Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- six-minute walking distance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
six-minute walking distance
Time Frame: hospital discharge
Secondary Outcomes
- 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)
