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

NCT01184547 | Completed DMC

• 2 other identifiers: 10-034A-15774.3a
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Burn Injury; Psychosocial Problem; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  12 weeks post discharge from ICU.

Secondary Outcomes (1)

• Peak aerobic capacity

  Change from discharge from the ICU to 12 weeks post discharge from ICU.

Study Arms (2)

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.

Behavioral: Combex

Standard Of Care

ACTIVE COMPARATOR

Standard of Care group, group with no exercise and quality of life. Intervention- No exercise training received.

Behavioral: Standard of Care

Interventions

Combex BEHAVIORAL

12 weeks of exercise with a trainer post discharge.

Also known as: Quality of life questionaires-BSHS-B, SF-12, and back to work

COMBEX

Standard of Care BEHAVIORAL

No exercise training received.

Also known as: Quality of life questionaires-BSHS-B, SF-12, and back to work

Standard Of Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• United States Department of Defense: collaborator
• American Burn Association: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• 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.

  PMID: 29366724 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Return to Work; Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Employment; Socioeconomic Factors; Population Characteristics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Oscar E. Suman, PhD

  University of Texas/Shriners Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 19, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-10

Locations

US (1)