Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00345969
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2006-06-27
Brief Title:
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ngdl 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
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 ngdl 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None