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Clinical Trials/NCT00695383
NCT00695383CompletedNot Applicable

Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery

KU Leuven2 sites in 1 country90 target enrollmentStarted: December 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
KU Leuven
Enrollment
90
Locations
2
Primary Endpoint
six-minute walking distance

Study Overview

Brief Summary

This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Detailed Description

Inactivity during prolonged bed rest leads to muscle dysfunction. Muscle function decreases even faster in ICU patients due to inflammation, pharmacological agents (corticosteroids, muscle relaxants, neuromuscular blockers, antibiotics), and the presence of neuromuscular syndromes, associated with critical illness. A recent recommendation document advices to start early with active and passive exercise in critically ill patients. However, no evidence is available concerning the feasibility of an early muscle training intervention in the acute ICU phase when patients are still under sedation. A rather new method to train bed-bound patients is the use of a bedside cycle ergometer. This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ICU stay > 5 days
  • Expected prolonged stay of at least 7 more days
  • Cardiorespiratory status that allows at least passive exercise therapy

Exclusion Criteria

  • Persistent or progressive neurological or (neuro)muscular disease
  • Coagulation disorders (INR > 1.5, [BP] < 50000/mm³)
  • Intracranial pressure > 20 mmHg
  • Psychiatric disorders or severe confusion

Outcomes

Primary Outcomes

six-minute walking distance

Time Frame: hospital discharge

Secondary Outcomes

  • quadriceps force(ICU discharge and hospital discharge)
  • functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)(ICU discharge and hospital discharge)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other

Study Sites (2)

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