An interventional study of Standardized Rehabilitation Therapy in Critically Injured Burn Patients, sponsored by Wake Forest University. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by Wake Forest University · Not applicable, Interventional, and Supportive care
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.
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
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Exclusion Criteria:
Standardized Rehabilitation Therapy (SRT): Participants randomized to the Standardized Rehabilitation Therapy arm will receive three types of interventions - Passive Range of Motion (PROM), Physical Therapy (PT) and Progressive Resistance Exercise (PRE). The SRT protocol will be administered by the BICU Mobility Team within 80 hours of ventilation and contains four levels of activity therapy. This Protocol will be delivered 7 days a week. Patients will be assessed daily and if appropriate will receive 3 separate sessions of activity each day.
Other: Standardized Rehabilitation Therapy
Hospital length of stay
Time frame: From date of randomization through 36 months post-study enrollment
Functional Status & Health Related Quality of Life
Time frame: ICU/Hospital Discharge, 3, 6 & 12 months post enrollment
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University