TEAM: Testosterone Supplementation and Exercise in Elderly Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testosterone Supplementation and Exercise in Elderly Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: LowT
* Behavioral: Resistance Training
* Drug: Placebo
* Drug: HighT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LowT+Resistance Training<br>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<br>* 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.<br>* Other names: Androgel;Behavioral: Resistance Training<br>* Weight training 45-60 minutes 3 times per week<br>* Other names: Progressive resistance training;|
| Experimental: LowT+No Resistance training<br>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<br>* 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.<br>* Other names: Androgel;|
| Experimental: HighT+Resistance Training<br>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<br>* Weight training 45-60 minutes 3 times per week<br>* Other names: Progressive resistance training;Drug: HighT<br>* 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.<br>* Other names: Androgel;|
| Experimental: HighT+No Resistance Training<br>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<br>* 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.<br>* Other names: Androgel;|
| Active Comparator: Placebo+Resistance Training<br>Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program | Behavioral: Resistance Training<br>* Weight training 45-60 minutes 3 times per week<br>* Other names: Progressive resistance training;Drug: Placebo<br>* 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.<br>|
| Placebo Comparator: Placebo+No Resistance Training<br>Placebo group applies two 2.5 gm placebo packets No exercise program | Drug: Placebo<br>* 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function (CS-PFP Total Score) | 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) | 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) | 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) | Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts). | Baseline and 12 months | 
| Fat Mass (kg) | Total change in Fat mass (kg) as evaluated by DXA | Baseline and 12 months | 
| Fat Free Mass (kg) | Total change in Fat free mass (kg) as evaluated by DXA | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, andropause, hypogonadism, AndroGel, exercise, PRT, T supplementation