Clinical trial NCT03071562: A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition in Older Adults Infected With HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Cognitive Impairment
Aging
Mobility Limitation
Medication Adherence
Depression
Quality of Life
Balance Problems
Keywords: HIV
Cognitive impairment
Aging
Physical Activity
Exercise
Yoga
Neuroplasticity
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-03-07
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participant self-report of HIV diagnosis
2. Identified cognitive concerns on the C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
3. Residence in the Halifax area
4. Capacity to provide informed consent
5. 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.

Primary outcomes:
measure: B-CAM (Brief Cognitive Ability Measure)
timeFrame: Will be assessed at baseline and 12 weeks.
measure: C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
timeFrame: Will be assessed during screening, baseline, and 12 weeks.
Secondary outcomes:
measure: Feasibility (Post-participation questionnaire)
timeFrame: Assessed at 12 weeks.
measure: Balance
timeFrame: Assessed at baseline and at 12 weeks.
measure: Walking Speed
timeFrame: Assessed at baseline and at 12 weeks.
measure: Depression
timeFrame: Assessed at baseline and at 12 weeks.
measure: Medication Adherence
timeFrame: Assessed at baseline and at 12 weeks.
measure: Health-related Quality of Life
timeFrame: Assessed at baseline and at 12 weeks.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: HIV clinic
state: Nova Scotia
Study officials:
References:
citation: Quigley A, Brouillette MJ, Gahagan J, O'Brien KK, MacKay-Lyons M. Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial. J Int Assoc Provid AIDS Care. 2020 Jan-Dec;19:2325958220935698. doi: 10.1177/2325958220935698.
citation: Quigley A, O'Brien KK, Brouillette MJ, MacKay-Lyons M. 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. JMIR Res Protoc. 2019 May 21;8(5):e13818. doi: 10.2196/13818.