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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00345969
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Physical Frailty
Hip Fracture
Elective Hip Replacement
Hypogonadism
Interventions Drug: Transdermal Testosterone gel (1%)
Behavioral: Supervised exercise training
Enrollment 25
Recruitment Details 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.
Pre-assignment Details Participants were carefully screened for exclusion criteria prior to randomization.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 12 13
Completed 11 11
Not Completed 1 2
Arm/Group Title Exercise + Placebo Exercise + Testosterone Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
Men who completed the intervention and provided baseline and follow-up data for primary outcome measures.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
81  (4) 77  (6) 80  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
11
 100.0%
22
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  18.2%
2
   9.1%
White
11
 100.0%
9
  81.8%
20
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Total Modified Physical Performance (mPPT) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 11 participants 22 participants
23  (4) 26  (3) 25  (4)
[1]
Measure Description: Range 0-36, (min-max); higher scores indicate better physical performance. The Total mPPT score is constructed by summing sub-scores of 9 performance tasks. Sub-scores have a range of 0-4 (min-max); higher sub-scores indicate better performance.
Total Testosterone level (ng/dL)  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 11 participants 11 participants 22 participants
252  (71) 248  (97) 250  (84)
BMI (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 11 participants 11 participants 22 participants
28  (3) 29  (5) 29  (4)
Body Weight (lbs.)  
Mean (Standard Deviation)
Unit of measure:  Lbs.
Number Analyzed 11 participants 11 participants 22 participants
193  (30) 195  (38) 194  (34)
1.Primary Outcome
Title Mean Change in Total Lean Body Mass
Hide Description Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: kg
0.5  (1.8) 2.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Skeletal Muscle Strength by 1-RM
Hide Description One-repetition maximum strength for leg extension
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 8 participants in the Exercise+Testosterone group provided Leg Extension 1-RM measurements at baseline and 6-month follow-up.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: lbs.
59.2  (33.3) 70.3  (37.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
Hide Description Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: ft/lb
10.4  (14.2) 19.8  (18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Leg Extension Torque at 60 Deg/Sec
Hide Description Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: ft/lb
12.7  (13.5) 19.4  (21.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Total Body Fat Mass
Hide Description Total Body Fat Mass as measured by DXA
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: kg
-0.51  (0.96) -1.1  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in Femoral Bone Mineral Density (BMD)
Hide Description Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: g/cm2
-0.008  (1.238) 0.084  (3.515)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Total Modified Physical Performance (mPPT) Score
Hide Description 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.
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 10 participants in the Exercise+Placebo group, and 9 participants in the Exercise+Testosterone group, provided baseline and follow-up mPPT measurements.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (3.7) 2.8  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Serum Testosterone Level
Hide Description Total Serum Testosterone Level (ng/mL)
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 participants in the Exercise+Testosterone group provided serum testosterone levels at baseline and 6-month follow-up.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
-15.3  (72.6) 121.2  (235.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change in Serum Prostate Specific Antigen (PSA) Level
Hide Description [Not Specified]
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.05  (0.27) 0.21  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Other Pre-specified Outcome
Title Change in Hematocrit
Hide Description Percentage of the volume of whole blood composed of Red Blood Cells
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: percent
0.14  (2.6) 2.5  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Other Pre-specified Outcome
Title Change in Serum Total Cholesterol Level
Hide Description [Not Specified]
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.2  (15.4) -9.0  (42.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change in Serum HDL Cholesterol Level
Hide Description [Not Specified]
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.4  (9.0) 1.7  (7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change in Serum LDL Cholesterol Level
Hide Description [Not Specified]
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.6  (15.3) -1.6  (39.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise + Placebo, Exercise + Testosterone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exercise + Placebo Exercise + Testosterone
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Exercise + Placebo Exercise + Testosterone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exercise + Placebo Exercise + Testosterone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/13 (7.69%)    
Cardiac disorders     
Atrial fibrillation * [1]  0/12 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant experienced new onset atrial fibrillation that required acute care hospitalization. The patient's symptoms occurred at rest and were not coincident with performing exercise.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercise + Placebo Exercise + Testosterone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/13 (7.69%)    
General disorders     
Fall * [1]  1/12 (8.33%)  1 0/13 (0.00%)  0
Renal and urinary disorders     
Elevated serum PSA level  [2]  0/12 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Participant experienced a fall during balance testing; no injury sustained.
[2]
Participant had elevated PSA level (7.2 ng/mL) at month 6 of study, which returned to normal at 30-day follow up.
Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ellen F. Binder, MD
Organization: Washington University School of Medicine
Phone: 314-286-2707
Responsible Party: Ellen F. Binder, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00345969     History of Changes
Other Study ID Numbers: HSC 02-1108
First Submitted: June 27, 2006
First Posted: June 29, 2006
Results First Submitted: January 15, 2016
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018