Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Hypogonadism Clinical Trial

Official title: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT00345969
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Completion date: August 2009