Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients

Study Overview
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Brief Summary
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Critically ill patients frequently develop muscle weakness due to critical illness-related acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased mortality rates. In addition, many patients continue to suffer from decreased exercise capacity and quality of life for months to years after the acute event. Besides controlling risk factors, no specific prevention or treatment exists. Recommendations advice to start early with active and passive exercise in critically ill patients (1). Having critically ill patients alert and engaged in progressive rehabilitation leading to mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to improved strength and physical function (2). This randomized controlled trial was designed to investigate whether a daily training session using a tilt table, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Official Title
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Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients

Conditions
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Patients Are Recruited From One Thoracic and Cardiac Surgery ICU

Intervention / Treatment
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* Device: the standard physiotherapy group
* Device: standing table group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours Exclusion Criteria: Polytrauma, Cerebral , spinal cord or spinal injury, Pelvic or lower limb fracture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the standard physiotherapy group<br>Physiotherapy rehabilitation techniques used in the management of this group include passive range of motion, active range of motion/bed exercises, sitting at edge of bed, sitting in armchair, active transfer from the bed to chair. Mobilization and rehabilitation program is progressively introduced after clinical stabilization with a goal of progressing to ambulation and pulmonary rehabilitation. | Device: the standard physiotherapy group<br>* Mobilization and rehabilitation program is progressively introduced after clinical stabilization<br>|
| Experimental: standing table group<br>The same program as standard physiotherapy group is applied, with daily sessions of standing table in supplement. Standing table was performed on a motorized tilt table (ref: table de verticalisation, Franco&fils). The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform, at 10° intervals from 30° to 80°. | Device: standing table group<br>* The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used. | Clinically important muscle weakness has been defined as a composite MRC score <80% of normal (eg, a score <48 out of a maximum of 60 based on examination of 3 muscle groups in each limb). MRC score is measured after randomization, before ICU discharge and before hospital discharge. | Medical Research Council, the patient is monitored and evaluate for up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to standing | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | Duration ( time and every day), the patient is monitored and evaluate for up to 1 month | 
| ICU stay |  | duration (day number), the patient is monitored and evaluate for up to 1 month | 
| Hospital stay |  | duration (day number), the patient is monitored and evaluate for up to 1 month | 
| Mechanical ventilation duration | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | time in minutes (every day), the patient is monitored and evaluate for up to 1 month | 
| Hospital mortality | number of deaths | number of death during the 3 years of the study | 
| Changes in blood pressure of more or less 20% of the reference value of rest required to stop the session or initiation of medical treatment | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | Blood Pressure(mm Hg) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | 
| Changes in heart rate of more or less 20% of the reference value of rest required to stop the session or initiation of medical treatment | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | heartt rate (beats a minute) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | 
| Onset of arrhythmia | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | irregular heart beat, every day the patient is monitored and evaluate for up to 1 month | 
| Appearance of a disorder repolarization | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | ECG Interpretation, every day the patient is monitored and evaluate for up to 1 month | 
| desaturation of more than 10% of the reference value requiring a decision of the meeting or any medical intervention, | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | % saturation, every day, the patient is monitored and evaluate for up to 1 month | 
| Increase in systolic pulmonary artery pressure more than 60 mmHg | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month | 
| Pneumothorax detected immediately after standing session | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | Chest radiography and clinical examination, every day the patient is monitored and evaluate for up to 1 month | 
| Agitation requiring the increase of sedation or complicated tear gastric catheter probe or endotracheal tube, | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | observation evry day, the patient is monitored and evaluate for up to 1 month | 
| Fall of the patient during a transfer | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | observation, every day the patient is monitored and evaluate for up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise therapy, Muscle Weakness, Physiotherapy, Critical illness, Intensive care, Mechanical ventilation, Rehabilitation