A Randomized Pilot Trial Evaluating the Impact and Feasibility of a Yoga-Mindfulness Intervention on Cognition, Quality of Life, Balance, Walking Speed, Medication Adherence, and Depression in Older Adults Infected With HIV
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- B-CAM (Brief Cognitive Ability Measure)
Study Overview
Brief Summary
Approximately 50% of people living with HIV (and as many as 80% over the age of 50) have difficulties with cognitive functions such as memory and thinking that can have a profound negative impact on activities of daily living and quality of life. Problems with memory and thinking are also associated with forgetting to take anti-retroviral drugs and experiencing challenges to balance, walking and mental health (anxiety and depression). There is increasing evidence that, in the general population, exercise has positive effects on cognition, physical functioning and mental health. Despite the recognition of multiple therapeutic benefits of exercise, little attention has been paid to its possible effects on cognition in people living with HIV. The purpose of the proposed pilot study is to compare the effects of a 12-week, randomly assigned, community-based yoga-mindfulness intervention on cognition, balance, walking, mental health and quality of life in 30 people >35 years of age living with HIV in the Halifax area. Yoga is of particular interest because it encompasses not only the physical but also spiritual, emotional, and mental dimensions of life. As such, it has tremendous potential to help stave off some of the devastating consequences of HIV infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Cognition, motor function (balance, walking speed), and affective (mental health, quality of life, medication adherence) evaluations will be administered at baseline and post-intervention (12 weeks) by a trained physiotherapist, blinded to the group assignment. The rationale for blinding the assessing physiotherapist is to reduce bias in scoring during the outcome assessment sessions.
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant self-report of HIV diagnosis
- •Identified cognitive concerns on the C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
- •Residence in the Halifax area
- •Capacity to provide informed consent
- •Aged 35 or older
Exclusion Criteria
- •If participants present with contraindications to exercise, they will be excluded from the study. If participants have participated in a yoga program within the past 6 months, they will be excluded.
Arms & Interventions
Yoga-mindfulness
Groups of 4-5 participants will engage in group-based sessions supervised by yoga-certified physiotherapists, 60 minutes per intervention/session, 3 sessions/week for 12 weeks. The yoga-mindfulness group will participate in a 60-minute Hatha-style yoga class, with meditation, active postures for strengthening and balance, and breathing exercises. Participants will be tracked for total distance and steps per day using accelerometers (Fitbit Flex).
Intervention: Yoga-mindfulness (Other)
Control
Participants in this group will not participate in an exercise program. They will be tracked for total distance and steps per day using accelerometers (Fitbit Flex).
Outcomes
Primary Outcomes
B-CAM (Brief Cognitive Ability Measure)
Time Frame: Will be assessed at baseline and 12 weeks.
Cognitive function will be measured using the Brief Cognitive Ability (B-CAM), a computerized cognitive test developed using Rasch Measurement Theory and Analysis that takes 30 minutes to administer.
C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
Time Frame: Will be assessed during screening, baseline, and 12 weeks.
Self-reported cognition will be assessed using the C3Q (Communicating Cognitive Challenges in HIV Questionnaire).
Secondary Outcomes
- Balance(Assessed at baseline and at 12 weeks.)
- Depression(Assessed at baseline and at 12 weeks.)
- Feasibility (Post-participation questionnaire)(Assessed at 12 weeks.)
- Walking Speed(Assessed at baseline and at 12 weeks.)
- Medication Adherence(Assessed at baseline and at 12 weeks.)
- Health-related Quality of Life(Assessed at baseline and at 12 weeks.)
Investigators
Adria Quigley
PhD Student
Nova Scotia Health Authority