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

Primary Purpose

HIV

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise group
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Division of Clinical EpidemiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control

Arm Description

The 45 minute exercise program will be performed 3 times a week and will consist of aerobic exercise and resistance training for 12 weeks.

No treatment

Outcomes

Primary Outcome Measures

Change in Cognitive Ability
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

Change in depression
Measured by Hospital Anxiety and Depression Scale (HADS)
Change in depression
Measured by RAND -36 Mental Health Inventory (MHI)
Change in stress levels
Measured by Trier Inventory for Chronic Stress (TICS)
Change in anxiety
Measured by Hospital Anxiety and Depression Scale (HADS)
Change in fatigue
Measured by RAND-36 Vitality
Change in motivation
Measured by Motivation Ladder
Change in global quality of life (QOL)
Measured by Person Generated Index (PGI)
Change in health related quality of life (HRQoL)
Measured by RAND-36
Change in health related quality of life (HRQoL)
Measured by WHOQOL-HIV
Change in measures of brain network function
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.
Change in skeletal muscle mass
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).
Change in muscle quality
Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre & Lorbergs, 2012).
Change in exercise capacity
Measured by step test
Change in functional walking capacity
Measured by Six Minute Walk Test (6MWT)
Change in quadriceps power
Measured using leg press and jump test
Change in core strength
Measured using curl ups/push ups
Change in grip strength
Measured using hand dynamometer
Change in gait speed
Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits
Change in exercise enjoyment
Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).
Change in physical activity
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.
Change in semantic fluency
Following question will be asked: Name as many animals as you can in 1 minute (in sitting).

Full Information

First Posted
January 20, 2017
Last Updated
February 10, 2017
Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR), Université du Québec a Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT03053817
Brief Title
The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
Official Title
The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR), Université du Québec a Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
The 45 minute exercise program will be performed 3 times a week and will consist of aerobic exercise and resistance training for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Other
Intervention Name(s)
Exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cognitive Ability
Description
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.
Time Frame
0 and 39 weeks
Secondary Outcome Measure Information:
Title
Change in depression
Description
Measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
0 and 39 weeks
Title
Change in depression
Description
Measured by RAND -36 Mental Health Inventory (MHI)
Time Frame
0 and 39 weeks
Title
Change in stress levels
Description
Measured by Trier Inventory for Chronic Stress (TICS)
Time Frame
0 and 39 weeks
Title
Change in anxiety
Description
Measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
0 and 39 weeks
Title
Change in fatigue
Description
Measured by RAND-36 Vitality
Time Frame
0 and 39 weeks
Title
Change in motivation
Description
Measured by Motivation Ladder
Time Frame
0 and 39 weeks
Title
Change in global quality of life (QOL)
Description
Measured by Person Generated Index (PGI)
Time Frame
0 and 39 weeks
Title
Change in health related quality of life (HRQoL)
Description
Measured by RAND-36
Time Frame
0 and 39 weeks
Title
Change in health related quality of life (HRQoL)
Description
Measured by WHOQOL-HIV
Time Frame
0 and 39 weeks
Title
Change in measures of brain network function
Description
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.
Time Frame
0 and 12 weeks
Title
Change in skeletal muscle mass
Description
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).
Time Frame
0 and 12 weeks
Title
Change in muscle quality
Description
Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre & Lorbergs, 2012).
Time Frame
0 and 12 weeks
Title
Change in exercise capacity
Description
Measured by step test
Time Frame
0 and 12 weeks
Title
Change in functional walking capacity
Description
Measured by Six Minute Walk Test (6MWT)
Time Frame
0 and 12 weeks
Title
Change in quadriceps power
Description
Measured using leg press and jump test
Time Frame
0 and 12 weeks
Title
Change in core strength
Description
Measured using curl ups/push ups
Time Frame
0 and 12 weeks
Title
Change in grip strength
Description
Measured using hand dynamometer
Time Frame
0 and 12 weeks
Title
Change in gait speed
Description
Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits
Time Frame
0 and 12 weeks
Title
Change in exercise enjoyment
Description
Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).
Time Frame
0 and 12 weeks
Title
Change in physical activity
Description
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.
Time Frame
0, 6 and 12 weeks
Title
Change in semantic fluency
Description
Following question will be asked: Name as many animals as you can in 1 minute (in sitting).
Time Frame
0 and 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Moriello, MSc
Phone
514-934-1934
Ext
36912
Email
carolina.moriello@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Dery
Phone
514-398-8980
Email
christine.dery@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy E Mayo, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Clinical Epidemiology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Mayo, PhD
Phone
514-934-1934
Ext
36906
Email
nancy.mayo@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Carolina Moriello, MSc
Phone
514-934-1934
Ext
36912
Email
carolina.moriello@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Nancy Mayo, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20304934
Citation
Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010 Mar 19;340:c1066. doi: 10.1136/bmj.c1066. No abstract available.
Results Reference
background
PubMed Identifier
21951520
Citation
Mullen SP, Olson EA, Phillips SM, Szabo AN, Wojcicki TR, Mailey EL, Gothe NP, Fanning JT, Kramer AF, McAuley E. Measuring enjoyment of physical activity in older adults: invariance of the physical activity enjoyment scale (paces) across groups and time. Int J Behav Nutr Phys Act. 2011 Sep 27;8:103. doi: 10.1186/1479-5868-8-103.
Results Reference
background
PubMed Identifier
18685451
Citation
Lee SY, Gallagher D. Assessment methods in human body composition. Curr Opin Clin Nutr Metab Care. 2008 Sep;11(5):566-72. doi: 10.1097/MCO.0b013e32830b5f23.
Results Reference
background
PubMed Identifier
23449969
Citation
Macintyre NJ, Lorbergs AL. Imaging-Based Methods for Non-invasive Assessment of Bone Properties Influenced by Mechanical Loading. Physiother Can. 2012 Spring;64(2):202-15. doi: 10.3138/ptc.2011-08bh. Epub 2012 Apr 5.
Results Reference
background
PubMed Identifier
1330274
Citation
Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Can J Sport Sci. 1992 Dec;17(4):338-45.
Results Reference
background
PubMed Identifier
15981790
Citation
Malita FM, Karelis AD, Toma E, Rabasa-Lhoret R. Effects of different types of exercise on body composition and fat distribution in HIV-infected patients: a brief review. Can J Appl Physiol. 2005 Apr;30(2):233-45. doi: 10.1139/h05-117.
Results Reference
background

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

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