Effects of a Community Based Exercise Program in Adults With Severe Burns (COMBEX)
Primary Purpose
Burn Injury, Psychosocial Problem, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combex
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Burn Injury
Eligibility 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
Sites / Locations
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COMBEX
Standard Of Care
Arm Description
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.
Standard of Care group, group with no exercise and quality of life. Intervention- No exercise training received.
Outcomes
Primary Outcome Measures
Burn Specific Health Scale Brief (BSHS-B)
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).
Veterans Rand Health Survey 12-item Health Survey (SF-12)
The SF-12 is a 12-item; self-report questionnaire that yields two subscales: physical health and mental health.
Return to Work
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 Outcome Measures
Peak aerobic capacity
A maximal exercise test on a treadmill using the Modified Bruce protocol. VO2peak will be measured by patient's breathing.
Full Information
NCT ID
NCT01184547
First Posted
August 13, 2010
Last Updated
November 4, 2020
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
United States Department of Defense, American Burn Association
1. Study Identification
Unique Protocol Identification Number
NCT01184547
Brief Title
Effects of a Community Based Exercise Program in Adults With Severe Burns
Acronym
COMBEX
Official Title
"Effects of a Community Based Exercise Program in Adults With Severe Burns"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
United States Department of Defense, American Burn Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury, Psychosocial Problem, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBEX
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Of Care
Arm Type
Active Comparator
Arm Description
Standard of Care group, group with no exercise and quality of life. Intervention- No exercise training received.
Intervention Type
Behavioral
Intervention Name(s)
Combex
Other Intervention Name(s)
Quality of life questionaires-BSHS-B, SF-12, and back to work
Intervention Description
12 weeks of exercise with a trainer post discharge.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Quality of life questionaires-BSHS-B, SF-12, and back to work
Intervention Description
No exercise training received.
Primary Outcome Measure Information:
Title
Burn Specific Health Scale Brief (BSHS-B)
Description
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).
Time Frame
Change from discharge from the ICU to 12 weeks post discharge from ICU.
Title
Veterans Rand Health Survey 12-item Health Survey (SF-12)
Description
The SF-12 is a 12-item; self-report questionnaire that yields two subscales: physical health and mental health.
Time Frame
Change from discharge from the ICU to 12 weeks post discharge from ICU.
Title
Return to Work
Description
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.
Time Frame
12 weeks post discharge from ICU.
Secondary Outcome Measure Information:
Title
Peak aerobic capacity
Description
A maximal exercise test on a treadmill using the Modified Bruce protocol. VO2peak will be measured by patient's breathing.
Time Frame
Change from discharge from the ICU to 12 weeks post discharge from ICU.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar E. Suman, PhD
Organizational Affiliation
University of Texas/Shriners Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29366724
Citation
Voigt CD, Foncerrada G, Pena R, Guillory AN, Andersen CR, Crandall CG, Wolf SE, Herndon DN, Suman OE. Effects of Community-Based Exercise in Adults With Severe Burns: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jan;101(1S):S36-S41. doi: 10.1016/j.apmr.2017.12.022. Epub 2018 Jan 31.
Results Reference
derived
Learn more about this trial
Effects of a Community Based Exercise Program in Adults With Severe Burns
We'll reach out to this number within 24 hrs