HIVNCT03053817
The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
A study testing Exercise group in people with HIV, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Dec 2018
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Division of Clinical Epidemiology
Montreal, Quebec, H3A 1A1
Nancy Mayo, PhD, 514-934-1934 ext. 36906, nancy.mayo@mcgill.ca
Carolina Moriello, MSc, 514-934-1934 ext. 36912, carolina.moriello@mcgill.ca
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Exercise group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The 45 minute exercise program will be performed 3 times a week and will consist of aerobic exercise and resistance training for 12 weeks. Receives: Other: Exercise group |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 39 weeks
Secondary outcomes (21)
Change in depression
Measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 0 and 39 weeks
Change in depression
Measured by RAND -36 Mental Health Inventory (MHI)
Measured: 0 and 39 weeks
Change in stress levels
Measured by Trier Inventory for Chronic Stress (TICS)
Measured: 0 and 39 weeks
Change in anxiety
Measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 0 and 39 weeks
Change in fatigue
Measured by RAND-36 Vitality
Measured: 0 and 39 weeks
Change in motivation
Measured by Motivation Ladder
Measured: 0 and 39 weeks
Change in global quality of life (QOL)
Measured by Person Generated Index (PGI)
Measured: 0 and 39 weeks
Change in health related quality of life (HRQoL)
Measured by RAND-36
Measured: 0 and 39 weeks
Change in health related quality of life (HRQoL)
Measured by WHOQOL-HIV
Measured: 0 and 39 weeks
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.
Measured: 0 and 12 weeks
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).
Measured: 0 and 12 weeks
Change in muscle quality
Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre \& Lorbergs, 2012).
Measured: 0 and 12 weeks
Change in exercise capacity
Measured by step test
Measured: 0 and 12 weeks
Change in functional walking capacity
Measured by Six Minute Walk Test (6MWT)
Measured: 0 and 12 weeks
Change in quadriceps power
Measured using leg press and jump test
Measured: 0 and 12 weeks
Change in core strength
Measured using curl ups/push ups
Measured: 0 and 12 weeks
Change in grip strength
Measured using hand dynamometer
Measured: 0 and 12 weeks
Change in gait speed
Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits
Measured: 0 and 12 weeks
Change in exercise enjoyment
Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).
Measured: 0 and 12 weeks
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.
Measured: 0, 6 and 12 weeks
Change in semantic fluency
Following question will be asked:
Name as many animals as you can in 1 minute (in sitting).
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startDec 2015
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université du Québec a Montréal
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy E Mayo, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053817
- Sponsor's protocol ID
- 15-384-MUHC
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20304934Mullen 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.
PubMed 21951520Lee 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.
PubMed 18685451Macintyre 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.
PubMed 23449969Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Can J Sport Sci. 1992 Dec;17(4):338-45.
PubMed 1330274Malita 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.
PubMed 15981790
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
- ClinicalTrials.gov ID
- NCT03053817
- Acronym / sponsor ID
- 15-384-MUHC
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Université du Québec a Montréal
- Study start
- Dec 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise groupThe 45 minute exercise program will be performed 3 times a week and will consist of aerobic exercise and resistance training for 12 weeks. |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise groupInterval 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. | Other | Exercise group |
Primary outcome
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.
21 secondary outcomes
Change in depression
Time frame: 0 and 39 weeks
Change in depression
Time frame: 0 and 39 weeks
Change in stress levels
Time frame: 0 and 39 weeks
Change in anxiety
Time frame: 0 and 39 weeks
Change in fatigue
Time frame: 0 and 39 weeks
Change in motivation
Time frame: 0 and 39 weeks
Change in global quality of life (QOL)
Time frame: 0 and 39 weeks
Change in health related quality of life (HRQoL)
Time frame: 0 and 39 weeks
Change in health related quality of life (HRQoL)
Time frame: 0 and 39 weeks
Change in measures of brain network function
Time frame: 0 and 12 weeks
Change in skeletal muscle mass
Time frame: 0 and 12 weeks
Change in muscle quality
Time frame: 0 and 12 weeks
Change in exercise capacity
Time frame: 0 and 12 weeks
Change in functional walking capacity
Time frame: 0 and 12 weeks
Change in quadriceps power
Time frame: 0 and 12 weeks
Change in core strength
Time frame: 0 and 12 weeks
Change in grip strength
Time frame: 0 and 12 weeks
Change in gait speed
Time frame: 0 and 12 weeks
Change in exercise enjoyment
Time frame: 0 and 12 weeks
Change in physical activity
Time frame: 0, 6 and 12 weeks
Change in semantic fluency
Time frame: 0 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 20304934Relton 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.
- Background: PubMed 21951520Mullen 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.
- Background: PubMed 18685451Lee 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.
- Background: PubMed 23449969Macintyre 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.
- Background: PubMed 1330274Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Can J Sport Sci. 1992 Dec;17(4):338-45.
- Background: PubMed 15981790Malita 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy E Mayo, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with HIV, run by McGill University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Moriello, MSc (514-934-1934 ext. 36912, carolina.moriello@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Ability (time frame: 0 and 39 weeks). 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 NCT03053817, which also lists 6 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 15 Feb 2017.