Exercise Training to Improve Brain Health in Older HIV+ Individuals
NCT ID: NCT02663934
Last Updated: 2023-11-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
75 participants
INTERVENTIONAL
2016-08-31
2020-11-30
Brief Summary
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Detailed Description
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While the impact of physical activity on brain health (assessed by neuropsychological performance and neuroimaging) has been well studied in older healthy HIV uninfected (HIV-) individuals and neurodegenerative conditions, few studies have concentrated on older PLWH. Both clinically and pathophysiologically, HIV associated neurocognitive disorders (HAND) differs from other neurodegenerative disorders seen with aging (e.g. Alzheimer's disease (AD). A positive association relationship between exercise and cognition has been observed in PLWH, but physical activity has been primarily examined using self-report questionnaires that are subjective and not quantitative. To date, no study has focused on the direct effects of exercise on neuropsychological performance or neuroimaging in PLWH.
The objective of this proposal is to conduct a prospective controlled intervention trial to determine if an increase in physical activity through a monitored aerobic and resistance exercise (EXS) program improves brain health in older PLWH. We will quantify physical function (physical activity using cardiorespiratory capacity and actigraphy) and brain function \[neuropsychological performance testing and neuroimaging (cerebral blood flow (CBF) and brain volume)\] in older physically inactive PLWH at baseline and 26 weeks after randomization to either an EXS or a social-interaction stretching (SIS) program. In addition, we will obtain stool samples, serum markers of neurogenesis, glucose regulation, and systemic inflammation.
A direct impact of these expected outcomes will be the adoption of a more physically active lifestyle by older PLWH and improved EXS guidelines and programs for older PLWH.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Exercise (EXS)
All EXS sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion exercises. Participants will follow an individualized exercise training prescription based on baseline cardiovascular testing. Individual aerobic exercise intensity is based on % of maximum heart rate achieved during the baseline cardiorespiratory fitness test. The target exercise HR will start at 50% and progress to 85% HR reserve. During aerobic exercise, a battery-operated HR monitor will monitor HR. Exercise intensity \& duration will be increased as the participant acclimates to the exercise prescription. Adaptation is determined when a given exercise intensity yields a lower HR than prior sessions conducted at the same intensity.
Exercise
The resistance exercise training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response, and when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks.
Social Interaction Stretching (SIS)
This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program.
Stretching and Social Interaction
Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program.
Interventions
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Exercise
The resistance exercise training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response, and when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks.
Stretching and Social Interaction
Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program.
Eligibility Criteria
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Inclusion Criteria
2. documented history of HIV infection
3. on stable combination antiretroviral therapy (cART) for approximately 3 months with undetectable plasma HIV RNA
4. physically inactive-sedentary lifestyle (approximately \<2 hours of exercise/week) and not engaged in regular exercise for approximately 3 months prior to enrollment
5. approximately 9 years of education
6. able to have an MRI
7. able to provide written informed consent (does not have LAR, POA, etc.)
Exclusion Criteria
2. cardiovascular/cerebrovascular disease or pulmonary disease that precludes ability to safely exercise
3. significant neurological disorders (e.g. stroke, head injury with loss of consciousness for \>30 minutes, developmental learning disability
4. presence of dementia or behavioral disorders that would prevent ability to follow the protocol
5. alcohol or substance abuse/ dependence within the last 6 months (DSM-4 TR)
6. contraindications to MRI scanning (e.g. claustrophobia, pacemaker)
7. pregnant or breast-feeding
8. unable to provide written informed consent
40 Years
ALL
No
Sponsors
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University of Missouri, St. Louis
OTHER
University of California, San Diego
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Beau M Ances, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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201508002
Identifier Type: -
Identifier Source: org_study_id
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