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Early Exercise Training in Critically Ill Patients

NCT ID: NCT00695383

Last Updated: 2008-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Critical Illness Intensive Care Muscle Weakness Deconditioning

Keywords

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Exercise therapy Physiotherapy Critical illness Intensive care Muscle weakness Mechanical ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Bedside cycle exercise therapy

Intervention Type BEHAVIORAL

A 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2

2

Group Type ACTIVE_COMPARATOR

Standard physiotherapy program

Intervention Type BEHAVIORAL

The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.

Interventions

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Bedside cycle exercise therapy

A 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2

Intervention Type BEHAVIORAL

Standard physiotherapy program

The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.

Intervention Type BEHAVIORAL

Other Intervention Names

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exercise therapy exercise training exercise cycle training cycle exercise Motomed Letto Usual physiotherapy Routine physiotherapy Mobilization

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Department of Rehabilitation Sciences, Katholieke Universiteit Leuven

Principal Investigators

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Rik Gosselink, PT, phD

Role: STUDY_DIRECTOR

Department of Rehabilitation Sciences, University Hospitals KULeuven

Chris Burtin, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Sciences, University Hospitals KULeuven

Locations

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Department of Rehabilitation Sciences, University Hospitals KULeuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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G 0523.06

Identifier Type: -

Identifier Source: org_study_id