Early Mobility for the Critically Injured Burn Patient

Stopped early · Not applicable

Conditions studied: Critically Injured Burn Patients

In brief

This study will demonstrate that Standardized Rehabilitation Therapy for burn patients with ARF reduces hospital stay through immediate improvement in functional capacity and functional performance. Our team comprises Burn Surgeons, Intensivists with expertise in Critical Care Trial design, Exercise Physiologists and Outpatient Functional Outcome Assessment Experts. The design was conceived through the US-Critical Illness and Injury Trials Group which allowed these investigators to bring varied expertise to the problems faced by critically ill Burn patients. Hypotheses:1) Standardized Rehabilitation Therapy (SRT) will shorten hospital stay in burn patients with ARF. 2) SRT will prevent loss in muscle size and loss of architecture during critical illness of severe burns. 3) SRT will improve objective functional measures and quality of life at 3, 6, 12, 24, and 36 months post-enrollment.

Key facts

Study ID

NCT01866735

Run by

Wake Forest University

People needed

12

Starts

2013-05-01

Expected to finish

2015-03-01

Last updated by the study team

2018-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Mechanically ventilated via an endotracheal tube or mask (via tracheostomy is acceptable if performed emergently due to burn injury)
• Burn injury requiring ICU admission

You may not qualify if…

• Inability to walk without assistance prior to burn injury (use of a cane or walkers not exclusions)
• Cognitive impairment prior to burn injury (non-verbal)
• Acute Stroke
• Body Mass Index (BMI) >50
• Neuromuscular disease that could impair ventilator weaning (myasthenia gravis, ALS, Gillian-Barre)
• Hospitalization within 30 days prior to burn injury
• Re-admission to ICU/BICU within current hospitalization
• Expected hospitalization length of stay < 3 days
• Hip fracture, unstable cervical spine or pathological fracture
• Mechanically ventilated >80 hours prior to study enrollment
• Current hospitalization or transferring hospital stay >7days prior to study enrollment
• DNR/DNI on admission
• Ineligible cancer treatment within the last 6 months
• Investigator judgment/determination that patient is unable to participate in intervention (SRT)
• Moribund
• Participation in treatment arm of another research study within the past 30 days/or at any time during the treatment phase of this study

Where it is running

• Washington University — St Louis, Missouri, United States
• University of North Carolina, Chapel-Hill — Chapel Hill, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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