Trial Outcomes & Findings for High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV (NCT NCT04550676)
NCT ID: NCT04550676
Last Updated: 2026-05-28
Results Overview
400-m walk time is a continuous measure of the total time required to complete a 400-m walking course. Lower values indicate a faster walking speed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
0-16 weeks
Results posted on
2026-05-28
Participant Flow
Participant milestones
| Measure |
High Intensity Interval Training
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Coaching Text (From HIIT)
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
Participants in this arm were previously randomized to HIIT and then re-randomized to coaching.
|
Control Text (From HIIT)
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
The participants in this arm were initially randomized to HIIT and then re-randomized to the control arm.
|
Coaching Text (From CME)
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
Participants in this arm were previously randomized to CME and then re-randomized to coaching.
|
Control Text (From CME)
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
The participants in this arm were initially randomized to CME and then re-randomized to control.
|
|---|---|---|---|---|---|---|
|
Part 1 (HIIT vs CME) Weeks 0-16
STARTED
|
61
|
57
|
0
|
0
|
0
|
0
|
|
Part 1 (HIIT vs CME) Weeks 0-16
COMPLETED
|
48
|
46
|
0
|
0
|
0
|
0
|
|
Part 1 (HIIT vs CME) Weeks 0-16
NOT COMPLETED
|
13
|
11
|
0
|
0
|
0
|
0
|
|
Part 2 (Coaching vs Control Text) Week
STARTED
|
0
|
0
|
25
|
22
|
21
|
24
|
|
Part 2 (Coaching vs Control Text) Week
COMPLETED
|
0
|
0
|
25
|
21
|
21
|
23
|
|
Part 2 (Coaching vs Control Text) Week
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
Baseline characteristics by cohort
| Measure |
Part 1: High Intensity Interval Training (HIIT)
n=61 Participants
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 1: Continuous Moderate Intensity Exercise (CME)
n=57 Participants
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 2: Control Text (From HIIT)
n=22 Participants
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to HIIT and then re-randomized to control.
|
Part 2: Control Text (From CME)
n=24 Participants
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to CME and then re-randomized to control.
|
Part 2: Coaching Text (From HIIT)
n=25 Participants
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages. The participants in this arm were initially randomized to HIIT and then re-randomized to coaching for Part 2.
|
Part 2: Coaching Text (From CME)
n=21 Participants
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages. The participants in this arm were initially randomized to CME and then re-randomized to coaching for Part 2.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
Part 1 · <=18 years
|
0 Participants
n=61 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=57 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=118 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Categorical
Part 1 · Between 18 and 65 years
|
53 Participants
n=61 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
47 Participants
n=57 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
100 Participants
n=118 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Categorical
Part 1 · >=65 years
|
8 Participants
n=61 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
10 Participants
n=57 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
18 Participants
n=118 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Categorical
Part 2 · <=18 years
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=22 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=24 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=25 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=21 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
n=92 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Categorical
Part 2 · Between 18 and 65 years
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
20 Participants
n=22 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
19 Participants
n=24 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
21 Participants
n=25 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
17 Participants
n=21 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
77 Participants
n=92 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Categorical
Part 2 · >=65 years
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
0 Participants
Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
2 Participants
n=22 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
5 Participants
n=24 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
4 Participants
n=25 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
4 Participants
n=21 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
15 Participants
n=92 Participants • Rows represent Part 1 and Part 2 Part 1 participants completed weeks 0-16 Part 2 participants included part 1 participants but were re-randomized for weeks 17-28.
|
|
Age, Continuous
Part 1
|
58.0 Years
STANDARD_DEVIATION 5.8 • n=61 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
58.6 Years
STANDARD_DEVIATION 6.1 • n=57 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
—
|
—
|
—
|
—
|
58.3 Years
STANDARD_DEVIATION 5.9 • n=118 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
|
Age, Continuous
Part 2
|
—
|
—
|
57.8 Years
STANDARD_DEVIATION 4.6 • n=22 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
60.0 Years
STANDARD_DEVIATION 6.4 • n=24 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
58.4 Years
STANDARD_DEVIATION 6.7 • n=25 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
58.6 Years
STANDARD_DEVIATION 6.3 • n=21 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
58.3 Years
STANDARD_DEVIATION 5.9 • n=92 Participants • Participants were randomized to Part 1 for weeks 0-16, then re-randomized to Part 2 for weeks 17-28.
|
|
Sex: Female, Male
Part 1 · Female
|
9 Participants
n=61 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
7 Participants
n=57 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
—
|
—
|
—
|
—
|
16 Participants
n=118 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
|
Sex: Female, Male
Part 1 · Male
|
52 Participants
n=61 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
50 Participants
n=57 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
—
|
—
|
—
|
—
|
102 Participants
n=118 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
|
Sex: Female, Male
Part 2 · Female
|
—
|
—
|
3 Participants
n=22 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
4 Participants
n=24 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
4 Participants
n=25 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
2 Participants
n=21 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
13 Participants
n=92 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
|
Sex: Female, Male
Part 2 · Male
|
—
|
—
|
19 Participants
n=22 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
20 Participants
n=24 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
21 Participants
n=25 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
19 Participants
n=21 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
79 Participants
n=92 Participants • Participants were randomized to part 1 for 0-16 weeks, then re-randomized to part 2 for weeks 17-28
|
|
Race/Ethnicity, Customized
Part 1: African American/Black
|
11 Participants
n=61 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
9 Participants
n=57 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
—
|
—
|
—
|
—
|
20 Participants
n=118 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 1: Hispanic/Latino/Latina
|
6 Participants
n=61 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
11 Participants
n=57 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
—
|
—
|
—
|
—
|
17 Participants
n=118 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 1: Other/Unreported
|
4 Participants
n=61 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
3 Participants
n=57 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
—
|
—
|
—
|
—
|
7 Participants
n=118 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 1: White, Non-Hispanic
|
40 Participants
n=61 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
34 Participants
n=57 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
—
|
—
|
—
|
—
|
74 Participants
n=118 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 2: African American/Black
|
—
|
—
|
4 Participants
n=22 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
3 Participants
n=24 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
4 Participants
n=25 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
3 Participants
n=21 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
14 Participants
n=92 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 2: Hispanic/Latino/Latina
|
—
|
—
|
2 Participants
n=22 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
7 Participants
n=24 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
2 Participants
n=25 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
3 Participants
n=21 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
14 Participants
n=92 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 2: Other/unreported
|
—
|
—
|
1 Participants
n=22 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
1 Participants
n=24 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
2 Participants
n=25 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
1 Participants
n=21 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
5 Participants
n=92 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
|
Race/Ethnicity, Customized
Part 2: White, Non-Hispanic
|
—
|
—
|
15 Participants
n=22 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
13 Participants
n=24 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
17 Participants
n=25 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
14 Participants
n=21 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
59 Participants
n=92 Participants • Participants were first randomized to part 1 (0-16 weeks), then re-randomized to part 2 (17-28 weeks).
|
PRIMARY outcome
Timeframe: 0-16 weeks400-m walk time is a continuous measure of the total time required to complete a 400-m walking course. Lower values indicate a faster walking speed.
Outcome measures
| Measure |
High Intensity Interval Training
n=43 Participants
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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=43 Participants
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
|---|---|---|
|
Change in Physical Function (Part 1)
|
-15.0 Seconds
Standard Deviation 18.8
|
-12.6 Seconds
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 0-16 weeksThe Lee Fatigue Score measures severity of fatigue. Possible scores range from 0 to 10, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
High Intensity Interval Training
n=42 Participants
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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=41 Participants
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
|---|---|---|
|
Change in Fatigue (Part 1)
Lee Fatigue AM Score
|
-1.6 score points
Standard Deviation 17.4
|
0.9 score points
Standard Deviation 20.1
|
|
Change in Fatigue (Part 1)
Lee Fatigue PM Score
|
7.2 score points
Standard Deviation 19.3
|
11.1 score points
Standard Deviation 22.3
|
Adverse Events
Part 1: High Intensity Interval Training (HIIT)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Part 1: Continuous Moderate Intensity Exercise (CME)
Serious events: 4 serious events
Other events: 28 other events
Deaths: 1 deaths
Part 2: Coaching Text (From HIIT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Coaching Text (From CME)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Control Text (From HIIT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Control Text (From CME)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: High Intensity Interval Training (HIIT)
n=61 participants at risk
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 1: Continuous Moderate Intensity Exercise (CME)
n=57 participants at risk
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 2: Coaching Text (From HIIT)
n=25 participants at risk
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages. The participants in this arm were initially randomized to HIIT and then re-randomized to coaching for Part 2.
|
Part 2: Coaching Text (From CME)
n=21 participants at risk
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
The participants in this arm were initially randomized to CME and then re-randomized to coaching.
|
Part 2: Control Text (From HIIT)
n=22 participants at risk
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to HIIT and then re-randomized to control.
|
Part 2: Control Text (From CME)
n=24 participants at risk
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to CME and then re-randomized to control.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection (hospitalization)
|
0.00%
0/61 • Up to Week 16
|
1.8%
1/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
|
Cardiac disorders
Syncope/pre-syncope episodes
|
0.00%
0/61 • Up to Week 16
|
1.8%
1/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
|
General disorders
Death due to pulmonary embolism
|
0.00%
0/61 • Up to Week 16
|
1.8%
1/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
|
Cardiac disorders
Syncope
|
0.00%
0/61 • Up to Week 16
|
1.8%
1/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
|
Infections and infestations
COVID hospitalization
|
0.00%
0/61 • Up to Week 16
|
0.00%
0/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
4.2%
1/24 • Up to Week 16
|
|
Infections and infestations
Pneumonia hospitalization
|
1.6%
1/61 • Up to Week 16
|
0.00%
0/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
|
General disorders
Seizure, pneumonia, hospitalization
|
1.6%
1/61 • Up to Week 16
|
0.00%
0/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
Other adverse events
| Measure |
Part 1: High Intensity Interval Training (HIIT)
n=61 participants at risk
HIIT (intervention): Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 1: Continuous Moderate Intensity Exercise (CME)
n=57 participants at risk
CME (active control): Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 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.
|
Part 2: Coaching Text (From HIIT)
n=25 participants at risk
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages. The participants in this arm were initially randomized to HIIT and then re-randomized to coaching for Part 2.
|
Part 2: Coaching Text (From CME)
n=21 participants at risk
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
The participants in this arm were initially randomized to CME and then re-randomized to coaching.
|
Part 2: Control Text (From HIIT)
n=22 participants at risk
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to HIIT and then re-randomized to control.
|
Part 2: Control Text (From CME)
n=24 participants at risk
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. The participants in this arm were initially randomized to CME and then re-randomized to control.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID
|
4.9%
3/61 • Up to Week 16
|
3.5%
2/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
4.2%
1/24 • Up to Week 16
|
|
Infections and infestations
Respiratory infections
|
16.4%
10/61 • Up to Week 16
|
15.8%
9/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
4.2%
1/24 • Up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
39.3%
24/61 • Up to Week 16
|
35.1%
20/57 • Up to Week 16
|
4.0%
1/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
4.5%
1/22 • Up to Week 16
|
4.2%
1/24 • Up to Week 16
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
4.9%
3/61 • Up to Week 16
|
8.8%
5/57 • Up to Week 16
|
0.00%
0/25 • Up to Week 16
|
0.00%
0/21 • Up to Week 16
|
0.00%
0/22 • Up to Week 16
|
0.00%
0/24 • Up to Week 16
|
Additional Information
Kristine Erlandson, MD (Contact PI)
University of Colorado
Phone: 303-724-4941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place