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Early Exercise Training in Critically Ill Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695383
Enrollment
90
Registered
2008-06-11
Start date
2005-12-31
Completion date
2007-02-28
Last updated
2008-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care, Muscle Weakness, Deconditioning

Keywords

Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation

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.

Interventions

BEHAVIORALBedside 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

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

Sponsors

Fund for Scientific Research, Flanders, Belgium
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
six-minute walking distancehospital discharge

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026