Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071562
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Adria Quigley, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE February 24, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • 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.
  • Balance [ Time Frame: Assessed at baseline and at 12 weeks. ]
    Balance will be measured using the Community Balance and Mobility test (CB&M).
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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.
  • Balance [ Time Frame: Assessed at baseline and at 12 weeks. ]
    Balance will be measured using the Community Balance and Mobility test (CB&M).
  • 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.
  • 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.
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Pilot Trial Evaluating the Impact of a Yoga Intervention on Cognition in Older Adults Infected With HIV
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE
  • HIV/AIDS
  • Cognitive Impairment
  • Aging
  • Mobility Limitation
  • Medication Adherence
  • Depression
  • Quality of Life
  • Balance Problems
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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).
    Intervention: Other: Yoga-mindfulness
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2020)
22
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
30
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071562
Other Study ID Numbers  ICMJE 4190yogaHIVcog
371452 ( Other Grant/Funding Number: 2016-06-28 Catalyst Grant: HIV/AIDS Community Based Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adria Quigley, Nova Scotia Health Authority
Study Sponsor  ICMJE Adria Quigley
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE Not Provided
PRS Account Nova Scotia Health Authority
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP