Clinical trial NCT01184547: Effects of a Community Based Exercise Program in Adults With Severe Burns
Official title: "Effects of a Community Based Exercise Program in Adults With Severe Burns"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Psychosocial Problem
Quality of Life
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: American Burn Association
First posted: 2010-08-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Burn Specific Health Scale Brief (BSHS-B)
timeFrame: Change from discharge from the ICU to 12 weeks post discharge from ICU.
measure: Veterans Rand Health Survey 12-item Health Survey (SF-12)
timeFrame: Change from discharge from the ICU to 12 weeks post discharge from ICU.
measure: Return to Work
timeFrame: 12 weeks post discharge from ICU.
Secondary outcomes:
measure: Peak aerobic capacity
timeFrame: Change from discharge from the ICU to 12 weeks post discharge from ICU.
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas/Shriners Hospital for Children
name: Oscar E. Suman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.