Clinical Trials Directory

Trials / Completed

CompletedNCT00695383

Early Exercise Training in Critically Ill Patients

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBedside cycle exercise therapyA 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
BEHAVIORALStandard physiotherapy programThe standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.

Timeline

Start date
2005-12-01
Primary completion
2007-02-01
Completion
2007-02-01
First posted
2008-06-11
Last updated
2008-06-11

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT00695383. Inclusion in this directory is not an endorsement.