Recruiting

Structured Exercise

Sponsor:

McGill University

Code:

NCT03053817

Conditions

HIV

Eligibility Criteria

Sex: Male

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise group

Study Details

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.

Conditions

HIV

Study ID

NCT03053817

Start date

Dec, 2015

Status verified date

Feb, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 35 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Control

No treatment

Interventions

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.

Primary outcome measure

  • Change in Cognitive Ability [ Time Frame: 0 and 39 weeks ]

Central Contacts and Locations

Central contacts

Locations

Division of Clinical Epidemiology

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Principal Investigator:

Nancy Mayo, PhD

More Information

Sponsor

McGill University

Last update posted

Feb 15, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2017-02-15.