The Impact of Structured Exercise on Brain Health in HIV Positive Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03053817|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Exercise group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Structured Exercise on Brain Health in HIV Positive Individuals|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||December 2018|
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.
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.
No Intervention: Control
- 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.
- Change in depression [ Time Frame: 0 and 39 weeks ]Measured by Hospital Anxiety and Depression Scale (HADS)
- Change in depression [ Time Frame: 0 and 39 weeks ]Measured by RAND -36 Mental Health Inventory (MHI)
- Change in stress levels [ Time Frame: 0 and 39 weeks ]Measured by Trier Inventory for Chronic Stress (TICS)
- Change in anxiety [ Time Frame: 0 and 39 weeks ]Measured by Hospital Anxiety and Depression Scale (HADS)
- Change in fatigue [ Time Frame: 0 and 39 weeks ]Measured by RAND-36 Vitality
- Change in motivation [ Time Frame: 0 and 39 weeks ]Measured by Motivation Ladder
- Change in global quality of life (QOL) [ Time Frame: 0 and 39 weeks ]Measured by Person Generated Index (PGI)
- Change in health related quality of life (HRQoL) [ Time Frame: 0 and 39 weeks ]Measured by RAND-36
- Change in health related quality of life (HRQoL) [ Time Frame: 0 and 39 weeks ]Measured by WHOQOL-HIV
- Change in measures of brain network function [ Time Frame: 0 and 12 weeks ]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.
- Change in skeletal muscle mass [ Time Frame: 0 and 12 weeks ]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).
- Change in muscle quality [ Time Frame: 0 and 12 weeks ]Peripheral quantitative computed tomography (pQCT) will be used to measure the muscle quality in lower extremity (MacIntyre & Lorbergs, 2012).
- Change in exercise capacity [ Time Frame: 0 and 12 weeks ]Measured by step test
- Change in functional walking capacity [ Time Frame: 0 and 12 weeks ]Measured by Six Minute Walk Test (6MWT)
- Change in quadriceps power [ Time Frame: 0 and 12 weeks ]Measured using leg press and jump test
- Change in core strength [ Time Frame: 0 and 12 weeks ]Measured using curl ups/push ups
- Change in grip strength [ Time Frame: 0 and 12 weeks ]Measured using hand dynamometer
- Change in gait speed [ Time Frame: 0 and 12 weeks ]Comfortable gait speed: GAITRite; Fast gait speed: GAITRite; Dual task gait speed: GAITRite and naming the fruits
- Change in exercise enjoyment [ Time Frame: 0 and 12 weeks ]Exercise enjoyment will be measured by Physical Activity Enjoyment Scale (PACES) (Mullen et al., 2011).
- Change in physical activity [ Time Frame: 0, 6 and 12 weeks ]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.
- Change in semantic fluency [ Time Frame: 0 and 12 weeks ]
Following question will be asked:
Name as many animals as you can in 1 minute (in sitting).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053817
|Contact: Carolina Moriello, MSc||514-934-1934 ext email@example.com|
|Contact: Christine Deryfirstname.lastname@example.org|
|Division of Clinical Epidemiology||Recruiting|
|Montreal, Quebec, Canada, H3A 1A1|
|Contact: Nancy Mayo, PhD 514-934-1934 ext 36906 email@example.com|
|Contact: Carolina Moriello, MSc 514-934-1934 ext 36912 firstname.lastname@example.org|
|Principal Investigator: Nancy Mayo, PhD|
|Principal Investigator:||Nancy E Mayo, PhD||McGill University|