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NCT Number: NCT03071562

A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Aging Balance Problems Behavior Behavioral Symptoms Blood-Borne Infections Cognition Disorders Cognitive Dysfunction Cognitive Impairment Communicable Diseases Depression Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Mental Disorders Mobility Limitation Motor Activity Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Quality of Life RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIV clinic

Halifax, Nova Scotia, B3H 2Y9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Adria Quigley

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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