Trial Outcomes & Findings for High Intensity Interval Exercise SCI (NCT NCT04940598)
NCT ID: NCT04940598
Last Updated: 2024-07-24
Results Overview
All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
baseline
Results posted on
2024-07-24
Participant Flow
Potential participants were identified by a computer-generated list of patients who are enrolled in the UAB SCI Model System and the Lakeshore Foundation Member Database and currently reside in the greater Birmingham, Alabama area. All potential participants were mailed a letter which describes the study, invites them to participate. Additional recruiting was done by posting fliers at the UAB Spain Rehabilitation Center (SRC) and Lakeshore Foundation.
Participant milestones
| Measure |
High Intensity Interval Exercise
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Intensity Interval Exercise SCI
Baseline characteristics by cohort
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
56.4 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
52.7 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Height
|
69.7 inches
STANDARD_DEVIATION 2.9 • n=99 Participants
|
66.7 inches
STANDARD_DEVIATION 6.4 • n=107 Participants
|
68.6 inches
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Body Weight
|
87.2 kg
STANDARD_DEVIATION 23.7 • n=99 Participants
|
94.3 kg
STANDARD_DEVIATION 30.9 • n=107 Participants
|
89.9 kg
STANDARD_DEVIATION 24.7 • n=206 Participants
|
|
VO2 Peak
|
11.6 ml/kg/min
STANDARD_DEVIATION 2.9 • n=99 Participants
|
10.1 ml/kg/min
STANDARD_DEVIATION .99 • n=107 Participants
|
11 ml/kg/min
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Insulin Sensitivity
|
3.5 matsuda
STANDARD_DEVIATION 1.8 • n=99 Participants
|
6.1 matsuda
STANDARD_DEVIATION 4.2 • n=107 Participants
|
4.5 matsuda
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Total Cholesterol
|
179.2 mg/dl
STANDARD_DEVIATION 36 • n=99 Participants
|
178 mg/dl
STANDARD_DEVIATION 4.3 • n=107 Participants
|
178.8 mg/dl
STANDARD_DEVIATION 27.4 • n=206 Participants
|
|
Triglycerides
|
132.6 mg/dl
STANDARD_DEVIATION 46.3 • n=99 Participants
|
126.3 mg/dl
STANDARD_DEVIATION 30 • n=107 Participants
|
130.2 mg/dl
STANDARD_DEVIATION 38.7 • n=206 Participants
|
|
HDL
|
45.6 mg/dl
STANDARD_DEVIATION 6.9 • n=99 Participants
|
51.7 mg/dl
STANDARD_DEVIATION .58 • n=107 Participants
|
47.9 mg/dl
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
LDL
|
107 mg/dl
STANDARD_DEVIATION 30.4 • n=99 Participants
|
101.1 mg/dl
STANDARD_DEVIATION 9 • n=107 Participants
|
104.8 mg/dl
STANDARD_DEVIATION 23.6 • n=206 Participants
|
|
Fasting Glucose
|
95.2 mg/dl
STANDARD_DEVIATION 3.5 • n=99 Participants
|
148.3 mg/dl
STANDARD_DEVIATION 85.6 • n=107 Participants
|
115.1 mg/dl
STANDARD_DEVIATION 53.4 • n=206 Participants
|
|
Fasting Insulin
|
10.6 mIU/L
STANDARD_DEVIATION 4.3 • n=99 Participants
|
7.6 mIU/L
STANDARD_DEVIATION 4.1 • n=107 Participants
|
9.5 mIU/L
STANDARD_DEVIATION 4.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: baselineAll subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Aerobic Capacity Baseline
|
11.6 ml/kg/min
Standard Deviation 2.9
|
10 ml/kg/min
Standard Deviation .99
|
PRIMARY outcome
Timeframe: 16weeks post trainingAll subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Aerobic Capacity Week 16
|
13.6 ml/kg/min
Standard Deviation 2.2
|
9.9 ml/kg/min
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: baselineOral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Matsuda Index Baseline
|
3.5 score on a scale
Standard Deviation 1.8
|
6.1 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: 16weeks post trainingOral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Matsuda Index Week 16
|
5.3 score on a scale
Standard Deviation 3.5
|
6.5 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: baselineLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Cholesterol Baseline
|
179.2 mg/dl
Standard Deviation 36
|
178 mg/dl
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: 16weeks post trainingLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Cholesterol Week 16
|
193.8 mg/dl
Standard Deviation 49.5
|
188 mg/dl
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: baselineDual-energy X-ray absorptiometry (DXA). Percent Body Fat
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Body Composition Baseline
|
42.4 Percent Fat
Standard Deviation 1.1
|
47.5 Percent Fat
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: 16weeks post trainingDual-energy X-ray absorptiometry (DXA). Percent Body Fat
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Body Composition Week 16
|
41.9 Percent Fat
Standard Deviation 2.8
|
46.9 Percent Fat
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: baselineLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Triglycerides Baseline
|
132.6 mg/dl
Standard Deviation 46.3
|
126.3 mg/dl
Standard Deviation 30.1
|
PRIMARY outcome
Timeframe: 16-weeks postLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
Triglycerides Week 16
|
122.8 mg/dl
Standard Deviation 39.1
|
102.3 mg/dl
Standard Deviation 44.3
|
PRIMARY outcome
Timeframe: BaselineLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
HDL Baseline
|
45.6 mg/dl
Standard Deviation 6.9
|
51.7 mg/dl
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 16-weeks post trainingLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
HDL Week 16
|
52 mg/dl
Standard Deviation 9.6
|
57.7 mg/dl
Standard Deviation 8
|
PRIMARY outcome
Timeframe: BaselineLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
LDL Baseline
|
107.1 mg/dl
Standard Deviation 30.4
|
101.1 mg/dl
Standard Deviation 8
|
PRIMARY outcome
Timeframe: 16-weeks post trainingLaboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Outcome measures
| Measure |
High Intensity Interval Exercise
n=5 Participants
High intensity interval arm crank exercise
high intensity interval exercise: HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
|
No-Exercise Control
n=3 Participants
No-exercise control group
No-exercise control group: No-exercise control group
|
|---|---|---|
|
LDL Week 16
|
117.5 mg/dl
Standard Deviation 48.1
|
109.7 mg/dl
Standard Deviation 22
|
Adverse Events
High Intensity Interval Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No-Exercise Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place