The Impact of Early Mobilization Protocol in Patients in the ICU

Quality of Life Clinical Trial

Official title:

The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769846
• Other study ID #: 07201712.8.0000.5346
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.

The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18 years of age or greater)

• Patients in the first 24 hours of mechanical ventilation.

• Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).

• Hemodynamically stable.

Exclusion Criteria:

• Rapidly developing neuromuscular disease

• Evolution of brain death

• Cardiopulmonary arrest

• Elevated intracranial pressure

• Ruptured/leaking aortic aneurysm

• Acute MI before peak troponin has been reached

• Absent lower limb

• Pregnancy

• Unstable fractures contributing to likely immobility

• Hospitalization prior to ICU admission >5 days

• Enrollment in another clinical trial

Related Conditions & MeSH terms

• ICU Length of Stay
• Muscle Thickness of the Quadriceps Femoris
• Muscle Weakness
• Paresis
• Quality of Life
• Weaning Acceleration

Intervention

Other:
• Early mobilization protocol
Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.

Locations

Country	Name	City	State
Brazil	University Hospital of Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle thickness (MT) of the quadriceps femoris.	MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).	Change from baseline at 14 day of ICU admission, an average of 1 month.
Primary	Muscle thickness (MT) of the diaphragm.	MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).	Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary	Rectus femoris cross-sectional area	Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).	Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary	Vastus intermedius, rectus femoris and diaphragm echo intensity.	Vastus intermedius, rectus femoris and diaphragm echo intensity will be assessed by ultrasonography (baseline and 14 day)	Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary	Rectus femoris and vastus intermedius thickness.	Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).	Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary	Muscle strength	Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.	First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.
Secondary	Gait speed	Gait speed will be measured by the six-meter gait speed test (GST)	Study completion, an average of 2 months (hospital discharge)
Secondary	Peripheral muscle strength of the lower limbs	Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test	Study completion, an average of 2 months (hospital discharge)
Secondary	Quality of life following hospital discharge	Quality of life will be measured by a questionnaire 36-item Short Form Health Survey	Three months after hospital discharge SF36
Secondary	Mortality		Patients will be followed until three months after hospital discharge
Secondary	ICU length of stay		Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.
Secondary	Weaning Acceleration		Patients will be followed until ICU discharge, an expected 2 days to 3 weeks
Secondary	Side effects of mobilization protocol	Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.	During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
Secondary	Length of hospital stay		Patients will be followed until hospital discharge, an expected 4 to 6 weeks