Early Exercise Training in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695383
• Other study ID #: G 0523.06
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: June 10, 2008
• Start date: December 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2008
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Deconditioning
• Intensive Care
• Muscle Weakness
• Paresis

Intervention

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
• Standard physiotherapy program
The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.

Locations

Country	Name	City	State
Belgium	Department of Rehabilitation Sciences, University Hospitals KULeuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six-minute walking distance		hospital discharge	No
Secondary	quadriceps force		ICU discharge and hospital discharge	No
Secondary	functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)		ICU discharge and hospital discharge	No