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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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.
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