Effects of a Community Based Exercise Program in Adults With Severe Burns
Completed · Not applicable
Conditions studied: Burn Injury, Psychosocial Problem, Quality of Life
In brief
The purpose of this proposal is to assess the efficacy of implementing a 12-week structured and supervised community-based exercise program (COMBEX) at hospital discharge. The investigators will assess the effect of exercise on mental health and physical function, along with its effects on the amelioration of the burn-induced catabolic response. The central hypothesis of this proposal is that exercise-induced physical and psychosocial benefits obtained during a supervised and structured COMBEX program in severely burned adults will improve physical function, and quality of life relative to Standard of Care (SOC).
Key facts
- Study ID
- NCT01184547
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 45
- Starts
- 2010-04-01
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2020-11-06
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is >18 ≤ 60 years of age and patient agrees to study; 30% Total Body Surface Area (TBSA) burn or greater; AND has been medically cleared for discharge and exercise participation by the treating burn surgeon.
You may not qualify if…
- The criteria or risk factors that exclude individuals from this study are:
- Known history of AIDS, AIDS Related Complex, HIV,
- Malignant neuroleptic hyperthermia,
- Active tuberculosis,
- Arthritis
- Cirrhosis,
- Cancer within 5 years
- Hyperlipidemia
- Bone or Endocrine Diseases
- Autoimmune Diseases
- Chronic Glucocorticoid or non-steroidal anti-inflammatory drug therapy
- Renal insufficiency (defined by creatinine >3.0 mg/dl),
- Hepatic disease (defined by elevated liver enzymes or bilirubin >3.0 mg/dl),
- Known coronary artery disease,
- Congestive heart failure,
- Uncontrolled asthma or pulmonary disease (e.g. emphysema, COPD),
- Associated head injuries requiring specific treatment,
- Mental retardation or autism or any other mental disorder, which makes it impossible to participate in an exercise program;
- Gastrointestinal disorders which impair absorption.
- Pregnancy if applicable
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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