Trial Outcomes & Findings for Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV (NCT NCT04946994)
NCT ID: NCT04946994
Last Updated: 2026-06-22
Results Overview
Change in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
0-16 weeks
Results posted on
2026-06-22
Participant Flow
Participant milestones
| Measure |
High Intensity Interval Training
High intensity interval training (HIIT): The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
Continuous moderate intensity exercise (CME): The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 46 participants had valid actigraphy data.
Baseline characteristics by cohort
| Measure |
High Intensity Interval Training
n=25 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=27 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=25 Participants
|
21 Participants
n=27 Participants
|
42 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=25 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=52 Participants
|
|
Age, Continuous
|
58.68 years
STANDARD_DEVIATION 6.47 • n=25 Participants
|
59.22 years
STANDARD_DEVIATION 6.85 • n=27 Participants
|
58.96 years
STANDARD_DEVIATION 6.61 • n=52 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=25 Participants
|
23 Participants
n=27 Participants
|
45 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=25 Participants
|
19 Participants
n=27 Participants
|
41 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=25 Participants
|
18 Participants
n=27 Participants
|
42 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=52 Participants
|
|
Sleep Quality
|
8.88 Score on a scale
STANDARD_DEVIATION 3.44 • n=25 Participants
|
8.46 Score on a scale
STANDARD_DEVIATION 3.09 • n=27 Participants
|
8.67 Score on a scale
STANDARD_DEVIATION 3.24 • n=52 Participants
|
|
Sleep Fragmentation Index
|
32.25 index
STANDARD_DEVIATION 15.30 • n=21 Participants • Only 46 participants had valid actigraphy data.
|
36.82 index
STANDARD_DEVIATION 12.74 • n=25 Participants • Only 46 participants had valid actigraphy data.
|
34.73 index
STANDARD_DEVIATION 14.00 • n=46 Participants • Only 46 participants had valid actigraphy data.
|
|
Sleep Efficiency
|
80.28 percentage of time asleep
STANDARD_DEVIATION 9.40 • n=21 Participants • Only 46 participants had valid actigraphy data.
|
78.92 percentage of time asleep
STANDARD_DEVIATION 6.87 • n=25 Participants • Only 46 participants had valid actigraphy data.
|
79.54 percentage of time asleep
STANDARD_DEVIATION 8.06 • n=46 Participants • Only 46 participants had valid actigraphy data.
|
|
Mean Sleep Duration
|
395.82 minutes per night
STANDARD_DEVIATION 65.59 • n=21 Participants • Only 46 participants had valid actigraphy data.
|
375.31 minutes per night
STANDARD_DEVIATION 67.21 • n=25 Participants • Only 46 participants had valid actigraphy data.
|
384.67 minutes per night
STANDARD_DEVIATION 66.55 • n=46 Participants • Only 46 participants had valid actigraphy data.
|
|
Interleukin Inflammation Markers IL-6
|
1.63 pg/mL
STANDARD_DEVIATION 2.15 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
1.34 pg/mL
STANDARD_DEVIATION 1.45 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
1.47 pg/mL
STANDARD_DEVIATION 1.79 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-8
|
4.58 pg/mL
STANDARD_DEVIATION 1.53 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
6.53 pg/mL
STANDARD_DEVIATION 3.14 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
5.64 pg/mL
STANDARD_DEVIATION 2.70 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-10
|
034 pg/mL
STANDARD_DEVIATION 0.30 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
0.29 pg/mL
STANDARD_DEVIATION 0.12 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
0.32 pg/mL
STANDARD_DEVIATION 0.22 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-13
|
3.06 pg/mL
STANDARD_DEVIATION 1.18 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
3.31 pg/mL
STANDARD_DEVIATION 1.48 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
3.20 pg/mL
STANDARD_DEVIATION 1.34 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-1β
|
0.17 pg/mL
STANDARD_DEVIATION 0.09 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
0.19 pg/mL
STANDARD_DEVIATION 0.10 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
0.18 pg/mL
STANDARD_DEVIATION 0.09 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-2
|
0.26 pg/mL
STANDARD_DEVIATION 0.15 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
0.29 pg/mL
STANDARD_DEVIATION 0.13 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
0.28 pg/mL
STANDARD_DEVIATION 0.14 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-4
|
0.03 pg/mL
STANDARD_DEVIATION 0.07 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
0.01 pg/mL
STANDARD_DEVIATION 0.01 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
0.02 pg/mL
STANDARD_DEVIATION 0.05 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interleukin Inflammation Markers IL-12p70
|
0.16 pg/mL
STANDARD_DEVIATION 0.06 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
0.11 pg/mL
STANDARD_DEVIATION 0.09 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
0.13 pg/mL
STANDARD_DEVIATION 0.08 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Interferon Gamma Inflammation Marker
|
7.95 pg/mL
STANDARD_DEVIATION 8.49 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
8.12 pg/mL
STANDARD_DEVIATION 10.11 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
8.04 pg/mL
STANDARD_DEVIATION 9.30 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
C-reactive Protein Inflammation Marker
|
135851.39 ng/mL
STANDARD_DEVIATION 350863.72 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
52108.52 ng/mL
STANDARD_DEVIATION 123902.66 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
90173.46 ng/mL
STANDARD_DEVIATION 253744.00 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
|
Tumor Necrosis Factor Alpha Inflammation Marker
|
2.23 pg/mL
STANDARD_DEVIATION 0.51 • n=20 Participants • Only 44 participants had valid inflammatory marker data.
|
2.39 pg/mL
STANDARD_DEVIATION 0.59 • n=24 Participants • Only 44 participants had valid inflammatory marker data.
|
2.32 pg/mL
STANDARD_DEVIATION 0.56 • n=44 Participants • Only 44 participants had valid inflammatory marker data.
|
PRIMARY outcome
Timeframe: 0-16 weeksChange in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality.
Outcome measures
| Measure |
High Intensity Interval Training
n=20 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=23 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Sleep Quality
|
-2.15 score on a scale
Standard Deviation 3.30
|
-1.43 score on a scale
Standard Deviation 2.29
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid actigraphy derived sleep fragmentation index data at both baseline and Week 16.
Change in sleep fragmentation index will be assessed through wrist actigraphy. Sleep Fragmentation Index is an actigraphy-derived metric generated by the Philips Respironics Actiwatch Spectrum Plus device. It quantifies sleep disruption by combining movement events and brief arousals detected throughout the sleep period. Higher values indicate greater sleep fragmentation (poorer sleep continuity), whereas lower values indicate more consolidated sleep (better sleep continuity). The index is calculated using the Actiwatch Spectrum Plus proprietary algorithm, which incorporates the frequency and intensity of movement epochs and wake episodes.
Outcome measures
| Measure |
High Intensity Interval Training
n=13 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=18 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Sleep Fragmentation Index
|
2.30 index
Standard Deviation 7.58
|
3.81 index
Standard Deviation 10.16
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid actigraphy-derived sleep efficiency data at both baseline and Week 16.
Change in sleep efficiency will be assessed through wrist actigraphy. Sleep efficiency reflects the percentage of time spent asleep while in bed and is derived from actigraphy-based sleep/wake scoring.
Outcome measures
| Measure |
High Intensity Interval Training
n=13 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=18 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Sleep Efficiency
|
0.83 percentage of time asleep
Standard Deviation 5.31
|
-3.52 percentage of time asleep
Standard Deviation 5.74
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid actigraphy derived sleep duration data at both baseline and Week 16.
Change in mean sleep duration will be assessed through wrist actigraphy. Mean sleep duration reflects the average number of minutes spent asleep per night and is derived from actigraphy based sleep/wake scoring.
Outcome measures
| Measure |
High Intensity Interval Training
n=13 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=18 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Mean Sleep Duration
|
8.83 minutes per night
Standard Deviation 98.16
|
15.36 minutes per night
Standard Deviation 52.86
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-6 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-6.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-6
|
-0.16 pg/mL
Standard Deviation 0.52
|
-0.25 pg/mL
Standard Deviation 0.75
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-8 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-8.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-8
|
0.14 pg/mL
Standard Deviation 0.37
|
-0.09 pg/mL
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-10 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-10.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-10
|
0.26 pg/mL
Standard Deviation 0.43
|
0.10 pg/mL
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-13 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-13.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-13
|
0.11 pg/mL
Standard Deviation 0.38
|
0.007 pg/mL
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-1β measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-1β.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-1β
|
0.16 pg/mL
Standard Deviation 0.45
|
-0.12 pg/mL
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-2 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-2.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-2
|
0.30 pg/mL
Standard Deviation 0.65
|
0.01 pg/mL
Standard Deviation 0.90
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-4 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-4.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-4
|
0.19 pg/mL
Standard Deviation 1.63
|
-0.49 pg/mL
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interleukin (IL)-12p70 measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interleukin (IL)-12p70.
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interleukin Inflammation Markers IL-12p70
|
-0.15 pg/mL
Standard Deviation 0.72
|
-0.18 pg/mL
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid interferon-gamma (IFN-y) measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining interferon gamma (IFN-y).
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Interferon Gamma Inflammation Marker
|
0.15 pg/ml
Standard Error 1.02
|
0.10 pg/ml
Standard Error 0.42
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid CRP measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining C-reactive protein (CRP).
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
C-reactive Protein Inflammation Marker
|
-0.30 ng/mL
Standard Deviation 1.07
|
0.65 ng/mL
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 0-16 weeksPopulation: Participants with valid TNF-α measurements at baseline and Week 16.
Change in inflammation markers. Specifically examining tumor necrosis factor alpha (TNF-α).
Outcome measures
| Measure |
High Intensity Interval Training
n=15 Participants
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=19 Participants
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Tumor Necrosis Factor Alpha Inflammation Marker
|
0.05 pg/mL
Standard Deviation 0.16
|
-0.02 pg/mL
Standard Deviation 0.18
|
Adverse Events
High Intensity Interval Training
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Continuous Moderate Intensity Exercise
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Intensity Interval Training
n=25 participants at risk
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=27 participants at risk
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Infections and infestations
infection related (including COVID)
|
4.0%
1/25 • Number of events 1 • Baseline to Week 16.
|
0.00%
0/27 • Baseline to Week 16.
|
|
Infections and infestations
infection related (including COVID); neurologic
|
4.0%
1/25 • Number of events 1 • Baseline to Week 16.
|
0.00%
0/27 • Baseline to Week 16.
|
|
Nervous system disorders
other
|
0.00%
0/25 • Baseline to Week 16.
|
3.7%
1/27 • Number of events 1 • Baseline to Week 16.
|
Other adverse events
| Measure |
High Intensity Interval Training
n=25 participants at risk
HIIT: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
Continuous Moderate Intensity Exercise
n=27 participants at risk
CME: The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint, Tendon or Muscle Pain
|
40.0%
10/25 • Number of events 10 • Baseline to Week 16.
|
48.1%
13/27 • Number of events 13 • Baseline to Week 16.
|
|
General disorders
Fatigue
|
12.0%
3/25 • Number of events 3 • Baseline to Week 16.
|
3.7%
1/27 • Number of events 1 • Baseline to Week 16.
|
|
Infections and infestations
Respiratory infection
|
8.0%
2/25 • Number of events 2 • Baseline to Week 16.
|
18.5%
5/27 • Number of events 5 • Baseline to Week 16.
|
|
Gastrointestinal disorders
Diarrhea, nausea or vomiting
|
4.0%
1/25 • Number of events 1 • Baseline to Week 16.
|
14.8%
4/27 • Number of events 4 • Baseline to Week 16.
|
|
Infections and infestations
COVID infection
|
8.0%
2/25 • Number of events 2 • Baseline to Week 16.
|
3.7%
1/27 • Number of events 1 • Baseline to Week 16.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place