Critical IllnessMoVe-ICUNCT02300662
Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit
A study testing Cycle Ergometer and Conventional physiotherapy in people with Critical Illness, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Cycle Ergometer and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- delayed weaning (3 failed spontaneous ventilation tests)
- body mass index > 35 kg/m2
- emergence of eschar in the calcaneus area during the protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035 903
About this study
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
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Cycle Ergometer, Conventional physiotherapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ErgometerDevice
Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.
Conventional physiotherapyOther
Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.
| Study group | Role | What they receive |
|---|---|---|
| Cycle Ergometer | Experimental | 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 Receives: Device: Cycle Ergometer; Other: Conventional physiotherapy |
| Conventional Physiotherapy | Sham comparator | Upper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cross-sectional quadriceps thickness
ultrasound measurement of the vastus intermedius and the rectus femoris muscles thickness
Measured: baseline and after seven days of protocol
Secondary outcomes (5)
change in length of fascicle
ultrasound measurement of the length of fascicle
Measured: baseline and after seven days of protocol
change in pennation angle of fascicles
ultrasound measurement of the pennation angle of fascicles
Measured: baseline and after seven days of protocol
change in thickness of vastus lateralis muscle
ultrasound measurement of the thickness of vastus lateralis muscle
Measured: baseline and after seven days of protocol
change in diaphragm thickness
ultrasound measurement of the diaphragm muscle thickness
Measured: baseline and after seven days of protocol
change in diaphragm excursion
ultrasound measurement of the inspiratory and expiratory diaphragmatic excursion
Measured: baseline and after seven days of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia R Vieira, ScD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300662
- Sponsor's protocol ID
- 10-0530
- Acronym
- MoVe-ICU
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26314881
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02300662
- Acronym / sponsor ID
- MoVe-ICU / 10-0530
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle Ergometer | Experimental | Device: Cycle Ergometer, Other: Conventional physiotherapyConventional physiotherapy and cycle ergometer 20 minutes, at 20 cycles per minute, once per day for as long as they remain on invasive mechanical ventilation |
| Conventional Physiotherapy | Sham comparator | Other: Conventional physiotherapyUpper and lower extremity functional diagonals from the proprioceptive neuromuscular facilitation method and manual bronchial hygiene exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycle ErgometerPassive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively. | Device | Cycle Ergometer |
| Conventional physiotherapyManual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary. | Other | Conventional Physiotherapy, Cycle Ergometer |
Primary outcome
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
5 secondary outcomes
change in length of fascicle
Time frame: baseline and after seven days of protocol
change in pennation angle of fascicles
Time frame: baseline and after seven days of protocol
change in thickness of vastus lateralis muscle
Time frame: baseline and after seven days of protocol
change in diaphragm thickness
Time frame: baseline and after seven days of protocol
change in diaphragm excursion
Time frame: baseline and after seven days of protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 26314881dos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia R Vieira, ScD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle Ergometer and Conventional physiotherapy in people with Critical Illness, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cross-sectional quadriceps thickness (time frame: baseline and after seven days of protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.