JMIR Publications

ABSTRACT

Background:

Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV are now grappling with increasingly complex health issues, including cognitive impairments in such areas 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 people living with HIV.

Objective:

The purpose of this pilot randomized trial is to determine the feasibility of a yoga intervention in order to lay the groundwork for a full-scale, multi-site, community-based trial for people living with HIV. Specific objectives are to: 1) Assess the feasibility of the study protocol and procedures; 2) Compare cognitive function in the yoga intervention group to the usual care control group after 12 weeks of the intervention in people living with HIV; 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 in people living with HIV.

Methods:

We propose a pilot randomized trial with two parallel groups comparing yoga versus control. We will recruit 25 people living with HIV (>35 years) from community and health organizations in Halifax, Nova Scotia, 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-minute group-based yoga sessions 3 times weekly 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 CONSORT extension for pilot studies, means of all outcomes, mean change, and 95% confidence intervals will be calculated for each group separately. Independent t-tests and Fisher exact tests will be used to compare the two groups at baseline. We will analyze quantitative post-intervention questionnaire responses using Chi-square tests, and open-ended responses will be analyzed thematically. Intention-to-treat and per-protocol analyses will be used in the analysis of the 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% are satisfied with the intervention as determined by a post-participation questionnaire.

Conclusions:

This pilot randomized trial will be the first to investigate the feasibility and effect of a yoga intervention on cognitive and physical outcomes in people living with HIV. This work will inform the feasibility of further investigation in terms of capacity-building, participant recruitment and retention, and assessment and intervention protocols. Clinical Trial: ClinicalTrials.gov identifier: NCT03071562