ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Exercise Training in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00695383
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Katholieke Universiteit Leuven

June 9, 2008
June 11, 2008
June 11, 2008
December 2005
February 2007   (Final data collection date for primary outcome measure)
six-minute walking distance [ Time Frame: hospital discharge ]
Same as current
No Changes Posted
  • quadriceps force [ Time Frame: ICU discharge and hospital discharge ]
  • functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item) [ Time Frame: ICU discharge and hospital discharge ]
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 Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Same as current
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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00695383
G 0523.06
No
Not Provided
Not Provided
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