Early Exercise Training in Critically Ill Patients

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00695383
First received: June 9, 2008
Last updated: June 10, 2008
Last verified: June 2008

June 9, 2008
June 10, 2008
December 2005
February 2007   (final data collection date for primary outcome measure)
six-minute walking distance [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00695383 on ClinicalTrials.gov Archive Site
  • quadriceps force [ Time Frame: ICU discharge and hospital discharge ] [ Designated as safety issue: No ]
  • functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item) [ Time Frame: ICU discharge and hospital discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Exercise Training in Critically Ill Patients
Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Critical Illness
  • Intensive Care
  • Muscle Weakness
  • Deconditioning
  • Behavioral: 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
    Other Names:
    • exercise therapy
    • exercise training
    • exercise
    • cycle training
    • cycle exercise
    • Motomed Letto
  • Behavioral: Standard physiotherapy program
    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
  • Experimental: 1
    Intervention: Behavioral: Bedside cycle exercise therapy
  • Active Comparator: 2
    Intervention: Behavioral: Standard physiotherapy program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00695383
G 0523.06
No
Prof. Dr. Rik Gosselink, Department of Rehabilitation Sciences, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Study Director: Rik Gosselink, PT, phD Department of Rehabilitation Sciences, University Hospitals KULeuven
Principal Investigator: Chris Burtin, PT, MSc Department of Rehabilitation Sciences, University Hospitals KULeuven
Katholieke Universiteit Leuven
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP