Muscle Weakness Clinical Trial
— MP-10Official 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
Verified date | October 2020 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 77 |
Est. completion date | September 25, 2020 |
Est. primary completion date | September 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of California-Davis/Shriners Hospitals for Children-Sacramento | Davis | California |
United States | University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site) | Galveston | Texas |
United States | United States Army Institute of Surgical Research | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | California State University, Sacramento, United States Army Institute of Surgical Research, University of Texas Southwestern Medical Center |
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in lean muscle mass | 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 | change in VO2 max | 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.] | |
Secondary | change in distance walked over 6 minutes | 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. |
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