Early Exercise Training in Critically Ill Patients

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.

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

Conditions
-----------------
Critical Illness, Intensive Care, Muscle Weakness, Deconditioning

Intervention / Treatment
-----------------
* Behavioral: Bedside cycle exercise therapy
* Behavioral: Standard physiotherapy program


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Bedside cycle exercise therapy<br>* 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<br>* Other names: Motomed Letto;|
| Active Comparator: 2<br> | Behavioral: Standard physiotherapy program<br>* The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.<br>* Other names: Mobilization;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six-minute walking distance |  | hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation