A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition in Older Adults Infected With HIV

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV/AIDS, Cognitive Impairment, Aging, Mobility Limitation, Medication Adherence, Depression, Quality of Life, Balance Problems

Intervention / Treatment
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* Other: Yoga-mindfulness


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga-mindfulness<br>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). | Other: Yoga-mindfulness<br>* Sample class: Warm-up (15 minutes) Standing poses (15 minutes) Balance poses (15 minutes) Abdominals & back bends (10 minutes) Cool-down (5 minutes) Seated meditation Alternate nostril breathing Bellows breath Shoulder/neck stretches Cat-cow Forward fold Sun salutations Warrior 1 Warrior 2 Triangle Extended side angle Reverse warrior High lunge with twist Tree pose Standing holding knee Modified warrior 3 (chair support) Half moon Bird-dog Side plank Bridge Cobra Sphinx Corpse pose Side-lying Seated om Every month, a smudging ceremony will take place with an Aboriginal Elder for 5-10 minutes at the start of the class.<br>|
| No Intervention: Control<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-CAM (Brief Cognitive Ability Measure) | 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. | Will be assessed at baseline and 12 weeks. | 
| C3Q (Communicating Cognitive Challenges in HIV Questionnaire) | Self-reported cognition will be assessed using the C3Q (Communicating Cognitive Challenges in HIV Questionnaire). | Will be assessed during screening, baseline, and 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Post-participation questionnaire) | Many domains of feasibility will be assessed using a post-intervention questionnaire with questions related to participant comfort, satisfaction, safety, attendance, and time commitment. | Assessed at 12 weeks. | 
| Balance | Balance will be measured using the Community Balance and Mobility test (CB&M). | Assessed at baseline and at 12 weeks. | 
| Walking Speed | Walking peed will be measured using the 10-meter walking test because it is a simple, well-recognized global health indicator that can predict survival probability. | Assessed at baseline and at 12 weeks. | 
| Depression | Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire. | Assessed at baseline and at 12 weeks. | 
| Medication Adherence | Participants will also be asked about Medication adherence (specifically antiretroviral) using the Simplified Medication Adherence Questionnaire (SMAQ). | Assessed at baseline and at 12 weeks. | 
| Health-related Quality of Life | Quality of life will be assessed using MOS-HIV, consisting of 10 domains (health perceptions, physical/role/ social functioning, pain, mental health, vitality, health distress, cognitive function, QOL). | Assessed at baseline and at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Yoga, Cognitive impairment, Aging, Physical Activity, Exercise, Neuroplasticity