Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients (MP-10)

November 4, 2020 updated by: The University of Texas Medical Branch, Galveston

Randomized, Controlled, Multicenter Study of the Effect of In-Patient Exercise Training on Length of Hospitalization, Mental Health, and Physical Performance in Burned Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After severe burns (≥ 30% total body surface area [TBSA] burns, patients enter a persistent and extensive hypermetabolic and catabolic state. Unfortunately, burn-induced muscle catabolism is exacerbated by the prolonged bed rest and inactivity that accompanies hospitalization, leading to further loss of muscle mass and extreme weakness. The persistence of weakness, fatigue, and muscle catabolism from prolonged bed rest and inactivity during the acute care stage ultimately delays rehabilitation and return to normal physical activities. Studies conducted in non-burn patients have shown that, aside from decreasing muscle mass, prolonged bed rest has a host of other negative physiological consequences.

The primary purpose of this randomized, controlled, multicenter study is being conducted to determine the efficacy of early in-patient exercise, when used as an adjunct to standard of care (SOC), in improving recovery of adults from burns. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (hereafter referred to as MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation). This objective will be met through a multicenter trial in children and adults (7 - 60 years) with ≥30% TBSA burns. Outcome variables will include BICU days, ventilator days, hospital days, peak treadmill time, and lean body mass and psychosocial function (See Section 8 for details).

Methods: Ninety-six subjects will be recruited from four sites (24 subjects each) for this study and all genders and ethnicities will be invited. All subject will have TBSA > 30% and be ages 7-60 years of age. The first objective of this multicenter study will be to characterize the SOC related to physical/occupational therapy of inpatients at four U.S. burn centers, through 25 question surveys. The second portion of the project will involve exercise research. The objective is to assess the efficacy of MP10, in conjunction with existing SOC, in reducing debilitation among discharged burn patients. This will be initiated following surgeon's prescription, roughly 3-5 days following the first surgery after admission.

Ergonomic exercise training for the in-patient subjects will be conducted using Leg and Arm Ergometer equipment, and the training period will be daily for 10 minutes. The duration will be the duration the patient is held in the Burn Intensive Care Unit (BICU). Testing will include the following: Lean mass (assessed via dual energy x-ray absorptiometry (DEXA), Cardiopulmonary and muscle endurance test (peak VO2 on treadmill test), and weekly 6 minute walk test.

Data Analysis: A repeated measure ANOVA will be calculated using lean body mass and peak VO2 as dependent variables with the independent variables of TBA%, duration of hospital stay (and days of ergonomic exercise), ventilator days, and demographics. The purpose of this study is to measure efficacy of exercise training while in BICU for thermal injury patients.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California-Davis/Shriners Hospitals for Children-Sacramento
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Galveston, Texas, United States, 77550
        • University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site)
      • San Antonio, Texas, United States, 78234
        • United States Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects ≥7 to 60 years of age
  2. >30% TBSA burned, as estimated by the physician in charge
  3. No evidence of organ failure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise + SOC PT/OT
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
ACTIVE_COMPARATOR: SOC PT/OT
Only SOC for treating in-patient burn subjects
Other: SOC PT/OT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in lean muscle mass
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VO2 max
Time Frame: 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.]
The maximal amount of oxygen per kilogram of body mass per minute(ml/kg/min) in a cardiopulmonary exercise test.
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
Time Frame: 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.
6 min walk test measures distance will be recorded in feet.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

University of Texas Southwestern Medical Center
United States Army Institute of Surgical Research
California State University, Sacramento

Investigators

  • Principal Investigator: Oscar Suman, University of Texas Medical Branch/Shriners Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2014

Primary Completion (ACTUAL)

September 25, 2020

Study Completion (ACTUAL)

September 25, 2020

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

April 14, 2016

First Posted (ESTIMATE)

April 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHC; IRB #14-0432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ONLY de-identified data will be deposited with main site (UTMB). Subsequently, if data is shared among all sites, it will be always in de-identified manner and stripped of all information that could identify the participant.

IPD Sharing Time Frame

Data will become available once study is completed and 7 years after that date, according to the IRB standards.

IPD Sharing Access Criteria

Once study personnel has completed CITI training and add to the study, will they have access to the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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