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Early Mobilization and Intensive Rehabilitation in the Critically Ill

NCT02864745 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-10-11

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

DEVICE

functional electrical stimulation-assisted cycle ergometry

Early intensive rehabilitation protocol, which includes the use of functional electrical stimulation-assisted cycle ergometry

OTHER

standard rehabilitation

This group will receive standard rehabilitation, which will be monitored, but not protocolised.

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Petr Waldauf · Faculty Hospital Kralovske Vinohrady

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2020-03-10
Completion
2020-03-10

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864745 on ClinicalTrials.gov