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Completed

NCT Number: NCT00695383

Early Exercise Training in Critically Ill Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Sciences, University Hospitals KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bedside cycle exercise therapy

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

Other names: exercise therapy, exercise training, exercise, cycle training, cycle exercise, Motomed Letto

Standard Physiotherapy Program

Behavioral

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

Other names: Usual physiotherapy, Routine physiotherapy, Mobilization

Primary outcomes

  1. six-minute walking distance

    Time frame: hospital discharge

Secondary outcomes

  1. quadriceps force

    Time frame: ICU discharge and hospital discharge

  2. functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)

    Time frame: ICU discharge and hospital discharge

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 11, 2008
Registry last updated
Jun 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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