Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COMBEX
Community Based Exercise Program or exercise group and quality of life Intervention- The community-based exercise program consisted of 12 weeks of exercise with a community-based trainer after hospital discharge.
  • Behavioral: Combex
    12 weeks of exercise with a trainer post discharge.
    Other names:
    • Quality of life questionaires-BSHS-B, SF-12, and back to work
Active Comparator
Standard Of Care
Standard of Care group, group with no exercise and quality of life. Intervention- No exercise training received.
  • Behavioral: Standard of Care
    No exercise training received.
    Other names:
    • Quality of life questionaires-BSHS-B, SF-12, and back to work

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Oscar E. Suman, PhD
409-770-6557
oesuman@utmb.edu

More Details

NCT ID
NCT01184547
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Oscar E. Suman, PhD
409-770-6557
oesuman@utmb.edu

Detailed Description

The current Standard of Care in the physical rehabilitation of burned individuals is to discharge them home with prescribed written, physical and occupational therapy rehabilitation activities. We believe that a supervised and structured COMBEX program early during the recovery phase will increase physical function, translate into improvements in QOL, and produce results far superior to current Standard of Care. We intend with this study to eliminate the physical inactivity that occurs with the present standard of care and connect burned victims with COMBEX. This is also important since an inactive lifestyle is a health risk factor even in the physically-able individual. Thus, a fitter burned individual should more readily meet the physical demands of activities of daily living. Activities of daily living, whether occupational or leisure, are integrated functions requiring cardiovascular and muscle endurance and muscle strength. Therefore, successful rehabilitation programs need to also optimize cardiopulmonary and muscle endurance, strength and function; a need that exercise should fulfill. Additionally, a successful rehabilitation program should improve QOL and community engagement. Accordingly, in the present grant application, we propose using exercise as the integral and central interventional tool to counteract physical dysfunction in burned individuals, thereby improving overall functional physical capacity, but also preventing secondary conditions that result from prolonged or maintained physical inactivity and disability. Finally, this increase in physical capacity will allow for an improvement in the QOL of burned individuals, evidenced by increased psychosocial responses measured by increased self-esteem, social interaction, return to work, and decreased anxiety and depression.

We propose to improve the current Standard of Care by the incorporation of a community-based, supervised, structured aerobic and resistive exercise rehabilitation program (COMBEX).

In addition, our present grant proposal attempts to bypass the exercise training in a burn center and translate it into community based facilities. To our knowledge, our studies are the only prospective, randomized studies of exercise and the physiological or psychosocial responses to aerobic or resistance training and quality of life in burned adults.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.