Trial Outcomes & Findings for Resistance Training and Testosterone After Spinal Cord Injury (NCT NCT01652040)
NCT ID: NCT01652040
Last Updated: 2018-05-03
Results Overview
Changes in body composition fat mass
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
26 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-05-03
Participant Flow
Participant milestones
| Measure |
RT+Tp
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
|
Testosterone Replacement Patches (Tp)
Applying Testosterone patches
Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resistance Training and Testosterone After Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
RT+Tp
n=11 Participants
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
|
Testosterone Replacement Patches (Tp)
n=11 Participants
Applying Testosterone patches
Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12 • n=39 Participants
|
35 years
STANDARD_DEVIATION 8 • n=41 Participants
|
36 years
STANDARD_DEVIATION 10 • n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 16 weeksChanges in body composition fat mass
Outcome measures
| Measure |
RT+Tp
n=11 Participants
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
|
Testosteroe Replacement Patches (Tp)
n=11 Participants
Applying Testosterone patches
Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
|
|---|---|---|
|
Body Composition
Baseline
|
31.84 percentage of fat mass
Standard Deviation 10.7
|
33.4 percentage of fat mass
Standard Deviation 9
|
|
Body Composition
Post-Intervention (After 16 weeks)
|
30.75 percentage of fat mass
Standard Deviation 10.3
|
32.12 percentage of fat mass
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 16 weeksBasal Metabolic Rate
Outcome measures
| Measure |
RT+Tp
n=11 Participants
Resistance training using electrical stimulation and ankle weights and Testosterone patches
Resistance Training and Testosterone Patches: We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
|
Testosteroe Replacement Patches (Tp)
n=11 Participants
Applying Testosterone patches
Testosterone Patches: The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
|
|---|---|---|
|
Metabolic Profile
Baseline
|
1525 kcal/day
Standard Deviation 261
|
1491 kcal/day
Standard Deviation 177
|
|
Metabolic Profile
Post-Intervention (After 16 weeks)
|
1665 kcal/day
Standard Deviation 243
|
1502 kcal/day
Standard Deviation 327
|
Adverse Events
Testosterone Replacement Patches (Tp)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RT+Tp
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