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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053817
• Other study ID #: 15-384-MUHC
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2017
• Last updated: February 10, 2017
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: McGill University
• Contact: Carolina Moriello, MSc
• Phone: 514-934-1934
• Email: carolina.moriello[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Division of Clinical Epidemiology	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Canadian Institutes of Health Research (CIHR), Universite du Quebec a Montreal

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. Review. — View 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. — View 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. Review. — View Citation

Mullen SP, Olson EA, Phillips SM, Szabo AN, Wójcicki 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in depression	Measured by Hospital Anxiety and Depression Scale (HADS)	0 and 39 weeks
Secondary	Change in depression	Measured by RAND -36 Mental Health Inventory (MHI)	0 and 39 weeks
Secondary	Change in stress levels	Measured by Trier Inventory for Chronic Stress (TICS)	0 and 39 weeks
Secondary	Change in anxiety	Measured by Hospital Anxiety and Depression Scale (HADS)	0 and 39 weeks
Secondary	Change in fatigue	Measured by RAND-36 Vitality	0 and 39 weeks
Secondary	Change in motivation	Measured by Motivation Ladder	0 and 39 weeks
Secondary	Change in global quality of life (QOL)	Measured by Person Generated Index (PGI)	0 and 39 weeks
Secondary	Change in health related quality of life (HRQoL)	Measured by RAND-36	0 and 39 weeks
Secondary	Change in health related quality of life (HRQoL)	Measured by WHOQOL-HIV	0 and 39 weeks
Secondary	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.	0 and 12 weeks
Secondary	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).	0 and 12 weeks
Secondary	Change in muscle quality	Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre & Lorbergs, 2012).	0 and 12 weeks
Secondary	Change in exercise capacity	Measured by step test	0 and 12 weeks
Secondary	Change in functional walking capacity	Measured by Six Minute Walk Test (6MWT)	0 and 12 weeks
Secondary	Change in quadriceps power	Measured using leg press and jump test	0 and 12 weeks
Secondary	Change in core strength	Measured using curl ups/push ups	0 and 12 weeks
Secondary	Change in grip strength	Measured using hand dynamometer	0 and 12 weeks
Secondary	Change in gait speed	Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits	0 and 12 weeks
Secondary	Change in exercise enjoyment	Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).	0 and 12 weeks
Secondary	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.	0, 6 and 12 weeks
Secondary	Change in semantic fluency	Following question will be asked: Name as many animals as you can in 1 minute (in sitting).	0 and 12 weeks