Burn InjuryCOMBEXNCT01184547
Effects of a Community Based Exercise Program in Adults With Severe Burns
A study testing Combex in people with Burn Injury and Psychosocial Problem, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Injury, Psychosocial Problem, Quality of Life
- What is being tested?
- Combex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: "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).
Read the 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.
- Conditions
- Burn Injury, Psychosocial Problem, Quality of Life
- Being tested
- Combex, Standard of Care
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombexBehavioural
Also called Quality of life questionaires-BSHS-B, SF-12, and back to work
12 weeks of exercise with a trainer post discharge.
Standard of CareBehavioural
Also called Quality of life questionaires-BSHS-B, SF-12, and back to work
No exercise training received.
| Study group | Role | What they receive |
|---|---|---|
| COMBEX | Experimental | 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. Receives: Behavioral: Combex |
| Standard Of Care | Active comparator | Standard of Care group, group with no exercise and quality of life. Intervention- No exercise training received. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from discharge from the ICU to 12 weeks post discharge from ICU.
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.
Measured: Change from discharge from the ICU to 12 weeks post discharge from ICU.
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.
Measured: 12 weeks post discharge from ICU.
Secondary outcomes (1)
Peak aerobic capacity
A maximal exercise test on a treadmill using the Modified Bruce protocol. VO2peak will be measured by patient's breathing.
Measured: Change from discharge from the ICU to 12 weeks post discharge from ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startApr 2010
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, American Burn Association
- Responsible party
- Sponsor
- Investigators
- Oscar E. Suman, PhD, Principal investigator, University of Texas/Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184547
- Sponsor's protocol ID
- 10-034
- Other IDs
- A-15774.3a
- Acronym
- COMBEX
- Status last verified
- Oct 2020
- First submitted
- 13 Aug 2010
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29366724
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of a Community Based Exercise Program in Adults With Severe Burns"
- ClinicalTrials.gov ID
- NCT01184547
- Acronym / sponsor ID
- COMBEX / 10-034
- Conditions
- Burn Injury, Psychosocial Problem, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- United States Department of Defense, American Burn Association
- Study start
- Apr 2010 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBEX | Experimental | Behavioral: CombexCommunity 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 | Active comparator | Behavioral: Standard of CareStandard of Care group, group with no exercise and quality of life. Intervention- No exercise training received. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (20 listed)
- The criteria or risk factors that exclude individuals from this study are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CombexAlso: Quality of life questionaires-BSHS-B, SF-12, and back to work12 weeks of exercise with a trainer post discharge. | Behavioural | COMBEX |
| Standard of CareAlso: Quality of life questionaires-BSHS-B, SF-12, and back to workNo exercise training received. | Behavioural | Standard Of Care |
Primary outcome
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).
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.
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.
1 secondary outcome
Peak aerobic capacity
Time frame: Change from discharge from the ICU to 12 weeks post discharge from ICU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 29366724Voigt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar E. Suman, PhD principal investigator
University of Texas/Shriners Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combex in people with Burn Injury and Psychosocial Problem, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burn Specific Health Scale Brief (BSHS-B) (time frame: Change from discharge from the ICU to 12 weeks post discharge from ICU.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.