Patients Are Recruited From One Thoracic and Cardiac Surgery ICUTILTNCT02047617

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

A study testing the standard physiotherapy group and standing table group in people with Patients Are Recruited From One Thoracic and Cardiac Surgery ICU, run by Centre Chirurgical Marie Lannelongue at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
What is being tested?: the standard physiotherapy group and standing table group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 1 siteFrance
Study dates: Aug 2013to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours

Who cannot join

Polytrauma,
Cerebral , spinal cord or spinal injury,
Pelvic or lower limb fracture

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Chirurgical MarieLannelongue
Le Plessis-Robinson, Île-de-France Region, 92350

Other trials in France

About this study

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.

Conditions: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
Being tested: the standard physiotherapy group, standing table group
Keywords: Muscle Weakness, Exercise therapy, Physiotherapy, Critical illness, Intensive care, Mechanical ventilation, Rehabilitation
Medical subject headings: Muscle Weakness, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the standard physiotherapy groupDevice
Mobilization and rehabilitation program is progressively introduced after clinical stabilization
standing table groupDevice
The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Study groups in NCT02047617
Study group	Role	What they receive
the standard physiotherapy group	Active comparator	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. Receives: Device: the standard physiotherapy group
standing table group	Experimental	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°. Receives: Device: standing table group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Medical Research Council, the patient is monitored and evaluate for up to 1 month

Secondary outcomes (14)

The time to standing
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Measured: Duration ( time and every day), the patient is monitored and evaluate for up to 1 month
ICU stay
Measured: duration (day number), the patient is monitored and evaluate for up to 1 month
Hospital stay
Measured: 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.
Measured: time in minutes (every day), the patient is monitored and evaluate for up to 1 month
Hospital mortality
number of deaths
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: % 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: observation, every day the patient is monitored and evaluate for up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Oct 2015

First posted28 Jan 2014 (estimated)
Study startAug 2013
Primary completionAug 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Patients Are Recruited From One Thoracic and Cardiac Surgery ICUStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047617
Sponsor's protocol ID: P12-37815003/2012A00665-38
Other IDs: IDRCB 2012-A00665-38
Acronym: TILT
Status last verified: Feb 2017
First submitted: 7 Oct 2013
Last updated: 27 Feb 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 18283429
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.
PubMed 19446324
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.
PubMed 29660670

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
ClinicalTrials.gov ID: NCT02047617
Acronym / sponsor ID: TILT / P12-37815003/2012A00665-38
Conditions: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
Keywords: Muscle Weakness, Exercise therapy, Physiotherapy, Critical illness, Intensive care, Mechanical ventilation, Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Centre Chirurgical Marie LannelongueUniversity, hospital or other
Study start: Aug 2013
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
the standard physiotherapy group	Active comparator	Device: the standard physiotherapy groupPhysiotherapy 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.
standing table group	Experimental	Device: standing table groupThe 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°.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours

Key exclusion criteria (3 listed)

Polytrauma,
Cerebral , spinal cord or spinal injury,
Pelvic or lower limb fracture

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
the standard physiotherapy groupMobilization and rehabilitation program is progressively introduced after clinical stabilization	Device	the standard physiotherapy group
standing table groupThe protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform	Device	standing table group

Primary outcome

Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used.
Time frame: 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.

14 secondary outcomes

The time to standing
Time frame: Duration ( time and every day), the patient is monitored and evaluate for up to 1 month
ICU stay
Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month
Hospital stay
Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month
Mechanical ventilation duration
Time frame: time in minutes (every day), the patient is monitored and evaluate for up to 1 month
Hospital mortality
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: irregular heart beat, every day the patient is monitored and evaluate for up to 1 month
Appearance of a disorder repolarization
Time frame: 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,
Time frame: % saturation, every day, the patient is monitored and evaluate for up to 1 month
Increase in systolic pulmonary artery pressure more than 60 mmHg
Time frame: systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month
Pneumothorax detected immediately after standing session
Time frame: 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,
Time frame: observation evry day, the patient is monitored and evaluate for up to 1 month
Fall of the patient during a transfer
Time frame: observation, every day the patient is monitored and evaluate for up to 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
Background: PubMed 18283429Gosselink 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.
Background: PubMed 19446324Schweickert 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.
Derived from this study: PubMed 29660670Sarfati 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.
Related InfoLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Céline SARFATI, physiotherapist principal investigator

Centre Chirurgical Marie Lannelongue

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used. (time frame: Medical Research Council, the patient is monitored and evaluate for up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02047617, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.