Trial Outcomes & Findings for Multimodality Intervention for Function and Metabolism in SCI (NCT NCT03576001)
NCT ID: NCT03576001
Last Updated: 2026-05-07
Results Overview
Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Week 16
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Multi-modality Intervention Group
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
|
Placebo Group
Hybrid exercise plus placebo medication
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
46
|
|
Overall Study
COMPLETED
|
28
|
38
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
Baseline characteristics by cohort
| Measure |
Placebo Group
n=46 Participants
Hybrid exercise plus placebo medication
|
Total
n=84 Participants
Total of all reporting groups
|
Multi-modality Intervention Group
n=38 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
|
|---|---|---|---|
|
Age, Continuous
|
42.87 years
STANDARD_DEVIATION 14.14 • n=46 Participants
|
44.00 years
STANDARD_DEVIATION 13.35 • n=84 Participants
|
45.37 years
STANDARD_DEVIATION 12.36 • n=38 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=46 Participants
|
8 Participants
n=84 Participants
|
3 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=46 Participants
|
76 Participants
n=84 Participants
|
35 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=46 Participants
|
6 Participants
n=84 Participants
|
2 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=46 Participants
|
77 Participants
n=84 Participants
|
35 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
1 Participants
n=84 Participants
|
1 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
35 Participants
n=46 Participants
|
61 Participants
n=84 Participants
|
26 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=46 Participants
|
16 Participants
n=84 Participants
|
8 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=46 Participants
|
2 Participants
n=84 Participants
|
2 Participants
n=38 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=46 Participants
|
5 Participants
n=84 Participants
|
2 Participants
n=38 Participants
|
|
VO2 Peak (L/min) During CPXT Arm Ergometry Exercise
|
0.99 L/min
STANDARD_DEVIATION 0.39 • n=44 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
0.99 L/min
STANDARD_DEVIATION 0.38 • n=79 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
0.99 L/min
STANDARD_DEVIATION 0.37 • n=35 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
VO2 Peak (mL/kg/min) During CPXT Arm Ergometry Exercise
|
11.82 mL/kg/min
STANDARD_DEVIATION 4.76 • n=44 Participants • Some values werenot obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
11.64 mL/kg/min
STANDARD_DEVIATION 4.30 • n=79 Participants • Some values werenot obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
11.43 mL/kg/min
STANDARD_DEVIATION 3.70 • n=35 Participants • Some values werenot obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
|
VO2 Peak (L/min) Achieved During FES-LC Exercise Alone
|
0.43 L/min
STANDARD_DEVIATION 0.27 • n=45 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
0.42 L/min
STANDARD_DEVIATION 0.23 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
0.40 L/min
STANDARD_DEVIATION 0.18 • n=38 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
VO2 Peak (mL/kg/min) Achieved During FES-LC Exercise Alone
|
5.23 mL/kg/min
STANDARD_DEVIATION 3.43 • n=45 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
5.05 mL/kg/min
STANDARD_DEVIATION 2.97 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
4.85 mL/kg/min
STANDARD_DEVIATION 2.33 • n=38 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
|
VO2 Peak (L/min) Achieved During Combined FES-LC and AE Exercise
|
1.11 L/min
STANDARD_DEVIATION 0.48 • n=45 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
1.14 L/min
STANDARD_DEVIATION 0.45 • n=81 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
1.17 L/min
STANDARD_DEVIATION 0.40 • n=36 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
VO2 Peak (mL/kg/min) Achieved During Combined FES-LC and AE Exercise
|
13.20 mL/kg/min
STANDARD_DEVIATION 5.69 • n=45 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
13.50 mL/kg/min
STANDARD_DEVIATION 5.29 • n=81 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
13.88 mL/kg/min
STANDARD_DEVIATION 4.78 • n=36 Participants • Some values were not obtained during specific visits due to the Covid-19 shutdown or machine malfunction.
|
|
Work Rate Max During Arm Ergometry Alone
|
62.21 Watts
STANDARD_DEVIATION 36.05 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
66.43 Watts
STANDARD_DEVIATION 34.04 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
71.76 Watts
STANDARD_DEVIATION 31.01 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
Work Rate Max During FES-LC Exercise Alone
|
10.80 Watts
STANDARD_DEVIATION 15.78 • n=41 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
8.46 Watts
STANDARD_DEVIATION 12.16 • n=76 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
5.71 Watts
STANDARD_DEVIATION 4.36 • n=35 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
Work Rate Max During Combined FES-LC + AE Exercise
|
78.00 Watts
STANDARD_DEVIATION 39.59 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
80.56 Watts
STANDARD_DEVIATION 38.3 • n=70 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
83.77 Watts
STANDARD_DEVIATION 37.79 • n=31 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise
|
714.4 N
STANDARD_DEVIATION 473.7 • n=40 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
768.2 N
STANDARD_DEVIATION 450.0 • n=72 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
825.3 N
STANDARD_DEVIATION 416.0 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
Muscle Endurance in the Chest Press Exercise
|
10.89 Repetitions to failure
STANDARD_DEVIATION 5.50 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
10.47 Repetitions to failure
STANDARD_DEVIATION 4.62 • n=66 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
9.93 Repetitions to failure
STANDARD_DEVIATION 3.18 • n=29 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down or machine malfunction.
|
|
Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA)
|
52.08 kg
STANDARD_DEVIATION 11.98 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
52.92 kg
STANDARD_DEVIATION 10.87 • n=71 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
53.95 kg
STANDARD_DEVIATION 9.43 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Upper Extremity Lean Tissue Mass Measured Using DXA
|
7.32 kg
STANDARD_DEVIATION 2.45 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
7.57 kg
STANDARD_DEVIATION 2.31 • n=71 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
7.88 kg
STANDARD_DEVIATION 2.13 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Lower Extremity Lean Tissue Mass Measured Using DXA
|
14.02 kg
STANDARD_DEVIATION 4.48 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
14.20 kg
STANDARD_DEVIATION 4.07 • n=71 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
14.42 kg
STANDARD_DEVIATION 3.58 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Trunk Lean Tissue Mass Measured Using DXA
|
27.44 kg
STANDARD_DEVIATION 6.13 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
27.81 kg
STANDARD_DEVIATION 5.72 • n=71 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
28.26 kg
STANDARD_DEVIATION 5.24 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Appendicular Lean Tissue Mass Measured Using DXA
|
21.34 kg
STANDARD_DEVIATION 5.82 • n=39 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
21.77 kg
STANDARD_DEVIATION 5.28 • n=71 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
22.3 kg
STANDARD_DEVIATION 4.59 • n=32 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Fasting Glucose
|
91.50 mg/dL
STANDARD_DEVIATION 13.12 • n=44 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
91.38 mg/dL
STANDARD_DEVIATION 18.56 • n=80 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
91.22 mg/dL
STANDARD_DEVIATION 20.20 • n=36 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Hemoglobin A1C
|
5.12 Percentage of hemoglobin
STANDARD_DEVIATION 0.38 • n=46 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
5.21 Percentage of hemoglobin
STANDARD_DEVIATION 0.61 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
5.32 Percentage of hemoglobin
STANDARD_DEVIATION 0.81 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Homeostatic Model Assessment for Insulin Resistance
|
2.19 HOMA-IR Score
STANDARD_DEVIATION 2.54 • n=42 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
2.16 HOMA-IR Score
STANDARD_DEVIATION 2.78 • n=76 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
2.13 HOMA-IR Score
STANDARD_DEVIATION 3.08 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Total Cholesterol
|
177.1 mg/dL
STANDARD_DEVIATION 41.88 • n=46 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
174.8 mg/dL
STANDARD_DEVIATION 38.57 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
172.0 mg/dL
STANDARD_DEVIATION 34.38 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Low-density Lipoprotein
|
107.7 mg/dL
STANDARD_DEVIATION 37.29 • n=45 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
106.3 mg/dL
STANDARD_DEVIATION 34.02 • n=82 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
104.6 mg/dL
STANDARD_DEVIATION 29.97 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Non-HDL Cholesterol
|
130.3 mg/dL
STANDARD_DEVIATION 41.73 • n=46 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
128.3 mg/dL
STANDARD_DEVIATION 37.90 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
125.9 mg/dL
STANDARD_DEVIATION 32.93 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
HDL Cholesterol
|
46.80 mg/dL
STANDARD_DEVIATION 12.59 • n=46 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
46.48 mg/dL
STANDARD_DEVIATION 11.41 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
46.08 mg/dL
STANDARD_DEVIATION 9.90 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Triglycerides
|
125.6 mg/dL
STANDARD_DEVIATION 80.09 • n=46 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
121.6 mg/dL
STANDARD_DEVIATION 73.06 • n=83 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
116.5 mg/dL
STANDARD_DEVIATION 63.98 • n=37 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
hsCRP
|
6063.41 ng/mL
STANDARD_DEVIATION 6639.21 • n=41 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
6481.62 ng/mL
STANDARD_DEVIATION 10322.04 • n=76 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
6994.94 ng/mL
STANDARD_DEVIATION 13515.33 • n=35 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score)
|
52.03 T-score
STANDARD_DEVIATION 6.36 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
52.75 T-score
STANDARD_DEVIATION 6.63 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
53.65 T-score
STANDARD_DEVIATION 6.94 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27)
|
4.05 Score
STANDARD_DEVIATION 5.20 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
3.13 Score
STANDARD_DEVIATION 4.33 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
1.97 Score
STANDARD_DEVIATION 2.52 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Brief Pain Inventory (BPI) (Score:0 - 10)
|
2.82 Score
STANDARD_DEVIATION 2.38 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
2.85 Score
STANDARD_DEVIATION 2.27 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
2.90 Score
STANDARD_DEVIATION 2.15 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Loneliness Questionnaire (Score: 3-9)
|
4.44 Score
STANDARD_DEVIATION 1.74 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
4.38 Score
STANDARD_DEVIATION 1.64 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
4.29 Score
STANDARD_DEVIATION 1.53 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Satisfaction With Life Scale (SWLS) (Score: 5 - 35)
|
20.91 Score
STANDARD_DEVIATION 7.29 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
20.81 Score
STANDARD_DEVIATION 7.75 • n=77 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
20.68 Score
STANDARD_DEVIATION 8.41 • n=34 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
|
Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21)
|
3.09 Score
STANDARD_DEVIATION 3.85 • n=43 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
2.32 Score
STANDARD_DEVIATION 3.23 • n=76 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
1.30 Score
STANDARD_DEVIATION 1.74 • n=33 Participants • Some values were not obtained during specific visits due to the Covid-19 shut down.
|
PRIMARY outcome
Timeframe: Week 16Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=11 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=15 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (L/Min) Achieved During Arm Ergometry Exercise Alone
|
0.11 L/min
Interval 0.03 to 0.2
|
0.09 L/min
Interval 0.01 to 0.16
|
PRIMARY outcome
Timeframe: Week 16Week 16 change from baseline in VO2 peak aerobic capacity during cardiopulmonary testing using arm ergometry exercise alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=37 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Arm Ergometry Exercise Alone
|
1.27 mL/kg/min
Interval 0.26 to 2.29
|
0.88 mL/kg/min
Interval 0.02 to 1.74
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in peak VO2 aerobic capacity achieved during the functional electrical stimulation -leg cycle (FES-LC) exercise alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=37 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (L/Min) Achieved During FES-LC Exercise Alone
|
0.06 L/min
Interval -0.01 to 0.14
|
0.02 L/min
Interval -0.04 to 0.09
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in peak VO2 aerobic capacity achieved during the functional electrical stimulation -leg cycle (FES-LC) exercise alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=37 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During FES-LC Exercise Alone
|
0.76 mL/kg/min
Interval -0.2 to 1.72
|
0.48 mL/kg/min
Interval -0.37 to 1.32
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the VO2 peak aerobic capacity during the combined functional electrical stimulation- leg cycling (FES-LC) and arm ergometry (AE) exercise
Outcome measures
| Measure |
Multi-modality Intervention Group
n=24 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (L/Min) Achieved During Combined FES-LC and AE Exercise
|
0.04 L/min
Interval -0.12 to 0.2
|
0 L/min
Interval -0.13 to 0.14
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the VO2 peak aerobic capacity during the combined functional electrical stimulation- leg cycling (FES-LC) and arm ergometry (AE) exercise
Outcome measures
| Measure |
Multi-modality Intervention Group
n=24 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in VO2 Peak (mL/kg/Min) Achieved During Combined FES-LC and AE Exercise
|
0.12 mL/kg/min
Interval -3.29 to 3.53
|
1.89 mL/kg/min
Interval -0.97 to 4.76
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Work Rate Max measured in Watts during arm ergometry alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=23 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=32 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Work Rate Max During Arm Ergometry Alone
|
10.74 Watts
Interval 2.65 to 18.82
|
6.49 Watts
Interval -0.7 to 13.68
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Work Rate Max measured in Watts during FES-LC exercise alone
Outcome measures
| Measure |
Multi-modality Intervention Group
n=23 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=32 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Work Rate Max During FES-LC Exercise Alone
|
1.98 Watts
Interval -1.32 to 5.28
|
0.28 Watts
Interval -2.45 to 3.01
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Work Rate Max measured in Watts during combined FES-LC + AE exercise
Outcome measures
| Measure |
Multi-modality Intervention Group
n=20 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=24 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Work Rate Max During Combined FES-LC + AE Exercise
|
8.91 Watts
Interval -4.66 to 22.47
|
5.76 Watts
Interval -6.32 to 17.85
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the one repetition maximum (1-RM) voluntary strength in the chest press exercise, measured in force units (Newtons)
Outcome measures
| Measure |
Multi-modality Intervention Group
n=24 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the One Repetition Maximum (1-RM) Voluntary Strength in the Chest Press Exercise
|
45.1 N
Interval 15.39 to 74.81
|
14.83 N
Interval -10.2 to 39.91
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline muscle endurance in the seated chest press exercise, measured in number of repetitions to failure
Outcome measures
| Measure |
Multi-modality Intervention Group
n=21 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=25 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Muscle Endurance in the Chest Press Exercise
|
-0.26 Repetitions
Interval -1.81 to 129.0
|
-0.33 Repetitions
Interval -1.72 to 1.05
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the whole body lean mass measured using dual energy X-ray absorptiometry (DXA), measured in kg
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Whole Body Lean Mass Measured Using Dual Energy X-ray Absorptiometry (DXA)
|
2.21 kg
Interval 1.25 to 3.18
|
0.38 kg
Interval -0.5 to 1.25
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the upper extremity lean tissue mass measured using DXA, measured in kg
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Upper Extremity Lean Tissue Mass Measured Using DXA
|
0.31 kg
Interval 0.11 to 0.51
|
0.01 kg
Interval -0.17 to 0.2
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the lower extremity lean tissue mass measured using DXA, measured in kg
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Lower Extremity Lean Tissue Mass Measured Using DXA
|
1.28 kg
Interval 0.89 to 1.67
|
0.37 kg
Interval 0.01 to 0.72
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the trunk lean tissue mass measured using DXA, measured in kg
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Trunk Lean Tissue Mass Measured Using DXA
|
0.60 kg
Interval 0.02 to 1.18
|
0.02 kg
Interval -0.5 to 0.54
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in the appendicular lean tissue mass measured using DXA, measured in kg
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=33 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in the Appendicular Lean Tissue Mass Measured Using DXA
|
1.61 kg
Interval 1.12 to 2.09
|
0.37 kg
Interval -0.07 to 0.8
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Fasting Glucose
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=40 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Fasting Glucose
|
4.52 mg/dL
Interval -0.46 to 9.49
|
-3.34 mg/dL
Interval -7.49 to 0.82
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Hemoglobin A1C
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1C
|
0.03 percentage of hemoglobin
Interval -0.08 to 0.14
|
-0.02 percentage of hemoglobin
Interval -0.11 to 0.07
|
SECONDARY outcome
Timeframe: 16 weeksWeek 16 change from baseline in insulin sensitivity will be measured as Homeostatic Model Assessment - Insulin Resistance Index. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) scores measure insulin sensitivity, with lower scores indicating better health. Generally, scores below 1.0 are considered optimal, 1.0 -1.9 indicates normal insulin sensitivity, 2.0 - 2.9 suggests early insulin resistance, and greater or equal than 3.0 indicates significant resistance, typically rising to greater or equal than 5.0 in type 2 diabetes.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=27 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=39 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline Homeostatic Model Assessment for Insulin Resistance
|
0.52 HOMA-IR Score
Interval -0.53 to 1.58
|
-0.86 HOMA-IR Score
Interval -1.74 to 0.01
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in total cholesterol, measured in mg/dL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Total Cholesterol
|
0.71 mg/dL
Interval -7.98 to 9.39
|
-2.02 mg/dL
Interval -9.09 to 5.05
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in Low-density lipoprotein, measured as mg/dL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Low-density Lipoprotein
|
0.57 mg/dL
Interval -6.7 to 7.82
|
-1.89 mg/dL
Interval -7.61 to 4.23
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in non-HDL cholesterol, measured in mg/dL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Non-HDL Cholesterol
|
1.80 mg/dL
Interval -5.97 to 9.57
|
-2.41 mg/dL
Interval -8.73 to 3.91
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in HDL cholesterol, measured in mg/dL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in HDL Cholesterol
|
-1.22 mg/dL
Interval -3.31 to 0.86
|
0.48 mg/dL
Interval -1.21 to 2.18
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in triglycerides, measured in mg/dL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=28 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=42 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Triglycerides
|
7.77 mg/dL
Interval -8.9 to 24.44
|
-6.01 mg/dL
Interval -19.6 to 7.55
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in hsCRP, measured in ng/mL
Outcome measures
| Measure |
Multi-modality Intervention Group
n=23 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=32 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Inflammatory Markers
|
-1157.18 ng/mL
Interval -52019.95 to 2902.6
|
1602.67 ng/mL
Interval -1829.47 to 5034.81
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline self-reported function and mobility measured by the Spinal Cord Injury Function Index (SCI-FI). The Basic Mobility Standardized T-Score comes from the Self-reported Function and Mobility (SCI-FI) Questionnaire. The Basic Mobility Standardized T-Score ranges from 31.97 to 68.48, with a mean of 50 and a standard deviation of 10. A higher Basic Mobility Standardized T-Score indicates better mobility.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=39 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Self-reported Function and Mobility (SCI-FI) (Basic Mobility Standardized Score: 31.97 - 68.48), With a Higher Score Indicating Better Mobility
|
-0.12 T-Score
Interval -1.86 to 1.63
|
1.67 T-Score
Interval 0.16 to 3.19
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in depressive symptoms, ascertained using the Patient Health Questionnaire - (PHQ-9). The score range is 0 to 27. A higher score indicates more severe depression.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=39 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Depressive Symptoms, Ascertained Using the Patient Health Questionnaire - 9 (PHQ-9) (Score: 0-27), With a Higher Score Indicating More Severe Depression
|
0.17 Score
Interval -0.87 to 1.2
|
0.80 Score
Interval -0.09 to 1.69
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline Brief Pain Inventory (BPI). Score range is 0 to 10. Higher scores indicate worse pain. Severity Score (0-10): Mean of 4 items (worst, least, average, and current pain).
Outcome measures
| Measure |
Multi-modality Intervention Group
n=30 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=38 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Pain and Its Impact on Life, Ascertained Using the Brief Pain Inventory (BPI) (Score:0 - 10), With a Higher Score Indicating More Pain
|
0.07 Score
Interval -0.57 to 0.71
|
0.35 Score
Interval -0.22 to 0.92
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline three-Item Loneliness Scale. Score range is 3 to 9, with a score of 3 indicating the least loneliness and 9 the most loneliness.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=30 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=38 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Loneliness, Using a 3-item Loneliness Questionnaire (Score: 3-9), With a Higher Score Indicating More Loneliness
|
0.18 Score
Interval -0.39 to 0.75
|
0.23 Score
Interval -0.27 to 0.73
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in satisfaction with life, ascertained using the Satisfaction with Life Scale (SWLS). The score range is from 5 to 35. Higher scores indicate more satisfaction with life.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=30 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=38 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Satisfaction With Life, Ascertained Using the Satisfaction With Life Scale (SWLS) (Score: 5 - 35), With a Higher Score Indicating More Satisfaction With Life
|
0.25 Score
Interval -1.88 to 2.37
|
0.50 Score
Interval -1.4 to 2.39
|
SECONDARY outcome
Timeframe: Week 16Week 16 change from baseline in anxiety ascertained using the Generalized Anxiety Disorder - 7 scale (GAD-7). Score range is 0 to 21. A higher score indicates worse anxiety.
Outcome measures
| Measure |
Multi-modality Intervention Group
n=29 Participants
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=39 Participants
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Change From Baseline in Anxiety Ascertained Using the Generalized Anxiety Disorder - 7 Scale (GAD-7) (Score: 0 - 21), With a Higher Score Indicating Worse Anxiety
|
0.80 Score
Interval -0.42 to 2.02
|
0.80 Score
Interval -0.25 to 1.85
|
Adverse Events
Multi-modality Intervention Group
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo Group
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multi-modality Intervention Group
n=36 participants at risk
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=44 participants at risk
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Infections and infestations
Hospitalization due to flu dx and pneumonia
|
2.8%
1/36 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
0.00%
0/44 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Gastrointestinal disorders
Hospitalization of stomach pain
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Infections and infestations
UTI Complication and Hospitalization
|
2.8%
1/36 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
0.00%
0/44 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for back pain
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Surgical and medical procedures
Hospitalization for a planned baclofen pump insertion/revision surgery
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Injury, poisoning and procedural complications
Chronic nonunited left subcapital femoral fracture
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Vascular disorders
RIJ thrombophlebitis
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Infections and infestations
Deep face neck infection
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Surgical and medical procedures
Hospitalization for an elective penile implant
|
2.8%
1/36 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
0.00%
0/44 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Surgical and medical procedures
Hospitalization for a planned laparoscopic assisted sigmoid colostomy surgery and an IUD removal
|
0.00%
0/36 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
Other adverse events
| Measure |
Multi-modality Intervention Group
n=36 participants at risk
Hybrid exercise (functional electrical stimulation - leg cycling, FES LC plus arm ergometry) plus Testosterone undecanoate
Testosterone Undecanoate: administered through injections by study staff
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
Placebo Group
n=44 participants at risk
Hybrid exercise plus placebo medication
hybrid exercise: hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
2.8%
1/36 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
8.3%
3/36 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
6.8%
3/44 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Gastrointestinal disorders
Gastrointestinal
|
5.6%
2/36 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
20.5%
9/44 • Number of events 10 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Hepatobiliary disorders
Hepatic/Biliary
|
2.8%
1/36 • Number of events 2 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
6.8%
3/44 • Number of events 4 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Renal and urinary disorders
Genital/Urinary
|
25.0%
9/36 • Number of events 11 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
20.5%
9/44 • Number of events 11 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Endocrine disorders
Endocrine/ Metabolic
|
8.3%
3/36 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
0.00%
0/44 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
33.3%
12/36 • Number of events 25 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
45.5%
20/44 • Number of events 24 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Blood and lymphatic system disorders
Hematologic/Lymphatic
|
5.6%
2/36 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
2.3%
1/44 • Number of events 1 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Nervous system disorders
Neurologic
|
5.6%
2/36 • Number of events 2 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
4.5%
2/44 • Number of events 2 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
38.9%
14/36 • Number of events 22 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
31.8%
14/44 • Number of events 24 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
Infections and infestations
Infectious Disease
|
5.6%
2/36 • Number of events 4 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
4.5%
2/44 • Number of events 3 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
|
General disorders
Other
|
36.1%
13/36 • Number of events 29 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
29.5%
13/44 • Number of events 23 • 16 weeks
The safety population was defined as the participants who were randomized and received at least 1 study treatment dose. Because only 80 out of the 84 randomized participants received at least 1 study treatment dose, the safety analysis population comprises of 80 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place