Trial Outcomes & Findings for Strength Training and Endurance Exercise for LIFE (NCT NCT02101060)
NCT ID: NCT02101060
Last Updated: 2021-05-11
Results Overview
VO2 peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).
COMPLETED
NA
33 participants
at baseline and at 16 weeks (before and after the intervention phase)
2021-05-11
Participant Flow
Participant milestones
| Measure |
Exercise
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
usual care controls
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Exercise
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
usual care controls
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Strength Training and Endurance Exercise for LIFE
Baseline characteristics by cohort
| Measure |
Exercise
n=17 Participants
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
n=16 Participants
usual care controls
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.03 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
61.17 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline and at 16 weeks (before and after the intervention phase)Population: We have incomplete data on completers in the control group.
VO2 peak will be used as the primary measure of aerobic capacity. Subjects will be asked to exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).
Outcome measures
| Measure |
Exercise
n=12 Participants
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
n=11 Participants
usual care controls
|
|---|---|---|
|
Aerobic Capacity
|
0.15 Liters/minute
Standard Error 0.04
|
0.02 Liters/minute
Standard Error 0.07
|
PRIMARY outcome
Timeframe: at baseline and at 16 weeks (before and after the intervention phase)Population: We have incomplete data on completers in these groups.
Exercise stress two-dimensional transthoracic echocardiography with tissue Doppler imaging (stress-echo) will be used to collect data on diastolic function. Reporting on ejection fraction. In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).
Outcome measures
| Measure |
Exercise
n=11 Participants
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
n=10 Participants
usual care controls
|
|---|---|---|
|
Diastolic Function
|
1.8 percentage
Standard Error 1.9
|
0.5 percentage
Standard Error 2.7
|
SECONDARY outcome
Timeframe: at baseline and at 16 weeks (before and after the intervention phase)Changes in plasma levels of biomarkers of chronic inflammation will be calculated pre/post intervention, and will be tested for association with changes in primary outcomes as well as between group differences. Presenting IL-18 values (log converted for analysis). In this Outcome, a mean difference between baseline to 16 weeks is reported (value at 16 weeks minus value at baseline).
Outcome measures
| Measure |
Exercise
n=12 Participants
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
n=12 Participants
usual care controls
|
|---|---|---|
|
Biomarkers of Systemic Inflammation
|
-0.04 pg/mL
Standard Error 0.02
|
-0.03 pg/mL
Standard Error 0.02
|
Adverse Events
Exercise
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise
n=17 participants at risk
16-week progressive aerobic and resistance exercise training
exercise: 16-week progressive aerobic and resistance exercise training
|
Control
n=16 participants at risk
usual care controls
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
5.9%
1/17 • Number of events 1 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
0.00%
0/16 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
|
Cardiac disorders
dizziness
|
0.00%
0/17 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
6.2%
1/16 • Number of events 1 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
6.2%
1/16 • Number of events 1 • Data collected from time of enrollment to completion of study. For intervention group, duration of study is approximately 30 weeks. For control group, duration of study is approximately 50 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place