Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients

NCT02739464 | Completed DMC

• 1 other identifier: SHC; IRB #14-0432
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 4

Brief Summary

This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).

Conditions

Muscle Weakness; Late Effect of Burn; Muscle; Fatigue, Heart; Burn Rehabilitation

Keywords

Burn; Exercise; Ergometer; MP-10

Outcome Measures

Primary Outcomes (1)

• change in lean muscle mass

  Kilograms

  It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.

Secondary Outcomes (2)

• change in VO2 max

  It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.]

• change in distance walked over 6 minutes

  It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.

Study Arms (2)

Exercise + SOC PT/OT

EXPERIMENTAL

SOC treatment plus a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation.

Other: Exercise + SOC PT/OT

SOC PT/OT

ACTIVE COMPARATOR

Only SOC for treating in-patient burn subjects

Other: SOC PT/OT

Interventions

Exercise + SOC PT/OT OTHER

Exercise + SOC PT/OT

SOC PT/OT OTHER

SOC PT/OT

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects ≥7 to 60 years of age
• \>30% TBSA burned, as estimated by the physician in charge
• No evidence of organ failure

You may not qualify if:

• Active Tuberculosis- based on clinical symptoms and/or abnormal chest x-ray in the upper lobe.
• Electrical burns
• Mental retardation or autism or any other mental disorder that makes it impossible to participate in an exercise program
• Pregnancy

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• United States Army Institute of Surgical Research: collaborator
• University of Texas Southwestern Medical Center: collaborator
• California State University, Sacramento: collaborator

Study Sites (4)

University of California-Davis/Shriners Hospitals for Children-Sacramento

Davis, California, 95616, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site)

Galveston, Texas, 77550, United States

Location

United States Army Institute of Surgical Research

San Antonio, Texas, 78234, United States

Location

Related Publications (40)

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  RESULT

MeSH Terms

Conditions

Muscle Weakness; Fatigue; Burns; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Oscar Suman

  University of Texas Medical Branch/Shriners Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 15, 2016
• Study Start: September 15, 2014
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available once study is completed and 7 years after that date, according to the IRB standards.
• Access Criteria: Once study personnel has completed CITI training and add to the study, will they have access to the data.

Locations

US (4)