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Completed

NCT Number: NCT01184547

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMBEX

Behavioral

12 weeks of exercise with a trainer post discharge.

Other names: Quality of life questionaires-BSHS-B, SF-12, and back to work

Standard of Care

Behavioral

No exercise training received.

Other names: Quality of life questionaires-BSHS-B, SF-12, and back to work

Primary outcomes

  1. Burn Specific Health Scale Brief (BSHS-B)

    Time frame: Change from discharge from the ICU to 12 weeks post discharge from ICU.

    The BSHS-B will be used to assess physical functioning and burn injury interference with work activities. The scale for the questionnaire include -0 extremely, 1-Quite a Bit, 2-moderately, 3- a little bit, 4-None (not at All).

  2. Veterans Rand Health Survey 12-item Health Survey (SF-12)

    Time frame: Change from discharge from the ICU to 12 weeks post discharge from ICU.

    The SF-12 is a 12-item; self-report questionnaire that yields two subscales: physical health and mental health.

  3. Return to Work

    Time frame: 12 weeks post discharge from ICU.

    Self-reported, short questionnaire taking approximately 10 minutes to complete. These questionnaires will assess the present employment status and the time from discharge to return to work, past and current employment status as well as job type and, if applicable, start dates for post-injury positions. Time from discharge to return to work will be measured in weeks. The questionnaire ask yes or questions. Also, two scales from 0-10, rate how difficult is to return to work and how satisfied are they are being back to work. 0 is none, 10 is extremely difficult/extremely satisfied.

Secondary outcomes

  1. Peak aerobic capacity

    Time frame: Change from discharge from the ICU to 12 weeks post discharge from ICU.

    A maximal exercise test on a treadmill using the Modified Bruce protocol. VO2peak will be measured by patient's breathing.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • American Burn Association
  • United States Department of Defense

Registry information

Official study title

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

Acronym: COMBEX

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2010
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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