This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Overview of Research Design: The purposes of this study are to evaluate, in frail elderly hip fracture patients, the effects of exercise training combined with testosterone therapy on measures of skeletal mass, muscle strength and functional capacity, bone mineral density, quality of life, and self-report of ADL performance. We will utilize many of the facilities currently available through the Washington University (WU) Division of Geriatrics and Gerontology, General Clinical Research Center, and the Program in Physical Theray. Eighty-eight community-dwelling post-hip fracture patients aged 65 and over will be recruited from area hospitals and home care programs to participate in a randomized, double-blind, placebo-controlled trial of exercise training and testosterone therapy. Participants will enroll in the study upon completion of standard physical therapy (12-16 weeks post fracture) because enrollment during the immediate post fracture period is not feasible, conflicts with standard care practicec, and may introduce greater risks. All participants will perform an exercise-training program that will consist of 2 months of flexibility, balance, walking and light resistance exercises, followed by 4 months of progressive resistance training. Participants will be randomly assigned to take testosterone in the forma of a 1% topical gel, or an identical placebo gel, for 6 months. Outcome measurements will be obtained at baseline and after 2 and 6 months of the intervention. The primary study outcome measures will be thigh muscle cross-sectional mass (by 1H-MRI), total lean body mass as measured by DXA, measures of skeletal muscle strength, and total score for an objective Physical Performance Test. Seconday outcome meausres will be bone mineral density (BMD, by DXA), measurements of balance, gait, peak aerobic power, self-report of performance of ADLs, mood, and quality of life. Rationale for a 2-group design with exercise training: Some may argue that we should employ a 4-group design for this trial in order to evaluate the independent effects of testosterone therapy and exercise training, or evaluate testosterone with a home exercise program. The recruitment demands of a 4-group trial are not feasible at this stage, and would probably require a multi-center trial. We are proposing to evaluate the effects of testosterone combined with exercise because preliminary data from our ongoing study suggest that although exercise training is superior to home exercise in reversing physical impairments in hip fracture patients, many subjects remain frail. A combined approach may be required to achieve maximal improvements in muscle mass and strenght and related physical impairments, and to reduce the risk of persistant disability. Data from studies of testosterone in men suggest that androgen therapy combined wtih exercise training has additive effects on muscle strength and body composition.
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