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Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial.

ABSTRACT: BACKGROUND:Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV (PLWH) are grappling with increasingly complex health issues, including cognitive impairments in areas such as memory, attention, processing speed, and motor function. Yoga has been shown to be an effective form of exercise and mindfulness-based stress reduction for many clinical populations. However, no randomized trials have evaluated the impact of yoga on cognitive and physical function among PLWH. OBJECTIVE:The aim of this pilot randomized trial was to determine the feasibility of a yoga intervention to lay the groundwork for a full-scale, multisite, community-based trial for PLWH. Specific objectives are to (1) assess the feasibility of study protocol and procedures, (2) compare cognition in the yoga group with the usual care control group after 12 weeks of the intervention in PLWH, and (3) compare the effects of the 12-week yoga intervention versus control on balance, walking speed, physical activity, mental health, medication adherence, and quality of life among PLWH. METHODS:We propose a pilot randomized trial with 2 parallel groups (yoga versus control). We will recruit 25 PLWH (>35 years) from community and health organizations in Halifax, Canada. After baseline assessment with blinded assessors, participants will be randomly assigned to the yoga or control group, using a random computer generator. Participants in the yoga group will engage in supervised 60-min group-based yoga sessions 3 times a week for 12 weeks at a yoga studio. Participants in the control group will maintain their current physical activity levels throughout the study. RESULTS:As per the Consolidated Standards of Reporting Trials extension for pilot studies, means of all outcomes, mean change, and 95% CIs will be calculated for each group separately. Two-tailed independent t tests and Fisher exact tests will be used to compare groups at baseline. We will analyze quantitative postintervention questionnaire responses using Chi-square tests, and open-ended responses will be analyzed thematically. Intention-to-treat and per-protocol analyses will be used to analyze secondary variables. Changes in outcome variables will be examined between groups and within groups. Effect sizes will be reported for each outcome. A priori adherence and satisfaction criteria will be met if participants attend >70% of the yoga sessions and if >70% of the participants are satisfied with the intervention as determined by a postparticipation questionnaire. Study enrollment began in January 2018, with results expected for October 2019. CONCLUSIONS:This pilot randomized trial will be the first to investigate the feasibility and effect of a yoga intervention on cognitive and physical outcomes among PLWH. This work will inform the feasibility of further investigations in terms of capacity building, participant recruitment and retention, and assessment and intervention protocols. TRIAL REGISTRATION:ClinicalTrials.gov NCT03071562; https://clinicaltrials.gov/ct2/show/NCT03071562 (Archived by WebCite at http://www.webcitation.org/785sfhWkw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13818.

SUBMITTER: Quigley A

PROVIDER: S-EPMC6547772 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial.

Quigley Adria A O'Brien Kelly K KK Brouillette Marie-Josée MJ MacKay-Lyons Marilyn M

JMIR research protocols 20190521 5

<h4>Background</h4>Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV (PLWH) are grappling with increasingly complex health issues, including cognitive impairments in areas such as memory, attention, processing speed, and motor function. Yoga has been shown to be an effective form of exercise and mindfulness-based stress reduction for many clinical populations. However, no randomized trials have evaluated the impact of yoga on cognitive and physical f ...[more]

PMID: 31115343

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Project description:BackgroundA significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older.MethodsFlow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups.ResultsThirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning.ConclusionsThis pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline.Trial registrationClinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.

Project description:BACKGROUND:Research supports the use of Web-based interventions to promote physical activity in diabetes management. However, previous interventions have found poor levels of engagement or have not included health professionals and people with diabetes in the design of the tool. OBJECTIVE:To develop and explore the feasibility and indicative effect of a Web-based physical activity promotion intervention in people diagnosed with type 2 diabetes living in remote or rural locations. METHODS:A qualitative approach using focus groups that included patients with diabetes and health professionals were run to identify key concepts, ideas, and features, which resulted in the design of a physical activity website. This site was tested using a quantitative approach with a qualitative 6-month pilot study that adopted a three-armed approach. Participants were randomized into three groups: a control group who received written diabetes-specific physical activity advice; an information Web group, a Web-based group who received the information online; and an intervention Web group, an interactive Web-based group who received online information plus interactive features, such as an activity log, personalized advice, and goal setting. RESULTS:A website was designed based on patient and health professional ideas for effective physical activity promotion. This website was tested with 31 participants, 61% (19/31) male, who were randomized into the groups. Website log-ins decreased over time: 4.5 times in month 1, falling to 3 times in month 6. Both the information Web group-mean 134.6 (SD 123.9) to mean 154.9 (SD 144.2) min-and the control group-mean 118.9 (SD 103.8) to mean 126.1 (SD 93.4) min, d=0.07-increased time spent in moderate-to-vigorous physical activity, but this decreased in the intervention Web group-mean 131.9 (SD 126.2) to mean 116.8 (SD 107.4) min. CONCLUSIONS:Access to online diabetes-specific physical information was effective in promoting physical activity in people with type 2 diabetes; access to interactive features was not associated with increases in activity. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number (ISRCTN): 96266587; http://www.isrctn.com/ISRCTN96266587 (Archived by WebCite at http://www.webcitation.org/6tzX6YesZ).

Project description:BackgroundHospitalization is often stressful and burdensome for people living with dementia (PwD) and their informal caregivers (ICs). Day clinic treatment may provide a suitable alternative, but is often precluded by a diagnosis of dementia. Furthermore, it is often caregiver-based ratings that measure treatment success as the validity of self-reports in PwD is critically discussed. We therefore set out to examine the feasibility of psychobiological stress measures in PwD and ICs and to evaluate treatment trajectories considering both the day clinic context and the daily life of the dyads.MethodA total of 40 dyads of PwD (mean age: 78.15 ± 6.80) and their ICs (mean age: 63.85 ± 13.09) completed paper-and-pencil questionnaires (covering stress, depressive symptoms, and caregiver burden among others) in addition to the measurement of hair cortisol concentrations (HCC) at admission, discharge, and follow-up 6 months after day clinic treatment. As part of an ambulatory assessment, for 2 days at the beginning and 2 days at the end of the day clinic treatment, PwD and ICs collected six saliva samples per day for the analysis of salivary cortisol (sCort) and alpha-amylase (sAA).ResultsPaper-and-pencil questionnaires and HCC assessments were more feasible than the ambulatory assessment. We found discrepancies between subjective and physiological markers of stress in PwD. Whereas HCC decreased over time, self-reported stress increased. Child-parent dyads reported decreases in neuropsychiatric symptoms, associated burden, and self-reported stress from admission to follow-up. In daily life, both PwD and ICs showed characteristic diurnal profiles of sAA and sCort, however, we found no differences in summary indicators of salivary stress markers over time.DiscussionThe psychobiological evaluation was feasible and added informative value, underlining the potential of physiological stress markers to complement self-reports on stress in PwD and to objectively evaluate treatment trajectories. In this sample, HCC was more feasible and acceptable as biological marker of stress compared to saliva samples. Concerning treatment trajectories, differential effects on the dyads were found, with child-parent dyads benefiting more from day clinic treatment compared to spousal dyads.

Project description:IntroductionManaging medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. People living with dementia may require medication administration assistance from formal and informal caregivers. Simplified medication regimens maintain the same therapeutic intent, but have less complex instructions and administration schedules. This protocol paper outlines a study to determine the feasibility of a multicomponent intervention to simplify medication regimens for people receiving community-based home care services.Methods and analysisThis is a non-randomised pilot and feasibility study. Research nurses will recruit 50 people receiving community-based home care services. All participants will receive the intervention from a clinical pharmacist, who will undertake medication reconciliation, assess each participant's capacity to self-manage their medication regimen and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be a description of study feasibility (recruitment and retention rates, protocol adherence and stakeholder acceptability). Secondary outcomes include the change in number of medication administration times per day, medication adherence, quality of life, participant satisfaction, medication incidents, falls and healthcare utilisation at 4 months.Ethics and disseminationEthical approval was obtained from the Monash University Human Research Ethics Committee and the community-based home care provider organisation's ethical review panel. Research findings will be disseminated to consumers and caregivers, health professionals, researchers and healthcare providers through the National Health and Medical Research Council Cognitive Decline Partnership Centre and through conference presentations, lay summaries and peer-reviewed publications. This study will enable an improved understanding of medication management and administration among people receiving community-based home care services. This study will inform the decision to proceed with a randomised controlled trial to assess the effect of this intervention.Trial registration numberACTRN12618001130257; Pre-results.

Dataset Information

Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial.

Publications

Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial.

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