NCT03053817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

January 20, 2017

Last Update Submit

February 10, 2017

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 and 39 weeks

Secondary Outcomes (21)

  • Change in depression

    0 and 39 weeks

  • Change in depression

    0 and 39 weeks

  • Change in stress levels

    0 and 39 weeks

  • Change in anxiety

    0 and 39 weeks

  • Change in fatigue

    0 and 39 weeks

  • +16 more secondary outcomes

Study Arms (2)

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.

Other: Exercise group

Control

NO INTERVENTION

No treatment

Interventions

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.

Exercise group

Eligibility Criteria

Age35 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Epidemiology

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Related Publications (6)

  • 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.

    PMID: 20304934BACKGROUND

  • 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.

    PMID: 21951520BACKGROUND

  • 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.

    PMID: 18685451BACKGROUND

  • 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.

    PMID: 23449969BACKGROUND

  • 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.

    PMID: 1330274BACKGROUND

  • 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.

    PMID: 15981790BACKGROUND

Study Officials

  • Nancy E Mayo, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Moriello, MSc

CONTACT

514-934-1934carolina.moriello@mcgill.ca

Christine Dery

CONTACT

514-398-8980christine.dery@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 20, 2017

First Posted

February 15, 2017

Study Start

December 1, 2015

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

CA(1)