Trial Information

The Effect of Testosterone Supplementation on Rehabilitation Outcomes

Our overall goal is to determine the safety and efficacy of testosterone supplementation as
an adjunct to traditional rehabilitation therapy on health outcomes in deconditioned older
men. Specifically, we will conduct a randomized, placebo-controlled trial to test the
hypothesis that supplementation with testosterone improves rehabilitation outcomes in
deconditioned older men. We will use objective validated measures (i.e., FIM, muscle
strength) to assess health outcomes.

We will begin enrolling subjects within three months of receipt of funding, and study 60
subjects (30 in each group) within 24 months. All subjects will undergo follow-up
evaluation 6 and 12 months after completion of inpatient rehabilitation and cessation of
testosterone supplementation. Therefore, this project will be completed within 3 years.
Our short term goal (within 3 years) is to delineate the safety and efficacy of testosterone
supplementation on rehabilitation outcomes in deconditioned older men. Our long range goal
is to determine whether other hormones (e.g., combined testosterone and growth hormone) are
helpful as an adjunct to traditional rehabilitation therapy in the care of older men