Trial Outcomes & Findings for Exercise Training to Improve Brain Health in Older HIV+ Individuals (NCT NCT02663934)
NCT ID: NCT02663934
Last Updated: 2023-11-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
6 months
Results posted on
2023-11-21
Participant Flow
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.
Participant milestones
| Measure |
Exercise (EXS)
All EXS sessions will be held 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 HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, 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.
The resistance EXS training component will follow aerobic EXS \& will consist of 4 upper \& 3 lower body routines. A combination of guided-motion machines \& free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each 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 \& 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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
20
|
|
Overall Study
COMPLETED
|
33
|
14
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Training to Improve Brain Health in Older HIV+ Individuals
Baseline characteristics by cohort
| Measure |
Exercise (EXS)
n=45 Participants
EXS sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Sessions will start with range of motion EXS. Participants will follow an individualized EXS training prescription based on baseline cardio testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, HR will be monitored by a battery-operated monitor. EXS intensity \& duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity.
Exercise: The resistance EXS training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines \& 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 EXS response, \& 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)
n=20 Participants
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.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
56.5 years
n=7 Participants
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
20 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Education
|
12.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
13.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Body Mass Index
|
30.5 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Viral Load Undetectable (<50 copies/mL)
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Median recent CD4 T-cell count (cells/mm3) (IQR)
|
581 cells/mm3
n=5 Participants
|
561 cells/mm3
n=7 Participants
|
578 cells/mm3
n=5 Participants
|
|
Median CD4 nadir T-cell count (cells/mm3) (IQR)
|
195 cells/mm3
n=5 Participants
|
47 cells/mm3
n=7 Participants
|
179.5 cells/mm3
n=5 Participants
|
|
Median CD8 T-cell count (cells/mm3) (IQR)
|
809 cells/mm3
n=5 Participants
|
689 cells/mm3
n=7 Participants
|
785 cells/mm3
n=5 Participants
|
|
Mean duration of HIV infection (in months) (SD)
|
225.4 Months of Infection
STANDARD_DEVIATION 117.6 • n=5 Participants
|
259.0 Months of Infection
STANDARD_DEVIATION 94.3 • n=7 Participants
|
235.4 Months of Infection
STANDARD_DEVIATION 109.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants who completed cognitive testing at baseline and 6 months.
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.
Outcome measures
| Measure |
Exercise (EXS)
n=33 Participants
All Exercise sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Sessions will start with range of motion exercises. Participants will follow an individualized EXS training prescription based on baseline cardio testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, HR will be monitored by a battery-operated HR monitor. EXS intensity \& duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity.
Exercise: The resistance EXS training component will follow aerobic EXS \& 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 EXS station. The program will initially consist of 1-2 sets of each EXS while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, and when the participant can comfortably lift the weight for 12 repetitions on any EXS, 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 EXS over 26 weeks.
|
Social Interaction Stretching (SIS)
n=14 Participants
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 Exercise 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 Exercise program. These Stretching participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the Exercise 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 Exercise program.
|
|---|---|---|
|
Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group
|
.10 z-score
Standard Deviation .29
|
.20 z-score
Standard Deviation .33
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Participants from both the Exercise and Stretching group's MRIs were analyzed for cortical volume change from pre-intervention to post-intervention.
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.
Outcome measures
| Measure |
Exercise (EXS)
n=33 Participants
All Exercise sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Sessions will start with range of motion exercises. Participants will follow an individualized EXS training prescription based on baseline cardio testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, HR will be monitored by a battery-operated HR monitor. EXS intensity \& duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity.
Exercise: The resistance EXS training component will follow aerobic EXS \& 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 EXS station. The program will initially consist of 1-2 sets of each EXS while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, and when the participant can comfortably lift the weight for 12 repetitions on any EXS, 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 EXS over 26 weeks.
|
Social Interaction Stretching (SIS)
n=14 Participants
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 Exercise 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 Exercise program. These Stretching participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the Exercise 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 Exercise program.
|
|---|---|---|
|
Changes in Brain Structural/Functional Measures in Older PLWH
|
-546.1 mm^3
Standard Deviation 10358
|
366.6 mm^3
Standard Deviation 8102
|
PRIMARY outcome
Timeframe: 6 MonthsInvestigators 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.
Outcome measures
| Measure |
Exercise (EXS)
n=33 Participants
All Exercise sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Sessions will start with range of motion exercises. Participants will follow an individualized EXS training prescription based on baseline cardio testing. Individual aerobic EXS intensity is based on % of maximum HR achieved during the baseline cardiorespiratory fitness test. The target EXS HR will start at 50% and progress to 85% HR reserve. During aerobic EXS, HR will be monitored by a battery-operated HR monitor. EXS intensity \& duration will be increased as the participant acclimates to the EXS prescription. Adaptation is determined when a given EXS intensity yields a lower HR than prior sessions conducted at the same intensity.
Exercise: The resistance EXS training component will follow aerobic EXS \& 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 EXS station. The program will initially consist of 1-2 sets of each EXS while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's EXS response, and when the participant can comfortably lift the weight for 12 repetitions on any EXS, 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 EXS over 26 weeks.
|
Social Interaction Stretching (SIS)
n=14 Participants
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 Exercise 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 Exercise program. These Stretching participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the Exercise 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 Exercise program.
|
|---|---|---|
|
Change in Level of Daily Activity
|
-23.9 Average Minutes per Day
Standard Deviation 114.8
|
-5.3 Average Minutes per Day
Standard Deviation 98.9
|
Adverse Events
Exercise (EXS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Social Interaction Stretching (SIS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brittany Nelson, Senior Clinical Research Coordinator
Washington University in St. Louis
Phone: 314-747-8425
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place