Early Mobility for the Critically Injured Burn Patient

Background: Burn injury requiring mechanical ventilation affects a high proportion of the
25,000 patients admitted to US Burn Centers every year. Patients with a burn injury and acute
respiratory failure (ARF) experience deconditioning, muscle weakness, joint contractures,
dyspnea, depression, and reduced health-related quality of life. Delivery of rehabilitative
therapy (physical therapy) within the Burn Intensive Care Unit (BICU) for burn patients
requiring mechanical ventilation is not uniform in its content, timing, or the acceptance of
its safety. Our published data indicate that Standardized Rehabilitation Therapy, initiated
in the ICU, is feasible and safe for Medical ICU patients. Data have shown reductions in
hospital stay, and improvements in functional outcomes. Mechanistically, it is understood
that patients with burns and concomitant ARF exhibit acute alterations of metabolism, with
the resultant loss of muscle strength. 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.

Objective/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. Specific Aims: Aim 1: To
determine whether standardized rehabilitation therapy for BICU patients requiring mechanical
ventilation will decrease hospital length of stay. Aim 2: To determine by serial ultrasound
and strength assessments whether standardized rehabilitation therapy decreases loss of biceps
and quadriceps size, architecture and strength during critical illness of the severe burn
patient. Aim 3: To determine whether standardized rehabilitation therapy will improve
functional capacity and performance, and quality of life.

Study Design: The investigators will conduct a two arm trial with stratified randomization in
150 burn patients with concomitant ARF to compare SRT, initiated while on mechanical
ventilation in the ICU and administered throughout the hospitalization, vs. Usual Care
(control). Standardized Rehabilitation Therapy will consist of: passive range of motion,
physical therapy, and progressive resistance exercise (strength training). Our unique
approach will provide an experienced Mobility Team (7days/week) consisting of a critical care
nurse, physical therapist, and nursing assistant to administer this protocol at 3 University
Hospital sites. The proposed study is a natural extension of our prior work, is
multidisciplinary, is supported by extensive preliminary studies, and is innovative in its
application of strength training techniques and in-hospital strength assessments.

Relevance: Burn patients with ARF suffer for months after hospital discharge with weakness
and decreased quality of life. This study will provide the information to prioritize and
budget for the rehabilitation needs of burn patients with ARF by demonstrating that
Standardized Rehabilitation Therapy, initiated in the ICU, reduces hospital length of stay
with immediate and sustained improvement in function and quality of life for burn patients
with ARF. Given that military burn patients and civilian burn patients utilize similar
resources and experience similar outcomes, the results of this study will be immediately
transferable to the military burn patient with concomitant ARF resulting in improved
outcomes.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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