ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02739464
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : July 2, 2017
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: Standard of Care 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: Experimental (MP-10)
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: Control
Only SOC for treating in-patient burn subjects
Other: Standard of Care PT/OT



Primary Outcome Measures :
  1. Dual X-ray Absorptiometry (DEXA) [ Time Frame: Patients will be followed for the duration of hospital stay (from admission to the hospital to when they are discharged from the hospital, with an expected average of 3 months +/- 1 month ]
    Body composition in patients will be assessed at admission to the hospital and when they are discharged from the hospital


Secondary Outcome Measures :
  1. Peak VO2 treadmill test [ Time Frame: patients will be followed for the duration of hospital stay (from admission to the hospital to when they are discharged from the hospital, with an expected average of 3 months +/- 1 month ]
    Peak VO2 treadmill test will be administered to patients at admission to the hospital (if not able to do test, a zero will be entered) and when they are discharged from the hospital

  2. Six minute Walk test [ Time Frame: patients will be followed for the duration of hospital stay (from admission to the hospital to when they are discharged from the hospital, with an expected average of 3 months +/- 1 month ]
    A six minute walk test will be administered to patients at admission to the hospital (if not able to do test, a zero will be entered) and when they are discharged from the hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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. Tuberculosis
  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


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

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: July 2, 2017
Last Verified: June 2017
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.

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