An interventional study of Exercise and Stretching and Social Interaction in HIV, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
Management and treatment of older persons living with HIV (PLWH) (≥ 40 years old) is becoming increasingly more complex as a majority is greater than 40 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.
Management of older persons living with HIV (PLWH) (≥ 40 years old) is becoming increasingly more complex as a majority is greater than 40 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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
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
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
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.
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.
Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group
This measure examines the global z-score which is an average of all the individual cognitive test z scores. We looked at changes in global Z-scores from baseline to follow-up (6 months). A Z-score of 0 represents the population mean. Z-scores are considered to be better when they are above the mean and represent a better outcome.
Time frame: 6 months
Changes in Brain Structural/Functional Measures in Older PLWH
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 (total cortex volume) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups.
Time frame: 26 weeks
Change in Level of Daily Activity
Investigators will examine the amount of change in daily activity based on 7-day actigraphy at baseline and then again at follow-up (26 weeks later). Daily activity is measured using an actigraph that participants wear on their wrist and it measures the amount of time spent in sedentary, slightly active, moderately active, vigorously active or very vigorously active categories.
Time frame: 6 Months
Participants were recruited from local clinics as well as a participant registry. Recruitment started in July of 2015 and concluded in November of 2020. There was a pause in recruitment due to the COVID-19 Pandemic from March 2020 through August 2020, and then was terminated early due to a rise in cases in our area in November 2020. A total of 462 were initially screened for the study \& 75 were initially enrolled in the study. Out of those 75, a total of 65 were randomized into the intervention.
| Milestone | Exercise (EXS) | Social Interaction Stretching (SIS) |
|---|---|---|
| Started | 45 | 20 |
| Completed | 33 | 14 |
| Not completed | 12 | 6 |
This measure examines the global z-score which is an average of all the individual cognitive test z scores. We looked at changes in global Z-scores from baseline to follow-up (6 months). A Z-score of 0 represents the population mean. Z-scores are considered to be better when they are above the mean and represent a better outcome.
| z-score | Exercise (EXS) | Social Interaction Stretching (SIS) |
|---|---|---|
| Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group | .10 ± .29 | .20 ± .33 |
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 (total cortex volume) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups.
| mm^3 | Exercise (EXS) | Social Interaction Stretching (SIS) |
|---|---|---|
| Changes in Brain Structural/Functional Measures in Older PLWH | -546.1 ± 10358 | 366.6 ± 8102 |
Investigators will examine the amount of change in daily activity based on 7-day actigraphy at baseline and then again at follow-up (26 weeks later). Daily activity is measured using an actigraph that participants wear on their wrist and it measures the amount of time spent in sedentary, slightly active, moderately active, vigorously active or very vigorously active categories.
| Average Minutes per Day | Exercise (EXS) | Social Interaction Stretching (SIS) |
|---|---|---|
| Change in Level of Daily Activity | -23.9 ± 114.8 | -5.3 ± 98.9 |
Collected over Through study completion, an average of approximately 6 months per participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise (EXS) | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Social Interaction Stretching (SIS) | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Mean | 56.5 (41 to 70) | 56.5 (50 to 71) | 56.5 (41 to 71) |
| Sex: Female, Male(Participants) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Female | 13 | 2 | 15 |
| Male | 32 | 18 | 50 |
| Race (NIH/OMB)(Participants) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 29 | 14 | 43 |
| White | 16 | 6 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| United States | 45 | 20 | 65 |
| Education(years) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Mean | 12.9 ± 2.4 | 13.9 ± 2.2 | 13.2 ± 2.4 |
| Body Mass Index(kg/m^2) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Mean | 30.5 ± 7.0 | 28.9 ± 5.7 | 29.7 ± 6.6 |
| Viral Load Undetectable (<50 copies/mL)(Participants) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Count of participants | 45 | 20 | 65 |
| Median recent CD4 T-cell count (cells/mm3) (IQR)(cells/mm3) | Exercise (EXS) | Social Interaction Stretching (SIS) | Total |
|---|---|---|---|
| Median | 581 (474 to 817) | 561 (362 to 771) | 578 (450 to 789) |
3 further baseline measures are reported on the registry.
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Plan to share: Undecided — Data will be shared when the study has closed.
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Washington University School of Medicine