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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071562
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Adria Quigley, Nova Scotia Health Authority

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Actual Primary Completion Date : August 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).



Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. Balance [ Time Frame: Assessed at baseline and at 12 weeks. ]
    Balance will be measured using the Community Balance and Mobility test (CB&M).

  3. 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.

  4. 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.

  5. 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).

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Canada, Nova Scotia
HIV clinic
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Adria Quigley
Canadian Institutes of Health Research (CIHR)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adria Quigley, PhD Student, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03071562    
Other Study ID Numbers: 4190yogaHIVcog
371452 ( Other Grant/Funding Number: 2016-06-28 Catalyst Grant: HIV/AIDS Community Based Research )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adria Quigley, Nova Scotia Health Authority:
HIV
Cognitive impairment
Aging
Physical Activity
Exercise
Yoga
Neuroplasticity
Additional relevant MeSH terms:
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Mobility Limitation
Depression
Cognitive Dysfunction
Behavioral Symptoms
Mental Disorders
Cognition Disorders
Neurocognitive Disorders