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

May 27, 2005
December 14, 2015
January 2005
November 2010   (final data collection date for primary outcome measure)
Physical Function (CS-PFP Total Score) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.
  • body composition
  • fat distribution
  • strength
  • power
  • function
Complete list of historical versions of study NCT00112151 on ClinicalTrials.gov Archive Site
  • Upper Body Muscle Strength (1-RM, kg) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.
  • Lower Body Muscle Strength (1-RM, kg) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.
  • Power (Power Rig, Watts) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).
  • Fat Mass (kg) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Total change in Fat mass (kg) as evaluated by DXA
  • Fat Free Mass (kg) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Total change in Fat free mass (kg) as evaluated by DXA
  • cognition
  • vascular reactivity
  • Obstructive sleep apnea
  • testosterone
  • estradiol
  • dehydroepiandrosterone (DHEA)
  • insulin-like growth factor I
  • insulin resistance
Not Provided
Not Provided
 
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Testosterone Supplementation and Exercise in Elderly Men
The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.

Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men.

This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT.

Please see link below for updated version of full protocol.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: LowT
    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)during the first 12 weeks. Total exposure duration is 52 weeks.
    Other Name: Androgel
  • Behavioral: Resistance Training
    Weight training 45-60 minutes 3 times per week
    Other Names:
    • PRT
    • Progressive resistance training
  • Drug: Placebo
    2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
  • Drug: HighT
    High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
    Other Name: Androgel
  • Experimental: 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

    Interventions:
    • Drug: LowT
    • Behavioral: Resistance Training
  • Experimental: 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

    Intervention: Drug: LowT
  • Experimental: 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

    Interventions:
    • Behavioral: Resistance Training
    • Drug: HighT
  • Experimental: 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

    Intervention: Drug: HighT
  • Active Comparator: Placebo+Resistance Training

    Placebo Group applies two 2.5 gm placebo packets

    1 year standard Progressive Resistance Training(PRT) program

    Interventions:
    • Behavioral: Resistance Training
    • Drug: Placebo
  • Placebo Comparator: Placebo+No Resistance Training

    Placebo group applies two 2.5 gm placebo packets

    No exercise program

    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)
  • Must reside in the Denver metro area

Exclusion Criteria:

  • Prostate/breast cancer
  • Unable to exercise safely
  • severe obesity (>34 body mass index [BMI])
  • Polycythemia
  • Diabetes
  • Use of drugs that could affect T levels
  • Cognitive dysfunction (MMSE less than 24)
  • PSA above the age-adjusted normal level or AUA greater than 19
  • Unable to pass stress test due to active CAD
Male
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112151
02-1056, R01AG019339
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Institute on Aging (NIA)
Principal Investigator: Robert S. Schwartz, MD University of Colorado, Denver
University of Colorado, Denver
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP