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Early Exercise Training in Critically Ill Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695383
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
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.
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
Katholieke Universiteit Leuven
  Purpose
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.

Condition Intervention
Critical Illness Intensive Care Muscle Weakness Deconditioning Behavioral: Bedside cycle exercise therapy Behavioral: Standard physiotherapy program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • six-minute walking distance [ Time Frame: hospital discharge ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 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

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695383


Locations
Belgium
Department of Rehabilitation Sciences, University Hospitals KULeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Investigators
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
  More Information

Responsible Party: Prof. Dr. Rik Gosselink, Department of Rehabilitation Sciences, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00695383     History of Changes
Other Study ID Numbers: G 0523.06
First Submitted: June 9, 2008
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by Katholieke Universiteit Leuven:
Exercise therapy
Physiotherapy
Critical illness
Intensive care
Muscle weakness
Mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Muscle Weakness
Paresis
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms