Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU (NCT02185989) | Clinical Trial Compass
CompletedNot Applicable
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
France314 participantsStarted 2014-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global muscle strength assessed by the MRC (Medical research Council, 1978) score
Timeframe: on the day of ICU discharge (+/- 1 day)