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

Primary Purpose

HIV/AIDS, Cognitive Impairment, Aging

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Yoga-mindfulness
Sponsored by
Adria Quigley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring HIV, Cognitive impairment, Aging, Physical Activity, Exercise, Yoga, Neuroplasticity

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HIV clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga-mindfulness

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
Self-reported cognition will be assessed using the C3Q (Communicating Cognitive Challenges in HIV Questionnaire).

Secondary Outcome Measures

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.
Balance
Balance will be measured using the Community Balance and Mobility test (CB&M).
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.
Depression
Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire.
Medication Adherence
Participants will also be asked about Medication adherence (specifically antiretroviral) using the Simplified Medication Adherence Questionnaire (SMAQ).
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).

Full Information

First Posted
February 24, 2017
Last Updated
January 21, 2020
Sponsor
Adria Quigley
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03071562
Brief Title
A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition in Older Adults Infected With HIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adria Quigley
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Cognitive Impairment, Aging, Mobility Limitation, Medication Adherence, Depression, Quality of Life, Balance Problems
Keywords
HIV, Cognitive impairment, Aging, Physical Activity, Exercise, Yoga, Neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga-mindfulness
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Yoga-mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
B-CAM (Brief Cognitive Ability Measure)
Description
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.
Time Frame
Will be assessed at baseline and 12 weeks.
Title
C3Q (Communicating Cognitive Challenges in HIV Questionnaire)
Description
Self-reported cognition will be assessed using the C3Q (Communicating Cognitive Challenges in HIV Questionnaire).
Time Frame
Will be assessed during screening, baseline, and 12 weeks.
Secondary Outcome Measure Information:
Title
Feasibility (Post-participation questionnaire)
Description
Many domains of feasibility will be assessed using a post-intervention questionnaire with questions related to participant comfort, satisfaction, safety, attendance, and time commitment.
Time Frame
Assessed at 12 weeks.
Title
Balance
Description
Balance will be measured using the Community Balance and Mobility test (CB&M).
Time Frame
Assessed at baseline and at 12 weeks.
Title
Walking Speed
Description
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.
Time Frame
Assessed at baseline and at 12 weeks.
Title
Depression
Description
Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire.
Time Frame
Assessed at baseline and at 12 weeks.
Title
Medication Adherence
Description
Participants will also be asked about Medication adherence (specifically antiretroviral) using the Simplified Medication Adherence Questionnaire (SMAQ).
Time Frame
Assessed at baseline and at 12 weeks.
Title
Health-related Quality of Life
Description
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).
Time Frame
Assessed at baseline and at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
HIV clinic
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32583707
Citation
Quigley A, Brouillette MJ, Gahagan J, O'Brien KK, MacKay-Lyons M. Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial. J Int Assoc Provid AIDS Care. 2020 Jan-Dec;19:2325958220935698. doi: 10.1177/2325958220935698.
Results Reference
derived
PubMed Identifier
31115343
Citation
Quigley A, O'Brien KK, Brouillette MJ, MacKay-Lyons M. Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial. JMIR Res Protoc. 2019 May 21;8(5):e13818. doi: 10.2196/13818.
Results Reference
derived

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

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