The Effect of Testosterone Supplementation on Rehabilitation Outcomes

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00037999
First received: May 24, 2002
Last updated: January 20, 2009
Last verified: May 2002
  Purpose

The objective of this project is to determine the safety and efficacy of testosterone supplementation as an adjunct to traditional rehabilitation therapy in the care of 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.

This project is important to the VA health care system because 38% of American veterans are aged (age > 65 years), bioavailable testosterone is diminished in older age men, low testosterone is associated with impaired muscle strength, and lack of muscle strength hinders rehabilitation. Older men who are not successfully rehabilitated often get admitted to nursing homes for long term care, at a cost of approximately $40,000/year. Payment for long term care is currently one of our most difficult health care problems. If testosterone supplementation improves rehabilitation outcomes, as our pilot data suggest it will, patients will be more satisfied and long-term care financial resources will be saved.

We will conduct a randomized, placebo-controlled trial to test the hypothesis that supplementation with testosterone improves rehabilitation outcomes in deconditioned older men. Specifically, we will screen all hospitalized older men with delayed discharge from the hospital (> 7 day hospital stay). Men who have at least one new impairment in their ability to perform activities of daily living (e.g., inability to walk), low serum testosterone concentration, and no contraindications (e.g., prostate or breast cancer) will be offered the opportunity to participate. Study participants will be randomized to receive either testosterone (5 mg transdermally each night) or placebo (matching transdermal patch) daily in a double-blind fashion for the duration of their hospital course (expected average duration of study is 29 days). Subjects will then receive their rehabilitation as usual, with all members of the health care team blinded as to whether the subject is receiving testosterone or placebo. At baseline, weekly, at discharge, and at 6 and 12 months after discharge, subjects will be assessed using validated measures (i.e., Functional Independence Measure - FIM). Our hypothesis is that testosterone supplementation, as an adjunct to traditional rehabilitation therapy, will improve rehabilitation outcomes.


Condition Intervention Phase
Aging
Frail Elderly
Rehabilitation
Procedure: Testosterone supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Testosterone Supplementation on Rehabilitation Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 60
Study Start Date: April 2001
Study Completion Date: March 2004
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Older men with diminished muscle strength

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037999

Locations
United States, Virginia
VA Medical Center
Richmond, Virginia, United States
Sponsors and Collaborators
Investigators
Investigator: David Wolff, Ph.D. Special Assistant to the Director Program Analysis and review Section (PARS), VA Rehabilitation Research & Development Service
Investigator: Vicki Mongiardo, Program Analyst Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037999     History of Changes
Other Study ID Numbers: E2419R
Study First Received: May 24, 2002
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Muscle strength
Testosterone
Rehabilitation
Impaired muscle strength

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 17, 2014