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Exercise Training to Improve Brain Health in Older HIV+ Individuals (Ex/HIV)

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ClinicalTrials.gov Identifier: NCT02663934
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
University of Missouri, St. Louis
University of California, San Diego
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Management and treatment of older persons living with HIV (PLWH) (≥ 50 years old) is becoming increasingly more complex as a majority is greater than 50 years old. This proposal will conduct a prospective controlled intervention trial to assess the quantitative and qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a social-interaction stretching (SIS) program on brain health (neuropsychological performance testing and neuroimaging measurements) in older PLWH. These results could influence public health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate the development of effective EXS programs for older PLWH.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Exercise Behavioral: Stretching and Social Interaction Not Applicable

Detailed Description:

Management of older persons living with HIV (PLWH) (≥ 50 years old) is becoming increasingly more complex as a majority is greater than 50 years old. Attempts to improve the quality of life of older PLWH using adjunctive therapeutics to combination antiretroviral therapy (cART) have largely been unsuccessful.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Training to Improve Brain Health in Older HIV+ Individuals
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Effects of exercise on cognitive function in older PLWH [ Time Frame: 26 weeks ]

    In the present trial the investigators anticipate that an EXS program will lead to >0.5 SD change in global Z- scores but the investigators recognize that the precise threshold for individual perception of improvement is variable. Mean change in supplementary domain Z-scores at 26 weeks will be compared between the EXS and SIS groups for all randomized participants using the Z-test.

    The investigators will test the mediating effect of improvements in physical function on cognitive performance in two ways: (i) between randomized groups, and (ii) within the EXS group. Linear models will be used to determine the mediating effect of the physical function markers (high/low physical activity and peak VO2) on the change from baseline in core domain specific Z-scores and the global Z-score, by including these markers, together with group assignment, as predictors in the model.


  2. Effects of exercise on brain structural/functional measures in older PLWH [ Time Frame: 26 weeks ]

    The Investigators will assess if an EXS program improves brain structure and function more than a SIS program in older sedentary PLWH. Changes in brain volumetrics (hippocampus, caudate, anterior cingulate, amygdala, thalamus, and putamen) and regional CBF (in the same regions) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups using ITT, AT, and PS analyses.

    The investigators will assess if greater improvements in physical function due to EXS are associated with larger brain volumetrics & increases in regional CBF. We will test the mediating effect of improvement of physical function on neuroimaging measures in two ways: between randomized groups & within the EXS group. Linear models will be used to determine the mediating effect of the physical function markers (high/low physical activity and peak VO2) on the change from BL in structural & functional neuroimaging measures, by including these markers, together with group assignment, as predictors in the model.




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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age > 50 years old
  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 regularly 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:

  1. approximately >2x/week of moderate (or greater) exercise
  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

Information from the National Library of Medicine

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): NCT02663934


Contacts
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Contact: Brittany M Nelson, BA 314-747-8425 bmnelson@wustl.edu
Contact: Elizabeth T Westerhaus, MA 314-747-1125 elizabethwesterhaus@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brittany Nelson    314-747-8425    bmnelson@wustl.edu   
Contact: Elizabeth Westerhaus    3147471125    elizabethwesterhaus@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
University of Missouri, St. Louis
University of California, San Diego
Investigators
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Principal Investigator: Beau M Ances, MD,PhD Washington University School of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02663934     History of Changes
Other Study ID Numbers: 201508002
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared when the study has closed.

Keywords provided by Washington University School of Medicine:
HIV, AIDS, Cognition, Memory, Exercise, Stretching