Depression Clinical Trial
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
Verified date | January 2020 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | September 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | HIV clinic | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Adria Quigley | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | |
Secondary | Balance | Balance will be measured using the Community Balance and Mobility test (CB&M). | Assessed at baseline and at 12 weeks. | |
Secondary | 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. | |
Secondary | Depression | Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire. | Assessed at baseline and at 12 weeks. | |
Secondary | 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. | |
Secondary | 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. |
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