We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU (PROMOREA1)

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: NCT02185989
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:

Early mobilization (from the first day if possible), first passive and then passive and active, is recommended for critically ill patients in whom it reduces the duration of mechanical ventilation, the length of hospital stay, improves functional status, muscle strength and quality of life after hospital discharge. The early addition of leg bicycling on a cyclo-ergometer is now part of common practice in the ICU. It can preserve or improve muscle strength and further increase the beneficial effects of early mobilization. Electrical muscle stimulation of the quadriceps, is practiced in some intensive care units, and it should, in theory, also through an improvement of muscle strength, increase the beneficial effects of early mobilization.

We hypothesized that early quadriceps electrical stimulation and early work on a cyclo-ergometer associated with a standard protocol of early passive/active mobilization in the ICU may improve muscle function and reduce the duration of mechanical ventilation, length of stay, the number of readmissions and improve the quality of life in the mid term in critically ill patients, as compared to a conventional protocol of early passive/active mobilization.


Condition or disease Intervention/treatment Phase
ICU-acquired Muscle Weakness Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Rehabilitation Combining Daily Electrical Muscle Stimulation and Early Bedside Cycling Exercise, Compared to Early Standard Rehabilitation. A Randomized, Assessor-blinded, Single-center Study in Intensive Care Patients.
Actual Study Start Date : July 15, 2014
Actual Primary Completion Date : November 24, 2016
Actual Study Completion Date : November 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Electrical muscle stimulation and bicycling
Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)
Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation
No Intervention: Standard early passive/active rehabilitation
In this control group, patients will undergo routine care that comprises standard early passive/active rehabilitation delivered by physiotherapist with the assistance of ICU nurses



Primary Outcome Measures :
  1. Global muscle strength assessed by the MRC (Medical research Council, 1978) score [ Time Frame: on the day of ICU discharge (+/- 1 day) ]
    Global muscle strength assessed by the MRC (Medical research Council, 1978) score on the day of ICU discharge (+/- 1 day) in all enrolled patients discharged alive from the ICU. This evaluation will be conducted by a physiotherapist blinded to the randomization group


Secondary Outcome Measures :
  1. Changes in thickness of the rectus femoris muscle of each thigh [ Time Frame: from inclusion to ICU discharge (+ / - 1 day) ]
    Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).

  2. Frequency of delirium in the ICU. [ Time Frame: During ICU stay ]
    Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).

  3. Quality of life [ Time Frame: 6 months after ICU discharge ]
    Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 18 yrs
  • expected length of stay in the ICU higher than 72 hours
  • motor autonomy sufficient for independent ambulation (ass assessed by patient/family/familial practitioner interview

Exclusion Criteria:

  • Opposition expressed by the patient, his/her legal representative or a member of his/her family
  • Pregnant woman
  • Resuscitated cardiac arrest before inclusion
  • Patient carrying a pacemaker or an implantable defibrillator
  • Patient under extracorporeal membrane oxygenation
  • Severe acute cerebral disease requiring deep sedation
  • Brain death
  • Guillain-Barré syndrome
  • Myasthenia gravis
  • Known Dementia than can affect the main endpoint assessment
  • Deep venous thrombosis or pulmonary embolism treated for less than 48 hours, or floating clot in femoral, iliac of inferior vena cava veins
  • Unstable traumatic injuries of the spine
  • Severe skin disease or surgical reasons that either prevent performing electrostimulation or bicycling in the next 2 days, or prevent patient's verticalization or transfer to chair in the next 5 days
  • Amputation of a lower limb at the trans-metatarsal level or higher
  • Inclusion in another interventional study with muscle strength assessment as the primary endpoint
  • Moribund patient

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): NCT02185989


Locations
Layout table for location information
France
Centre Hospitalier Régional d'Orléans
Orléans, France, 45000
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
Layout table for investigator information
Principal Investigator: Thierry Boulain, MD Centre Hospitalier Régional d'Orléans, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT02185989    
Other Study ID Numbers: CHRO 2014-001
ID RCB : 2014-A00566-41 ( Other Identifier: ANSM; Ministry of Health ; French government )
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Keywords provided by Centre Hospitalier Régional d'Orléans:
Critical Illness/*rehabilitation
Humans
*Intensive Care Units
Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control
Polyneuropathies/diagnosis/*etiology/physiopathology
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes