A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition in Older Adults Infected With HIV
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|ClinicalTrials.gov Identifier: NCT03071562|
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Cognitive Impairment Aging Mobility Limitation Medication Adherence Depression Quality of Life Balance Problems||Other: Yoga-mindfulness||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|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.|
|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 :||January 2017|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||September 2019|
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).
(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).
- B-CAM (Brief Cognitive Ability Measure) [ Time Frame: 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) [ Time Frame: Will be assessed during screening, baseline, and 12 weeks. ]Self-reported cognition will be assessed using the C3Q (Communicating Cognitive Challenges in HIV Questionnaire).
- Feasibility (Post-participation questionnaire) [ Time Frame: 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 [ Time Frame: Assessed at baseline and at 12 weeks. ]Balance will be measured using the Community Balance and Mobility test (CB&M).
- Walking Speed [ Time Frame: 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 [ Time Frame: Assessed at baseline and at 12 weeks. ]Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire.
- Medication Adherence [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071562
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 2Y9|