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

NCT ID: NCT03071562

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS Cognitive Impairment Aging Mobility Limitation Medication Adherence Depression Quality of Life Balance Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Yoga-mindfulness

Intervention Type OTHER

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Adria Quigley

OTHER

Sponsor Role lead

Responsible Party

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Adria Quigley

PhD Student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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HIV clinic

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32583707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31115343 (View on PubMed)

Other Identifiers

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371452

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4190yogaHIVcog

Identifier Type: -

Identifier Source: org_study_id

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