TEAM: Testosterone Supplementation and Exercise in Elderly Men

August 19, 2020 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function (CS-PFP Total Score)
Time Frame: Baseline and 12 months
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.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Body Muscle Strength (1-RM, kg)
Time Frame: Baseline and 12 months
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.
Baseline and 12 months
Lower Body Muscle Strength (1-RM, kg)
Time Frame: Baseline and 12 months
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.
Baseline and 12 months
Power (Power Rig, Watts)
Time Frame: Baseline and 12 months
Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).
Baseline and 12 months
Fat Mass (kg)
Time Frame: Baseline and 12 months
Total change in Fat mass (kg) as evaluated by DXA
Baseline and 12 months
Fat Free Mass (kg)
Time Frame: Baseline and 12 months
Total change in Fat free mass (kg) as evaluated by DXA
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Robert S. Schwartz, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 27, 2005

First Submitted That Met QC Criteria

May 27, 2005

First Posted (Estimate)

May 30, 2005

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-1056
  • R01AG019339 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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