Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Study Overview
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Brief Summary
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Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Detailed Description
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Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status. For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.

Official Title
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Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial

Conditions
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Weakness

Intervention / Treatment
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* Procedure: Cycle ergometer physiotherapy
* Procedure: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria of functional independence before hospital admission (Barthel scale > 70 points). Invasive mechanical ventilation < 72 hours. Signed informed consent. Exclusion Criteria: Neuromuscular disease (peripheric or central neurologic disorder). Presumed fatal evolution in 48 hours. Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism). Admission due to cardiac arrest. Pregnancy. Thrombopenia less than 50.000. Severe agitation. Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min. Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycle ergometer physiotherapy<br>15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit | Procedure: Cycle ergometer physiotherapy<br>* 15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy<br>* Other names: MOTOmed ® Letto 2;|
| Active Comparator: Conventional physiotherapy<br>30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit | Procedure: Conventional physiotherapy<br>* 30 minutes of conventional physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking test distance at six minutes |  | At hospital discharge, with an expected average of 4 weeks after hospital admission | 
| Short Form-36 Health Survey (SF-36), physical functioning section |  | At 28 days after hospital discharge, that is an expected average of 8 weeks | 
| Basic activities of daily living score (BADL) |  | At 28 days after hospital discharge, that is an expected average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Functional Testing |  | At the end of hospital stay, with an expected average of 5 weeks | 
| Presence of intensive care acquired paresis (Medical Research Council score < 48 points) |  | During ICU admission and ICU discharge, with an expected average of 2 weeks | 
| ICU mobilization scale |  | During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge | 
| Isometric quadriceps force (N/kg) | Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion. | During ICU admission, with an expected average of 2 weeks | 
| Walking test distance at six minutes |  | At 28 days and at 6 months after hospital discharge, that is up to 1 year | 
| Short Form-36 Health Survey (SF-36), physical functioning section |  | At 7 days and at 6 months after hospital discharge, that is up to 1 year | 
| Basic activities of daily living score (BADL) |  | At 7 days and at 6 months after hospital discharge, that is up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle weakness, rehabilitation, intensive care, mechanical ventilation, cyclo ergometer, physiotherapy