NCT00345969

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population. The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone. Secondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone. Comparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.

Conditions

• Physical Frailty
• Hip Fracture
• Elective Hip Replacement
• Hypogonadism

Interventions

Type	Name	Description
DRUG	Transdermal Testosterone gel (1%)	Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.
BEHAVIORAL	Supervised exercise training	Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-02-01
• Completion: 2009-08-01
• First posted: 2006-06-29
• Last updated: 2018-02-22
• Results posted: 2018-02-22

Locations

1 site across 1 country: United States