Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047617
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. The time to standing [ Time Frame: 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.

  2. ICU stay [ Time Frame: duration (day number), the patient is monitored and evaluate for up to 1 month ]
  3. Hospital stay [ Time Frame: duration (day number), the patient is monitored and evaluate for up to 1 month ]
  4. Mechanical ventilation duration [ Time Frame: 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.

  5. Hospital mortality [ Time Frame: number of death during the 3 years of the study ]
    number of deaths

  6. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  7. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  8. Onset of arrhythmia [ Time Frame: 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.

  9. Appearance of a disorder repolarization [ Time Frame: 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.

  10. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  11. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  12. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  13. 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 ]
    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  14. Fall of the patient during a transfer [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047617


Locations
Layout table for location information
France
Centre Chirurgical MarieLannelongue
Le Plessis Robinson, Ile de France, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
Layout table for investigator information
Principal Investigator: Céline SARFATI, physiotherapist Centre Chirurgical Marie Lannelongue

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT02047617     History of Changes
Other Study ID Numbers: P12-37815003/2012A00665-38
IDRCB 2012-A00665-38 ( Other Identifier: P12-37815003 )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Keywords provided by Centre Chirurgical Marie Lannelongue:
Muscle Weakness
Exercise therapy
Physiotherapy
Critical illness
Intensive care
Mechanical ventilation
Rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Nervous System Diseases