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Early Exercise Training in Critically Ill Patients

Primary Purpose

Critical Illness, Intensive Care, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bedside cycle exercise therapy
Standard physiotherapy program
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation Sciences, University Hospitals KULeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

six-minute walking distance

Secondary Outcome Measures

quadriceps force
functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)

Full Information

First Posted
June 9, 2008
Last Updated
June 10, 2008
Sponsor
KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00695383
Brief Title
Early Exercise Training in Critically Ill Patients
Official Title
Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Intensive Care, Muscle Weakness, Deconditioning
Keywords
Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Bedside cycle exercise therapy
Other Intervention Name(s)
exercise therapy, exercise training, exercise, cycle training, cycle exercise, Motomed Letto
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard physiotherapy program
Other Intervention Name(s)
Usual physiotherapy, Routine physiotherapy, Mobilization
Intervention Description
The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.
Primary Outcome Measure Information:
Title
six-minute walking distance
Time Frame
hospital discharge
Secondary Outcome Measure Information:
Title
quadriceps force
Time Frame
ICU discharge and hospital discharge
Title
functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)
Time Frame
ICU discharge and hospital discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rik Gosselink, PT, phD
Organizational Affiliation
Department of Rehabilitation Sciences, University Hospitals KULeuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chris Burtin, PT, MSc
Organizational Affiliation
Department of Rehabilitation Sciences, University Hospitals KULeuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences, University Hospitals KULeuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Early Exercise Training in Critically Ill Patients

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