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TEAM: Testosterone Supplementation and Exercise in Elderly Men

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00112151
First received: May 27, 2005
Last updated: December 14, 2015
Last verified: November 2015
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: LowT
Behavioral: Resistance Training
Drug: Placebo
Drug: HighT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from January 2005 through August 2009 of community dwelling men >=60 years of age in the Denver metropolitan area with active attempts to recruit men from all ethnic populations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
see eligibility criteria

Reporting Groups
  Description
LowT+Resistance Training

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)

1 year standard Progressive Resistance Training(PRT) program

LowT+No Resistance Training

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)

No exercise program

HighT+Resistance Training

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)

1 year standard Progressive Resistance Training(PRT) program

HighT+No Resistance Training

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)

No exercise program

Placebo+Resistance Training

Placebo Group applies two 2.5 gm placebo packets

1 year standard Progressive Resistance Training(PRT) program

Placebo+No Resistance Training

Placebo group applies two 2.5 gm placebo packets

No exercise program


Participant Flow:   Overall Study
    LowT+Resistance Training   LowT+No Resistance Training   HighT+Resistance Training   HighT+No Resistance Training   Placebo+Resistance Training   Placebo+No Resistance Training
STARTED   28   28   28   27   28   28 
COMPLETED   24   23   25   24   22   25 
NOT COMPLETED   4   5   3   3   6   3 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
LowT+Resistance Training

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)

1 year standard Progressive Resistance Training(PRT) program

LowT+No Resistance Training

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)

No exercise program

HighT+Resistance Training

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)

1 year standard Progressive Resistance Training(PRT) program

HighT+No Resistance Training

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)

No exercise program

Placebo+Resistance Training

Placebo Group applies two 2.5 gm placebo packets

1 year standard Progressive Resistance Training(PRT) program

Placebo+No Resistance Training

Placebo group applies two 2.5 gm placebo packets

No exercise program

Total Total of all reporting groups

Baseline Measures
   LowT+Resistance Training   LowT+No Resistance Training   HighT+Resistance Training   HighT+No Resistance Training   Placebo+Resistance Training   Placebo+No Resistance Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   28   28   27   28   28   167 
Age 
[Units: Participants]
             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   12   12   17   13   16   12   82 
>=65 years   16   16   11   14   12   16   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (7.6)   65.6  (4.5)   64.3  (4.6)   65.3  (5.5)   64.7  (4.5)   66.6  (5.4)   65.7  (5.5) 
Gender 
[Units: Participants]
             
Female   0   0   0   0   0   0   0 
Male   28   28   28   27   28   28   167 
Region of Enrollment 
[Units: Participants]
             
United States   28   28   28   27   28   28   167 


  Outcome Measures
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1.  Primary:   Physical Function (CS-PFP Total Score)   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   Upper Body Muscle Strength (1-RM, kg)   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Lower Body Muscle Strength (1-RM, kg)   [ Time Frame: Baseline and 12 months ]

4.  Secondary:   Power (Power Rig, Watts)   [ Time Frame: Baseline and 12 months ]

5.  Secondary:   Fat Mass (kg)   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Fat Free Mass (kg)   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Robert S. Schwartz, Head, Division of Geriatric Medicine
Organization: Univeristy of Colorado at Denver
phone: 303-724-1919
e-mail: robert.schwartz@ucdenver.edu


Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00112151     History of Changes
Other Study ID Numbers: 02-1056
R01AG019339 ( US NIH Grant/Contract Award Number )
Study First Received: May 27, 2005
Results First Received: November 4, 2015
Last Updated: December 14, 2015
Health Authority: United States: Federal Government