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

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ClinicalTrials.gov Identifier: NCT02739464
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
United States Army Institute of Surgical Research
University of Texas Southwestern Medical Center
California State University, Sacramento
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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).

Condition or disease Intervention/treatment Phase
Muscle Weakness Late Effect of Burn Muscle; Fatigue, Heart Burn Rehabilitation Other: Exercise + SOC PT/OT Other: SOC PT/OT Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized, Controlled, Multicenter Study of the Effect of In-Patient Exercise Training on Length of Hospitalization, Mental Health, and Physical Performance in Burned Patients
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739464


Contacts
Contact: Oscar Suman 409-770-6557 oesuman@utmb.edu
Contact: Shauna Glover 409-7706-6617 sqglover@utmb.edu

Locations
United States, California
University of California-Davis/Shriners Hospitals for Children-Sacramento Recruiting
Davis, California, United States, 95616
Contact: Soman Sen, MD    800-282-3284    soman.sen@ucdmc.ucdavis.edu   
Principal Investigator: Soman Sen, MD         
Sub-Investigator: Ingrid Parry, MS, PT         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Karen Kowalske, MD    214-648-3111    Karen.Kowalske@UTSouthwestern.edu   
Contact: Cindy Dolezal, RN       Cindy.Dolezal@UTSouthwestern.edu   
Principal Investigator: Karen Kowalske, MD         
Sub-Investigator: Steve Wolf, MD         
University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site) Recruiting
Galveston, Texas, United States, 77550
Contact: Oscar E Suman, PhD    409-770-6557    oesuman@utmb.edu   
Contact: Angela Agudelo, BS    409-770-6686    anagudel@utmb.edu   
Sub-Investigator: David N Herndon, MD         
Sub-Investigator: Jong E Lee, MD         
Principal Investigator: Oscar E Suman, PhD         
United States Army Institute of Surgical Research Not yet recruiting
San Antonio, Texas, United States, 78234
Contact: Julie Rizzo, MD    210-916-1523    julie.a.rizzo.mil@mail.mil   
Principal Investigator: Julie Rizzo, MD         
Sub-Investigator: Sandra Escolas, PhD         
Sub-Investigator: Reginald Richard, MS, PT         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
United States Army Institute of Surgical Research
University of Texas Southwestern Medical Center
California State University, Sacramento
Investigators
Principal Investigator: Oscar Suman University of Texas Medical Branch/Shriners Hospital for Children

Publications of Results:
General Principles of Exercise Prescription, in ACSM's Guidelines for Exercise Testing and Prescription, B.A. Franklin, Editor 2006, Lippincott Williams & Wilkins: Philadelphia.
Bartholomew, K. and E. Scharfe, Reliability and stability of adult attachment patterns. Personal relationships. J Pers Soc Psychol, 1994. 1: p. 23-43.

Other Publications:
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02739464     History of Changes
Other Study ID Numbers: SHC; IRB #14-0432
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Medical Branch, Galveston:
Burn
Exercise
Ergometer
MP-10

Additional relevant MeSH terms:
Fatigue
Burns
Muscle Weakness
Paresis
Signs and Symptoms
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes