Trial Outcomes & Findings for Functional Interval Training for Veterans Exercising Through Telehealth. (NCT NCT04103593)
NCT ID: NCT04103593
Last Updated: 2026-01-07
Results Overview
O2 consumption at peak exercise effort, VO2peak, is used as the standard measure of aerobic capacity in sedentary adults since the majority are not able to reach maximal aerobic capacity defined as a plateau in O2 consumption. VO2peak will be the average of the final 30 second values of O2 consumption at peak exercise on a treadmill using a modified Bruce protocol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
baseline and 13-weeks
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Exercise Group
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
exercise training: 12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
|
Control Group
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
31
|
36
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Interval Training for Veterans Exercising Through Telehealth.
Baseline characteristics by cohort
| Measure |
Exercise Group
n=45 Participants
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
exercise training: 12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
|
Control Group
n=44 Participants
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=37 Participants
|
27 Participants
n=56 Participants
|
57 Participants
n=95 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=37 Participants
|
17 Participants
n=56 Participants
|
32 Participants
n=95 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.6 • n=37 Participants
|
63.1 years
STANDARD_DEVIATION 7.5 • n=56 Participants
|
62.9 years
STANDARD_DEVIATION 7 • n=95 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=37 Participants
|
43 Participants
n=56 Participants
|
86 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=37 Participants
|
44 Participants
n=56 Participants
|
88 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=37 Participants
|
39 Participants
n=56 Participants
|
78 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
9 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=37 Participants
|
44 Participants
n=56 Participants
|
89 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: baseline and 13-weeksPopulation: Only participants who completed 12-week follow up testing. Among completers, 2 were missing VO2 data at Follow Up; Baseline data was provided for these participants.
O2 consumption at peak exercise effort, VO2peak, is used as the standard measure of aerobic capacity in sedentary adults since the majority are not able to reach maximal aerobic capacity defined as a plateau in O2 consumption. VO2peak will be the average of the final 30 second values of O2 consumption at peak exercise on a treadmill using a modified Bruce protocol
Outcome measures
| Measure |
Control Group
n=36 Participants
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training.
|
Exercise Group
n=31 Participants
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
exercise training: 12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
|
|---|---|---|
|
Change From Baseline VO2peak to After 12-week Exercise Intervention
Baseline
|
2.05 Liters/minute
Standard Deviation 0.57
|
1.99 Liters/minute
Standard Deviation 0.46
|
|
Change From Baseline VO2peak to After 12-week Exercise Intervention
12 Week Follow Up
|
2.07 Liters/minute
Standard Deviation 0.47
|
2.07 Liters/minute
Standard Deviation 0.53
|
|
Change From Baseline VO2peak to After 12-week Exercise Intervention
Change
|
0.00 Liters/minute
Standard Deviation 0.29
|
0.09 Liters/minute
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: baseline and 13-weeksEpigenome-wide association studies (EWAS)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: through study completion, an average of 1 yearRates will be calculated for enrollment, attendance, and retention
Outcome measures
Outcome data not reported
Adverse Events
Exercise Group
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Exercise Group
n=45 participants at risk
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
exercise training: 12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
|
Control Group
n=44 participants at risk
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/45 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
2.3%
1/44 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/45 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
2.3%
1/44 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Metabolism and nutrition disorders
Hospitalization
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
Other adverse events
| Measure |
Exercise Group
n=45 participants at risk
High-intensity circuit exercise training will be performed 3 times weekly for 12 weeks in a group setting. Circuit training is an exercise modality consisting of a series of exercises at different stations. Exercise training will be delivered by VTEL broadcast from the Salem VAMC to participants at the Atlanta VAMC and Baltimore VAMC. Rooms will be equipped with steps, hand and ankle weights, dumbbells, chairs and bands. No stationary exercise equipment will be used in either AEX or RT.
exercise training: 12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
|
Control Group
n=44 participants at risk
Sedentary activity (confirmed at eligibility no more than 1 structured physical activity/week) will be continued in participants randomized to the control group. Participants have the option after 12-week intervention phase to enter "delayed" exercise training to assure that all participants can receive exercise training.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Blister
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Cardiac disorders
Irregular heart rate
|
8.9%
4/45 • Number of events 4 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Surgical and medical procedures
Oral surgery
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Gastrointestinal disorders
Upset stomach/vomiting/diarrhea
|
11.1%
5/45 • Number of events 5 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Infections and infestations
COVID exposure
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Injury from a fall
|
4.4%
2/45 • Number of events 2 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Cardiac disorders
Dizziness
|
4.4%
2/45 • Number of events 2 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Hip and leg pain
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
3/45 • Number of events 3 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Cardiac disorders
Hypertensive episode
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Nervous system disorders
Arm weakness
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Injury from car crash
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Metabolism and nutrition disorders
Dizziness/low blood sugar related to diabetes
|
8.9%
4/45 • Number of events 5 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
2.2%
1/45 • Number of events 1 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Musculoskeletal and connective tissue disorders
Knee pain from arthritis
|
4.4%
2/45 • Number of events 2 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Cardiac disorders
Chest pain
|
4.4%
2/45 • Number of events 2 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
|
Infections and infestations
Cold/flu symptoms
|
13.3%
6/45 • Number of events 6 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
0.00%
0/44 • From consent to follow up testing (up to 1.5 years or as needed)
Not different
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place