Hypogonadism Clinical Trial
Official title:
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
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.
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.
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