Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Completed · Phase 3 · Has a placebo group

Conditions studied: Physical Frailty, Hip Fracture, Elective Hip Replacement, Hypogonadism

In brief

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

Key facts

Study ID

NCT00345969

Run by

Washington University School of Medicine

People needed

25

Starts

2004-11-01

Expected to finish

2009-08-01

Last updated by the study team

2018-02-22

Who can join

Age: 65 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male, age 65 years and older
• Total serum testosterone level < 350 ng/dl
• Total Modified Physical Performance Test Score <28

You may not qualify if…

• Inability to walk 50 feet independently
• Current use of estrogen, progestin, or androgen containing compound
• Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration
• Visual or hearing impairments that interfere with following directions
• Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training
• History of prostate cancer or hormone dependent neoplasia
• PSA level > 4 ng/ml
• Serum liver transaminase levels of greater than 2 standard deviations above normal
• Use of drugs for osteoporosis for less than 1 year
• Current participation in a vigorous exercise or weight-training program more than once per week
• History of sleep apnea requiring use of CPAP
• Uncontrolled thyroid disease
• Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)
• hematocrit > 50%
• AUA symptom score > 16.
• History of alcohol or substance abuse
• Presence of severe facial acne
• Active symptoms of depression with GDS score > 5 and symptoms severe enough to cause >5% weight loss in previous 3 months or interfere with research assessments

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.