Effects of a Community Based Exercise Program in Adults With Severe Burns



Status:Recruiting
Conditions:Hospital, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 60
Updated:7/25/2018
Start Date:April 2010
End Date:December 31, 2020
Contact:Oscar E. Suman, PhD
Email:oesuman@utmb.edu
Phone:409-770-6557

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"Effects of a Community Based Exercise Program in Adults With Severe Burns"

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).

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.

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
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Oscar E. Suman, PhD
Phone: 409-770-6557
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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from
Galveston, TX
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