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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ICU-acquired Muscle Weakness
- Sponsor
- Centre Hospitalier Régional d'Orléans
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- Global muscle strength assessed by the MRC (Medical research Council, 1978) score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- Frequency of delirium in the ICU.(During ICU stay)
- Changes in thickness of the rectus femoris muscle of each thigh(from inclusion to ICU discharge (+ / - 1 day))
- Quality of life(6 months after ICU discharge)