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Completed

NCT Number: NCT02300662

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035 903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycle Ergometer

Device

Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.

Conventional Physiotherapy

Other

Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.

Primary outcomes

  1. change in cross-sectional quadriceps thickness

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness

Secondary outcomes

  1. change in length of fascicle

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the length of fascicle

  2. change in pennation angle of fascicles

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the pennation angle of fascicles

  3. change in thickness of vastus lateralis muscle

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the thickness of vastus lateralis muscle

  4. change in diaphragm thickness

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the diaphragm muscle thickness

  5. change in diaphragm excursion

    Time frame: baseline and after seven days of protocol

    ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study 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

Acronym: MoVe-ICU

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2014
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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