Clinical trial NCT02300662: Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit
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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in cross-sectional quadriceps thickness
timeFrame: baseline and after seven days of protocol
Secondary outcomes:
measure: change in length of fascicle
timeFrame: baseline and after seven days of protocol
measure: change in pennation angle of fascicles
timeFrame: baseline and after seven days of protocol
measure: change in thickness of vastus lateralis muscle
timeFrame: baseline and after seven days of protocol
measure: change in diaphragm thickness
timeFrame: baseline and after seven days of protocol
measure: change in diaphragm excursion
timeFrame: baseline and after seven days of protocol
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Silvia R Vieira, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.