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

January 21, 2020 updated by: Adria Quigley

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • HIV Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Will be assessed at baseline and 12 weeks.
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).
Will be assessed during screening, baseline, and 12 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adria Quigley

Collaborators

Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (ACTUAL)

March 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4190yogaHIVcog
  • 371452 (OTHER_GRANT: 2016-06-28 Catalyst Grant: HIV/AIDS Community Based Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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