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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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.
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
|Contact: Oscar Sumanfirstname.lastname@example.org|
|Contact: Shauna Gloveremail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Angela Agudelo, BS 409-770-6686 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Julie Rizzo, MD|
|Sub-Investigator: Sandra Escolas, PhD|
|Sub-Investigator: Reginald Richard, MS, PT|
|Principal Investigator:||Oscar Suman||University of Texas Medical Branch/Shriners Hospital for Children|