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

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.

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.

Study Overview

• Status: Completed
• Conditions: ICU-acquired Muscle Weakness
• Intervention / Treatment: Other: Early electrical stimulation and early leg bicycling added to early standard rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45000
    • Centre Hospitalier Regional D'Orleans

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global muscle strength assessed by the MRC (Medical research Council, 1978) score	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	on the day of ICU discharge (+/- 1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in thickness of the rectus femoris muscle of each thigh	Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).	from inclusion to ICU discharge (+ / - 1 day)
Frequency of delirium in the ICU.	Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).	During ICU stay
Quality of life	Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire	6 months after ICU discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Thierry Boulain, MD, Centre Hospitalier Régional d'Orléans, France

Publications and helpful links

General Publications

• Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2014
• Primary Completion (Actual): November 24, 2016
• Study Completion (Actual): November 24, 2016

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 9, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Humans; Critical Illness/*rehabilitation; *Intensive Care Units; Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control; Polyneuropathies/diagnosis/*etiology/physiopathology
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: CHRO 2014-001; ID RCB : 2014-A00566-41 (Other Identifier: ANSM; Ministry of Health ; French government)