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

Sponsor

Centre Chirurgical Marie Lannelongue (Other)

Overall Status

Completed

CT.gov ID

NCT02047617

Collaborator

(none)

145

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Are Recruited From One Thoracic and Cardiac Surgery ICU	Device: the standard physiotherapy group Device: standing table group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: the standard physiotherapy group 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 Mobilization and rehabilitation program is progressively introduced after clinical stabilization
Experimental: standing table group 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 The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Arm

Intervention/Treatment

Active Comparator: the standard physiotherapy group

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

Mobilization and rehabilitation program is progressively introduced after clinical stabilization

Experimental: standing table group

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

The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Outcome Measures

Primary Outcome Measures

Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used. [Medical Research Council, the patient is monitored and evaluate for up to 1 month]
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.

Secondary Outcome Measures

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