search
Back to results

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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cycle Ergometer
Conventional physiotherapy
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cycle Ergometer

Conventional Physiotherapy

Arm Description

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

Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.

Outcomes

Primary Outcome Measures

change in cross-sectional quadriceps thickness
ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness

Secondary Outcome Measures

change in length of fascicle
ultrasound measurement of the length of fascicle
change in pennation angle of fascicles
ultrasound measurement of the pennation angle of fascicles
change in thickness of vastus lateralis muscle
ultrasound measurement of the thickness of vastus lateralis muscle
change in diaphragm thickness
ultrasound measurement of the diaphragm muscle thickness
change in diaphragm excursion
ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion

Full Information

First Posted
October 30, 2014
Last Updated
August 19, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT02300662
Brief Title
Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit
Acronym
MoVe-ICU
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cycle Ergometer
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Physiotherapy
Arm Type
Sham Comparator
Arm Description
Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises.
Intervention Type
Device
Intervention Name(s)
Cycle Ergometer
Intervention Description
Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.
Primary Outcome Measure Information:
Title
change in cross-sectional quadriceps thickness
Description
ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness
Time Frame
baseline and after seven days of protocol
Secondary Outcome Measure Information:
Title
change in length of fascicle
Description
ultrasound measurement of the length of fascicle
Time Frame
baseline and after seven days of protocol
Title
change in pennation angle of fascicles
Description
ultrasound measurement of the pennation angle of fascicles
Time Frame
baseline and after seven days of protocol
Title
change in thickness of vastus lateralis muscle
Description
ultrasound measurement of the thickness of vastus lateralis muscle
Time Frame
baseline and after seven days of protocol
Title
change in diaphragm thickness
Description
ultrasound measurement of the diaphragm muscle thickness
Time Frame
baseline and after seven days of protocol
Title
change in diaphragm excursion
Description
ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion
Time Frame
baseline and after seven days of protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia R Vieira, ScD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035 903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26314881
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs