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

Sponsor

Adria Quigley (Other)

Overall Status

Completed

CT.gov ID

NCT03071562

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Cognitive Impairment Aging Mobility Limitation Medication Adherence Depression Quality of Life Balance Problems	Other: Yoga-mindfulness	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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.
No Intervention: 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).

Arm

Intervention/Treatment

Experimental: 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).

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.

No Intervention: 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).

Outcome Measures

Primary Outcome Measures

B-CAM (Brief Cognitive Ability Measure) [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) [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 Outcome Measures

Feasibility (Post-participation questionnaire) [Assessed at 12 weeks.]
Many domains of feasibility will be assessed using a post-intervention questionnaire with questions related to participant comfort, satisfaction, safety, attendance, and time commitment.
Balance [Assessed at baseline and at 12 weeks.]
Balance will be measured using the Community Balance and Mobility test (CB&M).
Walking Speed [Assessed at baseline and at 12 weeks.]
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.
Depression [Assessed at baseline and at 12 weeks.]
Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire.
Medication Adherence [Assessed at baseline and at 12 weeks.]
Participants will also be asked about Medication adherence (specifically antiretroviral) using the Simplified Medication Adherence Questionnaire (SMAQ).
Health-related Quality of Life [Assessed at baseline and at 12 weeks.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.