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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 9, 2008
Last Updated: June 10, 2008
Health Authority: Belgium: Institutional Review Board

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
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014