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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Muscle Weakness; Intensive Care; Deconditioning
• Intervention / Treatment: Behavioral: Bedside cycle exercise therapy; Behavioral: Standard physiotherapy program

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Department of Rehabilitation Sciences, University Hospitals KULeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; exercise training; exercise therapy; 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: Mobilization; Usual physiotherapy; Routine physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
six-minute walking distance	hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
quadriceps force	ICU discharge and hospital discharge
functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)	ICU discharge and hospital discharge

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: June 9, 2008
• First Submitted That Met QC Criteria: June 10, 2008
• First Posted (Estimate): June 11, 2008

Study Record Updates

• Last Update Posted (Estimate): June 11, 2008
• Last Update Submitted That Met QC Criteria: June 10, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Critical illness; Physiotherapy; Exercise therapy; Mechanical ventilation; Intensive care; Muscle weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Critical Illness; Paresis
• Other Study ID Numbers: G 0523.06