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

This study is currently recruiting participants.
Verified June 2017 by The University of Texas Medical Branch, Galveston
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184547
First Posted: August 19, 2010
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
United States Department of Defense
American Burn Association
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  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).


Condition Intervention
Burn Injury Psychosocial Problem Quality of Life Behavioral: Quality of Life questionaires

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: "Effects of a Community Based Exercise Program in Adults With Severe Burns"

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Quality of Life/Return to Work [ Time Frame: Discharge ]
    We will administer questionnaires to evaluate return to work and psychosocial health status. These tests will consist of completed Short Form-12 (SF-12)and the Burn Specific Health Scale Brief (BSHS-B)

  • Quality of Life/Return to Work [ Time Frame: 12 Weeks post-Burn ]
    We will administer questionnaires to evaluate return to work and psychosocial health status. These tests will consist of completed SF-12 and the Burn Specific Health Scale Brief (BSHS-B)

  • Quality of Life/Return to Work [ Time Frame: 12 Months post-discharge ]
    We will administer questionnaires to evaluate return to work and psychosocial health status. These tests will consist of completed SF-12 and the Burn Specific Health Scale Brief (BSHS-B)


Secondary Outcome Measures:
  • Peak aerobic capacity [ Time Frame: Discharge ]
    Assessed with a cardiopulmonary exercise test

  • Peak Aerobic Capacity [ Time Frame: 12 Weeks Post-Discharge ]
    Assessed with a cardiopulmonary exercise test

  • Peak Aerobic Capacity [ Time Frame: 12 Months Post-Discharge ]
    Assessed with a cardiopulmonary exercise test


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COMBEX
Community Based Exercise Program or exercise group and quality of life
Behavioral: Quality of Life questionaires
To assess Return to work and quality of life
Other Name: BSHS-B, SF-36, and SF-12
Active Comparator: Standard Of Care
Standard of Care group, group with no exercise and quality of life
Behavioral: Quality of Life questionaires
To assess Return to work and quality of life
Other Name: BSHS-B, SF-36, and SF-12

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184547


Contacts
Contact: Oscar E. Suman, PhD 409-770-6557 oesuman@utmb.edu
Contact: Raquel Peña, MD, MHP 409-770-6584 rapena@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Oscar E. Suman, PhD    409-770-6557    oesuman@utmb.edu   
Contact: Frank Willis, PhD    409-770-6612    fbwillis@utmb.edu   
Principal Investigator: Oscar E. Suman, PhD         
Sub-Investigator: Walter J. Meyer, III, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
United States Department of Defense
American Burn Association
Investigators
Principal Investigator: Oscar E. Suman, PhD University of Texas/Shriners Hospital for Children
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01184547     History of Changes
Other Study ID Numbers: 10-034
A-15774.3a ( Other Grant/Funding Number: Department of Defense )
First Submitted: August 13, 2010
First Posted: August 19, 2010
Last Update Posted: July 11, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Burns
Wounds and Injuries