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

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ClinicalTrials.gov Identifier: NCT02300662
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Critical Illness Device: Cycle Ergometer Other: Conventional physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300662


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035 903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Silvia R Vieira, ScD Hospital de Clínicas de Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02300662     History of Changes
Other Study ID Numbers: 10-0530
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes