Clinical trial NCT03053817: 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
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Université du Québec a Montréal
First posted: 2017-02-15
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Cognitive Ability
timeFrame: 0 and 39 weeks
Secondary outcomes:
measure: Change in depression
timeFrame: 0 and 39 weeks
measure: Change in depression
timeFrame: 0 and 39 weeks
measure: Change in stress levels
timeFrame: 0 and 39 weeks
measure: Change in anxiety
timeFrame: 0 and 39 weeks
measure: Change in fatigue
timeFrame: 0 and 39 weeks
measure: Change in motivation
timeFrame: 0 and 39 weeks
measure: Change in global quality of life (QOL)
timeFrame: 0 and 39 weeks
measure: Change in health related quality of life (HRQoL)
timeFrame: 0 and 39 weeks
measure: Change in health related quality of life (HRQoL)
timeFrame: 0 and 39 weeks
measure: Change in measures of brain network function
timeFrame: 0 and 12 weeks
measure: Change in skeletal muscle mass
timeFrame: 0 and 12 weeks
measure: Change in muscle quality
timeFrame: 0 and 12 weeks
measure: Change in exercise capacity
timeFrame: 0 and 12 weeks
measure: Change in functional walking capacity
timeFrame: 0 and 12 weeks
measure: Change in quadriceps power
timeFrame: 0 and 12 weeks
measure: Change in core strength
timeFrame: 0 and 12 weeks
measure: Change in grip strength
timeFrame: 0 and 12 weeks
measure: Change in gait speed
timeFrame: 0 and 12 weeks
measure: Change in exercise enjoyment
timeFrame: 0 and 12 weeks
measure: Change in physical activity
timeFrame: 0, 6 and 12 weeks
measure: Change in semantic fluency
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Division of Clinical Epidemiology
state: Quebec
Study officials:
affiliation: McGill University
name: Nancy E Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.