ICU-acquired Muscle Weakness Clinical Trial
— PROMOREA1Official 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.
| Verified date | April 2017 |
| Source | Centre Hospitalier Régional d'Orléans |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 314 |
| Est. completion date | November 24, 2016 |
| Est. primary completion date | November 24, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Régional d'Orléans | Orléans |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional d'Orléans |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | Frequency of delirium in the ICU. | Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001). | During ICU stay | |
| Secondary | Quality of life | Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire | 6 months after ICU discharge |