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Trial record 12 of 13 for:    24108501 [PUBMED-IDS]

Early Mobilization and Intensive Rehabilitation in the Critically Ill (EMIR)

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ClinicalTrials.gov Identifier: NCT02864745
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Faculty Hospital Kralovske Vinohrady
Information provided by (Responsible Party):
Frantisek Duska, Charles University, Czech Republic

Brief Summary:
ICU acquired weakness contributes (ICUAW) to poor functional outcome in survivors of critical care. Most damage occurs during the first week of critical illness when patients are unable to cooperate with conventional active rehabilitation. Functional electrical stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial. Adults (n=150) mechanically ventilated for < 48 hours from 4 ICUs who are estimated to need >7 days of critical care will be randomized to receive either FES-CE-based intensified rehabilitation or routine care, which will continue until ICU discharge. Primary outcome: Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle biopsies to look at mitochondrial function, fibre typing and regulatory protein expression in response to FES-CE.

Condition or disease Intervention/treatment Phase
Critical Illness Device: functional electrical stimulation-assisted cycle ergometry Other: standard rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation-assisted Cycle Ergometry in Critically Ill: Linking Deranged Muscle Physiology to Long-term Functional Outcome
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Early rehabilitation arm
These patients will receive very early (<48 hours after ICU admission), protocolised, intensive rehabilitation, which will include functional electrical stimulation-assisted cycle ergometry.
Device: functional electrical stimulation-assisted cycle ergometry
Early intensive rehabilitation protocol, which includes the use of functional electrical stimulation-assisted cycle ergometry

Active Comparator: Standard-of-care
These patients will receive standard rehabilitation delivered by non-study physiotherapist.
Other: standard rehabilitation
This group will receive standard rehabilitation, which will be monitored, but not protocolised.




Primary Outcome Measures :
  1. Quality of life as per 36-Item Short Health Survey (SF-36) score [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. 4‐item Physical Fitness in Intensive Care test [ Time Frame: at 28 days or discharge from ICU whichever occurs earlier ]
    functional outcome at ICU d/c

  2. Muscle mass measured by rectus m. crosssectional area on B-mode ultrasound [ Time Frame: at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier ]
  3. Nitrogen balance measured in g/m2 of body surface area [ Time Frame: at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier ]
    The cumulative the difference between nitrogen intake and output

  4. Muscle power per Medical Research Council (MRC) score [ Time Frame: at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier ]
  5. Number of ventilator-free days [ Time Frame: at 28 days ]
    Number of days, out of 28 after admission, patient has NOT been supported by mechanical ventilation

  6. Number of rehabilitation interruptions due to physiological deterioration [ Time Frame: at 28 days or discharge from ICU whichever occurs earlier ]
  7. Number of episodes of elevated intracranial pressure [ Time Frame: at 28 days or discharge from ICU whichever occurs earlier ]
  8. Number of dialysis interruptions [ Time Frame: at 28 days or discharge from ICU whichever occurs earlier ]
  9. Length of ICU stay in days [ Time Frame: at 6 months ]

Other Outcome Measures:
  1. Estimated cost of care in Euro per patient per hospital stay [ Time Frame: at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years;
  • Mechanical ventilation, or imminent need of it at presentation;
  • Predicted ICU length of stay ≥7 days;

Exclusion Criteria:

  • Known primary systemic neuromuscular disease or permanent neurological damage at admission
  • Severe lower limb injury or amputation
  • Bedridden premorbid state
  • Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 24 h
  • Pregnancy
  • Presence of external fixator or superficial metallic implants in lower limb
  • Open wounds or skin abrasions at electrode application points
  • Presence of pacemaker, implanted defibrillator or other implanted electronic medical device
  • Transferred from another ICU after 24 hours of consecutive mechanical ventilation
  • Presence of other condition preventing the use of FES-‐CE or considered unsuitable for the study by a responsible medical team
  • Prior participating in another functional outcome-based intervention research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864745


Contacts
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Contact: Frantisek Duska +420267162451 frantisek.duska@fnkv.cz
Contact: Sarka Gregorova +42067163410 studijni.sestry@gmail.com

Locations
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Czechia
Kralovske Vinohrady University Hospital Recruiting
Prague, Czechia, 10034
Contact: Frantisek Duska    +420267162451    frantisek.duska@fnkv.cz   
Sponsors and Collaborators
Charles University, Czech Republic
Faculty Hospital Kralovske Vinohrady
Investigators
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Study Director: Petr Waldauf Faculty Hospital Kralovske Vinohrady

Additional Information:
Publications:

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Responsible Party: Frantisek Duska, Head of Dept. of Anaesthesia and Intensive Care, 3rd Faculty of Medicine, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT02864745     History of Changes
Other Study ID Numbers: 16-28663A
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frantisek Duska, Charles University, Czech Republic:
early rehabilitation
critically ill
muscle weakness
neuromuscular stimulation
functional electrical stimulation-assisted cycle ergometry
ICUAW
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes