Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Cycle Ergometer; Other: Conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035 903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cycle Ergometer; 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; Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.; Other: Conventional physiotherapy; Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.
Sham Comparator: Conventional Physiotherapy; Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.	Other: Conventional physiotherapy; Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Silvia R Vieira, ScD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• dos Santos LJ, de Aguiar Lemos F, Bianchi T, Sachetti A, Dall' Acqua AM, da Silva Naue W, Dias AS, Vieira SR. Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study): study protocol for a randomized controlled trial. Trials. 2015 Aug 28;16:383. doi: 10.1186/s13063-015-0914-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 10-0530