Clinical trial NCT02185989: Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICU-acquired Muscle Weakness
Keywords: Critical Illness/*rehabilitation
Humans
*Intensive Care Units
Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control
Polyneuropathies/diagnosis/*etiology/physiopathology
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Global muscle strength assessed by the MRC (Medical research Council, 1978) score
timeFrame: on the day of ICU discharge (+/- 1 day)
Secondary outcomes:
measure: Changes in thickness of the rectus femoris muscle of each thigh
timeFrame: from inclusion to ICU discharge (+ / - 1 day)
measure: Frequency of delirium in the ICU.
timeFrame: During ICU stay
measure: Quality of life
timeFrame: 6 months after ICU discharge
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
Study officials:
affiliation: Centre Hospitalier Régional d'Orléans, France
name: Thierry Boulain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.