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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were carefully screened for exclusion criteria prior to randomization.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Exercise + Placebo   Exercise + Testosterone
STARTED   12   13 
COMPLETED   11   11 
NOT COMPLETED   1   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men who completed the intervention and provided baseline and follow-up data for primary outcome measures.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Exercise + Placebo   Exercise + Testosterone   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 81  (4)   77  (6)   80  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      11 100.0%      11 100.0%      22 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 23  (4)   26  (3)   25  (4) 
[1] 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) 
[Units: ng/dL]
Mean (Standard Deviation)
 252  (71)   248  (97)   250  (84) 
BMI (kg/m2) 
[Units: Kg/m2]
Mean (Standard Deviation)
 28  (3)   29  (5)   29  (4) 
Body Weight (lbs.) 
[Units: Lbs.]
Mean (Standard Deviation)
 193  (30)   195  (38)   194  (34) 


  Outcome Measures

1.  Primary:   Mean Change in Total Lean Body Mass   [ Time Frame: Baseline and Six Months ]

2.  Primary:   Change in Skeletal Muscle Strength by 1-RM   [ Time Frame: Baseline and Six Months ]

3.  Secondary:   Change in Isokinetic Leg Extension Torque at 0 Deg/Sec   [ Time Frame: Baseline and Six Months ]

4.  Secondary:   Change in Leg Extension Torque at 60 Deg/Sec   [ Time Frame: Baseline and Six Months ]

5.  Secondary:   Change in Total Body Fat Mass   [ Time Frame: Baseline and Six Months ]

6.  Secondary:   Change in Femoral Bone Mineral Density (BMD)   [ Time Frame: Baseline and Six Months ]

7.  Secondary:   Change in Total Modified Physical Performance (mPPT) Score   [ Time Frame: Baseline and Six Months ]

8.  Secondary:   Change in Serum Testosterone Level   [ Time Frame: Baseline and Six Months ]

9.  Other Pre-specified:   Change in Serum Prostate Specific Antigen (PSA) Level   [ Time Frame: Baseline and Six Months ]

10.  Other Pre-specified:   Change in Hematocrit   [ Time Frame: Baseline and Six Months ]

11.  Other Pre-specified:   Change in Serum Total Cholesterol Level   [ Time Frame: Baseline and Six Months ]

12.  Other Pre-specified:   Change in Serum HDL Cholesterol Level   [ Time Frame: Baseline and Six Months ]

13.  Other Pre-specified:   Change in Serum LDL Cholesterol Level   [ Time Frame: Baseline and Six Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small number of subjects enrolled, single site trial, included both hip fracture patients and a few patients with elective hip joint replacement.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: ebinder@wustl.edu



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