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

NCT03071562 | Completed

• 2 other identifiers: 4190yogaHIVcog371452
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Will be assessed at baseline and 12 weeks.

• C3Q (Communicating Cognitive Challenges in HIV Questionnaire)

  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 Outcomes (6)

• Feasibility (Post-participation questionnaire)

  Assessed at 12 weeks.

• Balance

  Assessed at baseline and at 12 weeks.

• Walking Speed

  Assessed at baseline and at 12 weeks.

• Depression

  Assessed at baseline and at 12 weeks.

• Medication Adherence

  Assessed at baseline and at 12 weeks.

Study Arms (2)

Yoga-mindfulness

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

Yoga-mindfulness 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.

Yoga-mindfulness

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adria Quigley: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

HIV clinic

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (2)

• 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.

  PMID: 32583707 DERIVED

• 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.

  PMID: 31115343 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cognitive Dysfunction; Mobility Limitation; Medication Adherence; Depression; Motor Activity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 7, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)