Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Study Overview
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Brief Summary
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Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed. Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied. The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

Conditions
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Critically Ill Patients Under Mechanical Ventilation, Sedated Patients

Intervention / Treatment
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* Other: Passive legs mobilisation
* Other: Passive cycloergometer
* Other: Muscular electrical stimulation
* Other: FES cycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical ventilation Sedated Ramsay < 4 Exclusion Criteria: Rehabilitation contraindication Patient with pacemaker Patient under volume assist control FiO2 > 80% Patient under neuromuscular blockers Neurologic comorbidity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Passive legs mobilisation<br>A physiotherapist performs passive legs movement | Other: Passive legs mobilisation<br>* A physiotherapist performs a passive leg movement<br>|
| Active Comparator: Passive cycloergometer<br>A motorized cycloergometer performs passive legs cycling | Other: Passive cycloergometer<br>* A motorised cycloergometer performs a passive cycling<br>|
| Active Comparator: Muscular electrical stimulation<br>Quadriceps neuromuscular electrical stimulation | Other: Muscular electrical stimulation<br>* A neuromuscular electrical stimulation device performs a quadriceps located stimulation<br>|
| Active Comparator: FES cycling<br>A motorised cycloergometer performs a quadriceps neuromuscular electrical stimulation during passive | Other: FES cycling<br>* A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output by cardiac ultrasonography |  | Every 3 minutes during 10 minutes exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular oxygenation of vastus lateralis muscle by Near Infrared Spectroscopy |  | Continuously during ten minutes exercise | 
| Pulmonary artery Pressure by cardiac ultrasonography |  | Every 3 minutes during 10 minutes exercise | 
| Tricuspid annular plane systolic excursion by cardiac ultrasonography |  | Every 3 minutes during 10 minutes exercise | 
| Expiratory volume |  | Continuously during ten minutes exercise | 
| Respiratory rate |  | Continuously during ten minutes exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early rehabilitation, Mechanical ventilation, Physiotherapy