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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071562
• Other study ID #: 4190yogaHIVcog
• Secondary ID: 371452
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2019

Study information

• Verified date: January 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aging
• Balance Problems
• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depressive Disorder
• HIV/AIDS
• Medication Adherence
• Mobility Limitation
• Quality of Life

Intervention

Other:
• Yoga-mindfulness
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.

Locations

Country	Name	City	State
Canada	HIV clinic	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Adria Quigley	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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.