Effects of a Community Based Exercise Program in Adults With Severe Burns (COMBEX)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Ability to Return Work |
Behavioral: Quality of Life questionaires |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | "Effects of a Community Based Exercise Program in Adults With Severe Burns" |
- Quality of Life/Return to Work [ Time Frame: Discharge ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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)
- Peak aerobic capacity [ Time Frame: Discharge ] [ Designated as safety issue: No ]Assessed with a cardiopulmonary exercise test
- Peak Aerobic Capacity [ Time Frame: 12 Weeks Post-Discharge ] [ Designated as safety issue: No ]Assessed with a cardiopulmonary exercise test
- Peak Aerobic Capacity [ Time Frame: 12 Months Post-Discharge ] [ Designated as safety issue: No ]Assessed with a cardiopulmonary exercise test
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (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| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is >18 ≤ 59 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,
- Cirrhosis,
- 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
Contacts and Locations| Contact: Leybi L Ramirez, MD/MPH | 409-770-6584 | llramire@utmb.edu |
| Contact: Oscar E Suman, PhD | 409-770-6557 | oesuman@utmb.edu |
| United States, Texas | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Contact: Leybi L Ramirez, MD/MPH 409-770-6584 llramire@utmb.edu | |
| Contact: Oscar E Suman, PhD 409-770-6557 oesuman@utmb.edu | |
| Principal Investigator: Oscar E Suman, PhD | |
| Sub-Investigator: Walter J Meyer, III, MD | |
| Principal Investigator: | Oscar E Suman, PhD | University of Texas/Shriners Hospital for Children |
More Information
No publications provided
| Responsible Party: | The University of Texas, Galveston |
| ClinicalTrials.gov Identifier: | NCT01184547 History of Changes |
| Other Study ID Numbers: | 10-034, A-15774.3a |
| Study First Received: | August 13, 2010 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013