Overview

This trial is active, not recruiting.

Conditions muscle weakness, quality of life, weaning acceleration, icu length of stay
Treatment early mobilization protocol
Sponsor Universidade Federal de Santa Maria
Start date March 2013
End date November 2016
Trial size 38 participants
Trial identifier NCT01769846, 07201712.8.0000.5346

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 peripheral muscle strength, perceived functional status, 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Early Mobilization protocol: Patients in the treatment group additionally received a cycling exercise session 5 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 20 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position. In sedated patients, cycling was performed in a passive manner for 20 consecutive minutes at a fixed pedaling rate of 20 cycles/min.
early mobilization protocol
Patients in the treatment group additionally received a cycling exercise session 5 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 20 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position. In sedated patients, cycling was performed in a passive manner for 20 consecutive minutes at a fixed pedaling rate of 20 cycles/min.
(No Intervention)
Group will undergo usual mobilization per standard ICU care.

Primary Outcomes

Measure
Muscle strength
time frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. Medical Research Council (MRC) scale.

Secondary Outcomes

Measure
ICU length of stay
time frame: Patients will be followed until ICU discharge, an expected 2 days to 2 weeks
Weaning Acceleration
time frame: Patients will be followed until ICU discharge, an expected 2 days to 2 weeks
Functional mobility
time frame: Functional Status Score in the ICU (FSS-ICU) will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.
Side effects of mobilization protocol
time frame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
Quality of life following hospital discharge
time frame: Three months after hospital discharge SF36

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults (18 years of age or greater) - The patient must have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hour. - Consent declined - Adequate cardiovascular reserve - No signs of respiratory distress and respiratory rate (RR) <25 breaths per minute; and no physical exercise program prior to study enrollment, Exclusion Criteria: - Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on - Rapidly developing neuromuscular disease - Cardiopulmonary arrest - Motor component of Glasgow Coma Scale <5 - 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

Additional Information

Official title The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
Principal investigator Isabella Albuquerque, DSc.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Universidade Federal de Santa Maria.