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

NCT02185989 | Completed

• 2 other identifiers: CHRO 2014-001ID RCB : 2014-A00566-41
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU-acquired Muscle Weakness

Keywords

Critical Illness/*rehabilitation; Humans; *Intensive Care Units; Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control; Polyneuropathies/diagnosis/*etiology/physiopathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in thickness of the rectus femoris muscle of each thigh

  from inclusion to ICU discharge (+ / - 1 day)

• Frequency of delirium in the ICU.

  During ICU stay

• Quality of life

  6 months after ICU discharge

Study Arms (2)

Electrical muscle stimulation and bicycling

ACTIVE COMPARATOR

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

Standard early passive/active rehabilitation

NO INTERVENTION

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

Interventions

Early electrical stimulation and early leg bicycling added to early standard rehabilitation OTHER

Electrical muscle stimulation and bicycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Opposition expressed by the patient, his/her legal representative or a member of his/her family
• Pregnant woman
• 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
• Moribund patient

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Régional d'Orléans

Orléans, 45000, France

Location

Related Publications (1)

• 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.

  PMID: 30043066 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Polyneuropathies

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Thierry Boulain, MD

  Centre Hospitalier Régional d'Orléans, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 10, 2014
• Study Start: July 15, 2014
• Primary Completion: November 24, 2016
• Study Completion: November 24, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

FR (1)