Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/2/2016 |
| Start Date: | June 2000 |
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.
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.
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.
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.
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
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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