Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
Status:
Terminated
Trial end date:
2016-09-20
Target enrollment:
Participant gender:
Summary
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home
residents. Testosterone treatment is among the potentially beneficial treatments in addition
to resistance exercise for improving muscle strength and mass in frail adults. The
investigators have demonstrated that cycled administration of testosterone improves muscle
mass and strength in healthy adults. It is proposed that cycled testosterone administration
may be an effective adjuvant therapy for frail older men and women during rehabilitation
programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC)
rehabilitation will result in improved muscle mass and physical function when compared to
patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled
study, the investigators will test the effects of cycled testosterone administration (2 week
on treatment, 2 weeks off treatment) on body composition and physical function in male and
female nursing home residents undergoing rehabilitative care. Primary outcomes will be
assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip
dynamometers, short physical performance battery (SPPB), and quality of life (QOL)
questionnaires. Data from this pilot project will become the foundation for the development
of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of
testosterone treatment on physical function and independence in frail older adults.