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The Impact of Early Mobilization Protocol in Patients in the ICU

Primary Purpose

Muscle Weakness, Quality of Life, Weaning Acceleration

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Early mobilization protocol
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Mobilization protocol

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Muscle thickness (MT) of the quadriceps femoris.
MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).
Muscle thickness (MT) of the diaphragm.
MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).

Secondary Outcome Measures

Rectus femoris cross-sectional area
Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).
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)
Rectus femoris and vastus intermedius thickness.
Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).
Muscle strength
Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.
Gait speed
Gait speed will be measured by the six-meter gait speed test (GST)
Peripheral muscle strength of the lower limbs
Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test
Quality of life following hospital discharge
Quality of life will be measured by a questionnaire 36-item Short Form Health Survey
Mortality
ICU length of stay
Weaning Acceleration
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.
Length of hospital stay

Full Information

First Posted
January 11, 2013
Last Updated
October 9, 2018
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT01769846
Brief Title
The Impact of Early Mobilization Protocol in Patients in the ICU
Official Title
The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Quality of Life, Weaning Acceleration, ICU Length of Stay, Muscle Thickness of the Quadriceps Femoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Mobilization protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early mobilization protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle thickness (MT) of the quadriceps femoris.
Description
MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).
Time Frame
Change from baseline at 14 day of ICU admission, an average of 1 month.
Title
Muscle thickness (MT) of the diaphragm.
Description
MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).
Time Frame
Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary Outcome Measure Information:
Title
Rectus femoris cross-sectional area
Description
Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).
Time Frame
Change from baseline at 14 day of ICU admission, an average of 1 month.
Title
Vastus intermedius, rectus femoris and diaphragm echo intensity.
Description
Vastus intermedius, rectus femoris and diaphragm echo intensity will be assessed by ultrasonography (baseline and 14 day)
Time Frame
Change from baseline at 14 day of ICU admission, an average of 1 month.
Title
Rectus femoris and vastus intermedius thickness.
Description
Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).
Time Frame
Change from baseline at 14 day of ICU admission, an average of 1 month.
Title
Muscle strength
Description
Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.
Time Frame
First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.
Title
Gait speed
Description
Gait speed will be measured by the six-meter gait speed test (GST)
Time Frame
Study completion, an average of 2 months (hospital discharge)
Title
Peripheral muscle strength of the lower limbs
Description
Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test
Time Frame
Study completion, an average of 2 months (hospital discharge)
Title
Quality of life following hospital discharge
Description
Quality of life will be measured by a questionnaire 36-item Short Form Health Survey
Time Frame
Three months after hospital discharge SF36
Title
Mortality
Time Frame
Patients will be followed until three months after hospital discharge
Title
ICU length of stay
Time Frame
Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.
Title
Weaning Acceleration
Time Frame
Patients will be followed until ICU discharge, an expected 2 days to 3 weeks
Title
Side effects of mobilization protocol
Description
Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.
Time Frame
During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
Title
Length of hospital stay
Time Frame
Patients will be followed until hospital discharge, an expected 4 to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Albuquerque, DSc.
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
28538781
Citation
Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.
Results Reference
derived

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The Impact of Early Mobilization Protocol in Patients in the ICU

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