Clinical trial NCT00695383: Early Exercise Training in Critically Ill Patients
Official title: Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Intensive Care
Muscle Weakness
Deconditioning
Keywords: Exercise therapy
Physiotherapy
Critical illness
Intensive care
Muscle weakness
Mechanical ventilation
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2008-06-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: six-minute walking distance
timeFrame: hospital discharge
Secondary outcomes:
measure: quadriceps force
timeFrame: ICU discharge and hospital discharge
measure: functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)
timeFrame: ICU discharge and hospital discharge
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Rehabilitation Sciences, University Hospitals KULeuven
state: Vlaams-Brabant
Study officials:
affiliation: Department of Rehabilitation Sciences, University Hospitals KULeuven
name: Rik Gosselink, PT, phD
role: STUDY_DIRECTOR
affiliation: Department of Rehabilitation Sciences, University Hospitals KULeuven
name: Chris Burtin, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: