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

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.

Study Overview

• Status: Completed
• Conditions: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
• Intervention / Treatment: Device: the standard physiotherapy group; Device: standing table group

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Le Plessis Robinson, Ile de France, France, 92350
      • Centre Chirurgical MarieLannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue
• Investigators: Principal Investigator: Céline SARFATI, physiotherapist, Centre Chirurgical Marie Lannelongue

Publications and helpful links

General Publications

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
• Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
• Sarfati C, Moore A, Pilorge C, Amaru P, Mendialdua P, Rodet E, Stephan F, Rezaiguia-Delclaux S. Efficacy of early passive tilting in minimizing ICU-acquired weakness: A randomized controlled trial. J Crit Care. 2018 Aug;46:37-43. doi: 10.1016/j.jcrc.2018.03.031. Epub 2018 Apr 5.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Critical illness; Physiotherapy; Exercise therapy; Mechanical ventilation; Intensive care; Muscle Weakness
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: P12-37815003/2012A00665-38; IDRCB 2012-A00665-38 (Other Identifier: P12-37815003)