Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury

June 23, 2005 updated by: National Center for Research Resources (NCRR)

OBJECTIVES: I. Determine whether testosterone normalization ameliorates muscle protein hypercatabolism by increasing net protein synthesis in men with burn injury.

II. Determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men.

III. Determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men.

IV. Determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis.

V. Determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass and muscle strength in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to percent of total body surface area (TBSA) burned (no more than 40% vs more than 40%).

Patients receive standard inpatient burn care. During hospitalization, patients are randomized to one of two treatment arms:

Arm I: Patients receive testosterone intramuscularly (IM) weekly for 2-3 weeks during hospitalization.

Arm II: Patients receive standard care only during hospitalization.

After hospital discharge, patients with burns covering no more than 40% of TBSA are randomized to arm III, IV, or V, whereas patients with burns covering more than 40% of TBSA are randomized to arm III or V.

Arm III: Patients receive testosterone IM every 2 weeks for 2 months.

Arm IV: Patients receive testosterone as in arm III. Patients perform progressive resistance (weight lifting) exercises 3 times a week for 2 months concurrently with testosterone therapy.

Arm V.: Patients receive standard convalescence care only.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77550
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
          • Arny A. Ferrando
          • Phone Number: 409-770-6612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Second degree or worse burn injury Percent of total body surface area burned and degree of burn(s) must be carefully quantified

--Patient Characteristics--

Cardiovascular: No limiting or unstable angina No myocardial infarction within the past 6 months No horizontal or downsloping ST segment depression greater than 0.2 mV and/or frequent or repetitive arrhythmias (defined as more than 10 premature ventricular contractions per minute) No hypertension that is uncontrolled by one blood pressure medication No prior arrhythmia or valvular disease requiring treatment

Other: No history of prostate cancer or indication of an occult carcinoma, defined by PSA greater than 4.0 micrograms/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Texas

Investigators

  • Study Chair: Arny A. Ferrando, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

August 3, 2000

First Posted (ESTIMATE)

August 4, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15290
  • UTMB-97-284
  • UTMB-GCRC-474

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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