Early Mobility for the Critically Injured Burn Patient

May 29, 2018 updated by: Wake Forest University

Early ICU Standardized Rehabilitation Therapy for the Critically Injured Burn Patient

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel-Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Experimental: Standardized Rehabilitation Therapy

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hospital length of stay
Time Frame: From date of randomization through 36 months post-study enrollment
From date of randomization through 36 months post-study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Functional Status & Health Related Quality of Life
Time Frame: ICU/Hospital Discharge, 3, 6 & 12 months post enrollment
ICU/Hospital Discharge, 3, 6 & 12 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Washington University School of Medicine
United States Department of Defense
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter E Morris, MD, University Of Kentucky
  • Principal Investigator: James Holmes, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00019937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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