Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer.

Detailed Description
-----------------
A single blind randomized controlled trial (the MoVe ICU study) will be conducted to evaluate the effects on critical patients on invasive mechanical ventilation of early mobilization with a cycle ergometer. Patients (age > 18 years) will be recruited for this study from among those admitted to the intensive care department at the Hospital de Clínicas de Porto Alegre. Eligible patients will have been on invasive mechanical ventilation for at least 24 to 48 hours, will have spent maximum of 1 week in hospital and will not exhibit any characteristics restricting lower extremity mobility. These subjects will be randomized to receive either conventional physiotherapy or conventional physiotherapy with an additional cycle ergometer intervention. The intervention will be administered passively for 20 minutes, at 20 revolutions per minute, once per day, throughout the time the patients remain on invasive mechanical ventilation.

Official Title
-----------------
Early Mobilization With a Cycle Ergometer for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU Study): Study Protocol for a Randomized Controlled Trial

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Device: Cycle Ergometer
* Other: Conventional physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of both sexes aged >= 18 years will be recruited from among those admitted to the Hospital de Clínicas de Porto Alegre intensive care unit and put on invasive mechanical ventilation invasive mechanical ventilation for at least 24 to 48 hours after transfer from the emergency department or wards, no more than 1 week after admission Exclusion Criteria: neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. patients will also be excluded in the event of the following: extubation less than 48 hours after enrollment on the study haemodynamic instability (noradrenaline > 0.5 mc/kg/min for arterial blood pressure > 60 mmHg) complications during the protocol such as pneumothorax, deep vein thrombosis or pulmonary embolism Shilley catheter in the femoral vein reintubation delayed weaning (3 failed spontaneous ventilation tests) body mass index > 35 kg/m2 emergence of eschar in the calcaneus area during the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycle Ergometer<br>Conventional physiotherapy and cycle ergometer 20 minutes, at 20 cycles per minute, once per day for as long as they remain on invasive mechanical ventilation | Device: Cycle Ergometer<br>* Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.<br>Other: Conventional physiotherapy<br>* Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.<br>|
| Sham Comparator: Conventional Physiotherapy<br>Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises. | Other: Conventional physiotherapy<br>* Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cross-sectional quadriceps thickness | ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness | baseline and after seven days of protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in length of fascicle | ultrasound measurement of the length of fascicle | baseline and after seven days of protocol | 
| change in pennation angle of fascicles | ultrasound measurement of the pennation angle of fascicles | baseline and after seven days of protocol | 
| change in thickness of vastus lateralis muscle | ultrasound measurement of the thickness of vastus lateralis muscle | baseline and after seven days of protocol | 
| change in diaphragm thickness | ultrasound measurement of the diaphragm muscle thickness | baseline and after seven days of protocol | 
| change in diaphragm excursion | ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion | baseline and after seven days of protocol |