Early Exercise Training in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness; Intensive Care; Muscle Weakness; Deconditioning
• Interventions: Behavioral: Standard physiotherapy program; Behavioral: Bedside cycle exercise therapy

• Registration Number: NCT00695383
• Lead Sponsor: KU Leuven

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 Timeline

• Study Start: 2005-12
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2008-06
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Last Update Submitted: 2008-06-10
• Study First Posted: 2008-06-11
• Last Update Posted: 2008-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Standard physiotherapy program	-
1	Bedside cycle exercise therapy	-

Primary Outcome Measures

Name	Time	Method
six-minute walking distance	hospital discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Rehabilitation Sciences, University Hospitals KULeuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium