The Impact of Early Mobilization Protocol in Patients in the ICU

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Universidade Federal de Santa Maria
Sponsor:
Information provided by (Responsible Party):
Isabella Martins de Albuquerque, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier:
NCT01769846
First received: January 11, 2013
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Muscle Weakness
Quality of Life
Other: Early mobilization protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Santa Maria:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: Patients will be followed until ICU discharge, an expected 2 days to 2 weeks ] [ Designated as safety issue: No ]
  • Weaning Acceleration [ Time Frame: Patients will be followed until ICU discharge, an expected 2 days to 2 weeks ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Side effects of mobilization protocol [ Time Frame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks. ] [ Designated as safety issue: Yes ]
    Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Responde in peripheral oxygen saturation.

  • Quality of life following hospital discharge [ Time Frame: Three months after hospital discharge SF36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Mobilization protocol
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.
Other: 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: Control group
Group will undergo usual mobilization per standard ICU care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769846

Locations
Brazil
University Hospital of Santa Maria Recruiting
Santa Maria, Rio Grande do Sul, Brazil
Contact: Isabella Albuquerque, DCs.    +555581111120    albuisa@gmail.com   
Principal Investigator: Isabella Albuquerque, DSc.         
Sponsors and Collaborators
Universidade Federal de Santa Maria
Investigators
Principal Investigator: Isabella Albuquerque, DSc. Universidade Federal de Santa Maria
  More Information

No publications provided

Responsible Party: Isabella Martins de Albuquerque, Professor DSc., Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT01769846     History of Changes
Other Study ID Numbers: 07201712.8.0000.5346
Study First Received: January 11, 2013
Last Updated: July 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014