search
Back to results

Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU (PROMOREA1)

Primary Purpose

ICU-acquired Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early electrical stimulation and early leg bicycling added to early standard rehabilitation
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ICU-acquired Muscle Weakness focused on measuring Critical Illness/*rehabilitation, Humans, *Intensive Care Units, Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control, Polyneuropathies/diagnosis/*etiology/physiopathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Régional d'Orléans

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Electrical muscle stimulation and bicycling

Standard early passive/active rehabilitation

Arm Description

Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Frequency of delirium in the ICU.
Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).
Quality of life
Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire

Full Information

First Posted
July 4, 2014
Last Updated
April 12, 2017
Sponsor
Centre Hospitalier Régional d'Orléans
search

1. Study Identification

Unique Protocol Identification Number
NCT02185989
Brief Title
Electrical Muscle Stimulation and Bicycling Combined to Early Standard Rehabilitation in the ICU
Acronym
PROMOREA1
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 15, 2014 (Actual)
Primary Completion Date
November 24, 2016 (Actual)
Study Completion Date
November 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU-acquired Muscle Weakness
Keywords
Critical Illness/*rehabilitation, Humans, *Intensive Care Units, Muscle Weakness/diagnosis/*etiology/physiopathology/prevention & control, Polyneuropathies/diagnosis/*etiology/physiopathology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical muscle stimulation and bicycling
Arm Type
Active Comparator
Arm Description
Patients will undergo early electrical stimulation of the quadriceps and early leg bicycling in addition to routine care (which comprises early standard mobilization)
Arm Title
Standard early passive/active rehabilitation
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Early electrical stimulation and early leg bicycling added to early standard rehabilitation
Primary Outcome Measure Information:
Title
Global muscle strength assessed by the MRC (Medical research Council, 1978) score
Description
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
Time Frame
on the day of ICU discharge (+/- 1 day)
Secondary Outcome Measure Information:
Title
Changes in thickness of the rectus femoris muscle of each thigh
Description
Changes in thickness of the rectus femoris muscle of each thigh, as measured by ultrasound imaging, between inclusion and ICU discharge (+ / - 1 day).
Time Frame
from inclusion to ICU discharge (+ / - 1 day)
Title
Frequency of delirium in the ICU.
Description
Delirium is defined by the CAM-ICU scale (Ely CCM 2001 Ely JAMA 2001).
Time Frame
During ICU stay
Title
Quality of life
Description
Quality of life 6 months after ICU discharge assessed by the SF-36 questionnaire
Time Frame
6 months after ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Boulain, MD
Organizational Affiliation
Centre Hospitalier Régional d'Orléans, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orléans
ZIP/Postal Code
45000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30043066
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs