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The Impact of Early Mobilization Protocol in Patients in the ICU

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ClinicalTrials.gov Identifier: NCT01769846
Recruitment Status : Recruiting
First Posted : January 17, 2013
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Isabella Martins de Albuquerque, Universidade Federal de Santa Maria

Brief 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.


Condition or disease Intervention/treatment
Muscle Weakness Quality of Life Weaning Acceleration ICU Length of Stay Muscle Thickness of the Quadriceps Femoris Other: Early mobilization protocol

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : March 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Early Mobilization protocol
Early Mobilization protocol: Patients in the treatment group additionally received a progressive cycling exercise session 7 days a week, until the last day of ICU stay, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). Cycling exercise will be realized during 30 consecutive minutes, initially in continuos and passive (classified patients with RASS - 4) exercise, at a fixed pedaling rate of 20 cycles/min and after in actively (classified patients with RASS 0), with an exercise intensity of 3-5 on the Borg rate of perceived exertion scale.
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. Conventional physical and respiratory therapy were provided by the ICU physical therapists twice daily, for approximately 30 min, 7 days per week. The protocol included vibrocompression maneuvers; lung hyperinflation by the mechanical ventilator; and tracheal aspiration, when necessary; as well as passive and active-assisted motor exercises for arms and legs, depending on the clinical course of patients.



Primary Outcome Measures :
  1. Muscle thickness (MT) of the quadriceps femoris [ Time Frame: Change from baseline at 14 day of ICU admission, an average of 1 month. ]
    MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).


Secondary Outcome Measures :
  1. Rectus femoris cross-sectional area [ Time Frame: Change from baseline at 14 day of ICU admission, an average of 1 month. ]
    Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).

  2. Vastus intermedius and rectus femoris echo intensity. [ Time Frame: Change from baseline at 14 day of ICU admission, an average of 1 month. ]
    Vastus intermedius and rectus femoris echo intensity will be assessed by ultrasonography (baseline and 14 day)

  3. Quality of life following hospital discharge [ Time Frame: Three months after hospital discharge SF36 ]
    Quality of life will be measured by a questionnaire 36-item Short Form Health Survey

  4. Muscle strength [ Time Frame: First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month. ]
    Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.

  5. Gait speed [ Time Frame: Study completion, an average of 2 months (hospital discharge) ]
    Gait speed will be measured by the six-meter gait speed test (GST)

  6. Peripheral muscle strength of the lower limbs [ Time Frame: Study completion, an average of 2 months (hospital discharge) ]
    Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test

  7. Mortality [ Time Frame: Patients will be followed until three months after hospital discharge ]
  8. ICU length of stay [ Time Frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks. ]
  9. Weaning Acceleration [ Time Frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks ]
  10. Side effects of mobilization protocol [ Time Frame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks. ]
    Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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