Early Exercise Training in Critically Ill Patients

Catholic University (KU) of Leuven

Status: Completed

Conditions: Deconditioning; Critical Illness; Muscle Weakness; Intensive Care

Treatments: Behavioral: Bedside cycle exercise therapy; Behavioral: Standard physiotherapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT00695383

G 0523.06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

1

Experimental group

Treatment:

Behavioral: Bedside cycle exercise therapy

2

Active Comparator group

Treatment:

Behavioral: Standard physiotherapy program