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
  Purpose
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.

Condition Intervention Phase
Healthy
Drug: LowT
Behavioral: Resistance Training
Drug: Placebo
Drug: HighT
Phase 2

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
Official Title: Testosterone Supplementation and Exercise in Elderly Men

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 167
Study Start Date: January 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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

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
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

Behavioral: Resistance Training
Weight training 45-60 minutes 3 times per week
Other Names:
  • PRT
  • Progressive resistance training
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: 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

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
Active Comparator: Placebo+Resistance Training

Placebo Group applies two 2.5 gm placebo packets

1 year standard Progressive Resistance Training(PRT) program

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.
Placebo Comparator: Placebo+No Resistance Training

Placebo group applies two 2.5 gm placebo packets

No exercise program

Drug: Placebo
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112151

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
Investigators
Principal Investigator: Robert S. Schwartz, MD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00112151     History of Changes
Other Study ID Numbers: 02-1056  R01AG019339 
Study First Received: May 27, 2005
Results First Received: November 4, 2015
Last Updated: December 14, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
andropause
hypogonadism
AndroGel
exercise
PRT
Testosterone
T supplementation

Additional relevant MeSH terms:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2016