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The Effect of Testosterone Supplementation on Rehabilitation Outcomes


Phase 2
65 Years
N/A
Not Enrolling
Male
Aging, Frail Elderly, Rehabilitation

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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

Inclusion Criteria


Older men with diminished muscle strength

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

David Wolff, Ph.D. Special Assistant to the Director

Investigator Affiliation:

Program Analysis and review Section (PARS), VA Rehabilitation Research & Development Service

Authority:

United States: Federal Government

Study ID:

E2419R

NCT ID:

NCT00037999

Start Date:

April 2001

Completion Date:

March 2004

Related Keywords:

  • Aging
  • Frail Elderly
  • Rehabilitation
  • Muscle strength
  • Testosterone
  • Rehabilitation
  • Impaired muscle strength

Name

Location

VA Medical CenterRichmond, Virginia