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The Impact of Structured Exercise on Brain Health in HIV Positive Individuals

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ClinicalTrials.gov Identifier: NCT03053817
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Universite du Quebec a Montreal
Information provided by (Responsible Party):
Nancy Mayo, McGill University

Brief Summary:

Exercise programs that combine resistance exercise with aerobic training yield optimal health benefits for people with HIV. The global aim of this study is to contribute evidence for the impact potential of a comprehensive exercise program on brain health in people with HIV.

This study is part of a larger project based upon a cohort multiple randomized controlled design. Within a fully characterized cohort which is followed over time, people meeting the specific criteria for an exercise intervention will be identified. The sample will be randomly selected to receive the intervention; the remaining eligible persons will serve as controls. The intervention group will receive a 45 minute structured exercise program 3 times a week consisting of aerobic exercise and resistance training for a total of 12 weeks.


Condition or disease Intervention/treatment Phase
HIV Other: Exercise group Not Applicable

Detailed Description:

Exercise is an inexpensive intervention with widespread benefits to vascular and musculoskeletal health and few harms. Showing an additional benefit to brain health and cognition in particular is likely to encourage adoption and help elucidate mechanisms underpinning brain health in HIV.

The primary objective of the study is to estimate, in comparison to individuals not offered the exercise intervention, the extent to which a comprehensive exercise program impacts on indicators of brain health, where these indicators are the primary outcome of cognitive ability (B-CAM) and the related brain health outcomes of depression, anxiety, fatigue, motivation, and speed of motor performance.

A secondary objective is to estimate the extent to which changes in brain health are mediated through exercise induced changes in brain network function as measured by EEG and/or by exercise induced changes in muscle power, aerobic capacity, physical function, and body composition.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
Study Start Date : December 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise group
The 45 minute exercise program will be performed 3 times a week and will consist of aerobic exercise and resistance training for 12 weeks.
Other: Exercise group
Interval training will be performed for 21 minutes including a 3 minute warm-up and cool-down period. The interval program will be 15 minutes at 65-75% of maximal heart rate with 30 sec. bursts of exercise to 80-85%; intervals. Resistance training will be done as a circuit and will make use of weight machines and functional exercises. Resistance will be done in 2 sets of 15 repetitions and will last 24 minutes. The work load of the program is calibrated and is conducted at a specified rhythm. All exercise sessions will be supervised.
No Intervention: Control
No treatment



Primary Outcome Measures :
  1. Change in Cognitive Ability [ Time Frame: 0 and 39 weeks ]
    The primary outcome is cognitive ability as measured by B-CAM. This is part of the measurement platform for all and the value taken at the regular assessment prior to the exercise intervention will serve as the baseline value and the subsequent evaluation 9 months following will serve as the follow-up value. The strategy ensures that the intervention cohort does not have additional measurements of cognitive ability than the control cohort. The items on the B-CAM fit the Rasch Model and as such have linearized units on a logit scale.


Secondary Outcome Measures :
  1. Change in depression [ Time Frame: 0 and 39 weeks ]
    Measured by Hospital Anxiety and Depression Scale (HADS)

  2. Change in depression [ Time Frame: 0 and 39 weeks ]
    Measured by RAND -36 Mental Health Inventory (MHI)

  3. Change in stress levels [ Time Frame: 0 and 39 weeks ]
    Measured by Trier Inventory for Chronic Stress (TICS)

  4. Change in anxiety [ Time Frame: 0 and 39 weeks ]
    Measured by Hospital Anxiety and Depression Scale (HADS)

  5. Change in fatigue [ Time Frame: 0 and 39 weeks ]
    Measured by RAND-36 Vitality

  6. Change in motivation [ Time Frame: 0 and 39 weeks ]
    Measured by Motivation Ladder

  7. Change in global quality of life (QOL) [ Time Frame: 0 and 39 weeks ]
    Measured by Person Generated Index (PGI)

  8. Change in health related quality of life (HRQoL) [ Time Frame: 0 and 39 weeks ]
    Measured by RAND-36

  9. Change in health related quality of life (HRQoL) [ Time Frame: 0 and 39 weeks ]
    Measured by WHOQOL-HIV

  10. Change in measures of brain network function [ Time Frame: 0 and 12 weeks ]
    The measures of brain network function are derived from event related potential (ERPs) which are electric potentials produced by the brain in response to auditory or visual stimulation, respectively. These brain responses are easily recorded noninvasively with scalp electrodes (EEG). ERPs allow insights into the neural mechanisms underlying specific cognitive processes. The potentials of interest here include the N1, N2, P2 and P3 ERPs.

  11. Change in skeletal muscle mass [ Time Frame: 0 and 12 weeks ]
    A total body Dual energy X-ray absorptiometry (DEXA) scan will be done to compute skeletal muscle mass (whole body, spine and thigh) (Lee & Gallagher, 2009).

  12. Change in muscle quality [ Time Frame: 0 and 12 weeks ]
    Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre & Lorbergs, 2012).

  13. Change in exercise capacity [ Time Frame: 0 and 12 weeks ]
    Measured by step test

  14. Change in functional walking capacity [ Time Frame: 0 and 12 weeks ]
    Measured by Six Minute Walk Test (6MWT)

  15. Change in quadriceps power [ Time Frame: 0 and 12 weeks ]
    Measured using leg press and jump test

  16. Change in core strength [ Time Frame: 0 and 12 weeks ]
    Measured using curl ups/push ups

  17. Change in grip strength [ Time Frame: 0 and 12 weeks ]
    Measured using hand dynamometer

  18. Change in gait speed [ Time Frame: 0 and 12 weeks ]
    Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits

  19. Change in exercise enjoyment [ Time Frame: 0 and 12 weeks ]
    Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).

  20. Change in physical activity [ Time Frame: 0, 6 and 12 weeks ]
    The data from the accelerometer will be used to estimate the extent to which the structured exercise program carries over into everyday life. Participants will be asked to wear an ActivPal accelerometer for 5-7 days prior to the start of the intervention, at 6 weeks, and after 12 weeks, to objectively measure habitual physical activity.

  21. Change in semantic fluency [ Time Frame: 0 and 12 weeks ]

    Following question will be asked:

    Name as many animals as you can in 1 minute (in sitting).




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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

The exercise intervention will target individuals recruited from two Montreal clinics who identified at cohort entry they were interested in being approached for different trials if they eligible.

Inclusion Criteria:

  • men and women aged ≥ 35 years, HIV+ for at least 1 year, able to communicate adequately in either French or English, and able to give written informed consent.

Also, participants must identify that they are mostly sedentary by reporting that they perform moderate level physical activity of 30 minutes duration less than twice a week or have limitations in performing vigorous activities, walking a kilometer, or climbing stairs. Individuals answering yes to any of the Physical Activities Readiness Questionnaire (PAR-Q) (Thomas et al., 1992) items except taking medication (Item 6) will require clearance from their physician to be included.

Exclusion Criteria:

  • people with dementia (MOCA < 18) or treating physician's concern about capacity to consent, life expectancy of < 3 years or other personal factors limiting the ability to participate in follow-up, non-HIV-related neurological disorder likely to affect cognition, known active CNS opportunistic infection or hepatitis C requiring interferon (IFN) treatment during the follow-up period, psychiatric disorder on the psychotic axis, current substance use disorder or severe substance use disorder within the past 12 months.

Also excluded will be people with a contraindication for exercise from cardiovascular or musculoskeletal co-morbidity as gathered from the medical history and from the PAR-Q (Thomas et al., 1992).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053817


Contacts
Contact: Carolina Moriello, MSc 514-934-1934 ext 36912 carolina.moriello@mcgill.ca
Contact: Christine Dery 514-398-8980 christine.dery@mcgill.ca

Locations
Canada, Quebec
Division of Clinical Epidemiology Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Nancy Mayo, PhD    514-934-1934 ext 36906    nancy.mayo@mcgill.ca   
Contact: Carolina Moriello, MSc    514-934-1934 ext 36912    carolina.moriello@mcgill.ca   
Principal Investigator: Nancy Mayo, PhD         
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
Universite du Quebec a Montreal
Investigators
Principal Investigator: Nancy E Mayo, PhD McGill University

Publications:
Responsible Party: Nancy Mayo, Dr., McGill University
ClinicalTrials.gov Identifier: NCT03053817     History of Changes
Other Study ID Numbers: 15-384-MUHC
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided