyroidism in chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Cai, Panpan; Tang, Xiaohong; Qin, Wei; Ji, Ling; Li, Zi

    2016-04-01

    The goal of this systematic review is to evaluate the efficacy and safety of paricalcitol versus active non-selective vitamin D receptor activators (VDRAs) for secondary hyperparathyroidism (SHPT) management in chronic kidney disease (CKD) patients. PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), clinicaltrials.gov (inception to September 2015), and ASN Web site were searched for relevant studies. A meta-analysis of randomized controlled trials (RCTs) and quasi-RCTs that assessed the effects and adverse events of paricalcitol and active non-selective VDRA in adult CKD patients with SHPT was performed using Review Manager 5.2. A total of 10 trials involving 734 patients were identified for this review. The quality of included trials was limited, and very few trials reported all-cause mortality or cardiovascular calcification without any differences between two groups. Compared with active non-selective VDRAs, paricalcitol showed no significant difference in both PTH reduction (MD -7.78, 95% CI -28.59-13.03, P = 0.46) and the proportion of patients who achieved the target reduction of PTH (OR 1.27, 95% CI 0.87-1.85, P = 0.22). In addition, no statistical differences were found in terms of serum calcium, episodes of hypercalcemia, serum phosphorus, calcium × phosphorus products, and bone metabolism index. Current evidence is insufficient, showing paricalcitol is superior to active non-selective VDRAs in lowering PTH or reducing the burden of mineral loading. Further trials are required to prove the tissue-selective effect of paricalcitol and to overcome the limitation of current research.

  20. Postural adaptations to repeated optic flow stimulation in older adults

    OpenAIRE

    O’Connor, Kathryn W.; Loughlin, Patrick J.; Redfern, Mark S.; Sparto, Patrick J.

    2008-01-01

    The purpose of this study is to understand the processes of adaptation (changes in within-trial postural responses) and habituation (reductions in between-trial postural responses) to visual cues in older and young adults. Of particular interest were responses to sudden increases in optic flow magnitude. The postural sway of 25 healthy young adults and 24 healthy older adults was measured while subjects viewed anterior-posterior 0.4 Hz sinusoidal optic flow for 45 s. Three trials for each of ...

  1. Scalable Algorithms for Adaptive Statistical Designs

    Directory of Open Access Journals (Sweden)

    Robert Oehmke

    2000-01-01

    Full Text Available We present a scalable, high-performance solution to multidimensional recurrences that arise in adaptive statistical designs. Adaptive designs are an important class of learning algorithms for a stochastic environment, and we focus on the problem of optimally assigning patients to treatments in clinical trials. While adaptive designs have significant ethical and cost advantages, they are rarely utilized because of the complexity of optimizing and analyzing them. Computational challenges include massive memory requirements, few calculations per memory access, and multiply-nested loops with dynamic indices. We analyze the effects of various parallelization options, and while standard approaches do not work well, with effort an efficient, highly scalable program can be developed. This allows us to solve problems thousands of times more complex than those solved previously, which helps make adaptive designs practical. Further, our work applies to many other problems involving neighbor recurrences, such as generalized string matching.

  2. [Features of adaptive responses in right-handers and left-handers, and their relationship to the functional activity of the brain].

    Science.gov (United States)

    Barkar, A A; Markina, L D

    2014-01-01

    In the article there is considered the relationship between adaptation state of the organism and features of bioelectric activity of the brain in right-handers and left-handers. Practically healthy persons of both genders, 23-45 years of age, with the chronic stress disorder were examined. Adaptation status was evaluated with a computer software "Anti-stress", features of bioelectric brain activity were detected by means of spectral and coherent EEG analysis, also the character of motor and sensory asymmetries was determined. The obtained data showed that the response of the organism to excitators of varying strength is a system one and manifested at different levels; adaptation status and bioelectrical activity in right-handers and left-handers have features.

  3. Lessons learned from the London Exercise and Pregnant (LEAP Smokers randomised controlled trial process evaluation: implications for the design of physical activity for smoking cessation interventions during pregnancy

    Directory of Open Access Journals (Sweden)

    Nikoletta Giatras

    2017-01-01

    Full Text Available Abstract Background The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved. Methods Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures. Topics included recruitment, retention and how the physical activity intervention for pregnant smokers was delivered and how it was adapted when necessary to suit the women. The focus groups were audio-recorded, transcribed verbatim and subjected to thematic analysis. Results Five themes emerged related to barriers or enablers to intervention delivery: (1 nature of the intervention; (2 personal characteristics of trial participants; (3 practical issues; (4 researchers’ engagement with participants; (5 training and support needs. Researchers perceived that participants may have been deterred by the intensive and generic nature of the intervention and the need to simultaneously quit smoking and increase physical activity. Women also appeared hampered by pregnancy ailments, social deprivation, and poor mental health. Researchers observed that their status as health professionals was valued by participants but it was challenging to maintain contact with participants. Training and support needs were identified for dealing with pregnant teenagers, participants’ friends and family, and post-natal return to smoking. Conclusions Future exercise interventions for smoking cessation in pregnancy may benefit by increased tailoring of the intervention to the characteristics of the

  4. Opportunities and Challenges for Drug Development: Public-Private Partnerships, Adaptive Designs and Big Data.

    Science.gov (United States)

    Yildirim, Oktay; Gottwald, Matthias; Schüler, Peter; Michel, Martin C

    2016-01-01

    Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public-private partnerships, adaptive designs and big data. Public-private partnerships come in many different forms with regard to scope, duration and type and number of participants. They range from project-specific collaborations to strategic alliances to large multi-party consortia. Each of them offers specific opportunities and faces distinct challenges. Among types of collaboration, investigator-initiated studies are becoming increasingly popular but have legal, ethical, and financial implications. Adaptive trial designs are also increasingly discussed. However, adaptive should not be used as euphemism for the repurposing of a failed trial; rather it requires carefully planning and specification before a trial starts. Adaptive licensing can be a counter-part of adaptive trial design. The use of Big Data is another opportunity to leverage existing information into knowledge useable for drug discovery and development. Respecting limitations of informed consent and privacy is a key challenge in the use of Big Data. Speakers and participants at the symposium were convinced that appropriate use of the above new options may indeed help to increase the efficiency of future drug development.

  5. Conflict monitoring and adaptation as reflected by N2 amplitude in obsessive-compulsive disorder.

    Science.gov (United States)

    Riesel, A; Klawohn, J; Kathmann, N; Endrass, T

    2017-06-01

    Feelings of doubt and perseverative behaviours are key symptoms of obsessive-compulsive disorder (OCD) and have been linked to hyperactive error and conflict signals in the brain. While enhanced neural correlates of error monitoring have been robustly shown, far less is known about conflict processing and adaptation in OCD. We examined event-related potentials during conflict processing in 70 patients with OCD and 70 matched healthy comparison participants, focusing on the stimulus-locked N2 elicited in a flanker task. Conflict adaptation was evaluated by analysing sequential adjustments in N2 and behaviour, i.e. current conflict effects as a function of preceding conflict. Patients with OCD showed enhanced N2 amplitudes compared with healthy controls. Further, patients showed stronger conflict adaptation effects on reaction times and N2 amplitude. Thus, the effect of previous compatibility was larger in patients than in healthy participants as indicated by greater N2 adjustments in change trials (i.e. iC, cI). As a result of stronger conflict adaptation in patients, N2 amplitudes were comparable between groups in incompatible trials following incompatible trials. Larger N2 amplitudes and greater conflict adaptation in OCD point to enhanced conflict monitoring leading to increased recruitment of cognitive control in patients. This was most pronounced in change trials and was associated with stronger conflict adjustment in N2 and behaviour. Thus, hyperactive conflict monitoring in OCD may be beneficial in situations that require a high amount of control to resolve conflict, but may also reflect an effortful process that is linked to distress and symptoms of OCD.

  6. Opportunities and challenges for drug development: public-private partnerships, adaptive designs and big data

    Directory of Open Access Journals (Sweden)

    Oktay Yildirim

    2016-12-01

    Full Text Available Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research & Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e. public-private partnerships, adaptive designs and big data. Public-private partnerships come in many different forms with regard to scope, duration and type and number of participants. They range from project-specific collaborations to strategic alliances to large multi-party consortia. Each of them offers specific opportunities and faces distinct challenges. Among types of collaboration, investigator-initiated studies are becoming increasingly popular but have legal, ethical and financial implications. Adaptive trial designs are also increasingly discussed. However, adaptive should not be used as euphemism for the repurposing of a failed trial; rather it requires carefully planning and specification before a trial starts. Adaptive licensing can be a counter-part of adaptive trial design. The use of Big Data is another opportunity to leverage existing information into knowledge useable for drug discovery and development. Respecting limitations of informed consent and privacy is a key challenge in the use of Big Data. Speakers and participants at the symposium were convinced that appropriate use of the above new options may indeed help to increase the efficiency of future drug development.

  7. Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

    Science.gov (United States)

    Yildirim, Oktay; Gottwald, Matthias; Schüler, Peter; Michel, Martin C.

    2016-01-01

    Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public–private partnerships, adaptive designs and big data. Public–private partnerships come in many different forms with regard to scope, duration and type and number of participants. They range from project-specific collaborations to strategic alliances to large multi-party consortia. Each of them offers specific opportunities and faces distinct challenges. Among types of collaboration, investigator-initiated studies are becoming increasingly popular but have legal, ethical, and financial implications. Adaptive trial designs are also increasingly discussed. However, adaptive should not be used as euphemism for the repurposing of a failed trial; rather it requires carefully planning and specification before a trial starts. Adaptive licensing can be a counter-part of adaptive trial design. The use of Big Data is another opportunity to leverage existing information into knowledge useable for drug discovery and development. Respecting limitations of informed consent and privacy is a key challenge in the use of Big Data. Speakers and participants at the symposium were convinced that appropriate use of the above new options may indeed help to increase the efficiency of future drug development. PMID:27999543

  8. The Effects of Unilateral Adaptation of Hearing Aids on Symptoms of Depression and Social Activity Constraints of Elderly

    Directory of Open Access Journals (Sweden)

    Santos, Fernanda Dutra dos

    2015-01-01

    Full Text Available Introduction Hearing loss is one of the most common problems in the elderly population. Besides compromising oral communication, it directly affects social relations and prevents elderly patients from living actively in society, possibly leading to the onset of depression or other conditions. Objective To analyze the effects of unilateral adaptation of hearing aids on symptoms of depression and the social activity constraints of elderly subjects with hearing impairment. Methods The sample consisted of elderly subjects with hearing loss who did not use hearing aids. Data were collected in two phases. Initially, all participants underwent an audiological assessment and answered the Hearing Handicap Inventory for Elderly (summarized version and the Geriatric Depression Scale. All subjects participated in the selection and hearing aid adaptation processes and became monaural hearing aid users. After 30 days of hearing aid use, they were assessed with the same instruments. The results of the questionnaires before and after hearing aid adaptation were compared. Results The sample consisted of 13 individuals, between 60 and 90 years old (mean 72.85 ± 11.05 years. Data analysis showed that there was significant improvement in social activity constraints (p < 0.001 and in symptoms of depression (p = 0.031. Conclusion Results show that, in the sample studied, unilateral hearing aid adaptation reduced social activity constraints and depression symptoms.

  9. Adaptive Active Noise Suppression Using Multiple Model Switching Strategy

    Directory of Open Access Journals (Sweden)

    Quanzhen Huang

    2017-01-01

    Full Text Available Active noise suppression for applications where the system response varies with time is a difficult problem. The computation burden for the existing control algorithms with online identification is heavy and easy to cause control system instability. A new active noise control algorithm is proposed in this paper by employing multiple model switching strategy for secondary path varying. The computation is significantly reduced. Firstly, a noise control system modeling method is proposed for duct-like applications. Then a multiple model adaptive control algorithm is proposed with a new multiple model switching strategy based on filter-u least mean square (FULMS algorithm. Finally, the proposed algorithm was implemented on Texas Instruments digital signal processor (DSP TMS320F28335 and real time experiments were done to test the proposed algorithm and FULMS algorithm with online identification. Experimental verification tests show that the proposed algorithm is effective with good noise suppression performance.

  10. Cognitive Flexibility Training: A Large-Scale Multimodal Adaptive Active-Control Intervention Study in Healthy Older Adults

    Directory of Open Access Journals (Sweden)

    Jessika I. V. Buitenweg

    2017-11-01

    Full Text Available As aging is associated with cognitive decline, particularly in the executive functions, it is essential to effectively improve cognition in older adults. Online cognitive training is currently a popular, though controversial method. Although some changes seem possible in older adults through training, far transfer, and longitudinal maintenance are rarely seen. Based on previous literature we created a unique, state-of-the-art intervention study by incorporating frequent sessions and flexible, novel, adaptive training tasks, along with an active control group. We created a program called TAPASS (Training Project Amsterdam Seniors and Stroke, a randomized controlled trial. Healthy older adults (60–80 y.o. were assigned to a frequent- (FS or infrequent switching (IS experimental condition or to the active control group and performed 58 half-hour sessions over the course of 12 weeks. Effects on executive functioning, processing- and psychomotor speed, planning, verbal long term memory, verbal fluency, and reasoning were measured on four time points before, during and after the training. Additionally, we examined the explorative question which individual aspects added to training benefit. Besides improvements on the training, we found significant time effects on multiple transfer tasks in all three groups that likely reflected retest effects. No training-specific improvements were detected, and we did not find evidence of additional benefits of individual characteristics. Judging from these results, the therapeutic value of using commercially available training games to train the aging brain is modest, though any apparent effects should be ascribed more to expectancy and motivation than to the elements in our training protocol. Our results emphasize the importance of using parallel tests as outcome measures for transfer and including both active and passive control conditions. Further investigation into different training methods is advised

  11. Valuing Trial Designs from a Pharmaceutical Perspective Using Value-Based Pricing.

    Science.gov (United States)

    Breeze, Penny; Brennan, Alan

    2015-11-01

    Our aim was to adapt the traditional framework for expected net benefit of sampling (ENBS) to be more compatible with drug development trials from the pharmaceutical perspective. We modify the traditional framework for conducting ENBS and assume that the price of the drug is conditional on the trial outcomes. We use a value-based pricing (VBP) criterion to determine price conditional on trial data using Bayesian updating of cost-effectiveness (CE) model parameters. We assume that there is a threshold price below which the company would not market the new intervention. We present a case study in which a phase III trial sample size and trial duration are varied. For each trial design, we sampled 10,000 trial outcomes and estimated VBP using a CE model. The expected commercial net benefit is calculated as the expected profits minus the trial costs. A clinical trial with shorter follow-up, and larger sample size, generated the greatest expected commercial net benefit. Increasing the duration of follow-up had a modest impact on profit forecasts. Expected net benefit of sampling can be adapted to value clinical trials in the pharmaceutical industry to optimise the expected commercial net benefit. However, the analyses can be very time consuming for complex CE models. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd.

  12. Self-adapted sliding scale spectroscopy ADC

    International Nuclear Information System (INIS)

    Xu Qichun; Wang Jingjin

    1992-01-01

    The traditional sliding scale technique causes a disabled range that is equal to the sliding length, thus reduces the analysis range of a MCA. A method for reduce ADC's DNL, which is called self-adapted sliding scale method, has been designed and tested. With this method, the disabled range caused by a traditional sliding scale method can be eliminated by a random trial scale and there is no need of an additional amplitude discriminator with swing threshold. A special trial-and-correct logic is presented. The tested DNL of the spectroscopy ADC described here is less than 0.5%

  13. The effect of adaptive versus static practicing on student learning - evidence from a randomized field experiment

    NARCIS (Netherlands)

    van Klaveren, Chris; Vonk, Sebastiaan; Cornelisz, Ilja

    2017-01-01

    Schools and governments are increasingly investing in adaptive practice software. To date, the evidence whether adaptivity improves learning outcomes is limited and mixed. A large-scale randomized control trial is conducted in Dutch secondary schools to evaluate the effectiveness of an adaptive

  14. Adaptive Neural-Sliding Mode Control of Active Suspension System for Camera Stabilization

    Directory of Open Access Journals (Sweden)

    Feng Zhao

    2015-01-01

    Full Text Available The camera always suffers from image instability on the moving vehicle due to the unintentional vibrations caused by road roughness. This paper presents a novel adaptive neural network based on sliding mode control strategy to stabilize the image captured area of the camera. The purpose is to suppress vertical displacement of sprung mass with the application of active suspension system. Since the active suspension system has nonlinear and time varying characteristics, adaptive neural network (ANN is proposed to make the controller robustness against systematic uncertainties, which release the model-based requirement of the sliding model control, and the weighting matrix is adjusted online according to Lyapunov function. The control system consists of two loops. The outer loop is a position controller designed with sliding mode strategy, while the PID controller in the inner loop is to track the desired force. The closed loop stability and asymptotic convergence performance can be guaranteed on the basis of the Lyapunov stability theory. Finally, the simulation results show that the employed controller effectively suppresses the vibration of the camera and enhances the stabilization of the entire camera, where different excitations are considered to validate the system performance.

  15. Influence of physical education on the level of adaptation of students to educational activity.

    Directory of Open Access Journals (Sweden)

    Korolinska S.V.

    2012-06-01

    Full Text Available Examined and summarized problems of adaptation of students to educational activity. 100 students took part in research. Found out a row socially psychological factors which determine efficiency of process of adaptation of students to the scientific process. Practical recommendations are developed on organization of educational process of students. It is recommended widely to utillize a physical culture as mean of reduction of adaptation period and increase of level of physical and mental capacity. It is marked that almost 90% students have rejections in a health. Also over 50% - unsatisfactory physical preparedness. It is set that for the students of the II course the indexes of low situation anxiety prevail as compared to the I course. It is set that the characteristic feature of the psychological state during an examination session is emotionally volitional instability.

  16. Adaptive thermogenesis by dietary n-3 polyunsaturated fatty acids: Emerging evidence and mechanisms.

    Science.gov (United States)

    Fan, Rong; Koehler, Karsten; Chung, Soonkyu

    2018-04-19

    Brown/beige fat plays a crucial role in maintaining energy homeostasis through non-shivering thermogenesis in response to cold temperature and excess nutrition (adaptive thermogenesis). Although numerous molecular and genetic regulators have been identified, relatively little information is available regarding thermogenic dietary molecules. Recently, a growing body of evidence suggests that high consumption of n-3 polyunsaturated fatty acids (PUFA) or activation of GPR120, a membrane receptor of n-3 PUFA, stimulate adaptive thermogenesis. In this review, we summarize the emerging evidence that n-3 PUFA promote brown/beige fat formation and highlight the potential mechanisms whereby n-3 PUFA require GPR120 as a signaling platform or act independently. Human clinical trials are revisited in the context of energy expenditure. Additionally, we explore some future perspective that n-3 PUFA intake might be a useful strategy to boost or sustain metabolic activities of brown/beige fat at different lifecycle stages of pregnancy and senescence. Given that a high ratio of n-6/n-3 PUFA intake is associated with the development of obesity and type 2 diabetes, understanding the impact of n-6/n-3 ratio on energy expenditure and adaptive thermogenesis will inform the implementation of a novel nutritional strategy for preventing obesity. Copyright © 2018 Elsevier B.V. All rights reserved.

  17. The relationship between skeletal muscle mitochondrial citrate synthase activity and whole body oxygen uptake adaptations in response to exercise training

    DEFF Research Database (Denmark)

    Vigelsø Hansen, Andreas; Andersen, Nynne Bjerre; Dela, Flemming

    2014-01-01

    Citrate synthase (CS) activity is a validated biomarker for mitochondrial density in skeletal muscle. CS activity is also used as a biochemical marker of the skeletal muscle oxidative adaptation to a training intervention, and a relationship between changes in whole body aerobic capacity and chan......Citrate synthase (CS) activity is a validated biomarker for mitochondrial density in skeletal muscle. CS activity is also used as a biochemical marker of the skeletal muscle oxidative adaptation to a training intervention, and a relationship between changes in whole body aerobic capacity...

  18. The effectiveness of a Housing First adaptation for ethnic minority groups: findings of a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vicky Stergiopoulos

    2016-10-01

    Full Text Available Abstract Background Little is known about the effectiveness of Housing First (HF among ethnic minority groups, despite its growing popularity for homeless adults experiencing mental illness. This randomized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management, enhanced by anti-racism and anti-oppression practices for homeless adults with mental illness from diverse ethnic minority backgrounds. Methods This unblinded pragmatic field trial was carried out in community settings in Toronto, Canada. Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness, who met study criteria for moderate needs for mental health services. Participants were randomized to either adapted HF (n = 135 or usual care (n = 102 and followed every 3 months for 24 months. The primary study outcome was housing stability; secondary outcomes included physical and mental health, social functioning, quality of life, arrests and health service use. Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care. Results During the 24-month study period, HF participants were stably housed a significantly greater proportion of time compared to usual care participants, 75 % (95 % CI 70 to 81 vs. 41 % (95 % CI 35 to 48, respectively, for a difference of 34 %, 95 % CI 25 to 43. HF also led to improvements in community integration over the course of the study: the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care (change in mean difference = 2.2, 95 % CI 0.06 to 4.3. Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period (OR = 0.37, 95 % CI 0.18 to 0.72. Conclusion Housing First enhanced with anti-racism and anti-oppression practices can

  19. Physical Activity during Cancer Treatment (PACT Study: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    de Wit G Ardine

    2010-06-01

    Full Text Available Abstract Background Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. Methods/Design The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term and after 9 months (long term. Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey, impact on functioning and autonomy (Impact on functioning and autonomy questionnaire, anxiety and depression (Hospital Anxiety and Depression Scale, physical fitness (aerobic peak capacity, muscle strength, body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level

  20. New approaches to trials in glomerulonephritis.

    Science.gov (United States)

    Craig, Jonathan C; Tong, Allison; Strippoli, Giovanni F M

    2017-01-01

    Randomized controlled trials are required to reliably identify interventions to improve the outcomes for people with glomerulonephritis (GN). Unfortunately, although easier, observational studies are inherently unreliable even though the findings of both study designs agree most of the time. Currently there are ∼790 trials in GN, but suboptimal design and reporting, together with small sample sizes, mean that they may not be reliable for decision making. If the history is somewhat bleak, the future looks bright, with recent initiatives to improve the quality, size and relevance of clinical trials in nephrology, including greater patient engagement, trial networks, core outcome sets, registry-based trials and adaptive designs. Given the current state of the evidence informing the care of people with GN, disruptive technologies and pervasive culture change is required to ensure that the potential of trials to improve the health of people with this complex condition is to be realized. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  1. Frontostriatal and behavioral adaptations to daily sugar-sweetened beverage intake: a randomized controlled trial.

    Science.gov (United States)

    Burger, Kyle S

    2017-03-01

    Background: Current obesity theories suggest that the repeated intake of highly palatable high-sugar foods causes adaptions in the striatum, parietal lobe, and prefrontal and visual cortices in the brain that may serve to perpetuate consumption in a feed-forward manner. However, the data for humans are cross-sectional and observational, leaving little ability to determine the temporal precedence of repeated consumption on brain response. Objective: We tested the impact of regular sugar-sweetened beverage intake on brain and behavioral responses to beverage stimuli. Design: We performed an experiment with 20 healthy-weight individuals who were randomly assigned to consume 1 of 2 sugar-sweetened beverages daily for 21 d, underwent 2 functional MRI sessions, and completed behavioral and explicit hedonic assessments. Results: Consistent with preclinical experiments, daily beverage consumption resulted in decreases in dorsal striatal response during receipt of the consumed beverage ( r = -0.46) and decreased ventromedial prefrontal response during logo-elicited anticipation ( r = -0.44). This decrease in the prefrontal response correlated with increases in behavioral disinhibition toward the logo of the consumed beverage ( r = 0.54; P = 0.02). Daily beverage consumption also increased precuneus response to both juice logos compared with a tasteless control ( r = 0.45), suggesting a more generalized effect toward beverage cues. Last, the repeated consumption of 1 beverage resulted in an explicit hedonic devaluation of a similar nonconsumed beverage ( P < 0.001). Conclusions: Analogous to previous reports, these initial results provide convergent data for a role of regular sugar-sweetened beverage intake in altering neurobehavioral responses to the regularly consumed beverage that may also extend to other beverage stimuli. Future research is required to provide evidence of replication in a larger sample and to establish whether the neurobehavioral adaptations observed

  2. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

    2017-08-01

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end

  3. A cluster-randomized controlled trial of strategies to increase adolescents' physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP) trial.

    Science.gov (United States)

    Rosenkranz, Richard R; Lubans, David R; Peralta, Louisa R; Bennie, Andrew; Sanders, Taren; Lonsdale, Chris

    2012-10-01

    The physical activity (PA) levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE) programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children's motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT), on PA levels, and their hypothesized antecedents, during year 8 PE lessons. This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16) and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1) explaining the relevance of activities; (2) providing choice from PA options selected by the teacher; (3) providing equipment and free choice of activities; or (4) usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested within teachers as a random effect. Study

  4. The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence.

    Science.gov (United States)

    McCauley, Elizabeth; Gudmundsen, Gretchen; Schloredt, Kelly; Martell, Christopher; Rhew, Isaac; Hubley, Samuel; Dimidjian, Sona

    2016-01-01

    This study aimed to examine implementation feasibility and initial treatment outcomes of a behavioral activation (BA) based treatment for adolescent depression, the Adolescent Behavioral Activation Program (A-BAP). A randomized, controlled trial was conducted with 60 clinically referred adolescents with a depressive disorder who were randomized to receive either 14 sessions of A-BAP or uncontrolled evidenced-based practice for depression. The urban sample was 64% female, predominantly Non-Hispanic White (67%), and had an average age of 14.9 years. Measures of depression, global functioning, activation, and avoidance were obtained through clinical interviews and/or through parent and adolescent self-report at preintervention and end of intervention. Intent-to-treat linear mixed effects modeling and logistic regression analysis revealed that both conditions produced statistically significant improvement from pretreatment to end of treatment in depression, global functioning, and activation and avoidance. There were no significant differences across treatment conditions. These findings provide the first step in establishing the efficacy of BA as a treatment for adolescent depression and support the need for ongoing research on BA as a way to enhance the strategies available for treatment of depression in this population.

  5. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility.

    Science.gov (United States)

    Wójcicki, Thomas R; Grigsby-Toussaint, Diana; Hillman, Charles H; Huhman, Marian; McAuley, Edward

    2014-10-30

    The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group's administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be

  6. An Adaptive CBPR Approach to Create Weight Management Materials for a School-Based Health Center Intervention

    Directory of Open Access Journals (Sweden)

    Andrew L. Sussman

    2013-01-01

    Full Text Available Purpose. From our previous clinical work with overweight/obese youth, we identified the need for research to create an effective weight management intervention to address the growing prevalence of adolescent metabolic syndrome. Formative assessment through an adaptive community-based participatory research (CBPR approach was conducted toward the development of a nutritional and physical activity (DVD and clinician toolkit for a school-based health center (SBHC weight management intervention. Methods. We first conducted parent and adolescent interviews on views and experiences about obesity while convening a community advisory council (CAC recruited from two participating urban New Mexico high schools. Thematic findings from the interviews were analyzed with the CAC to develop culturally and developmentally appropriate intervention materials. Results. Themes from the parent and adolescent interviews included general barriers/challenges, factors influencing motivation, and change facilitators. The CAC and university-based research team reached consensus on the final content of nutrition and physical activity topics to produce a DVD and clinician toolkit through six monthly sessions. These materials used in the SBHC intervention resulted in a greater reduction of body mass index when compared to adolescents receiving standard care. Conclusions. Formative assessment using an adaptive CBPR approach resulted in the creation of culturally and age appropriate weight reduction materials that were acceptable to study participants. This trial is registered with ClinicalTrials.gov NCT00841334.

  7. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  8. Adapted motivational interviewing to improve the uptake of treatment for glaucoma in Nigeria: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Abdull, Mohammed M; Gilbert, Clare; McCambridge, Jim; Evans, Jennifer

    2014-04-29

    Glaucoma is a chronic eye disease associated with irreversible visual loss. In Africa, glaucoma patients often present late, with very advanced disease. One-off procedures, such as laser or surgery, are recommended in Africa because of lack of or poor adherence to medical treatment. However, acceptance of surgery is usually extremely low. To prevent blindness, adherence to treatment needs to improve, using acceptable, replicable and cost-effective interventions. After reviewing the literature and interviewing patients in Bauchi (Nigeria) motivational interviewing (MI) was selected as the intervention for this trial, with adaptation for glaucoma (MIG). MI is designed to strengthen personal motivation for, and commitment to a specific goal by eliciting and exploring a person's reasons for change within an atmosphere of acceptance and compassion. The aim of this study is to assess whether MIG increases the uptake of laser or surgery amongst glaucoma patients where this is the recommended treatment. The hypothesis is that MIG increases the uptake of treatment. This will be the first trial of MI in Africa. This is a hospital based, single centre, randomized controlled trial of MIG plus an information sheet on glaucoma and its treatment (the latter being "standard care") compared with standard care alone for glaucoma patients where the treatment recommended is surgery or laser.Those eligible for the trial are adults aged 17 years and above who live within 200 km of Bauchi with advanced glaucoma where the examining ophthalmologist recommends surgery or laser. After obtaining written informed consent, participants will be randomly allocated to MIG plus standard care, or standard care alone. Motivational interviewing will be delivered in Hausa or English by one of two MIG trained personnel. One hundred and fifty participants will be recruited to each arm. The primary outcome is the proportion of participants undergoing laser or surgery within two months of the date given

  9. Conflict adaptation in emotional task underlies the amplification of target.

    Science.gov (United States)

    Chechko, Natalia; Kellermann, Thilo; Schneider, Frank; Habel, Ute

    2014-04-01

    A primary function of cognitive control is to adjust the cognitive system according to situational demands. The so-called "conflict adaptation effect" elicited in laboratory experiments is supposed to reflect the above function. Neuroimaging studies suggest that adaptation of nonemotional conflict is mediated by the dorsolateral prefrontal cortex through a top-down enhancement of task-relevant (target), relative to task-irrelevant (distractor), stimulus representation in the sensory cortices. The adaptation of emotional conflict, on the other hand, is suggested to be related to the rostral anterior cingulate inhibiting the processing of emotional distractors through a top-down modulation of amygdala responsivity. In the present study, we manipulated, on a trial-by-trial basis, the levels of semantic interference conflict triggered by the incompatibility between emotional faces (targets) and emotional words (distractors) in a modified version of the emotional Stroop task. Similar to previous observations involving nonemotional interference effects, the behavioral adaptation of emotional conflict was found to be paralleled by a stronger recruitment of the fusiform face area. Additional areas related to the conflict adaptation effect were the bilateral insula, the bilateral frontal operculum (fO), the right amygdala, the left precentral and postcentral gyri, and the parietal cortex. These findings suggest that augmentation of cortical responses to task-relevant information in emotional conflict may be related to conflict adaptation processes in a way that has been observed in nonemotional conflict, challenging the view that brain circuitries underlying the conflict adaptation effect depend only on the nature of conflict.

  10. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  11. Physical activity as a treatment for depression: the TREAD randomised trial protocol.

    Science.gov (United States)

    Baxter, Helen; Winder, Rachel; Chalder, Melanie; Wright, Christine; Sherlock, Sofie; Haase, Anne; Wiles, Nicola J; Montgomery, Alan A; Taylor, Adrian H; Fox, Ken R; Lawlor, Debbie A; Peters, Tim J; Sharp, Deborah J; Campbell, John; Lewis, Glyn

    2010-11-12

    Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments. The results of the trial will provide information about the effectiveness of

  12. Comparative costs and activity from a sample of UK clinical trials units.

    Science.gov (United States)

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  13. Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy.

    Science.gov (United States)

    Fureman, Brandy E; Friedman, Daniel; Baulac, Michel; Glauser, Tracy; Moreno, Jonathan; Dixon-Salazar, Tracy; Bagiella, Emilia; Connor, Jason; Ferry, Jim; Farrell, Kathleen; Fountain, Nathan B; French, Jacqueline A

    2017-10-03

    The randomized controlled trial is the unequivocal gold standard for demonstrating clinical efficacy and safety of investigational therapies. Recently there have been concerns raised about prolonged exposure to placebo and ineffective therapy during the course of an add-on regulatory trial for new antiepileptic drug approval (typically ∼6 months in duration), due to the potential risks of continued uncontrolled epilepsy for that period. The first meeting of the Research Roundtable in Epilepsy on May 19-20, 2016, focused on "Reducing placebo exposure in epilepsy clinical trials," with a goal of considering new designs for epilepsy regulatory trials that may be added to the overall development plan to make it, as a whole, safer for participants while still providing rigorous evidence of effect. This topic was motivated in part by data from a meta-analysis showing a 3- to 5-fold increased rate of sudden unexpected death in epilepsy in participants randomized to placebo or ineffective doses of new antiepileptic drugs. The meeting agenda included rationale and discussion of different trial designs, including active-control add-on trials, placebo add-on to background therapy with adjustment, time to event designs, adaptive designs, platform trials with pooled placebo control, a pharmacokinetic/pharmacodynamic approach to reducing placebo exposure, and shorter trials when drug tolerance has been ruled out. The merits and limitations of each design were discussed and are reviewed here. © 2017 American Academy of Neurology.

  14. Improving Clinical Trial Efficiency: Thinking outside the Box.

    Science.gov (United States)

    Mandrekar, Sumithra J; Dahlberg, Suzanne E; Simon, Richard

    2015-01-01

    Clinical trial design strategies have evolved over the past few years as a means to accelerate the drug development process so that the right therapies can be delivered to the right patients. Basket, umbrella, and adaptive enrichment strategies represent a class of novel designs for testing targeted therapeutics in oncology. Umbrella trials include a central infrastructure for screening and identification of patients, and focus on a single tumor type or histology with multiple subtrials, each testing a targeted therapy within a molecularly defined subset. Basket trial designs offer the possibility to include multiple molecularly defined subpopulations, often across histology or tumor types, but included in one cohesive design to evaluate the targeted therapy in question. Adaptive enrichment designs offer the potential to enrich for patients with a particular molecular feature that is predictive of benefit for the test treatment based on accumulating evidence from the trial. This review will aim to discuss the fundamentals of these design strategies, the underlying statistical framework, the logistical barriers of implementation, and, ultimately, the interpretation of the trial results. New statistical approaches, extensive multidisciplinary collaboration, and state of the art data capture technologies are needed to implement these strategies in practice. Logistical challenges to implementation arising from centralized assay testing, requirement of multiple specimens, multidisciplinary collaboration, and infrastructure requirements will also be discussed. This review will present these concepts in the context of the National Cancer Institute's precision medicine initiative trials: MATCH, ALCHEMIST, Lung MAP, as well as other trials such as FOCUS4.

  15. Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information.

    Science.gov (United States)

    Acolet, Dominique; Allen, Elizabeth; Houston, Rosie; Wilkinson, Andrew R; Costeloe, Kate; Elbourne, Diana

    2011-11-01

    Research findings are not rapidly or fully implemented into policies and practice in care. To assess whether an 'active' strategy was more likely to lead to changes in policy and practice in preterm baby care than traditional information dissemination. Cluster randomised trial. 180 neonatal units (87 active, 93 control) in England; clinicians from active arm units; babies born Dissemination of research report; slides; information about newborn care position statement. ACTIVE ARM: As above plus offer to become 'regional 'champion' (attend two workshops, support clinicians to implement research evidence regionally), or attend one workshop, promote implementation of research evidence locally. timing of surfactant administration; admission temperature; staffing of resuscitation team present at birth. 48/87 Lead clinicians in the active arm attended one or both workshops. There was no evidence of difference in post-intervention policies between trial arms. Practice outcomes based on babies in the active (169) and control arms (186), in 45 and 49 neonatal units respectively, showed active arm babies were more likely to have been given surfactant on labour ward (RR=1.30; 95% CI 0.99 to 1.70); p=0.06); to have a higher temperature on admission to neonatal intensive care unit (mean difference=0.29(o)C; 95% CI 0.22 to 0.55; p=0.03); and to have had the baby's trunk delivered into a plastic bag (RR=1.27; 95% CI 1.01 to 1.60; p=0.04) than the control group. The effect on having an 'ideal' resuscitation team at birth was in the same direction of benefit for the active arm (RR=1.18; 95% CI 0.97 to 1.43; p=0.09). The costs of the intervention were modest. This is the first trial to evaluate methods for transferring information from neonatal research into local policies and practice in England. An active approach to research dissemination is both feasible and cost-effective. Current controlled trials ISRCTN89683698.

  16. Lessons learned from the London Exercise and Pregnant (LEAP) Smokers randomised controlled trial process evaluation: implications for the design of physical activity for smoking cessation interventions during pregnancy.

    Science.gov (United States)

    Giatras, Nikoletta; Wanninkhof, Elisabeth; Leontowitsch, Miranda; Lewis, Beth; Taylor, Adrian; Cooper, Sue; Ussher, Michael

    2017-01-17

    The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved. Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures. Topics included recruitment, retention and how the physical activity intervention for pregnant smokers was delivered and how it was adapted when necessary to suit the women. The focus groups were audio-recorded, transcribed verbatim and subjected to thematic analysis. Five themes emerged related to barriers or enablers to intervention delivery: (1) nature of the intervention; (2) personal characteristics of trial participants; (3) practical issues; (4) researchers' engagement with participants; (5) training and support needs. Researchers perceived that participants may have been deterred by the intensive and generic nature of the intervention and the need to simultaneously quit smoking and increase physical activity. Women also appeared hampered by pregnancy ailments, social deprivation, and poor mental health. Researchers observed that their status as health professionals was valued by participants but it was challenging to maintain contact with participants. Training and support needs were identified for dealing with pregnant teenagers, participants' friends and family, and post-natal return to smoking. Future exercise interventions for smoking cessation in pregnancy may benefit by increased tailoring of the intervention to the characteristics of the women, including their psychological profile, socio

  17. A cluster-randomised controlled trial to promote physical activity in adolescents: the Raising Awareness of Physical Activity (RAW-PA) Study.

    Science.gov (United States)

    Ridgers, Nicola D; Timperio, Anna; Brown, Helen; Ball, Kylie; Macfarlane, Susie; Lai, Samuel K; Richards, Kara; Ngan, Winsfred; Salmon, Jo

    2017-01-04

    Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA) Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents' daily physical activity levels. RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex) and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13-14 years). Participants' moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity) will also be collected. To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents' physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy. Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016.

  18. Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials.

    Science.gov (United States)

    Dimairo, Munyaradzi; Julious, Steven A; Todd, Susan; Nicholl, Jonathan P; Boote, Jonathan

    2015-12-23

    Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders. We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation. Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles. There are still persistent and important perceptions of individual and organisational obstacles

  19. Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial

    NARCIS (Netherlands)

    Pisters, M.F.; Veenhof, C.; de Bakker, D.H.; Schellevis, F.G.; Dekker, J.

    2010-01-01

    Question: Does behavioural graded activity result in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee? Design: Analysis of secondary outcomes of a cluster-randomised trial with concealed allocation, assessor blinding, and

  20. A Coorientational Analysis of Trial Lawyer and News Reporter Relationships.

    Science.gov (United States)

    Lipschultz, Jeremy Harris

    A study considered the relationships of trial lawyers and news reporters, using the coorientation measurement model and Q-methodology, and adapting an analysis of variance experimental design. Sixty statements were constructed and administered to 24 subjects (12 trial lawyers and 12 news reporters) in two large midwestern cities. It was found…

  1. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    Directory of Open Access Journals (Sweden)

    Fukuoka Yoshimi

    2011-12-01

    Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

  2. Online Adaptive Optimal Control of Vehicle Active Suspension Systems Using Single-Network Approximate Dynamic Programming

    Directory of Open Access Journals (Sweden)

    Zhi-Jun Fu

    2017-01-01

    Full Text Available In view of the performance requirements (e.g., ride comfort, road holding, and suspension space limitation for vehicle suspension systems, this paper proposes an adaptive optimal control method for quarter-car active suspension system by using the approximate dynamic programming approach (ADP. Online optimal control law is obtained by using a single adaptive critic NN to approximate the solution of the Hamilton-Jacobi-Bellman (HJB equation. Stability of the closed-loop system is proved by Lyapunov theory. Compared with the classic linear quadratic regulator (LQR approach, the proposed ADP-based adaptive optimal control method demonstrates improved performance in the presence of parametric uncertainties (e.g., sprung mass and unknown road displacement. Numerical simulation results of a sedan suspension system are presented to verify the effectiveness of the proposed control strategy.

  3. One-Shot Learning of Human Activity With an MAP Adapted GMM and Simplex-HMM.

    Science.gov (United States)

    Rodriguez, Mario; Orrite, Carlos; Medrano, Carlos; Makris, Dimitrios

    2016-05-10

    This paper presents a novel activity class representation using a single sequence for training. The contribution of this representation lays on the ability to train an one-shot learning recognition system, useful in new scenarios where capturing and labeling sequences is expensive or impractical. The method uses a universal background model of local descriptors obtained from source databases available on-line and adapts it to a new sequence in the target scenario through a maximum a posteriori adaptation. Each activity sample is encoded in a sequence of normalized bag of features and modeled by a new hidden Markov model formulation, where the expectation-maximization algorithm for training is modified to deal with observations consisting in vectors in a unit simplex. Extensive experiments in recognition have been performed using one-shot learning over the public datasets Weizmann, KTH, and IXMAS. These experiments demonstrate the discriminative properties of the representation and the validity of application in recognition systems, achieving state-of-the-art results.

  4. Adaptive Mutations in Influenza A/California/07/2009 Enhance Polymerase Activity and Infectious Virion Production

    Science.gov (United States)

    Slaine, Patrick D.; MacRae, Cara; Kleer, Mariel; Lamoureux, Emily; McAlpine, Sarah; Warhuus, Michelle; Comeau, André M.; Hatchette, Todd

    2018-01-01

    Mice are not natural hosts for influenza A viruses (IAVs), but they are useful models for studying antiviral immune responses and pathogenesis. Serial passage of IAV in mice invariably causes the emergence of adaptive mutations and increased virulence. Here, we report the adaptation of IAV reference strain A/California/07/2009(H1N1) (also known as CA/07) in outbred Swiss Webster mice. Serial passage led to increased virulence and lung titers, and dissemination of the virus to brains. We adapted a deep-sequencing protocol to identify and enumerate adaptive mutations across all genome segments. Among mutations that emerged during mouse-adaptation, we focused on amino acid substitutions in polymerase subunits: polymerase basic-1 (PB1) T156A and F740L and polymerase acidic (PA) E349G. These mutations were evaluated singly and in combination in minigenome replicon assays, which revealed that PA E349G increased polymerase activity. By selectively engineering three PB1 and PA mutations into the parental CA/07 strain, we demonstrated that these mutations in polymerase subunits decreased the production of defective viral genome segments with internal deletions and dramatically increased the release of infectious virions from mouse cells. Together, these findings increase our understanding of the contribution of polymerase subunits to successful host adaptation. PMID:29783694

  5. Engineering Online and In-person Social Networks for Physical Activity: A Randomized Trial

    Science.gov (United States)

    Rovniak, Liza S.; Kong, Lan; Hovell, Melbourne F.; Ding, Ding; Sallis, James F.; Ray, Chester A.; Kraschnewski, Jennifer L.; Matthews, Stephen A.; Kiser, Elizabeth; Chinchilli, Vernon M.; George, Daniel R.; Sciamanna, Christopher N.

    2016-01-01

    Background Social networks can influence physical activity, but little is known about how best to engineer online and in-person social networks to increase activity. Purpose To conduct a randomized trial based on the Social Networks for Activity Promotion model to assess the incremental contributions of different procedures for building social networks on objectively-measured outcomes. Methods Physically inactive adults (n = 308, age, 50.3 (SD = 8.3) years, 38.3% male, 83.4% overweight/obese) were randomized to 1 of 3 groups. The Promotion group evaluated the effects of weekly emailed tips emphasizing social network interactions for walking (e.g., encouragement, informational support); the Activity group evaluated the incremental effect of adding an evidence-based online fitness walking intervention to the weekly tips; and the Social Networks group evaluated the additional incremental effect of providing access to an online networking site for walking, and prompting walking/activity across diverse settings. The primary outcome was mean change in accelerometer-measured moderate-to-vigorous physical activity (MVPA), assessed at 3 and 9 months from baseline. Results Participants increased their MVPA by 21.0 mins/week, 95% CI [5.9, 36.1], p = .005, at 3 months, and this change was sustained at 9 months, with no between-group differences. Conclusions Although the structure of procedures for targeting social networks varied across intervention groups, the functional effect of these procedures on physical activity was similar. Future research should evaluate if more powerful reinforcers improve the effects of social network interventions. Trial Registration Number NCT01142804 PMID:27405724

  6. Decision Making in Concurrent Multitasking: Do People Adapt to Task Interference?

    Science.gov (United States)

    Nijboer, Menno; Taatgen, Niels A.; Brands, Annelies; Borst, Jelmer P.; van Rijn, Hedderik

    2013-01-01

    While multitasking has received a great deal of attention from researchers, we still know little about how well people adapt their behavior to multitasking demands. In three experiments, participants were presented with a multicolumn subtraction task, which required working memory in half of the trials. This primary task had to be combined with a secondary task requiring either working memory or visual attention, resulting in different types of interference. Before each trial, participants were asked to choose which secondary task they wanted to perform concurrently with the primary task. We predicted that if people seek to maximize performance or minimize effort required to perform the dual task, they choose task combinations that minimize interference. While performance data showed that the predicted optimal task combinations indeed resulted in minimal interference between tasks, the preferential choice data showed that a third of participants did not show any adaptation, and for the remainder it took a considerable number of trials before the optimal task combinations were chosen consistently. On the basis of these results we argue that, while in principle people are able to adapt their behavior according to multitasking demands, selection of the most efficient combination of strategies is not an automatic process. PMID:24244527

  7. Decision making in concurrent multitasking: do people adapt to task interference?

    Directory of Open Access Journals (Sweden)

    Menno Nijboer

    Full Text Available While multitasking has received a great deal of attention from researchers, we still know little about how well people adapt their behavior to multitasking demands. In three experiments, participants were presented with a multicolumn subtraction task, which required working memory in half of the trials. This primary task had to be combined with a secondary task requiring either working memory or visual attention, resulting in different types of interference. Before each trial, participants were asked to choose which secondary task they wanted to perform concurrently with the primary task. We predicted that if people seek to maximize performance or minimize effort required to perform the dual task, they choose task combinations that minimize interference. While performance data showed that the predicted optimal task combinations indeed resulted in minimal interference between tasks, the preferential choice data showed that a third of participants did not show any adaptation, and for the remainder it took a considerable number of trials before the optimal task combinations were chosen consistently. On the basis of these results we argue that, while in principle people are able to adapt their behavior according to multitasking demands, selection of the most efficient combination of strategies is not an automatic process.

  8. Relationships Between Vestibular Measures as Potential Predictors for Spaceflight Sensorimotor Adaptation

    Science.gov (United States)

    Clark, T. K.; Peters, B.; Gadd, N. E.; De Dios, Y. E.; Wood, S.; Bloomberg, J. J.; Mulavara, A. P.

    2016-01-01

    Introduction: During space exploration missions astronauts are exposed to a series of novel sensorimotor environments, requiring sensorimotor adaptation. Until adaptation is complete, sensorimotor decrements occur, affecting critical tasks such as piloted landing or docking. Of particularly interest are locomotion tasks such as emergency vehicle egress or extra-vehicular activity. While nearly all astronauts eventually adapt sufficiently, it appears there are substantial individual differences in how quickly and effectively this adaptation occurs. These individual differences in capacity for sensorimotor adaptation are poorly understood. Broadly, we aim to identify measures that may serve as pre-flight predictors of and individual's adaptation capacity to spaceflight-induced sensorimotor changes. As a first step, since spaceflight is thought to involve a reinterpretation of graviceptor cues (e.g. otolith cues from the vestibular system) we investigate the relationships between various measures of vestibular function in humans. Methods: In a set of 15 ground-based control subjects, we quantified individual differences in vestibular function using three measures: 1) ocular vestibular evoked myogenic potential (oVEMP), 2) computerized dynamic posturography and 3) vestibular perceptual thresholds. oVEMP responses are elicited using a mechanical stimuli approach. Computerized dynamic posturography was used to quantify Sensory Organization Tests (SOTs), including SOT5M which involved performing pitching head movements while balancing on a sway-reference support surface with eyes closed. We implemented a vestibular perceptual threshold task using the tilt capabilities of the Tilt-Translation Sled (TTS) at JSC. On each trial, the subject was passively roll-tilted left ear down or right ear down in the dark and verbally provided a forced-choice response regarding which direction they felt tilted. The motion profile was a single-cycle sinusoid of angular acceleration with a

  9. A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial.

    Science.gov (United States)

    Goodyer, I M; Dubicka, B; Wilkinson, P; Kelvin, R; Roberts, C; Byford, S; Breen, S; Ford, C; Barrett, B; Leech, A; Rothwell, J; White, L; Harrington, R

    2008-05-01

    To determine if, in the short term, depressed adolescents attending routine NHS Child and Adolescent Mental Health Services (CAMHS), and receiving ongoing active clinical care, treatment with selective serotonin reuptake inhibitors (SSRIs) plus cognitive behaviour therapy (CBT) compared with SSRI alone, results in better healthcare outcomes. A pragmatic randomised controlled trial (RCT) was conducted on depressed adolescents attending CAMHS who had not responded to a psychosocial brief initial intervention (BII) prior to randomisation. Six English CAMHS participated in the study. A total of 208 patients aged between 11 and 17 years were recruited and randomised. All participants received active routine clinical care in a CAMHS outpatient setting and an SSRI and half were offered CBT. The duration of the trial was a 12-week treatment phase, followed by a 16-week maintenance phase. Follow-up assessments were at 6, 12 and 28 weeks. The primary outcome measure was the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA). Secondary outcome measures were self-report depressive symptoms, interviewer-rated depressive signs and symptoms, interviewer-rated psychosocial impairment and clinical global impression of response to treatment. Information on resource use was collected in interview at baseline and at the 12- and 28-week follow-up assessments using the Child and Adolescent Service Use Schedule (CA-SUS). Of the 208 patients randomised, 200 (96%) completed the trial to the primary end-point at 12 weeks. By the 28-week follow-up, 174 (84%) participants were re-evaluated. Overall, 193 (93%) participants had been assessed at one or more time points. Clinical characteristics indicated that the trial was conducted on a severely depressed group. There was significant recovery at all time points in both arms. The findings demonstrated no difference in treatment effectiveness for SSRI + CBT over SSRI only for the primary or secondary outcome measures at

  10. Reference system of competence and engagement in adapted physical activities of people with recent spinal cord injury.

    Science.gov (United States)

    Gernigon, Christophe; Pereira Dias, Catarina; Riou, François; Briki, Walid; Ninot, Grégory

    2015-01-01

    This study tested whether persons with Recent Spinal Cord Injury (RSCI) who practice adapted physical activities (APA) and those who do not differ with regard to achievement goals, physical self-perceptions, and global self-esteem. Adults with RSCI in rehabilitation centers voluntarily completed questionnaires of achievement goals and self-esteem. Then, based on whether they engaged or not in APA programs, they were considered participants or non-participants in APA. Compared to participants in APA, non-participants were more oriented toward mastery-avoidance goals and had lower scores of physical self-worth and global self-esteem. No differences were found for other achievement goals and for low-level dimensions of physical self. These findings suggest that mastery-avoidance goals are associated with a maladaptive motivational pattern when intrapersonal comparison conveys a threat for the self. Practical implications for rehabilitation programs for persons with RSCI are offered. Adapted Physical Activities (APA) programs are supervised physical activity programs in which the choice of the activity as well as the frequency, the duration, and the intensity of practice are adapted to the inpatients' capabilities. Attempts to master physical activities can be seen as threatening experiences to be avoided by persons with Recent Spinal Cord Injury (RSCI) in rehabilitation centers. Comparing one's capabilities in physical activities with those of other persons with RSCI is not motivationally detrimental with respect to the practice of these activities. Upon persons with RSCI' arrival in rehabilitation centers, physical educators should promote a friendly competitive climate in the practice of APA to help inpatients recover healthy levels of physical self-perceptions and global self-esteem as well as motivation to exercise.

  11. Investigating the Impact of Formal Reflective Activities on Skill Adaptation in a Work-Related Instrumental Learning Setting

    Science.gov (United States)

    Roessger, Kevin M.

    2013-01-01

    In work-related, instrumental learning contexts the role of reflective activities is unclear. Kolb's (1985) experiential learning theory and Mezirow's transformative learning theory (2000) predict skill-adaptation as a possible outcome. This prediction was experimentally explored by manipulating reflective activities and assessing participants'…

  12. Classical and adaptive clinical trial designs using ExpDesign Studio

    National Research Council Canada - National Science Library

    Chang, Mark

    2008-01-01

    ... Relationship 2.2.9 Parallel Design 17 2.2.10 Crossover Design 17 2.2.11 Factorial Design 18 Selection of a Trial Design 18 2.3.1 Balanced Versus Unbalanced Designs 18 2.3.2 Crossover Versus Parallel...

  13. Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.

    Science.gov (United States)

    Gold, Rachel; Hollombe, Celine; Bunce, Arwen; Nelson, Christine; Davis, James V; Cowburn, Stuart; Perrin, Nancy; DeVoe, Jennifer; Mossman, Ned; Boles, Bruce; Horberg, Michael; Dearing, James W; Jaworski, Victoria; Cohen, Deborah; Smith, David

    2015-10-16

    Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices. Having a better understanding of how different

  14. Activity and heart rate in semi-domesticated reindeer during adaptation to emergency feeding.

    Science.gov (United States)

    Nilsson, A; Ahman, B; Norberg, H; Redbo, I; Eloranta, E; Olsson, K

    2006-06-15

    Although reindeer are well adapted to limited food resources during winter, semi-domesticated reindeer are regularly fed when snow conditions are bad in order to prevent starvation. Feeding sometimes results in health problems and loss of animals. This study was made to assess if activity pattern in reindeer could be used as a tool for the reindeer herder in early detection of animals that are not adapting to feeding. The frequency of 10 behavioural categories was recorded in five groups of penned, eight-month-old, female semi-domesticated reindeer. Three reindeer per group were fitted with heart rate monitors. Lying was the most frequent behaviour, whilst there were few cases of agonistic behaviour. Heart rate varied during the day, with peaks during feeding and low heart rates in the early morning. Restricted feed intake resulted in more locomotion and seeking but less ruminating compared to feeding ad libitum. This was followed by a generally lower heart rate in reindeer in the restricted groups compared to controls. Subsequent feeding with different combinations of lichens, silage and pellets ad libitum resulted initially in significantly more of the animals lying curled up, compared to controls, combined with increased heart rates. As the experiment continued the general activity pattern, as well as the heart rate, gradually became more similar in all groups. Lying curled was the behavioural indicator most consistently affected by feed deprivation and adaptation to feeding and may thus be a useful indicator to distinguish individual reindeer that are not adjusting to feeding.

  15. A new robust adaptive controller for vibration control of active engine mount subjected to large uncertainties

    International Nuclear Information System (INIS)

    Fakhari, Vahid; Choi, Seung-Bok; Cho, Chang-Hyun

    2015-01-01

    This work presents a new robust model reference adaptive control (MRAC) for vibration control caused from vehicle engine using an electromagnetic type of active engine mount. Vibration isolation performances of the active mount associated with the robust controller are evaluated in the presence of large uncertainties. As a first step, an active mount with linear solenoid actuator is prepared and its dynamic model is identified via experimental test. Subsequently, a new robust MRAC based on the gradient method with σ-modification is designed by selecting a proper reference model. In designing the robust adaptive control, structured (parametric) uncertainties in the stiffness of the passive part of the mount and in damping ratio of the active part of the mount are considered to investigate the robustness of the proposed controller. Experimental and simulation results are presented to evaluate performance focusing on the robustness behavior of the controller in the face of large uncertainties. The obtained results show that the proposed controller can sufficiently provide the robust vibration control performance even in the presence of large uncertainties showing an effective vibration isolation. (paper)

  16. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-06-01

    The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

  17. Visuo-proprioceptive interactions during adaptation of the human reach.

    Science.gov (United States)

    Judkins, Timothy; Scheidt, Robert A

    2014-02-01

    We examined whether visual and proprioceptive estimates of transient (midreach) target capture errors contribute to motor adaptation according to the probabilistic rules of information integration used for perception. Healthy adult humans grasped and moved a robotic handle between targets in the horizontal plane while the robot generated springlike loads that varied unpredictably from trial to trial. For some trials, a visual cursor faithfully tracked hand motion. In others, the handle's position was locked and subjects viewed motion of a point-mass cursor driven by hand forces. In yet other trials, cursor feedback was dissociated from hand motion or altogether eliminated. We used time- and frequency-domain analyses to characterize how sensorimotor memories influence performance on subsequent reaches. When the senses were used separately, subjects were better at rejecting physical disturbances applied to the hand than virtual disturbances applied to the cursor. In part, this observation reflected differences in how participants used sensorimotor memories to adapt to perturbations when performance feedback was limited to only proprioceptive or visual information channels. When both vision and proprioception were available to guide movement, subjects processed memories in a manner indistinguishable from the vision-only condition, regardless of whether the cursor tracked the hand faithfully or whether we experimentally dissociated motions of the hand and cursor. This was true even though, on average, perceptual uncertainty in the proprioceptive estimation of movement extent exceeded that of visual estimation by just 47%. In contrast to perceptual tasks wherein vision and proprioception both contribute to an optimal estimate of limb state, our findings support a switched-input, multisensory model of predictive load compensation wherein visual feedback of transient performance errors overwhelmingly dominates proprioception in determining adaptive reach performance.

  18. Rationale and study protocol of the EASY Minds (Encouraging Activity to Stimulate Young Minds) program: cluster randomized controlled trial of a primary school-based physical activity integration program for mathematics.

    Science.gov (United States)

    Riley, Nicholas; Lubans, David R; Holmes, Kathryn; Morgan, Philip J

    2014-08-08

    Novel strategies are required to increase school-based physical activity levels of children. Integrating physical activity in mathematics lessons may lead to improvements in students' physical activity levels as well as enjoyment, engagement and learning. The primary aim of this study is to evaluate the impact of a curriculum-based physical activity integration program known as EASY Minds (Encouraging Activity to Stimulate Young Minds) on children's daily school time physical activity levels. Secondary aims include exploring the impact of EASY Minds on their engagement and 'on task' behaviour in mathematics. Grade 5/6 classes from eight public schools in New South Wales, Australia will be randomly allocated to intervention (n = 4) or control (n = 4) groups. Teachers from the intervention group will receive one day of professional development, a resource pack and asked to adapt their lessons to embed movement-based learning in their daily mathematics program in at least three lessons per week over a six week period. Intervention support will be provided via a weekly email and three lesson observations. The primary outcomes will be children's physical activity levels (accelerometry) across both the school day and during mathematics lessons (moderate-to-vigorous physical activity and sedentary time). Children's 'on-task' behaviour, enjoyment of mathematics and mathematics attainment will be assessed as secondary outcomes. A detailed process evaluation will be undertaken. EASY Minds is an innovative intervention that has the potential to improve key physical and academic outcomes for primary school aged children and help guide policy and practice regarding the teaching of mathematics. Australian and New Zealand Clinical Trials Register ACTRN12613000637741 13/05/2013.

  19. Adaptation to nursing home: The role of leisure activities in light of motivation and relatedness.

    Science.gov (United States)

    Altintas, Emin; De Benedetto, Giorgio; Gallouj, Karim

    Based on the motivational sequence described in Self-Determination Theory, this study explored the relationship between relatedness, motivation, adaptation and leisure in nursing homes. We formulated the hypothesis that the variables of the study would be found in an integrative mediational sequence: Participation in leisure activities→Relatedness→Self-determined motivation→Adaptation to nursing homes. Participants (N=112, mean age=84.17) were invited to complete questionnaires assessing these variables. Results of the path analysis found an unsatisfactory fit for this model but revealed another model (Model 2) with a good fit index: Relatedness→Participation in leisure activities→Self-determined motivation→Adaptation to nursing homes→Relatedness. Model 2 fitted better than model 1: the Chi-square values were not significant, Chi 2 (df=2)=5.1, p=0.078 and other indices were satisfactory (CFI=0.930, RMSEA=0.049 and NFI=0.918). These results suggest that feeling connected and secure in the relationships with others, and integrated as an individual to the group contribute to enhance leisure practice, self-determined motivation, and finally adaptation to life environment. Consequently, the relatedness promotes leisure activities practice which represents a central adaptive behavior in nursing homes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  20. Adaptive Randomization of Neratinib in Early Breast Cancer.

    Science.gov (United States)

    Park, John W; Liu, Minetta C; Yee, Douglas; Yau, Christina; van 't Veer, Laura J; Symmans, W Fraser; Paoloni, Melissa; Perlmutter, Jane; Hylton, Nola M; Hogarth, Michael; DeMichele, Angela; Buxton, Meredith B; Chien, A Jo; Wallace, Anne M; Boughey, Judy C; Haddad, Tufia C; Chui, Stephen Y; Kemmer, Kathleen A; Kaplan, Henry G; Isaacs, Claudine; Nanda, Rita; Tripathy, Debasish; Albain, Kathy S; Edmiston, Kirsten K; Elias, Anthony D; Northfelt, Donald W; Pusztai, Lajos; Moulder, Stacy L; Lang, Julie E; Viscusi, Rebecca K; Euhus, David M; Haley, Barbara B; Khan, Qamar J; Wood, William C; Melisko, Michelle; Schwab, Richard; Helsten, Teresa; Lyandres, Julia; Davis, Sarah E; Hirst, Gillian L; Sanil, Ashish; Esserman, Laura J; Berry, Donald A

    2016-07-07

    The heterogeneity of breast cancer makes identifying effective therapies challenging. The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clinical stage II or III breast cancer, evaluated multiple new agents added to standard chemotherapy to assess the effects on rates of pathological complete response (i.e., absence of residual cancer in the breast or lymph nodes at the time of surgery). We used adaptive randomization to compare standard neoadjuvant chemotherapy plus the tyrosine kinase inhibitor neratinib with control. Eligible women were categorized according to eight biomarker subtypes on the basis of human epidermal growth factor receptor 2 (HER2) status, hormone-receptor status, and risk according to a 70-gene profile. Neratinib was evaluated against control with regard to 10 biomarker signatures (prospectively defined combinations of subtypes). The primary end point was pathological complete response. Volume changes on serial magnetic resonance imaging were used to assess the likelihood of such a response in each patient. Adaptive assignment to experimental groups within each disease subtype was based on Bayesian probabilities of the superiority of the treatment over control. Enrollment in the experimental group was stopped when the 85% Bayesian predictive probability of success in a confirmatory phase 3 trial of neoadjuvant therapy reached a prespecified threshold for any biomarker signature ("graduation"). Enrollment was stopped for futility if the probability fell to below 10% for every biomarker signature. Neratinib reached the prespecified efficacy threshold with regard to the HER2-positive, hormone-receptor-negative signature. Among patients with HER2-positive, hormone-receptor-negative cancer, the mean estimated rate of pathological complete response was 56% (95% Bayesian probability interval [PI], 37 to 73%) among 115 patients in the neratinib group, as compared with 33% among 78 controls (95% PI, 11 to 54

  1. Financial motivation undermines potential enjoyment in an intensive diet and activity intervention

    Science.gov (United States)

    Moller, Arlen C.; Buscemi, Joanna; McFadden, H. Gene; Hedeker, Donald; Spring, Bonnie

    2013-01-01

    The use of material incentives in healthy lifestyle interventions is becoming widespread. However, self-determination theory (SDT) posits that when material incentives are perceived as controlling, they undermine intrinsic motivation. We analyzed data from the Make Better Choices trial—a trial testing strategies for improving four risk behaviors: low fruit–vegetable intake, high saturated fat intake, low physical activity, and high sedentary activity. At baseline, participants reported the degree to which financial incentives were an important motivator (financial motivation); self-reported enjoyment of each behavior was assessed before and after the 3-week incentivization phase. Consistent with SDT, after controlling for general motivation and group assignment, lower financial motivation predicted more adaptive changes in enjoyment. Whereas participants low in financial motivation experienced adaptive changes, adaptive changes were suppressed among those high in financial motivation. PMID:24142187

  2. Recruitment to publicly funded trials--are surgical trials really different?

    Science.gov (United States)

    Cook, Jonathan A; Ramsay, Craig R; Norrie, John

    2008-09-01

    Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

  3. Protein Adaptations in Archaeal Extremophiles

    Directory of Open Access Journals (Sweden)

    Christopher J. Reed

    2013-01-01

    Full Text Available Extremophiles, especially those in Archaea, have a myriad of adaptations that keep their cellular proteins stable and active under the extreme conditions in which they live. Rather than having one basic set of adaptations that works for all environments, Archaea have evolved separate protein features that are customized for each environment. We categorized the Archaea into three general groups to describe what is known about their protein adaptations: thermophilic, psychrophilic, and halophilic. Thermophilic proteins tend to have a prominent hydrophobic core and increased electrostatic interactions to maintain activity at high temperatures. Psychrophilic proteins have a reduced hydrophobic core and a less charged protein surface to maintain flexibility and activity under cold temperatures. Halophilic proteins are characterized by increased negative surface charge due to increased acidic amino acid content and peptide insertions, which compensates for the extreme ionic conditions. While acidophiles, alkaliphiles, and piezophiles are their own class of Archaea, their protein adaptations toward pH and pressure are less discernible. By understanding the protein adaptations used by archaeal extremophiles, we hope to be able to engineer and utilize proteins for industrial, environmental, and biotechnological applications where function in extreme conditions is required for activity.

  4. Protein Adaptations in Archaeal Extremophiles

    Science.gov (United States)

    Reed, Christopher J.; Lewis, Hunter; Trejo, Eric; Winston, Vern; Evilia, Caryn

    2013-01-01

    Extremophiles, especially those in Archaea, have a myriad of adaptations that keep their cellular proteins stable and active under the extreme conditions in which they live. Rather than having one basic set of adaptations that works for all environments, Archaea have evolved separate protein features that are customized for each environment. We categorized the Archaea into three general groups to describe what is known about their protein adaptations: thermophilic, psychrophilic, and halophilic. Thermophilic proteins tend to have a prominent hydrophobic core and increased electrostatic interactions to maintain activity at high temperatures. Psychrophilic proteins have a reduced hydrophobic core and a less charged protein surface to maintain flexibility and activity under cold temperatures. Halophilic proteins are characterized by increased negative surface charge due to increased acidic amino acid content and peptide insertions, which compensates for the extreme ionic conditions. While acidophiles, alkaliphiles, and piezophiles are their own class of Archaea, their protein adaptations toward pH and pressure are less discernible. By understanding the protein adaptations used by archaeal extremophiles, we hope to be able to engineer and utilize proteins for industrial, environmental, and biotechnological applications where function in extreme conditions is required for activity. PMID:24151449

  5. Measuring physical activity during pregnancy - Cultural adaptation of the Pregnancy Physical Activity Questionnaire (PPAQ) and assessment of its reliability in Polish conditions.

    Science.gov (United States)

    Krzepota, Justyna; Sadowska, Dorota; Sempolska, Katarzyna; Pelczar, Małgorzata

    2017-12-23

    The assessment of physical activity during pregnancy is crucial in perinatal care and it is an important research topic. Unfortunately, in Poland there is a lack of one commonly accepted questionnaire of physical activity during pregnancy. The aim of this study was to adapt the Pregnancy Physical Activity Questionnaire (PPAQ) to Polish conditions and assess the reliability of its Polish version (PPAQ-PL). The PPAQ was translated from English into Polish and its reliability tested. 64 correctly completed (twice, one week apart) questionnaires were qualified for analysis. Test-retest reliability was assessed using Intraclass Correlation Coefficient (ICC). As a result of the adaptation and psychometric assessment, in the Polish version of the questionnaire the number of questions was reduced from 36 to 35 by removing the question concerning 'mowing lawn while on a riding mower'. The ICC value for total activity was 0.75, which confirms a substantial level of reliability. The ICC values for subscales of intensity ranged from 0.53 (light) - 0.86 (vigorous). For subscales of type, ICC values ranged from 0.59 (transportation) - 0.89 (household/caregiving). The PPAQ-PL can be accepted as a reliable tool for the assessing physical activity of pregnant women in Poland. Information obtained using the questionnaire might be helpful in monitoring health behaviours, preventing obesity, as well as designing and promoting physical activity programmes for pregnant women.

  6. Adaptation rearrangements of heart of young sportsmen depending on the orientation of the training activity

    Directory of Open Access Journals (Sweden)

    Viktor Lastochkin

    2016-06-01

    Full Text Available Purpose: studying of the main parameters of morphofunctional condition of the left ventricular cavity of heart of sportsmen in the conditions of the training and competitive activity. Material & Methods: three groups of children (n=30 of 7–9, 10–12, 13–14 years old, who begin to train in sports with the manifestation of endurance and high-speed and power qualities, the qualified sportsmen at the age of 15–16 years old, who are engaged in run on 400 m with barriers, and karatekas (n=15+n=15, not engaged children of the same aged groups (n=40. The following methods of the research were applied: analysis of special literature, pedagogical supervisions, pedagogical experiment, echocardiological methods of the research. Results: the considerable connection of types of heart of young sportsmen with indicators of exercise stress of various orientations is established. Sportsmen with the optimum vegeto-rhythmic indicators have the essential advantages in adaptation morphofunctional displacements in heart and warm productivity at sportsmen with satisfactory vegetative-rhythmic indicators. Conclusions: adaptation morphofunctional displacements in activity of the cardio-respiratory system are closely connected with the prevailing orientation of the training process and can be used as the objective test of adaptation to the special loadings in sport.

  7. Data-adaptive Robust Optimization Method for the Economic Dispatch of Active Distribution Networks

    DEFF Research Database (Denmark)

    Zhang, Yipu; Ai, Xiaomeng; Fang, Jiakun

    2018-01-01

    Due to the restricted mathematical description of the uncertainty set, the current two-stage robust optimization is usually over-conservative which has drawn concerns from the power system operators. This paper proposes a novel data-adaptive robust optimization method for the economic dispatch...... of active distribution network with renewables. The scenario-generation method and the two-stage robust optimization are combined in the proposed method. To reduce the conservativeness, a few extreme scenarios selected from the historical data are used to replace the conventional uncertainty set....... The proposed extreme-scenario selection algorithm takes advantage of considering the correlations and can be adaptive to different historical data sets. A theoretical proof is given that the constraints will be satisfied under all the possible scenarios if they hold in the selected extreme scenarios, which...

  8. Wheelchair users' experience of non-adapted and adapted clothes during sailing, quad rugby or wheel-walking.

    Science.gov (United States)

    Kratz, G; Söderback, I; Guidetti, S; Hultling, C; Rykatkin, T; Söderström, M

    1997-01-01

    The purpose of the present quasi-experimental post-test-design study was to compare 32 wheelchair users' (mostly para/tetraplegics) experience of wearing specially adapted clothes and non-adapted clothes for sailing, quad rugby or wheel-walking. Four existing assessment instruments were used: the Klein-Bell Activities of Daily Living Scale; a two-part Basic Information Questionnaire eliciting experience of effort, comfort and feeling of physical condition; the Experience Sampling Form for investigating the individuals' attitudes in terms of involvement and affective and activity mood states, and the Occupational Therapy Assessment of Leisure Time interview framework for collecting data about experience of leisure time. The wheelchair users all associated significantly greater comfort with use of the adapted clothes and, particularly the 'sailors', better physical condition. Overall, significantly greater involvement and more positive affect states were associated with the adapted clothes than with conventional garments, and mood state changed for the better. The wheelchair users set a higher priority upon work or leisure activities than upon independence in activities of daily living, and for this reason the Klein-Bell ratings showed great variation between the 'sailors' and the 'quad rugby players' (range 57%-93%), though these groups demonstrated more independence than the 'wheel-walkers'. The results of the study confirm the value of adapting sportswear for handicapped people. Such adaptations should also be of benefit for other activities than those studied.

  9. Do adapted vignettes improve medical decision-making capacity for individuals with Alzheimer's disease?

    Science.gov (United States)

    Thalén, Liv; Heimann Mühlenbock, Katarina; Almkvist, Ove; Eriksdotter, Maria; Sundström, Erik; Tallberg, Ing-Mari

    2017-12-01

    Medical decision-making capacity (MDC) is known to decline in individuals with Alzheimer's disease (AD). The vignette method uses hypothetical information as a prerequisite for measuring the capacity to make well-informed decisions to clinical trials. Our aim was to investigate if adapted vignettes can help individuals with mild AD to assimilate information, make decisions and express them in an understandable way, compared to corresponding decisions based on linguistically more demanding vignettes, as measured by the Swedish Linguistic Instrument for Medical Decision-making (LIMD). Two vignettes from LIMD were altered linguistically with the aim to facilitate understanding for individuals with AD. An experimental within-subject design was used to study the influence on MDC of readability (original/adapted vignettes) and content (two different clinical trials). We included 24 patients with mild AD in this prospective study, which read all four vignettes along with a few other tests. This allowed us to investigate the association between MDC and cognitive function. Adapted vignettes did not yield significant differences regarding MDC as compared with original vignettes using a two-way repeated measures analysis of variance. A difference was found between the two clinical trials where LIMD score was significantly higher for Kidney disease than hypertension vignettes. Our results indicate that adapted vignettes may not improve MDC for individuals with mild AD. MDC was affected by which clinical trial the vignettes regarded, which implies that other factors affecting MDC need to be investigated, like length of text and vocabulary used. © 2017 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

  10. Development of Shunt-Type Three-Phase Active Power Filter with Novel Adaptive Control for Wind Generators

    Directory of Open Access Journals (Sweden)

    Ming-Hung Chen

    2015-01-01

    Full Text Available This paper proposes a new adaptive filter for wind generators that combines instantaneous reactive power compensation technology and current prediction controller, and therefore this system is characterized by low harmonic distortion, high power factor, and small DC-link voltage variations during load disturbances. The performance of the system was first simulated using MATLAB/Simulink, and the possibility of an adaptive digital low-pass filter eliminating current harmonics was confirmed in steady and transient states. Subsequently, a digital signal processor was used to implement an active power filter. The experimental results indicate, that for the rated operation of 2 kVA, the system has a total harmonic distortion of current less than 5.0% and a power factor of 1.0 on the utility side. Thus, the transient performance of the adaptive filter is superior to the traditional digital low-pass filter and is more economical because of its short computation time compared with other types of adaptive filters.

  11. Development of Shunt-Type Three-Phase Active Power Filter with Novel Adaptive Control for Wind Generators.

    Science.gov (United States)

    Chen, Ming-Hung

    2015-01-01

    This paper proposes a new adaptive filter for wind generators that combines instantaneous reactive power compensation technology and current prediction controller, and therefore this system is characterized by low harmonic distortion, high power factor, and small DC-link voltage variations during load disturbances. The performance of the system was first simulated using MATLAB/Simulink, and the possibility of an adaptive digital low-pass filter eliminating current harmonics was confirmed in steady and transient states. Subsequently, a digital signal processor was used to implement an active power filter. The experimental results indicate, that for the rated operation of 2 kVA, the system has a total harmonic distortion of current less than 5.0% and a power factor of 1.0 on the utility side. Thus, the transient performance of the adaptive filter is superior to the traditional digital low-pass filter and is more economical because of its short computation time compared with other types of adaptive filters.

  12. The 'Women's Lifestyle Study', 2-year randomized controlled trial of physical activity counselling in primary health care: rationale and study design

    Directory of Open Access Journals (Sweden)

    Dowell Anthony C

    2007-07-01

    Full Text Available Abstract Background Physical inactivity is an independent risk factor for diabetes and heart disease. There is evidence that increasing physical activity can reduce the risk of developing these chronic diseases, but less evidence about effective ways to increase adherence to physical activity. Interventions are therefore needed that produce sustained increases in adherence to physical activity, are cost-effective and improve clinical endpoints. Methods The Women's Lifestyle Study is a two year randomized controlled trial involving a nurse-led intervention to increase physical activity in 40–74 year old physically inactive women recruited from primary care. Baseline measures were assessed in a face-to-face interview with a primary care nurse. The intervention involved delivery of a 'Lifestyle script' by a primary care nurse followed by telephone counselling for nine months and a face-to-face nurse visit at six months. Outcome measurements are assessed at 12 and 24 months. The primary outcome is physical activity measured using a validated physical activity questionnaire. Secondary outcomes include blood pressure, weight, waist circumference, physical fitness (step test, serum HbA1c, fasting glucose, lipids, insulin, and quality of life (SF36. Costs were measured prospectively to allow a subsequent cost-effectiveness evaluation if the trial is positive. Discussion Due to report in 2008, the Women's Lifestyle Study tests the effectiveness of an enhanced low-cost, evidence-based intervention in increasing physical activity, and improving cardiovascular and diabetes risk indicators over two years. If successful in demonstrating improvements in health outcomes, this randomized controlled trial will be the first to demonstrate long-term cardiovascular and diabetes risk health benefit, in addition to improvements in physical activity, from a sustainable physical activity intervention based in primary care. Trial Registration Australian Clinical Trials

  13. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

    Science.gov (United States)

    Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

    2014-09-01

    To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Temporal and spatial adaptations during the acquisition of a reversal movement.

    Science.gov (United States)

    van Loon, E M; Buekers, M J; Helsen, W; Magill, R A

    1998-03-01

    Adjustments of the biphasic movement in a coincidence anticipation task were studied using an erroneous knowledge of results (KR) paradigm. Forty participants received either no KR, correct KR, erroneous (+100 ms) KR, or 100 trials of correct KR followed by 50 trials of erroneous KR. Kinematic analyses revealed that for this 100-50 KR group the extension part of the movement was temporally adjusted under the influence of erroneous KR. Although accompanied by a decrease in movement amplitude, this did not account for the temporal shift in movement outcome, because all groups showed a reduction in amplitude. It is argued that changing external time constraints mainly results in temporal adaptations. However, spatial adaptations do play a role in kinematic changes during acquisition.

  15. The HAPPY (Healthy and Active Parenting Programmme for early Years feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity

    Directory of Open Access Journals (Sweden)

    Rosemary R. C. McEachan

    2016-03-01

    Full Text Available Abstract Background The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY. Methods A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m2 were recruited between 10–26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59 or usual care (N = 61. Appropriate outcome measures for a full trial were explored, including: infant’s length and weight, woman’s BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content. Results Recruitment targets were met (~20 women/month with a recruitment rate of 30 % of eligible women (120/396. There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1–12. Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of −0.25 standard deviation scores for infant weight at 12 months (95 % CI:

  16. Brain-behavioral adaptability predicts response to cognitive behavioral therapy for emotional disorders: A person-centered event-related potential study.

    Science.gov (United States)

    Stange, Jonathan P; MacNamara, Annmarie; Kennedy, Amy E; Hajcak, Greg; Phan, K Luan; Klumpp, Heide

    2017-06-23

    Single-trial-level analyses afford the ability to link neural indices of elaborative attention (such as the late positive potential [LPP], an event-related potential) with downstream markers of attentional processing (such as reaction time [RT]). This approach can provide useful information about individual differences in information processing, such as the ability to adapt behavior based on attentional demands ("brain-behavioral adaptability"). Anxiety and depression are associated with maladaptive information processing implicating aberrant cognition-emotion interactions, but whether brain-behavioral adaptability predicts response to psychotherapy is not known. We used a novel person-centered, trial-level analysis approach to link neural indices of stimulus processing to behavioral responses and to predict treatment outcome. Thirty-nine patients with anxiety and/or depression received 12 weeks of cognitive behavioral therapy (CBT). Prior to treatment, patients performed a speeded reaction-time task involving briefly-presented pairs of aversive and neutral pictures while electroencephalography was recorded. Multilevel modeling demonstrated that larger LPPs predicted slower responses on subsequent trials, suggesting that increased attention to the task-irrelevant nature of pictures interfered with reaction time on subsequent trials. Whereas using LPP and RT averages did not distinguish CBT responders from nonresponders, in trial-level analyses individuals who demonstrated greater ability to benefit behaviorally (i.e., faster RT) from smaller LPPs on the previous trial (greater brain-behavioral adaptability) were more likely to respond to treatment and showed greater improvements in depressive symptoms. These results highlight the utility of trial-level analyses to elucidate variability in within-subjects, brain-behavioral attentional coupling in the context of emotion processing, in predicting response to CBT for emotional disorders. Copyright © 2017 Elsevier Ltd

  17. Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial.

    Science.gov (United States)

    Mascarenhas, Maya Nina; Chan, June Maylin; Vittinghoff, Eric; Van Blarigan, Erin Lynn; Hecht, Frederick

    2018-05-18

    Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes for all women. As hypothesized, in

  18. A Mixed-Methods Trial of Broad Band Noise and Nature Sounds for Tinnitus Therapy: Group and Individual Responses Modeled under the Adaptation Level Theory of Tinnitus.

    Science.gov (United States)

    Durai, Mithila; Searchfield, Grant D

    2017-01-01

    Objectives: A randomized cross-over trial in 18 participants tested the hypothesis that nature sounds, with unpredictable temporal characteristics and high valence would yield greater improvement in tinnitus than constant, emotionally neutral broadband noise. Study Design: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary measures were: loudness and annoyance ratings, loudness level matches, minimum masking levels, positive and negative emotionality, attention reaction and discrimination time, anxiety, depression and stress. Each sound was administered using MP3 players with earbuds for 8 continuous weeks, with a 3 week wash-out period before crossing over to the other treatment sound. Measurements were undertaken for each arm at sound fitting, 4 and 8 weeks after administration. Qualitative interviews were conducted at each of these appointments. Results: From a baseline TFI score of 41.3, sound therapy resulted in TFI scores at 8 weeks of 35.6; broadband noise resulted in significantly greater reduction (8.2 points) after 8 weeks of sound therapy use than nature sounds (3.2 points). The positive effect of sound on tinnitus was supported by secondary outcome measures of tinnitus, emotion, attention, and psychological state, but not interviews. Tinnitus loudness level match was higher for BBN at 8 weeks; while there was little change in loudness level matches for nature sounds. There was no change in minimum masking levels following sound therapy administration. Self-reported preference for one sound over another did not correlate with changes in tinnitus. Conclusions: Modeled under an adaptation level theory framework of tinnitus perception, the results indicate that the introduction of broadband noise shifts internal adaptation level weighting away from the tinnitus signal, reducing tinnitus magnitude. Nature sounds may modify the affective components of tinnitus via a secondary, residual pathway, but this appears to be less important

  19. Effect of a care plan based on Roy adaptation model biological dimension on stroke patients' physiologic adaptation level.

    Science.gov (United States)

    Alimohammadi, Nasrollah; Maleki, Bibi; Shahriari, Mohsen; Chitsaz, Ahmad

    2015-01-01

    Stroke is a stressful event with several functional, physical, psychological, social, and economic problems that affect individuals' different living balances. With coping strategies, patients try to control these problems and return to their natural life. The aim of this study is to investigate the effect of a care plan based on Roy adaptation model biological dimension on stroke patients' physiologic adaptation level. This study is a clinical trial in which 50 patients, affected by brain stroke and being admitted in the neurology ward of Kashani and Alzahra hospitals, were randomly assigned to control and study groups in Isfahan in 2013. Roy adaptation model care plan was administered in biological dimension in the form of four sessions and phone call follow-ups for 1 month. The forms related to Roy adaptation model were completed before and after intervention in the two groups. Chi-square test and t-test were used to analyze the data through SPSS 18. There was a significant difference in mean score of adaptation in physiological dimension in the study group after intervention (P adaptation in the patients affected by brain stroke in the study and control groups showed a significant increase in physiological dimension in the study group by 47.30 after intervention (P adaptation model biological dimension care plan can result in an increase in adaptation in patients with stroke in physiological dimension. Nurses can use this model for increasing patients' adaptation.

  20. Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial

    Science.gov (United States)

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2012-01-01

    Introduction Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. Methods and analysis A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. Ethical and dissemination The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. Trial registration This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials

  1. Techniques for extracting single-trial activity patterns from large-scale neural recordings

    Science.gov (United States)

    Churchland, Mark M; Yu, Byron M; Sahani, Maneesh; Shenoy, Krishna V

    2008-01-01

    Summary Large, chronically-implanted arrays of microelectrodes are an increasingly common tool for recording from primate cortex, and can provide extracellular recordings from many (order of 100) neurons. While the desire for cortically-based motor prostheses has helped drive their development, such arrays also offer great potential to advance basic neuroscience research. Here we discuss the utility of array recording for the study of neural dynamics. Neural activity often has dynamics beyond that driven directly by the stimulus. While governed by those dynamics, neural responses may nevertheless unfold differently for nominally identical trials, rendering many traditional analysis methods ineffective. We review recent studies – some employing simultaneous recording, some not – indicating that such variability is indeed present both during movement generation, and during the preceding premotor computations. In such cases, large-scale simultaneous recordings have the potential to provide an unprecedented view of neural dynamics at the level of single trials. However, this enterprise will depend not only on techniques for simultaneous recording, but also on the use and further development of analysis techniques that can appropriately reduce the dimensionality of the data, and allow visualization of single-trial neural behavior. PMID:18093826

  2. Habituation and adaptation of the vestibuloocular reflex: a model of differential control by the vestibulocerebellum

    Science.gov (United States)

    Cohen, H.; Cohen, B.; Raphan, T.; Waespe, W.

    1992-01-01

    We habituated the dominant time constant of the horizontal vestibuloocular reflex (VOR) of rhesus and cynomolgus monkeys by repeated testing with steps of velocity about a vertical axis and adapted the gain of the VOR by altering visual input with magnifying and reducing lenses. After baseline values were established, the nodulus and ventral uvula of the vestibulocerebellum were ablated in two monkeys, and the effects of nodulouvulectomy and flocculectomy on VOR gain adaptation and habituation were compared. The VOR time constant decreased with repeated testing, rapidly at first and more slowly thereafter. The gain of the VOR was unaffected. Massed trials were more effective than distributed trials in producing habituation. Regardless of the schedule of testing, the VOR time constant never fell below the time constant of the semicircular canals (approximately 5 s). This finding indicates that only the slow component of the vestibular response, the component produced by velocity storage, was habituated. In agreement with this, the time constant of optokinetic after-nystagmus (OKAN) was habituated concurrently with the VOR. Average values for VOR habituation were obtained on a per session basis for six animals. The VOR gain was adapted by natural head movements in partially habituated monkeys while they wore x 2.2 magnifying or x 0.5 reducing lenses. Adaptation occurred rapidly and reached about +/- 30%, similar to values obtained using forced rotation. VOR gain adaptation did not cause additional habituation of the time constant. When the VOR gain was reduced in animals with a long VOR time constant, there were overshoots in eye velocity that peaked at about 6-8 s after the onset or end of constant-velocity rotation. These overshoots occurred at times when the velocity storage integrator would have been maximally activated by semicircular canal input. Since the activity generated in the canals is not altered by visual adaptation, this finding indicates that the gain

  3. Robots that can adapt like animals.

    Science.gov (United States)

    Cully, Antoine; Clune, Jeff; Tarapore, Danesh; Mouret, Jean-Baptiste

    2015-05-28

    Robots have transformed many industries, most notably manufacturing, and have the power to deliver tremendous benefits to society, such as in search and rescue, disaster response, health care and transportation. They are also invaluable tools for scientific exploration in environments inaccessible to humans, from distant planets to deep oceans. A major obstacle to their widespread adoption in more complex environments outside factories is their fragility. Whereas animals can quickly adapt to injuries, current robots cannot 'think outside the box' to find a compensatory behaviour when they are damaged: they are limited to their pre-specified self-sensing abilities, can diagnose only anticipated failure modes, and require a pre-programmed contingency plan for every type of potential damage, an impracticality for complex robots. A promising approach to reducing robot fragility involves having robots learn appropriate behaviours in response to damage, but current techniques are slow even with small, constrained search spaces. Here we introduce an intelligent trial-and-error algorithm that allows robots to adapt to damage in less than two minutes in large search spaces without requiring self-diagnosis or pre-specified contingency plans. Before the robot is deployed, it uses a novel technique to create a detailed map of the space of high-performing behaviours. This map represents the robot's prior knowledge about what behaviours it can perform and their value. When the robot is damaged, it uses this prior knowledge to guide a trial-and-error learning algorithm that conducts intelligent experiments to rapidly discover a behaviour that compensates for the damage. Experiments reveal successful adaptations for a legged robot injured in five different ways, including damaged, broken, and missing legs, and for a robotic arm with joints broken in 14 different ways. This new algorithm will enable more robust, effective, autonomous robots, and may shed light on the principles

  4. The ProActive trial protocol – a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766

    Directory of Open Access Journals (Sweden)

    Ekelund Ulf

    2004-10-01

    Full Text Available Abstract Background Increasing prevalence of obesity and disorders associated with sedentary living constitute a major global public health problem. While previous evaluations of interventions to increase physical activity have involved communities or individuals with established disease, less attention has been given to interventions for individuals at risk of disease. Methods/design ProActive aims to evaluate the efficacy of a theoretical, evidence- and family-based intervention programme to increase physical activity in a sedentary population, defined as being at-risk through having a parental family history of diabetes. Primary care diabetes or family history registers were used to recruit 365 individuals aged 30–50 years, screened for activity level. Participants were assigned by central randomisation to three intervention programmes: brief written advice (comparison group, or a psychologically based behavioural change programme, delivered either by telephone (distance group or face-to-face in the family home over one year. The protocol-driven intervention programme is delivered by trained facilitators, and aims to support increases in physical activity through the introduction and facilitation of a range of self-regulatory skills (e.g. goal setting. The primary outcome is daytime energy expenditure and its ratio to resting energy expenditure, measured at baseline and one year using individually calibrated heart rate monitoring. Secondary measures include self-report of individual and family activity, psychological mediators of behaviour change, physiological and biochemical correlates, acceptability, and costs, measured at baseline, six months and one year. The primary intention to treat analysis will compare groups at one-year post randomisation. Estimation of the impact on diabetes incidence will be modelled using data from a parallel ten-year cohort study using similar measures. Discussion ProActive is the first efficacy trial of an

  5. Frontostriatal and behavioral adaptations to daily sugar-sweetened beverage intake: a randomized controlled trial123

    Science.gov (United States)

    2017-01-01

    Background: Current obesity theories suggest that the repeated intake of highly palatable high-sugar foods causes adaptions in the striatum, parietal lobe, and prefrontal and visual cortices in the brain that may serve to perpetuate consumption in a feed-forward manner. However, the data for humans are cross-sectional and observational, leaving little ability to determine the temporal precedence of repeated consumption on brain response. Objective: We tested the impact of regular sugar-sweetened beverage intake on brain and behavioral responses to beverage stimuli. Design: We performed an experiment with 20 healthy-weight individuals who were randomly assigned to consume 1 of 2 sugar-sweetened beverages daily for 21 d, underwent 2 functional MRI sessions, and completed behavioral and explicit hedonic assessments. Results: Consistent with preclinical experiments, daily beverage consumption resulted in decreases in dorsal striatal response during receipt of the consumed beverage (r = −0.46) and decreased ventromedial prefrontal response during logo-elicited anticipation (r = −0.44). This decrease in the prefrontal response correlated with increases in behavioral disinhibition toward the logo of the consumed beverage (r = 0.54; P = 0.02). Daily beverage consumption also increased precuneus response to both juice logos compared with a tasteless control (r = 0.45), suggesting a more generalized effect toward beverage cues. Last, the repeated consumption of 1 beverage resulted in an explicit hedonic devaluation of a similar nonconsumed beverage (P < 0.001). Conclusions: Analogous to previous reports, these initial results provide convergent data for a role of regular sugar-sweetened beverage intake in altering neurobehavioral responses to the regularly consumed beverage that may also extend to other beverage stimuli. Future research is required to provide evidence of replication in a larger sample and to establish whether the neurobehavioral adaptations observed

  6. ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial

    DEFF Research Database (Denmark)

    Boysen, Gudrun; Krarup, Lars-Henrik; Zeng, Xianrong

    2009-01-01

    training programme before discharge and at five follow-up visits during 24 months. Control patients had follow-up visits with the same frequency but without instructions in physical activity. MAIN OUTCOME MEASURES: Physical activity assessed with the Physical Activity Scale for the Elderly (PASE) at each......OBJECTIVES: To investigate if repeated verbal instructions about physical activity to patients with ischaemic stroke could increase long term physical activity. DESIGN: Multicentre, multinational, randomised clinical trial with masked outcome assessment. SETTING: Stroke units in Denmark, China...... infarction, or falls and fractures. CONCLUSION: Repeated encouragement and verbal instruction in being physically active did not lead to a significant increase in physical activity measured by the PASE score. More intensive strategies seem to be needed to promote physical activity after ischaemic stroke...

  7. Promoting gross motor skills and physical activity in childcare: A translational randomized controlled trial.

    Science.gov (United States)

    Jones, Rachel A; Okely, Anthony D; Hinkley, Trina; Batterham, Marijka; Burke, Claire

    2016-09-01

    Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  8. Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trial.

    Science.gov (United States)

    Campanini, Rosaly F B; Schoedl, Aline F; Pupo, Mariana C; Costa, Ana Clara H; Krupnick, Janice L; Mello, Marcelo F

    2010-01-01

    Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.

  9. Fostering Engagement Activities To Advance Adaptation And Resiliency

    Science.gov (United States)

    Dissen, J.; Owen, T.; Brewer, M.; Hollingshead, A.; Mecray, E. L.; Werner, K.

    2015-12-01

    As the understanding of climate risks grows for public and private companies, the dissemination of meaningful climate and environmental information becomes important for improved risk management practices and innovation. In a broader effort to build capacity for adaptation and demonstrate the value of investment in resiliency, NCEI and its partners have made several shifts to showcase an improved understanding of uses and applications of climate and environmental data and information. The NOAA NCEI engagement initiative includes actively exploring ways to: 1) identify opportunities in data use and applications and 2) characterize needs and requirements from customers to help inform investment in the relevant science. This presentation will highlight: 1) NCEI's engagement initiative strategy, 2) our regional and national partnerships as agents of engagement in the region, 3) a few examples of uses of climate information with select stakeholders and 4) justification of customer engagement and requirements as a critical component in informing the science agenda.

  10. MIDAS: a practical Bayesian design for platform trials with molecularly targeted agents.

    Science.gov (United States)

    Yuan, Ying; Guo, Beibei; Munsell, Mark; Lu, Karen; Jazaeri, Amir

    2016-09-30

    Recent success of immunotherapy and other targeted therapies in cancer treatment has led to an unprecedented surge in the number of novel therapeutic agents that need to be evaluated in clinical trials. Traditional phase II clinical trial designs were developed for evaluating one candidate treatment at a time and thus not efficient for this task. We propose a Bayesian phase II platform design, the multi-candidate iterative design with adaptive selection (MIDAS), which allows investigators to continuously screen a large number of candidate agents in an efficient and seamless fashion. MIDAS consists of one control arm, which contains a standard therapy as the control, and several experimental arms, which contain the experimental agents. Patients are adaptively randomized to the control and experimental agents based on their estimated efficacy. During the trial, we adaptively drop inefficacious or overly toxic agents and 'graduate' the promising agents from the trial to the next stage of development. Whenever an experimental agent graduates or is dropped, the corresponding arm opens immediately for testing the next available new agent. Simulation studies show that MIDAS substantially outperforms the conventional approach. The proposed design yields a significantly higher probability for identifying the promising agents and dropping the futile agents. In addition, MIDAS requires only one master protocol, which streamlines trial conduct and substantially decreases the overhead burden. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  11. Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wenborn, Jennifer; Hynes, Sinéad; Moniz-Cook, Esme; Mountain, Gail; Poland, Fiona; King, Michael; Omar, Rumana; Morris, Steven; Vernooij-Dassen, Myrra; Challis, David; Michie, Susan; Russell, Ian; Sackley, Catherine; Graff, Maud; O'Keeffe, Aidan; Crellin, Nadia; Orrell, Martin

    2016-02-03

    A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual. This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists. COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK. Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

  12. Promoting Well-Being in Old Age: The Psychological Benefits of Two Training Programs of Adapted Physical Activity

    Directory of Open Access Journals (Sweden)

    Antonella Delle Fave

    2018-05-01

    Full Text Available In the last few decades, the relationship between physical conditions and mental health has increasingly attracted the interest of researchers and professionals across disciplines. This relationship is especially relevant in old age, as the challenges posed by aging at various levels represent crucial concerns for policy makers. Due to the remarkable increase in life expectancy across countries, sustainable prevention strategies are needed to help individuals preserve psychophysical well-being in old age. In particular, the regular practice of a moderately intense physical activity is recommended by the World Health Organization to enhance balance, prevent falls, strengthen muscles, and promote psychophysical well-being. Daily physical exercise represents a beneficial and low-cost strategy, easily accessible to the general population and potentially customizable to specific needs through brief training programs. Based on these premises, the present research aimed at longitudinally evaluating mental well-being among 58 Italian people aged 67–85, who were involved in two Adapted Physical Activity (APA training programs. Inclusion criteria for participation comprised high autonomy levels in daily activities, no cognitive impairment, sedentary habits or only occasional performance of moderate physical activity. Based on physical and functional assessment, 39 participants joined a program of adapted motor activity (PoliFit; Study 1, while 19 participants attended a variant program specifically designed for people with osteoporosis (OsteoFit; Study 2. Well-being dimensions were assessed through the Mental Health Continuum-Short Form, the Emotion Regulation Questionnaire and the Satisfaction with Life Scale. Physical functioning were evaluated before and after the programs through the Short Physical Performance Battery and the Handgrip Dynamometer Jamar Test. Findings highlighted that, besides physical benefits, participants reported significantly

  13. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease: randomised controlled trial.

    Science.gov (United States)

    van Nimwegen, Marlies; Speelman, Arlène D; Overeem, Sebastiaan; van de Warrenburg, Bart P; Smulders, Katrijn; Dontje, Manon L; Borm, George F; Backx, Frank J G; Bloem, Bastiaan R; Munneke, Marten

    2013-03-01

    To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Multicentre randomised controlled trial. 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). 586 sedentary patients with idiopathic Parkinson's disease aged between 40 and 75 years with mild to moderate disease severity (Hoehn and Yahr stage ≤ 3). Patients were randomly assigned to the ParkFit programme or a matched general physiotherapy intervention. ParkFit is a multifaceted behavioural change programme, designed specifically to achieve an enduring increase in the level of physical activity (coaches using motivational strategies; ambulatory feedback). The primary endpoint was the level of physical activity, measured every six months with a standardised seven day recall (LASA physical activity questionnaire-LAPAQ). Secondary endpoints included two other measures of physical activity (activity diary and ambulatory activity monitor), quality of life (Parkinson's disease questionnaire-PDQ-39), and fitness (six minute walk test). 540 (92.2%) patients completed the primary outcome. During follow-up, overall time spent on physical activities (LAPAQ) was comparable between the groups (adjusted group difference 7%, 95% confidence interval -3 to 17%; P=0.19). Analyses of three secondary outcomes indicated increased physical activity in ParkFit patients, as suggested by the activity diary (difference 30%; Pactivity monitor (difference 12%; Pphysical activity, as measured with the LAPAQ. The analysis of the secondary endpoints justifies further work into the possible merits of behavioural change programmes to increase physical activities in daily life in Parkinson's disease. Clinical trials NCT00748488.

  14. Effects of Long-Term Acupuncture Treatment on Resting-State Brain Activity in Migraine Patients: A Randomized Controlled Trial on Active Acupoints and Inactive Acupoints

    Science.gov (United States)

    Zhao, Ling; Liu, Jixin; Zhang, Fuwen; Dong, Xilin; Peng, Yulin; Qin, Wei; Wu, Fumei; Li, Ying; Yuan, Kai; von Deneen, Karen M.; Gong, Qiyong; Tang, Zili; Liang, Fanrong

    2014-01-01

    Background Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. Methods and Results A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. Conclusions Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003635 PMID:24915066

  15. An Exploratory Investigation into the Effects of Adaptation in Child-Robot Interaction

    Science.gov (United States)

    Salter, Tamie; Michaud, François; Létourneau, Dominic

    The work presented in this paper describes an exploratory investigation into the potential effects of a robot exhibiting an adaptive behaviour in reaction to a child’s interaction. In our laboratory we develop robotic devices for a diverse range of children that differ in age, gender and ability, which includes children that are diagnosed with cognitive difficulties. As all children vary in their personalities and styles of interaction, it would follow that adaptation could bring many benefits. In this abstract we give our initial examination of a series of trials which explore the effects of a fully autonomous rolling robot exhibiting adaptation (through changes in motion and sound) compared to it exhibiting pre-programmed behaviours. We investigate sensor readings on-board the robot that record the level of ‘interaction’ that the robot receives when a child plays with it and also we discuss the results from analysing video footage looking at the social aspect of the trial.

  16. CHAMP: Cognitive behaviour therapy for health anxiety in medical patients, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Murphy David

    2011-06-01

    Full Text Available Abstract Background Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population. Method/Design The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years. Discussion This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also

  17. Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.

    Science.gov (United States)

    Wages, N A; Slingluff, C L; Petroni, G R

    2017-04-01

    In recent years, investigators have asserted that the 3 + 3 design lacks flexibility, making its use in modern early-phase trial settings, such as combinations and/or biological agents, inefficient. More innovative approaches are required to address contemporary research questions, such as those posed in trials involving immunotherapies. We describe the implementation of an adaptive design for identifying an optimal treatment regimen, defined by low toxicity and high immune response, in an early-phase trial of a melanoma helper peptide vaccine plus novel adjuvant combinations. Operating characteristics demonstrate the ability of the method to effectively recommend optimal regimens in a high percentage of trials with reasonable sample sizes. The proposed design is a practical, early-phase, adaptive method for use with combined immunotherapy regimens. This design can be applied more broadly to early-phase combination studies, as it was used in an ongoing study of two small molecule inhibitors in relapsed/refractory mantle cell lymphoma. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  18. Active and Adaptive Learning from Biased Data with Applications in Astronomy

    DEFF Research Database (Denmark)

    Kremer, Jan

    This thesis addresses the problem of machine learning from biased datasets in the context of astronomical applications. In astronomy there are many cases in which the training sample does not follow the true distribution. The thesis examines different types of biases and proposes algorithms...... set. Against this background, the thesis begins with a survey of active learning algorithms for the support vector machine. If the cost of additional labeling is prohibitive, unlabeled data can often be utilized instead and the sample selection bias can be overcome through domain adaptation, that is...... to handle them. During learning and when applying the predictive model, active learning enables algorithms to select training examples from a pool of unlabeled data and to request the labels. This allows for selecting examples that maximize the algorithm's accuracy despite an initial bias in the training...

  19. Auto-adaptive averaging: Detecting artifacts in event-related potential data using a fully automated procedure

    NARCIS (Netherlands)

    Talsma, D.

    2008-01-01

    The auto-adaptive averaging procedure proposed here classifies artifacts in event-related potential data by optimizing the signal-to-noise ratio. This method rank orders single trials according to the impact of each trial on the ERP average. Then, the minimum residual background noise level in the

  20. Auto-adaptive averaging: Detecting artifacts in event-related potential data using a fully automated procedure.

    NARCIS (Netherlands)

    Talsma, D.

    2008-01-01

    The auto-adaptive averaging procedure proposed here classifies artifacts in event-related potential data by optimizing the signal-to-noise ratio. This method rank orders single trials according to the impact of each trial on the ERP average. Then, the minimum residual background noise level in the

  1. Concordance between four European centres of PET reporting criteria designed for use in multicentre trials in Hodgkin lymphoma

    DEFF Research Database (Denmark)

    Barrington, Sally F; Qian, Wendi; Somer, Edward J

    2010-01-01

    To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries.......To determine if PET reporting criteria for the Response Adapted Treatment in Hodgkin Lymphoma (RATHL) trial could enable satisfactory agreement to be reached between 'core' laboratories operating in different countries....

  2. Intelligent Electric Power Systems with Active-Adaptive Electric Networks: Challenges for Simulation Tools

    Directory of Open Access Journals (Sweden)

    Ufa Ruslan A.

    2015-01-01

    Full Text Available The motivation of the presented research is based on the needs for development of new methods and tools for adequate simulation of intelligent electric power systems with active-adaptive electric networks (IES including Flexible Alternating Current Transmission System (FACTS devices. The key requirements for the simulation were formed. The presented analysis of simulation results of IES confirms the need to use a hybrid modelling approach.

  3. Roy's Adaptation Model-Guided Education and Promoting the Adaptation of Veterans With Lower Extremities Amputation.

    Science.gov (United States)

    Azarmi, Somayeh; Farsi, Zahra

    2015-10-01

    Any defect in extremities of the body can affect different life aspects. The purpose of this study was to investigate the effect of Roy's adaptation model-guided education on promoting the adaptation of veterans with lower extremities amputation. In a randomized clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of veterans clinic in Tehran, Iran, were recruited with convenience method and were randomly assigned to intervention and control groups during 2013 - 2014. For data collection, Roy's adaptation model questionnaire was used. After completing the questionnaires in both groups, maladaptive behaviors were determined in the intervention group and an education program based on Roy's adaptation model was implemented. After two months, both groups completed the questionnaires again. Data was analyzed with SPSS software. Independent t-test showed statistically significant differences between the two groups in the post-test stage in terms of the total score of adaptation (P = 0.001) as well as physiologic (P = 0.0001) and role function modes (P = 0.004). The total score of adaptation (139.43 ± 5.45 to 127.54 ± 14.55, P = 0.006) as well as the scores of physiologic (60.26 ± 5.45 to 53.73 ± 7.79, P = 0.001) and role function (20.30 ± 2.42 to 18.13 ± 3.18, P = 0.01) modes in the intervention group significantly increased, whereas the scores of self-concept (42.10 ± 4.71 to 39.40 ± 5.67, P = 0.21) and interdependence (16.76 ± 2.22 to 16.30 ± 2.57, P = 0.44) modes in the two stages did not have a significant difference. Findings of this research indicated that the Roy's adaptation model-guided education promoted the adaptation level of physiologic and role function modes in veterans with lower extremities amputation. However, this intervention could not promote adaptation in self-concept and interdependence modes. More intervention is advised based on Roy's adaptation model for improving the

  4. EMPLOYEE ADAPTATION AS KEY ACTIVITY IN HUMAN RESOURCE MANAGEMENT UPON IMPLEMENTING AND MAINTAINING DESIRED ORGANISATIONAL CULTURE

    Directory of Open Access Journals (Sweden)

    Zdenko Stacho

    2017-11-01

    Full Text Available In order to achieve the greatest possible equivalence between human resources in a company and desired organisational culture elements declared by a company, it is necessary to interconnect activities within individual functions of human resource management with desired values, attitudes and work behaviour. Such an interconnection is crucial for a positive response of employees to a suitable organisational culture, its embedding in their behaviour and subsequent sharing and spreading of organisational values. This paper will specifically define individual activities related to the adaptation of employees which need to be carried out in this regard. Based on a research conducted between 2011 and 2013, the paper will also define the present state and level of focus of organisations operating in Slovakia on both organisational culture as a whole and organisational culture in the context of employee adaptation.

  5. Basal ganglia-dependent processes in recalling learned visual-motor adaptations.

    Science.gov (United States)

    Bédard, Patrick; Sanes, Jerome N

    2011-03-01

    Humans learn and remember motor skills to permit adaptation to a changing environment. During adaptation, the brain develops new sensory-motor relationships that become stored in an internal model (IM) that may be retained for extended periods. How the brain learns new IMs and transforms them into long-term memory remains incompletely understood since prior work has mostly focused on the learning process. A current model suggests that basal ganglia, cerebellum, and their neocortical targets actively participate in forming new IMs but that a cerebellar cortical network would mediate automatization. However, a recent study (Marinelli et al. 2009) reported that patients with Parkinson's disease (PD), who have basal ganglia dysfunction, had similar adaptation rates as controls but demonstrated no savings at recall tests (24 and 48 h). Here, we assessed whether a longer training session, a feature known to increase long-term retention of IM in healthy individuals, could allow PD patients to demonstrate savings. We recruited PD patients and age-matched healthy adults and used a visual-motor adaptation paradigm similar to the study by Marinelli et al. (2009), doubling the number of training trials and assessed recall after a short and a 24-h delay. We hypothesized that a longer training session would allow PD patients to develop an enhanced representation of the IM as demonstrated by savings at the recall tests. Our results showed that PD patients had similar adaptation rates as controls but did not demonstrate savings at both recall tests. We interpret these results as evidence that fronto-striatal networks have involvement in the early to late phase of motor memory formation, but not during initial learning.

  6. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  7. A behavioural intervention increases physical activity in people with subacute spinal cord injury: a randomised trial

    Directory of Open Access Journals (Sweden)

    Carla FJ Nooijen

    2016-01-01

    Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural

  8. Trial watch: Immunogenic cell death induction by anticancer chemotherapeutics.

    Science.gov (United States)

    Garg, Abhishek D; More, Sanket; Rufo, Nicole; Mece, Odeta; Sassano, Maria Livia; Agostinis, Patrizia; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2017-01-01

    The expression "immunogenic cell death" (ICD) refers to a functionally unique form of cell death that facilitates (instead of suppressing) a T cell-dependent immune response specific for dead cell-derived antigens. ICD critically relies on the activation of adaptive responses in dying cells, culminating with the exposure or secretion of immunostimulatory molecules commonly referred to as "damage-associated molecular patterns". Only a few agents can elicit bona fide ICD, including some clinically established chemotherapeutics such as doxorubicin, epirubicin, idarubicin, mitoxantrone, bleomycin, bortezomib, cyclophosphamide and oxaliplatin. In this Trial Watch, we discuss recent progress on the development of ICD-inducing chemotherapeutic regimens, focusing on studies that evaluate clinical efficacy in conjunction with immunological biomarkers.

  9. From feedback- to response-based performance monitoring in active and observational learning.

    Science.gov (United States)

    Bellebaum, Christian; Colosio, Marco

    2014-09-01

    Humans can adapt their behavior by learning from the consequences of their own actions or by observing others. Gradual active learning of action-outcome contingencies is accompanied by a shift from feedback- to response-based performance monitoring. This shift is reflected by complementary learning-related changes of two ACC-driven ERP components, the feedback-related negativity (FRN) and the error-related negativity (ERN), which have both been suggested to signal events "worse than expected," that is, a negative prediction error. Although recent research has identified comparable components for observed behavior and outcomes (observational ERN and FRN), it is as yet unknown, whether these components are similarly modulated by prediction errors and thus also reflect behavioral adaptation. In this study, two groups of 15 participants learned action-outcome contingencies either actively or by observation. In active learners, FRN amplitude for negative feedback decreased and ERN amplitude in response to erroneous actions increased with learning, whereas observational ERN and FRN in observational learners did not exhibit learning-related changes. Learning performance, assessed in test trials without feedback, was comparable between groups, as was the ERN following actively performed errors during test trials. In summary, the results show that action-outcome associations can be learned similarly well actively and by observation. The mechanisms involved appear to differ, with the FRN in active learning reflecting the integration of information about own actions and the accompanying outcomes.

  10. Landscape of early clinical trials for childhood and adolescence cancer in Spain.

    Science.gov (United States)

    Bautista, F; Gallego, S; Cañete, A; Mora, J; Diaz de Heredia, C; Cruz, O; Fernández, J M; Rives, S; Madero, L; Castel, V; Cela, M E; Ramírez, G; Sábado, C; Acha, T; Astigarraga, I; Sastre, A; Muñoz, A; Guibelalde, M; Moreno, L

    2016-07-01

    Despite numerous advances, survival remains dismal for children and adolescents with poor prognosis cancers or those who relapse or are refractory to first line treatment. There is, therefore, a major unmet need for new drugs. Recent advances in the knowledge of molecular tumor biology open the door to more adapted therapies according to individual alterations. Promising results in the adult anticancer drug development have not yet been translated into clinical practice. We report the activity in early pediatric oncology trials in Spain. All members of the Spanish Society of Pediatric Hematology Oncology (SEHOP) were contacted to obtain information about early trials open in each center. 22 phase I and II trials were open as of May 2015: 15 for solid tumors (68 %) and 7 for hematological malignancies (32 %). Fourteen (64 %) were industry sponsored. Since 2010, four centers have joined the Innovative Therapies For Children With Cancer, an international consortium whose aim is developing novel therapies for pediatric cancers. A substantial number of studies have opened in these 5 years, improving the portfolio of trials for children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents and their benefits. Clinical trials are the way to evaluate new drugs, avoiding the use of off-label drugs that carry significant risks. The Spanish pediatric oncology community through the SEHOP is committed to develop and participate in collaborative academic trials, to favor the advancement and optimization of existing therapies in pediatric cancer.

  11. Conflict Adaptation and Cue Competition during Learning in an Eriksen Flanker Task

    Science.gov (United States)

    Ghinescu, Rodica; Ramsey, Ashley K.; Gratton, Gabriele; Fabiani, Monica

    2016-01-01

    Two experiments investigated competition between cues that predicted the correct target response to a target stimulus in a response conflict procedure using a flanker task. Subjects received trials with five-character arrays with a central target character and distractor flanker characters that matched (compatible) or did not match (incompatible) the central target. Subjects’ expectancies for compatible and incompatible trials were manipulated by presenting pre-trial cues that signaled the occurrence of compatible or incompatible trials. On some trials, a single cue predicted the target stimulus and the required target response. On other trials, a second redundant, predictive cue was also present on such trials. The results showed an effect of competition between cues for control over strategic responding to the target stimuli, a finding that is predicted by associative learning theories. The finding of competition between pre-trial cues that predict incompatible trials, but not cues that predict compatible trials, suggests that different strategic processes may occur during adaptation to conflict when different kinds of trials are expected. PMID:27941977

  12. Effect of dronabinol therapy on physical activity in anorexia nervosa: a randomised, controlled trial

    DEFF Research Database (Denmark)

    Andries, Alin; Gram, Bibi; Støving, René Klinkby

    2015-01-01

    PURPOSE: The level of physical activity is inappropriately high in up to 80 % of the patients suffering of anorexia nervosa (AN), as a result of conscious efforts to lose weight, affect regulation and biological adaptive changes to starvation induced by hypothermia and neuroendocrine mechanisms...

  13. Adaptation, test-retest reliability, and construct validity of the Physical Activity Neighborhood Environment Scale in Nigeria (PANES-N).

    Science.gov (United States)

    Oyeyemi, Adewale L; Sallis, James F; Oyeyemi, Adetoyeje Y; Amin, Mariam M; De Bourdeaudhuij, Ilse; Deforche, Benedicte

    2013-11-01

    This study adapted the Physical Activity Neighborhood Environment Scale (PANES) to the Nigerian context and assessed the test-retest reliability and construct validity of the Nigerian version (PANESN). A multidisciplinary panel of experts adapted the original PANES to reflect the built and social environment of Nigeria. The adapted PANES was subjected to cognitive testing and test retest reliability in a diverse sample of Nigerian adults (N = 132) from different neighborhood types. Intraclass Correlation Coefficients (ICC) was used to assess test-retest reliability, and construct validity was investigated with Analysis of Covariance for differences in environmental attributes between neighborhoods. Four of the 17 items on the original PANES were significantly modified, 3 were removed and 2 new items were incorporated into the final version of adapted PANES-N. Test-retest reliability was substantial to almost perfect (ICC = 0.62-1.00) for all items on the PANES-N, and residents of neighborhoods in the inner city reported higher residential density, land use mix and safety, but lower pedestrian facilities and aesthetics than did residents of government reserved area/new layout neighborhoods. The PANES-N appears promising for assessing environmental perceptions related to physical activity in Nigeria, but further testing is required to assess its applicability across Africa.

  14. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  15. Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program.

    Science.gov (United States)

    Koutoukidis, Dimitrios A; Lopes, Sonia; Atkins, Lou; Croker, Helen; Knobf, M Tish; Lanceley, Anne; Beeken, Rebecca J

    2018-03-27

    About 80% of endometrial cancer survivors (ECS) are overweight or obese and have sedentary behaviors. Lifestyle behavior interventions are promising for improving dietary and physical activity behaviors, but the constructs associated with their effectiveness are often inadequately reported. The aim of this study was to systematically adapt an evidence-based behavior change program to improve healthy lifestyle behaviors in ECS. Following a review of the literature, focus groups and interviews were conducted with ECS (n = 16). An intervention mapping protocol was used for the program adaptation, which consisted of six steps: a needs assessment, formulation of matrices of change objectives, selection of theoretical methods and practical applications, program production, adoption and implementation planning, and evaluation planning. Social Cognitive Theory and Control Theory guided the adaptation of the intervention. The process consisted of eight 90-min group sessions focusing on shaping outcome expectations, knowledge, self-efficacy, and goals about healthy eating and physical activity. The adapted performance objectives included establishment of regular eating, balanced diet, and portion sizes, reduction in sedentary behaviors, increase in lifestyle and organized activities, formulation of a discrepancy-reducing feedback loop for all above behaviors, and trigger management. Information on managing fatigue and bowel issues unique to ECS were added. Systematic intervention mapping provided a framework to design a cancer survivor-centered lifestyle intervention. ECS welcomed the intervention and provided essential feedback for its adaptation. The program has been evaluated through a randomized controlled trial.

  16. Armoured spiderman: morphological and behavioural adaptations of a specialised araneophagous predator (Araneae: Palpimanidae)

    Science.gov (United States)

    Pekár, Stano; Šobotník, Jan; Lubin, Yael

    2011-07-01

    In a predator-prey system where both intervenients come from the same taxon, one can expect a strong selection on behavioural and morphological traits involved in prey capture. For example, in specialised snake-eating snakes, the predator is unaffetced by the venom of the prey. We predicted that similar adaptations should have evolved in spider-eating (araneophagous) spiders. We investigated potential and actual prey of two Palpimanus spiders ( P. gibbulus, P. orientalis) to support the prediction that these are araneophagous predators. Specific behavioural adaptations were investigated using a high-speed camera during staged encounters with prey, while morphological adaptations were investigated using electron microscopy. Both Palpimanus species captured a wide assortment of spider species from various guilds but also a few insect species. Analysis of the potential prey suggested that Palpimanus is a retreat-invading predator that actively searches for spiders that hide in a retreat. Behavioural capture adaptations include a slow, stealthy approach to the prey followed by a very fast attack. Morphological capture adaptations include scopulae on forelegs used in grabbing prey body parts, stout forelegs to hold the prey firmly, and an extremely thick cuticle all over the body preventing injury from a counter bite of the prey. Palpimanus overwhelmed prey that was more than 200% larger than itself. In trials with another araneophagous spider, Cyrba algerina (Salticidae), Palpimanus captured C. algerina in more than 90% of cases independent of the size ratio between the spiders. Evidence indicates that both Palpimanus species possesses remarkable adaptations that increase its efficiency in capturing spider prey.

  17. Adaptations to the coping power program's structure, delivery settings, and clinician training.

    Science.gov (United States)

    Lochman, John E; Powell, Nicole; Boxmeyer, Caroline; Andrade, Brendan; Stromeyer, Sara L; Jimenez-Camargo, Luis Alberto

    2012-06-01

    This article describes the conceptual framework for the Coping Power program that has focused on proximal risk factors that can actively alter preadolescent children's aggressive behavior. The results of initial controlled efficacy trials are summarized. However, consistent with the theme of this special section, some clinicians and workshop participants have indicated barriers to the implementation of the Coping Power program in their service settings. In response to these types of concerns, three key areas of programmatic adaptation of the program that serve to address these concerns are then described in the article. First, existing and in-process studies of variations in how the program can be delivered are presented. Existing findings indicate how the child component fares when delivered by itself without the parent component, how simple monthly boosters affect intervention effects, and whether the program can be reduced by a third of its length and still be effective. Research planned or in progress on program variations examines whether group versus individual delivery of the program affects outcomes, whether the program can be adapted for early adolescents, whether the program can be delivered in an adaptive manner with the use of the Family Check Up, and whether a brief, efficient version of the program in conjunction with Internet programming can be developed and be effective. Second, the program has been and is being developed for use in different settings, other than the school-based delivery in the efficacy trials. Research has examined its use with aggressive deaf youth in a residential setting, with Oppositional Defiant Disorder and Conduct Disorder children in outpatient clinics, and in after-school programs. Third, the article reports how variations in training clinicians affect their ability to effectively use the program. PsycINFO Database Record (c) 2012 APA, all rights reserved.

  18. Increasing students’ physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Amy S. Ha

    2017-07-01

    Full Text Available Abstract Background The Self-determined Exercise and Learning For FITness (SELF-FIT is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students’ moderate-to-vigorous physical activity (MVPA during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students’ MVPA during school physical education. Methods Secondary 2 students (approximately aged 14 years from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students’ MVPA during PE lessons. Secondary outcomes include students’ leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness. Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students’ perceptions of the intervention. Discussion The SELF-FIT intervention has been designed to improve students’ health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable

  19. Community dynamics and glycoside hydrolase activities of thermophilic bacterial consortia adapted to switchgrass

    Energy Technology Data Exchange (ETDEWEB)

    Gladden, J.M.; Allgaier, M.; Miller, C.S.; Hazen, T.C.; VanderGheynst, J.S.; Hugenholtz, P.; Simmons, B.A.; Singer, S.W.

    2011-05-01

    Industrial-scale biofuel production requires robust enzymatic cocktails to produce fermentable sugars from lignocellulosic biomass. Thermophilic bacterial consortia are a potential source of cellulases and hemicellulases adapted to harsher reaction conditions than commercial fungal enzymes. Compost-derived microbial consortia were adapted to switchgrass at 60 C to develop thermophilic biomass-degrading consortia for detailed studies. Microbial community analysis using small-subunit rRNA gene amplicon pyrosequencing and short-read metagenomic sequencing demonstrated that thermophilic adaptation to switchgrass resulted in low-diversity bacterial consortia with a high abundance of bacteria related to thermophilic paenibacilli, Rhodothermus marinus, and Thermus thermophilus. At lower abundance, thermophilic Chloroflexi and an uncultivated lineage of the Gemmatimonadetes phylum were observed. Supernatants isolated from these consortia had high levels of xylanase and endoglucanase activities. Compared to commercial enzyme preparations, the endoglucanase enzymes had a higher thermotolerance and were more stable in the presence of 1-ethyl-3-methylimidazolium acetate ([C2mim][OAc]), an ionic liquid used for biomass pretreatment. The supernatants were used to saccharify [C2mim][OAc]-pretreated switchgrass at elevated temperatures (up to 80 C), demonstrating that these consortia are an excellent source of enzymes for the development of enzymatic cocktails tailored to more extreme reaction conditions.

  20. Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ly Kien

    2012-05-01

    Full Text Available Abstract Background The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones. Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. Methods The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, ‘Effective meditation’. The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. Discussions We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist’s prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10

  1. The functional organization of trial-related activity in lexical processing after early left hemispheric brain lesions: An event-related fMRI study.

    Science.gov (United States)

    Fair, Damien A; Choi, Alexander H; Dosenbach, Yannic B L; Coalson, Rebecca S; Miezin, Francis M; Petersen, Steven E; Schlaggar, Bradley L

    2010-08-01

    Children with congenital left hemisphere damage due to perinatal stroke are capable of acquiring relatively normal language functions despite experiencing a cortical insult that in adults often leads to devastating lifetime disabilities. Although this observed phenomenon is accepted, its neurobiological mechanisms are not well characterized. In this paper we examined the functional neuroanatomy of lexical processing in 13 children/adolescents with perinatal left hemispheric damage. In contrast to many previous perinatal infarct fMRI studies, we used an event-related design, which allowed us to isolate trial-related activity and examine correct and error trials separately. Using both group and single subject analysis techniques we attempt to address several methodological factors that may contribute to some discrepancies in the perinatal lesion literature. These methodological factors include making direct statistical comparisons, using common stereotactic space, using both single subject and group analyses, and accounting for performance differences. Our group analysis, investigating correct trial-related activity (separately from error trials), showed very few statistical differences in the non-involved right hemisphere between patients and performance matched controls. The single subject analysis revealed atypical regional activation patterns in several patients; however, the location of these regions identified in individual patients often varied across subjects. These results are consistent with the idea that alternative functional organization of trial-related activity after left hemisphere lesions is in large part unique to the individual. In addition, reported differences between results obtained with event-related designs and blocked designs may suggest diverging organizing principles for sustained and trial-related activity after early childhood brain injuries. 2009 Elsevier Inc. All rights reserved.

  2. [Stress-induced cellular adaptive mutagenesis].

    Science.gov (United States)

    Zhu, Linjiang; Li, Qi

    2014-04-01

    The adaptive mutations exist widely in the evolution of cells, such as antibiotic resistance mutations of pathogenic bacteria, adaptive evolution of industrial strains, and cancerization of human somatic cells. However, how these adaptive mutations are generated is still controversial. Based on the mutational analysis models under the nonlethal selection conditions, stress-induced cellular adaptive mutagenesis is proposed as a new evolutionary viewpoint. The hypothetic pathway of stress-induced mutagenesis involves several intracellular physiological responses, including DNA damages caused by accumulation of intracellular toxic chemicals, limitation of DNA MMR (mismatch repair) activity, upregulation of general stress response and activation of SOS response. These responses directly affect the accuracy of DNA replication from a high-fidelity manner to an error-prone one. The state changes of cell physiology significantly increase intracellular mutation rate and recombination activity. In addition, gene transcription under stress condition increases the instability of genome in response to DNA damage, resulting in transcription-associated DNA mutagenesis. In this review, we summarize these two molecular mechanisms of stress-induced mutagenesis and transcription-associated DNA mutagenesis to help better understand the mechanisms of adaptive mutagenesis.

  3. Error signals driving locomotor adaptation

    DEFF Research Database (Denmark)

    Choi, Julia T; Jensen, Peter; Nielsen, Jens Bo

    2016-01-01

    Locomotor patterns must be adapted to external forces encountered during daily activities. The contribution of different sensory inputs to detecting perturbations and adapting movements during walking is unclear. Here we examined the role of cutaneous feedback in adapting walking patterns to force...... walking (Choi et al. 2013). Sensory tests were performed to measure cutaneous touch threshold and perceptual threshold of force perturbations. Ankle movement were measured while subjects walked on the treadmill over three periods: baseline (1 min), adaptation (1 min) and post-adaptation (3 min). Subjects...

  4. Lithocholic acid controls adaptive immune responses by inhibition of Th1 activation through the Vitamin D receptor.

    Science.gov (United States)

    Pols, Thijs W H; Puchner, Teresa; Korkmaz, H Inci; Vos, Mariska; Soeters, Maarten R; de Vries, Carlie J M

    2017-01-01

    Bile acids are established signaling molecules next to their role in the intestinal emulsification and uptake of lipids. We here aimed to identify a potential interaction between bile acids and CD4+ Th cells, which are central in adaptive immune responses. We screened distinct bile acid species for their potency to affect T cell function. Primary human and mouse CD4+ Th cells as well as Jurkat T cells were used to gain insight into the mechanism underlying these effects. We found that unconjugated lithocholic acid (LCA) impedes Th1 activation as measured by i) decreased production of the Th1 cytokines IFNγ and TNFαα, ii) decreased expression of the Th1 genes T-box protein expressed in T cells (T-bet), Stat-1 and Stat4, and iii) decreased STAT1α/β phosphorylation. Importantly, we observed that LCA impairs Th1 activation at physiological relevant concentrations. Profiling of MAPK signaling pathways in Jurkat T cells uncovered an inhibition of ERK-1/2 phosphorylation upon LCA exposure, which could provide an explanation for the impaired Th1 activation. LCA induces these effects via Vitamin D receptor (VDR) signaling since VDR RNA silencing abrogated these effects. These data reveal for the first time that LCA controls adaptive immunity via inhibition of Th1 activation. Many factors influence LCA levels, including bile acid-based drugs and gut microbiota. Our data may suggest that these factors also impact on adaptive immunity via a yet unrecognized LCA-Th cell axis.

  5. Adaptive Interventions in Drug Court: A Pilot Experiment

    Science.gov (United States)

    Marlowe, Douglas B.; Festinger, David S.; Arabia, Patricia L.; Dugosh, Karen L.; Benasutti, Kathleen M.; Croft, Jason R.; McKay, James R.

    2009-01-01

    This pilot study (N = 30) experimentally examined the effects of an adaptive intervention in an adult misdemeanor drug court. The adaptive algorithm adjusted the frequency of judicial status hearings and clinical case-management sessions according to pre-specified criteria in response to participants' ongoing performance in the program. Results revealed the adaptive algorithm was acceptable to both clients and staff, feasible to implement with greater than 85% fidelity, and showed promise for eliciting clinically meaningful improvements in drug abstinence and graduation rates. Estimated effect sizes ranged from 0.40 to 0.60 across various dependent measures. Compared to drug court as-usual, participants in the adaptive condition were more likely to receive responses from the drug court team for inadequate performance in the program and received those responses after a substantially shorter period of time. This suggests the adaptive algorithm may have more readily focused the drug court team's attention on poorly-performing individuals, thus allowing the team to “nip problems in the bud” before they developed too fully. These preliminary data justify additional research evaluating the effects of the adaptive algorithm in a fully powered experimental trial. PMID:19724664

  6. Adaptation to delayed force perturbations in reaching movements.

    Directory of Open Access Journals (Sweden)

    Noa Levy

    Full Text Available Adaptation to deterministic force perturbations during reaching movements was extensively studied in the last few decades. Here, we use this methodology to explore the ability of the brain to adapt to a delayed velocity-dependent force field. Two groups of subjects preformed a standard reaching experiment under a velocity dependent force field. The force was either immediately proportional to the current velocity (Control or lagged it by 50 ms (Test. The results demonstrate clear adaptation to the delayed force perturbations. Deviations from a straight line during catch trials were shifted in time compared to post-adaptation to a non-delayed velocity dependent field (Control, indicating expectation to the delayed force field. Adaptation to force fields is considered to be a process in which the motor system predicts the forces to be expected based on the state that a limb will assume in response to motor commands. This study demonstrates for the first time that the temporal window of this prediction needs not to be fixed. This is relevant to the ability of the adaptive mechanisms to compensate for variability in the transmission of information across the sensory-motor system.

  7. Development of web-based computer-tailored advice to promote physical activity among people older than 50 years.

    Science.gov (United States)

    Peels, Denise A; van Stralen, Maartje M; Bolman, Catherine; Golsteijn, Rianne Hj; de Vries, Hein; Mudde, Aart N; Lechner, Lilian

    2012-03-02

    The Active Plus project is a systematically developed theory- and evidence-based, computer-tailored intervention, which was found to be effective in changing physical activity behavior in people aged over 50 years. The process and effect outcomes of the first version of the Active Plus project were translated into an adapted intervention using the RE-AIM framework. The RE-AIM model is often used to evaluate the potential public health impact of an intervention and distinguishes five dimensions: reach, effectiveness, adoption, implementation, and maintenance. To gain insight into the systematic translation of the first print-delivered version of the Active Plus project into an adapted (Web-based) follow-up project. The focus of this study was on the reach and effectiveness dimensions, since these dimensions are most influenced by the results from the original Active Plus project. We optimized the potential reach and effect of the interventions by extending the delivery mode of the print-delivered intervention into an additional Web-based intervention. The interventions were adapted based on results of the process evaluation, analyses of effects within subgroups, and evaluation of the working mechanisms of the original intervention. We pretested the new intervention materials and the Web-based versions of the interventions. Subsequently, the new intervention conditions were implemented in a clustered randomized controlled trial. Adaptations resulted in four improved tailoring interventions: (1) a basic print-delivered intervention, (2) a basic Web-based intervention, (3) a print-delivered intervention with an additional environmental component, and (4) a Web-based version with an additional environmental component. Pretest results with participants showed that all new intervention materials had modest usability and relatively high appreciation, and that filling in an online questionnaire and performing the online tasks was not problematic. We used the pretest results

  8. Psychotherapy with traumatised refugees – the design of a randomised clinical trial

    DEFF Research Database (Denmark)

    Vindbjerg, Erik; Carlsson, Jessica Mariana; Klimpke, Christoph Axel

    2014-01-01

    There is little evidence as to which kind of psychotherapy is the most effective in the treatment of traumatised refugees. At the Competence Center for  Transcultural Psychiatry, a series of clinical trials have been conducted since 2008. The first results are pending publication. The aim...... of this paper is to discuss some of the challenges in adapting Cognitive Behavioural Therapy (CBT) to the treatment of traumatised refugees, as well as describe a randomised clinical trial designed to test two such adaptations. In the described trial one group receives CBT with a focus on cognitive...... restructuring while the other group receives CBT focusing on Stress Management. A main goal of this setup is to test whether some, perhaps even most, of the traumatised refugees referred to treatment, may benefit from a more direct focus on current stress, and its alleviation through simple, repetitive...

  9. Age-related changes and sex differences in postural control adaptability in children during periodic floor oscillation with eyes closed.

    Science.gov (United States)

    Fujiwara, Katsuo; Kiyota, Takeo; Mammadova, Aida; Yaguchi, Chie

    2011-01-01

    We investigated age-related changes and sex differences in adaptability of anticipatory postural control in children. Subjects comprised 449 children (4-12 years old) and 109 young adults (18-29 years old). Subjects stood with eyes closed on a force-platform fixed to a floor oscillator. We conducted five trials of 1-minute oscillation (0.5 Hz frequency, 2.5 cm amplitude) in the anteroposterior direction. Postural steadiness was quantified as the mean speed of the center of pressure in the anteroposterior direction (CoPy). In young adults, CoPy speed decreased rapidly until the third trial for both sexes. Adaptability was evaluated by changes in steadiness. The adaptability of children was categorized as "good," "moderate," and "poor," compared with a standard variation of the mean CoPy speed regression line between the first and fifth trials in young adults. Results were as follows: (1) anticipatory postural control adaptability starts to develop from age 6 in boys and 5 in girls, and greatly improves at age 7-8 in boys and 6 in girls; (2) the adaptability of children at age 11-12 (74% of boys and 63% of girls were categorized as "good") has not yet reached the same level as for young adults; (3) the adaptability at age 11-12 for girls is temporarily disturbed due to early puberty.

  10. Performance study of Active Queue Management methods: Adaptive GRED, REDD, and GRED-Linear analytical model

    Directory of Open Access Journals (Sweden)

    Hussein Abdel-jaber

    2015-10-01

    Full Text Available Congestion control is one of the hot research topics that helps maintain the performance of computer networks. This paper compares three Active Queue Management (AQM methods, namely, Adaptive Gentle Random Early Detection (Adaptive GRED, Random Early Dynamic Detection (REDD, and GRED Linear analytical model with respect to different performance measures. Adaptive GRED and REDD are implemented based on simulation, whereas GRED Linear is implemented as a discrete-time analytical model. Several performance measures are used to evaluate the effectiveness of the compared methods mainly mean queue length, throughput, average queueing delay, overflow packet loss probability, and packet dropping probability. The ultimate aim is to identify the method that offers the highest satisfactory performance in non-congestion or congestion scenarios. The first comparison results that are based on different packet arrival probability values show that GRED Linear provides better mean queue length; average queueing delay and packet overflow probability than Adaptive GRED and REDD methods in the presence of congestion. Further and using the same evaluation measures, Adaptive GRED offers a more satisfactory performance than REDD when heavy congestion is present. When the finite capacity of queue values varies the GRED Linear model provides the highest satisfactory performance with reference to mean queue length and average queueing delay and all the compared methods provide similar throughput performance. However, when the finite capacity value is large, the compared methods have similar results in regard to probabilities of both packet overflowing and packet dropping.

  11. Effect of Roy's Adaptation Model-Guided Education on Coping Strategies of the Veterans with Lower Extremities Amputation: A Double-Blind Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Farsi, Zahra; Azarmi, Somayeh

    2016-04-01

    Any defect in the extremities of the body can affect different life aspects. The purpose of this study was to investigate the effect of Roy's adaptation model-guided education on coping strategies of the veterans with lower extremities amputation. In a double-blind randomized controlled clinical trial, 60 veterans with lower extremities amputation referring to Kowsar Orthotics and Prosthetics Center of Veterans Clinic in Tehran, Iran were recruited using convenience method and randomly assigned to intervention and control groups in 2013-2014. Lazarus and Folkman coping strategies questionnaire was used to collect the data. After completing the questionnaires in both groups, maladaptive behaviours were determined in the intervention group and an education program based on Roy's adaptation model was implemented. After 2 months, both groups completed the questionnaires again. Data were analyzed using SPSS software. Independent T-test showed that the score of the dimensions of coping strategies did not have a statistically significant difference between the intervention and control groups in the pre-intervention stage (P>0.05). This test showed a statistically significant difference between the two groups in the post-intervention stage in terms of the scores of different dimensions of coping strategies (P>0.05), except in dimensions of social support seeking and positive appraisal (P>0.05). The findings of this research indicated that the Roy's adaptation model-guided education improved the majority of coping strategies in veterans with lower extremities amputation. It is recommended that further interventions based on Roy's adaptation model should be performed to improve the coping of the veterans with lower extremities amputation. IRCT2014081118763N1.

  12. Optimal spectral tracking--adapting to dynamic regime change.

    Science.gov (United States)

    Brittain, John-Stuart; Halliday, David M

    2011-01-30

    Real world data do not always obey the statistical restraints imposed upon them by sophisticated analysis techniques. In spectral analysis for instance, an ergodic process--the interchangeability of temporal for spatial averaging--is assumed for a repeat-trial design. Many evolutionary scenarios, such as learning and motor consolidation, do not conform to such linear behaviour and should be approached from a more flexible perspective. To this end we previously introduced the method of optimal spectral tracking (OST) in the study of trial-varying parameters. In this extension to our work we modify the OST routines to provide an adaptive implementation capable of reacting to dynamic transitions in the underlying system state. In so doing, we generalise our approach to characterise both slow-varying and rapid fluctuations in time-series, simultaneously providing a metric of system stability. The approach is first applied to a surrogate dataset and compared to both our original non-adaptive solution and spectrogram approaches. The adaptive OST is seen to display fast convergence and desirable statistical properties. All three approaches are then applied to a neurophysiological recording obtained during a study on anaesthetic monitoring. Local field potentials acquired from the posterior hypothalamic region of a deep brain stimulation patient undergoing anaesthesia were analysed. The characterisation of features such as response delay, time-to-peak and modulation brevity are considered. Copyright © 2010 Elsevier B.V. All rights reserved.

  13. Use of the foil activation method with arbitrary trial functions to determine neutron energy spectra

    International Nuclear Information System (INIS)

    Kelly, J.G.; Vehar, D.W.

    1987-01-01

    Neutron Spectra have been measured by the foil activation method in thirteen different environments in and around the Sandia Pulsed Reactor (SPR-III), the White Sands Missile Range FBR, and the Annular Core Research Reactor (ACRR). The unfolded spectra were obtained by using the SANDII code in a manner which was not dependent on the initial trial. This altered technique is, therefore, better suited for the determination of spectra in environments that are difficult to predict by calculation, and it tends to reveal features that may be biased out by the use of standard trial functions

  14. Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

    Science.gov (United States)

    Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

    2017-07-11

    The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical

  15. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial.

    Science.gov (United States)

    Finkelstein, Eric A; Haaland, Benjamin A; Bilger, Marcel; Sahasranaman, Aarti; Sloan, Robert A; Nang, Ei Ei Khaing; Evenson, Kelly R

    2016-12-01

    Despite the increasing popularity of activity trackers, little evidence exists that they can improve health outcomes. We aimed to investigate whether use of activity trackers, alone or in combination with cash incentives or charitable donations, lead to increases in physical activity and improvements in health outcomes. In this randomised controlled trial, employees from 13 organisations in Singapore were randomly assigned (1:1:1:1) with a computer generated assignment schedule to control (no tracker or incentives), Fitbit Zip activity tracker, tracker plus charity incentives, or tracker plus cash incentives. Participants had to be English speaking, full-time employees, aged 21-65 years, able to walk at least ten steps continuously, and non-pregnant. Incentives were tied to weekly steps, and the primary outcome, moderate-to-vigorous physical activity (MVPA) bout min per week, was measured via a sealed accelerometer and assessed on an intention-to-treat basis at 6 months (end of intervention) and 12 months (after a 6 month post-intervention follow-up period). Other outcome measures included steps, participants meeting 70 000 steps per week target, and health-related outcomes including weight, blood pressure, and quality-of-life measures. This trial is registered at ClinicalTrials.gov, number NCT01855776. Between June 13, 2013, and Aug 15, 2014, 800 participants were recruited and randomly assigned to the control (n=201), Fitbit (n=203), charity (n=199), and cash (n=197) groups. At 6 months, compared with control, the cash group logged an additional 29 MVPA bout min per week (95% CI 10-47; p=0·0024) and the charity group an additional 21 MVPA bout min per week (2-39; p=0·0310); the difference between Fitbit only and control was not significant (16 MVPA bout min per week [-2 to 35; p=0·0854]). Increases in MVPA bout min per week in the cash and charity groups were not significantly greater than that of the Fitbit group. At 12 months, the Fitbit group logged an

  16. Rich context information for just-in-time adaptive intervention promoting physical activity.

    Science.gov (United States)

    Cruciani, F; Nugent, C; Cleland, I; McCullagh, P

    2017-07-01

    Sedentary lifestyle and inadequate levels of physical activity represent two serious health risk factors. Nevertheless, within developed countries, 60% of people aged over 60 are deemed to be sedentary. Consequently, interest in behavior change to promote physical activity is increasing. In particular, the role of emerging mobile apps to facilitate behavior change has shown promising results. Smart technologies can help in providing rich context information including an objective assessment of the level of physical activity and information on the emotional and physiological state of the person. Collectively, this can be used to develop innovative persuasive solutions for adaptive behavior change. Such solutions offer potential in reducing levels of sedentary behavior. This work presents a study exploring new ways of employing smart technologies to facilitate behavior change. It is achieved by means of (i) developing a knowledge base on sedentary behaviors and recommended physical activity guidelines, and (ii) a context model able to combine information on physical activity, location, and a user's diary to develop a context-aware virtual coach with the ability to select the most appropriate behavior change strategy on a case by case basis.

  17. Time-dependent postural control adaptations following a neuromuscular warm-up in female handball players: a randomized controlled trial.

    Science.gov (United States)

    Steib, Simon; Zahn, Peter; Zu Eulenburg, Christine; Pfeifer, Klaus; Zech, Astrid

    2016-01-01

    Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control. Fourty one (24.0 ± 5.9 years) female handball athletes were randomized to an intervention or control group. The intervention group implemented a 15-min specific neuromuscular warm-up program, three times per week for eleven weeks, whereas the control group continued with their regular warm-up. Balance was assessed at five time points. Measures included the star excursion balance test (SEBT), and center of pressure (COP) sway velocity during single-leg standing. No baseline differences existed between groups in demographic data. Adherence to neuromuscular warm-up was 88.7 %. Mean COP sway velocity decreased significantly over time in the intervention group (-14.4 %; p  control group (-6.2 %; p  = 0.056). However, these effects did not differ significantly between groups ( p  = .098). Mean changes over time in the SEBT score were significantly greater ( p  = .014) in the intervention group (+5.48) compared to the control group (+3.45). Paired t-tests revealed that the first significant balance improvements were observed after 6 weeks of training. A neuromuscular warm-up positively influences balance variables associated with an increased risk of lower extremity injuries in female handball athletes. The course of adaptations suggests that a training volume of 15 min, three times weekly over at least six weeks produces measurable changes. Retrospectively registered on 4th October 2016. Registry: clinicaltrials.gov. Trial number: NCT02925377.

  18. Analysis technique for controlling system wavefront error with active/adaptive optics

    Science.gov (United States)

    Genberg, Victor L.; Michels, Gregory J.

    2017-08-01

    The ultimate goal of an active mirror system is to control system level wavefront error (WFE). In the past, the use of this technique was limited by the difficulty of obtaining a linear optics model. In this paper, an automated method for controlling system level WFE using a linear optics model is presented. An error estimate is included in the analysis output for both surface error disturbance fitting and actuator influence function fitting. To control adaptive optics, the technique has been extended to write system WFE in state space matrix form. The technique is demonstrated by example with SigFit, a commercially available tool integrating mechanical analysis with optical analysis.

  19. Extracellular signal-regulated protein kinases 1 and 2 activation by addictive drugs: a signal toward pathological adaptation.

    Science.gov (United States)

    Pascoli, Vincent; Cahill, Emma; Bellivier, Frank; Caboche, Jocelyne; Vanhoutte, Peter

    2014-12-15

    Addiction is a chronic and relapsing psychiatric disorder that is thought to occur in vulnerable individuals. Synaptic plasticity evoked by drugs of abuse in the so-called neuronal circuits of reward has been proposed to underlie behavioral adaptations that characterize addiction. By increasing dopamine in the striatum, addictive drugs alter the balance of dopamine and glutamate signals converging onto striatal medium-sized spiny neurons (MSNs) and activate intracellular events involved in long-term behavioral alterations. Our laboratory contributed to the identification of salient molecular changes induced by administration of addictive drugs to rodents. We pioneered the observation that a common feature of addictive drugs is to activate, by a double tyrosine/threonine phosphorylation, the extracellular signal-regulated kinases 1 and 2 (ERK1/2) in the striatum, which control a plethora of substrates, some of them being critically involved in cocaine-mediated molecular and behavioral adaptations. Herein, we review how the interplay between dopamine and glutamate signaling controls cocaine-induced ERK1/2 activation in MSNs. We emphasize the key role of N-methyl-D-aspartate receptor potentiation by D1 receptor to trigger ERK1/2 activation and its subsequent nuclear translocation where it modulates both epigenetic and genetic processes engaged by cocaine. We discuss how cocaine-induced long-term synaptic and structural plasticity of MSNs, as well as behavioral adaptations, are influenced by ERK1/2-controlled targets. We conclude that a better knowledge of molecular mechanisms underlying ERK1/2 activation by drugs of abuse and/or its role in long-term neuronal plasticity in the striatum may provide a new route for therapeutic treatment in addiction. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  20. Adaptation of the international physical activity questionnarie for the elderly doi: 10.5007/1980-0037.2010v12n6p480

    Directory of Open Access Journals (Sweden)

    Giovana Zarpellon Mazo

    2010-09-01

    Full Text Available The International Physical Activity Questionnaire (IPAQ estimates the weekly energy expenditure for physical activities (PA. This instrument was validated for use with Brazilian older adults. The need to adapt the structure and application of the IPAQ arose from the difficulties of older adults to correctly measure the number of days, time and intensity of PA (domains during a normal week and the difficulties encountered by the interviewers in field research. The adapted IPAQ consists of five domains and 15 questions and is applied by interview because of the low educational level of Brazilian older adults. The instrument is applied in its long form to permit better discrimination of PA in each domain and refers to a normal week to help recall morning, afternoon and evening activities. In addition, it includes details about mild, moderate and vigorous intensity. The training of the interviewers is fundamental. The report of the IPAQ adapted for older adults should be delivered in minutes per week and should use the classification active (≤ 150 min/week. The IPAQ adapted for older adults is an international instrument that is valid for the Brazilian elderly population. The instrument is a noninvasive easily applied method of low cost that reaches large population groups, among other advantages.

  1. A randomised controlled trial of three very brief interventions for physical activity in primary care

    Directory of Open Access Journals (Sweden)

    Sally Pears

    2016-09-01

    Full Text Available Abstract Background Very brief interventions (VBIs for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83, Pedometer (n = 74, or Combined (n = 80 intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157. Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results For the primary outcome the estimated effect sizes (95 % CI relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7, +23.5 (−51.3, +98.3, and −3.1 (−69.3, +63.1 counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. Trial registration Current Controlled Trials ISRCTN02863077 . Retrospectively registered 05/10/2012.

  2. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Science.gov (United States)

    Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

    2008-01-01

    Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

  3. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley James H

    2008-05-01

    Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

  4. A randomized controlled trial of an online, modular, active learning training program for behavioral activation for depression.

    Science.gov (United States)

    Puspitasari, Ajeng J; Kanter, Jonathan W; Busch, Andrew M; Leonard, Rachel; Dunsiger, Shira; Cahill, Shawn; Martell, Christopher; Koerner, Kelly

    2017-08-01

    This randomized-controlled trial assessed the efficacy of a trainer-led, active-learning, modular, online behavioral activation (BA) training program compared with a self-paced online BA training with the same modular content. Seventy-seven graduate students (M = 30.3 years, SD = 6.09; 76.6% female) in mental health training programs were randomly assigned to receive either the trainer-led or self-paced BA training. Both trainings consisted of 4 weekly sessions covering 4 core BA strategies. Primary outcomes were changes in BA skills as measured by an objective role-play assessment and self-reported use of BA strategies. Assessments were conducted at pre-, post-, and 6-weeks after training. A series of longitudinal mixed effect models assessed changes in BA skills and a longitudinal model implemented with generalized estimating equations assessed BA use over time. Significantly greater increases in total BA skills were found in the trainer-led training condition. The trainer-led training condition also showed greater increases in all core BA skills either at posttraining, follow-up, or both. Reported use of BA strategies with actual clients increased significantly from pre- to posttraining and maintained at follow-up in both training conditions. This trial adds to the literature on the efficacy of online training as a method to disseminate BA. Online training with an active learning, modular approach may be a promising and accessible implementation strategy. Additional strategies may need to be paired with the online BA training to assure the long-term implementation and sustainability of BA in clinical practice. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  5. Maintained physical activity and physiotherapy in the management of distal upper limb pain - a protocol for a randomised controlled trial (the arm pain trial).

    Science.gov (United States)

    Jones, Gareth T; Mertens, Kathrin; Macfarlane, Gary J; Palmer, Keith T; Coggon, David; Walker-Bone, Karen; Burton, Kim; Heine, Peter J; McCabe, Candy; McNamee, Paul; McConnachie, Alex

    2014-03-10

    Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Results from this trial will contribute to the evidence base underpinning the

  6. Phenomenology and adapted physical activity: philosophy and professional practice.

    Science.gov (United States)

    Standal, Øyvind F

    2014-01-01

    Through the increased use of qualitative research methods, the term phenomenology has become a quite familiar notion for researchers in adapted physical activity (APA). In contrast to this increasing interest in phenomenology as methodology, relatively little work has focused on phenomenology as philosophy or as an approach to professional practice. Therefore, the purpose of this article is to examine the relevance of phenomenology as philosophy and as pedagogy to the field of APA. First, phenomenology as philosophy is introduced through three key notions, namely the first-person perspective, embodiment, and life-world. The relevance of these terms to APA is then outlined. Second, the concept of phenomenological pedagogy is introduced, and its application and potential for APA are discussed. In conclusion, it is argued that phenomenology can help theorize ways of understanding human difference in movement contexts and form a basis of action-oriented research aiming at developing professional practice.

  7. Wii Fit® training vs. Adapted Physical Activities: which one is the most appropriate to improve the balance of independent senior subjects? A randomized controlled study.

    Science.gov (United States)

    Toulotte, Claire; Toursel, Cindy; Olivier, Nicolas

    2012-09-01

    To compare the effectiveness of three protocols (Adapted Physical Activities, Wii Fit(®), Adapted Physical Activities + Wii Fit(®)) on the balance of independent senior subjects. Case comparison study. Healthy elderly subjects living in independent community dwellings. Thirty-six subjects, average age 75.09 ± 10.26 years, took part in this study, and were randomly assigned to one of the four experimental groups: G1 followed an Adapted Physical Activities training programme, while the second group (G2) participated in Wii Fit(®) training and the third one (G3) combined both methods. There was no training for the fourth group (G4). All subjects trained once a week (1 hour) for 20 weeks and were assessed before and after treatment. The Tinetti test, unipedal tests and the Wii Fit(®) tests. After training, the scores in the Tinetti test decreased significantly (P Wii Fit(®)) and G3 (