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HIV/AIDSNCT03071562

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

A study testing Yoga-mindfulness in people with HIV/AIDS and Cognitive Impairment, run by Adria Quigley at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
HIV/AIDS, Cognitive Impairment, Aging
What is being tested?
Yoga-mindfulness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
Jan 2017to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • HIV clinic

    Halifax, Nova Scotia, B3H 2Y9

Other trials in Canada

About this study

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

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.

Being tested
Yoga-mindfulness
Keywords
HIV, Cognitive impairment, Aging, Physical Activity, Exercise, Yoga, Neuroplasticity
Medical subject headings
Acquired Immunodeficiency Syndrome, Cognitive Dysfunction, Mobility Limitation, Medication Adherence, Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga-mindfulnessOther

    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.

Study groups in NCT03071562
Study groupRoleWhat they receive
Yoga-mindfulnessExperimentalGroups 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).
Receives: Other: Yoga-mindfulness
ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Will be assessed at baseline and 12 weeks.

  2. C3Q (Communicating Cognitive Challenges in HIV Questionnaire)

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

    Measured: Will be assessed during screening, baseline, and 12 weeks.

Secondary outcomes (6)

  1. 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.

    Measured: Assessed at 12 weeks.

  2. Balance

    Balance will be measured using the Community Balance and Mobility test (CB\&M).

    Measured: Assessed at baseline and at 12 weeks.

  3. 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.

    Measured: Assessed at baseline and at 12 weeks.

  4. Depression

    Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-report questionnaire.

    Measured: Assessed at baseline and at 12 weeks.

  5. Medication Adherence

    Participants will also be asked about Medication adherence (specifically antiretroviral) using the Simplified Medication Adherence Questionnaire (SMAQ).

    Measured: Assessed at baseline and at 12 weeks.

  6. 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).

    Measured: Assessed at baseline and at 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2017
  2. Study startJan 2017
  3. Primary completionAug 2019
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03071562
Sponsor's protocol ID
4190yogaHIVcog
Other IDs
371452
Status last verified
Jan 2020
First submitted
24 Feb 2017
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32583707

  • 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.

    PubMed 31115343

Questions about this trial

What is this clinical trial studying?

A study testing Yoga-mindfulness in people with HIV/AIDS and Cognitive Impairment, run by Adria Quigley at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

B-CAM (Brief Cognitive Ability Measure) (time frame: Will be assessed at baseline and 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03071562, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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