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Completed

NCT Number: NCT02185989

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

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.

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Key information

Conditions

ICU-acquired Muscle Weakness Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional d'Orléans

Orléans, 45000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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.

Acronym: PROMOREA1

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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