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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02739464 |
|
Recruitment Status :
Completed
First Posted : April 15, 2016
Last Update Posted : November 6, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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) |
| Actual Enrollment : | 77 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 |
| Actual Study Start Date : | September 15, 2014 |
| Actual Primary Completion Date : | September 25, 2020 |
| Actual Study Completion Date : | September 25, 2020 |
| 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 |
- 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.
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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
| United States, California | |
| University of California-Davis/Shriners Hospitals for Children-Sacramento | |
| Davis, California, United States, 95616 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site) | |
| Galveston, Texas, United States, 77550 | |
| United States Army Institute of Surgical Research | |
| San Antonio, Texas, United States, 78234 | |
| Principal Investigator: | Oscar Suman | University of Texas Medical Branch/Shriners Hospital for Children |
Other Publications:
| Responsible Party: | The University of Texas Medical Branch, Galveston |
| ClinicalTrials.gov Identifier: | NCT02739464 |
| Other Study ID Numbers: |
SHC; IRB #14-0432 |
| First Posted: | April 15, 2016 Key Record Dates |
| Last Update Posted: | November 6, 2020 |
| Last Verified: | October 2020 |
| 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 |
|
Burn Exercise Ergometer MP-10 |
|
Muscle Weakness Burns Wounds and Injuries Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes |