Trial Outcomes & Findings for Exercise and Testosterone Therapy in Elderly Men With Physical Frailty (NCT NCT00345969)
NCT ID: NCT00345969
Last Updated: 2018-02-22
Results Overview
Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
COMPLETED
PHASE3
25 participants
Baseline and Six Months
2018-02-22
Participant Flow
Participants were recruited from orthopedic units of local hospitals, rehabilitation facilities (both acute rehabilitation units and SNFs), home care programs, and the community-at-large.
Participants were carefully screened for exclusion criteria prior to randomization.
Participant milestones
| Measure |
Exercise + Placebo
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
Exercise + Testosterone
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Baseline characteristics by cohort
| Measure |
Exercise + Placebo
n=11 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
Exercise + Testosterone
n=11 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81 years
STANDARD_DEVIATION 4 • n=39 Participants
|
77 years
STANDARD_DEVIATION 6 • n=41 Participants
|
80 years
STANDARD_DEVIATION 7 • 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
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
20 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
|
|
Total Modified Physical Performance (mPPT) score
|
23 units on a scale
STANDARD_DEVIATION 4 • n=39 Participants
|
26 units on a scale
STANDARD_DEVIATION 3 • n=41 Participants
|
25 units on a scale
STANDARD_DEVIATION 4 • n=35 Participants
|
|
Total Testosterone level (ng/dL)
|
252 ng/dL
STANDARD_DEVIATION 71 • n=39 Participants
|
248 ng/dL
STANDARD_DEVIATION 97 • n=41 Participants
|
250 ng/dL
STANDARD_DEVIATION 84 • n=35 Participants
|
|
BMI (kg/m2)
|
28 kg/m2
STANDARD_DEVIATION 3 • n=39 Participants
|
29 kg/m2
STANDARD_DEVIATION 5 • n=41 Participants
|
29 kg/m2
STANDARD_DEVIATION 4 • n=35 Participants
|
|
Body Weight (lbs.)
|
193 lbs.
STANDARD_DEVIATION 30 • n=39 Participants
|
195 lbs.
STANDARD_DEVIATION 38 • n=41 Participants
|
194 lbs.
STANDARD_DEVIATION 34 • n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Six MonthsTotal Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Outcome measures
| Measure |
Exercise + Testosterone
n=11 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=11 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Mean Change in Total Lean Body Mass
|
2.3 kg
Standard Deviation 1.0
|
0.5 kg
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.
One-repetition maximum strength for leg extension
Outcome measures
| Measure |
Exercise + Testosterone
n=8 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=11 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Skeletal Muscle Strength by 1-RM
|
70.3 lbs.
Standard Deviation 37.5
|
59.2 lbs.
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in Exercise+Placebo group, and 8 participants in Exercise+Testosterone group, provided Leg Extension torque measurements at baseline and 6-month follow-up.
Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
Outcome measures
| Measure |
Exercise + Testosterone
n=8 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
|
19.8 ft/lb
Standard Deviation 18.1
|
10.4 ft/lb
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in the Exercise+Placebo group, and 8 participants in the Exercise+Testosterone group, provided Leg extension torque measurements at baseline and 6 month follow-up.
Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
Outcome measures
| Measure |
Exercise + Testosterone
n=8 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Leg Extension Torque at 60 Deg/Sec
|
19.4 ft/lb
Standard Deviation 21.4
|
12.7 ft/lb
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsTotal Body Fat Mass as measured by DXA
Outcome measures
| Measure |
Exercise + Testosterone
n=11 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=11 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Total Body Fat Mass
|
-1.1 kg
Standard Deviation 1.7
|
-0.51 kg
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in the Exercise+Placebo group, and 10 participants in the Exercise+Testosterone group, provided femoral bone density measurements at baseline and the 6 month follow-up.
Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
Outcome measures
| Measure |
Exercise + Testosterone
n=10 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Femoral Bone Mineral Density (BMD)
|
0.084 g/cm2
Standard Deviation 3.515
|
-0.008 g/cm2
Standard Deviation 1.238
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.
The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living \[ADL\]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Total Modified Physical Performance (mPPT) Score
|
2.8 units on a scale
Standard Deviation 4.4
|
5.0 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and Six MonthsPopulation: Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.
Total Serum Testosterone Level (ng/mL)
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=11 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Serum Testosterone Level
|
121.2 ng/mL
Standard Deviation 235.5
|
-15.3 ng/mL
Standard Deviation 72.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum PSA level measurements at baseline and 6 month follow-up.
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Serum Prostate Specific Antigen (PSA) Level
|
0.21 ng/mL
Standard Deviation 0.63
|
0.05 ng/mL
Standard Deviation 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided hematocrit measurements at baseline and 6-month follow-up.
Percentage of the volume of whole blood composed of Red Blood Cells
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=10 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Hematocrit
|
2.5 percent
Standard Deviation 4.8
|
0.14 percent
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for cholesterol measurements at baseline and 6 months.
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=9 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Serum Total Cholesterol Level
|
-9.0 mg/dL
Standard Deviation 42.9
|
-3.2 mg/dL
Standard Deviation 15.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for HDL cholesterol measurements at baseline and 6 months.
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=9 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Serum HDL Cholesterol Level
|
1.7 mg/dL
Standard Deviation 7.8
|
-1.4 mg/dL
Standard Deviation 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: Only 9 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided serum for LDL cholesterol measurements at baseline and 6 months.
Outcome measures
| Measure |
Exercise + Testosterone
n=9 Participants
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
Exercise + Placebo
n=9 Participants
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
|---|---|---|
|
Change in Serum LDL Cholesterol Level
|
-1.6 mg/dL
Standard Deviation 39.0
|
-3.6 mg/dL
Standard Deviation 15.3
|
Adverse Events
Exercise + Placebo
Exercise + Testosterone
Serious adverse events
| Measure |
Exercise + Placebo
n=12 participants at risk
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
Exercise + Testosterone
n=13 participants at risk
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Exercise + Placebo
n=12 participants at risk
Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months.
|
Exercise + Testosterone
n=13 participants at risk
Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months.
|
|---|---|---|
|
Renal and urinary disorders
Elevated serum PSA level
|
0.00%
0/12 • 12 months
|
7.7%
1/13 • Number of events 1 • 12 months
|
|
General disorders
Fall
|
8.3%
1/12 • Number of events 1 • 12 months
|
0.00%
0/13 • 12 months
|
Additional Information
Ellen F. Binder, MD
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60