Effect of Progressive Early Mobilization in Patients With Trauma
Study Details
Study Description
Brief Summary
The overall goals of this proposed research are (1) to investigate the feasibility of a structured and interdisciplinary progressive EM protocol for critically ill patients with trauma in a trauma ICU and (2) to determine the effectiveness of the progressive EM protocol, which is designed for implementation with trauma patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Purpose: Trauma is often accompanied by injury-related neurological impairments, early physiological instabilities, and the use of high numbers of invasive catheters. Relatedly, patients with trauma have high rates of major disability and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols may minimize the functional declines experienced by patients in general during intensive care unit (ICU) stays, but few studies have investigated the effects of such protocols on trauma patients in particular. In addition, prior early mobilization studies have found that the survivors of trauma often experience a greater incidence of neurological injuries than other critical care patients. However, no randomized controlled trials thus far have utilized objective evaluations to measure the influence or effect of progressive EM protocols on the functional recovery of trauma patients. Therefore, we aim to explore the effects of using a progressive EM protocol in a trauma ICU on the functional mobility of trauma patients.
Objective: The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with trauma in a trauma ICU and (2) to determine the effectiveness of the progressive EM protocol, which is designed for implementation with trauma patients, on the functional and in-body outcomes of such patients.
Research methods: The study will be a single-blind, randomized controlled trial with a blinded assessment at the end of the follow-up period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: early mobilization (ER) group Participants in the EM group will undergo the progressive early mobilization protocol in the trauma ICU in a manner consistent with the our hospital practice guidelines indicated by the Modified Trauma ICU Mobility Scale for progressive mobilization during the ICU stay. The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay |
Behavioral: Early mobilization
The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay.
|
| Active Comparator: standard early rehabilitation (SER) group Patients in the SER group will receive standard physiotherapy including passive range of motion exercises, active exercises, bed mobility, and respiratory therapy during their ICU stays. In the SER group, out-of-bed mobilization (>=Level III in the Modified Trauma ICU Mobility Scale) will be started as soon as possible after ICU discharge. |
Behavioral: Early mobilization
The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay.
|
Outcome Measures
Primary Outcome Measures
- The total score-change of of the Perme ICU Mobility Score [at baseline; at the time of ICU discharge, an average of 14 days; the time of hospital discharge, an average of 50 days; three-month after onset]
The Perme ICU Mobility Score ranges from 0 to 32 points and is obtained by summing the score of 15 items, each one scored from 2 to 4 points. This score reflects the patient's mobility status in specific circumstances.
Secondary Outcome Measures
- The total score-change of of the motor domain of the Functional Independence Measure (FIM-motor) [at baseline; at the time of ICU discharge, an average of 14 days; the time of hospital discharge, an average of 50 days; three-month after onset]
the FIM-motor consist of self-care tasks (eating, grooming, bathing, upper-body dressing, lower-body dressing, and using the toilet), sphincter control (bladder and bowel management), transfers (from bed or a chair to the toilet, bath, or shower), and locomotion ability (walking or wheelchair mobility, and stair climbing)
- the achievement level of Modified Trauma ICU Mobility Scale [at baseline; at the time of ICU discharge, an average of 14 days; the time of hospital discharge, an average of 50 days]
the achievement of Modified Trauma ICU Mobility Scale, Level 0-10
- the days of achievement of the walking motor milestone [up to 3 months]
walking on a level surface for ≥50 meters with or without an assistive device
- the values tested by in body s10 about lean body mass parameters [at baseline; at the time of ICU discharge, an average of 14 days; the time of hospital discharge, an average of 50 days; three-month after onset]
including skeletal muscle mass, body fat mass, total body water etc.
- the length of stay in the ICU [up to 3 months]
the length of stay in the ICU
- the hospital length of stay [up to 3 months]
the hospital length of stay
- the days of ventilator used [up to 3 months]
the days of ventilator used
- the discharge disposition after hospital discharge [up to 3 months]
where a patient is being discharged - i.e. home, home with home care, skilled nursing facility, or rehab center.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Expected to stay for at least 72 hours in the ICU,
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20 years of age with living independently before the onset of critical illness
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relatively stable vital signs with a Glasgow Coma Scale (GCS) score of ≥6
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relatively stable respiratory status (SpO2 >92%, high mechanical ventilator setting: FiO2 ≤60%, and positive end-expiratory pressure ≤10 cmH2O)
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stable cardiovascular system (resting heart rate ≤130 bpm or no use of high-dose vasopressor of more than 0.2 μg kg-1 min-1)
Exclusion Criteria:
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predicted mortality within the next 24 hours
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palliative care
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consistent increase of intracranial pressure (>20 mmHg)
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pregnancy
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uncontrolled seizure
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active bleeding
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ruptured or leaking aortic aneurysm
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development of acute myocardial infarction during ICU stay
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rapid development of degenerative neuromuscular diseases
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contraindication for early walking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hsiao-Ching Yen | Taipei | Changhua Country | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Wen-Shiang Chen, Ph.D, Department of Physical Medicine and Rehabilitation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202012084RIN