Trial Outcomes & Findings for Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause (NCT NCT02404792)
NCT ID: NCT02404792
Last Updated: 2019-01-16
Results Overview
Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-01-16
Participant Flow
Participant milestones
| Measure |
Participants With HIV
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
HIV-Uninfected Controls
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded.At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
37
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Baseline characteristics by cohort
| Measure |
HIV-Uninfected Controls
n=37 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Participants With HIV
n=32 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: 37 and 32 had baseline values; 29 and 27 (uninfected and with HIV, respectively) completed 24 weeks.
Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower
Outcome measures
| Measure |
HIV-uninfected Controls
n=37 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Participants With HIV
n=32 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
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|---|---|---|
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Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
Change 0-12 weeks
|
-20 percentage change
Interval -24.0 to -16.0
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-20 percentage change
Interval -24.0 to -16.0
|
|
Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)
Change 13-24 weeks
|
-8 percentage change
Interval -12.0 to -4.0
|
-10 percentage change
Interval -14.0 to -5.0
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SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing data on one participant with HIV that completed the study. Data listed below ONLY includes data on persons with measurements at both baseline and week 24.
Measures at baseline and following 24 weeks of exercise
Outcome measures
| Measure |
HIV-uninfected Controls
n=26 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Participants With HIV
n=29 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
|---|---|---|
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Changes in Insulin-like Growth Factor (IGF)-1
Baseline
|
79.87 IGF-1 (ng/mL)
Interval 66.33 to 96.18
|
86.4 IGF-1 (ng/mL)
Interval 78.46 to 95.13
|
|
Changes in Insulin-like Growth Factor (IGF)-1
Week 24
|
85.42 IGF-1 (ng/mL)
Interval 69.49 to 104.99
|
84.65 IGF-1 (ng/mL)
Interval 76.77 to 93.34
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SECONDARY outcome
Timeframe: Baseline and 24 weeksThe primary outcome is change from 0 to 24 weeks. These changes in inflammation are measured at baseline (pre-exercise) and at 24 weeks (post exercise).
Outcome measures
| Measure |
HIV-uninfected Controls
n=37 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Participants With HIV
n=32 Participants
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
|---|---|---|
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Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
Change in IL-6
|
-2 percentage of change
Interval -16.0 to 22.0
|
10 percentage of change
Interval -10.0 to 34.0
|
|
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
Change in sTNFr1
|
2.3 percentage of change
Interval -3.5 to 8.3
|
-2.5 percentage of change
Interval -8.2 to 3.6
|
|
Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.
Change in TNFalpha
|
1.3 percentage of change
Interval -11.1 to 15.4
|
-2.5 percentage of change
Interval -15.0 to 11.7
|
Adverse Events
HIV-uninfected Controls
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Participants With HIV
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV-uninfected Controls
n=37 participants at risk
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
Participants With HIV
n=32 participants at risk
All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL.
At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks.
|
|---|---|---|
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Musculoskeletal and connective tissue disorders
Musculoskeletal injury/pain
|
16.2%
6/37 • Number of events 9 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
40.6%
13/32 • Number of events 20 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
2.7%
1/37 • Number of events 1 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
0.00%
0/32 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
|
Cardiac disorders
Dizzyness or lightheadedness
|
0.00%
0/37 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
12.5%
4/32 • Number of events 4 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
|
Cardiac disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
0.00%
0/32 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
|
Cardiac disorders
Chest pain and shortness of breath
|
2.7%
1/37 • Number of events 1 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
0.00%
0/32 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
|
General disorders
Fatigue
|
0.00%
0/37 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
3.1%
1/32 • Number of events 1 • Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place