Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients
Primary Purpose
Critically Ill
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Progressive mobilization
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill
Eligibility Criteria
Inclusion Criteria:
- Being able to roll in the bed and bridge.
- Barthel score of at least 70 weeks before admission to the ICU
- Ability to interact with the researcher
Exclusion Criteria:
- Mortality rate in excess of 50% according to Acute Physiology and Chronic Health Disease Classification System II (APACHEII)
- Present intracranial pressure increase
- Cardiorespiratory arrest,
- Has unstable fractures that hamper progression in levels of mobilization,
- Severe lower limb injury or amputation
- Neuromuscular disease
- Underwent radiotherapy and / or chemotherapy in the last 6 months.
Sites / Locations
- Mansueto Gomes Neto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental: Mobilization
Control: Usual care
Arm Description
These patients will receive standard rehabilitation delivered by non-study physiotherapist. In addition, the patients will undergo a protocol of progressive mobilization with individualized dose control and training load stratified according to functional levels and performance.
These patients will receive standard rehabilitation delivered by non-study physiotherapist.
Outcomes
Primary Outcome Measures
Length of ICU stay in days
Time in days, from baseline to discharge from ICU
Secondary Outcome Measures
Muscle mass
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound
Change in muscle strength
Muscle Strength measured by hand held dynamometer
Physical activity: total activity
accelerometry measurement of the total activity
Activity and participation
Measurement characteristics of World Health Organisation Disability Assessment Schedule II
Mortality
Mortality
Functional Status
Functional Status Measured Using Functional Status Score for the Intensive Care Unit (involves five functional tasks (rolling, supine to sit transfer, sit to stand transfer, sitting on the edge of bed and walking). Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform at all) to 7 (complete independence)
Surgical Optimal Mobilisation Score (SOMS) level
Surgical Optimal Mobilisation Score (SOMS) level algorithm for goal-directed mobility ranges from '0-No mobility' to '4-Ambulation'. The intermediate steps are '1-Passive Range of Motion,' '2-Sitting,' and '3-Standing.'
Mobility
Timed up-and-go score
Health-Related Quality of Life: SF-36
Health-Related Quality of Life will be measured by a questionnaire 36-item Short Form Health Survey. The SF-36 is a widely used generic instrument for evaluating HRQoL, consisting of eight subscales evaluating specific health status domains and two summary scales, a Physical Component Summary and a Mental Component Summary. Scores on the SF-36 range from 0 to 100, with higher scores indicating better health status.
Days with mechanical ventilation
Number of uninterrupted days in use of mechanical ventilation
Length of hospital stay in days
Time in days, from baseline to discharge from hospital
Muscle thickness
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm
Full Information
NCT ID
NCT03596853
First Posted
June 21, 2018
Last Updated
April 29, 2019
Sponsor
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT03596853
Brief Title
Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients
Official Title
Effects of the Addition of a Protocol of Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immobilization and bed rest of patients in intensive care units (ICU) increases their risk for muscle dysfunction and prolonged mechanical ventilation, leading to physical deconditioning and loss of functionality. Active mobilization is a therapeutic strategy that typically involves exercises in which the patient uses his or her own strength and muscular control, is a feasible, safe, and low-cost intervention to improve muscle dysfunction and disability in patients at the ICU. Despite scientific advances, the current description and prescriptions of exercises at the ICU remain incomplete with respect to the control and the description of the variables of training load (volume and intensity), programming, and progression.
Detailed Description
This prospective double-blind (patient and evaluator). This study will be conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial will be performed at the University Hospital Professor Edgard Santos in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 2.371.933). Before enrollment, written informed consent will be obtained from participants or their legal guardians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Masking: Triple (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Mobilization
Arm Type
Experimental
Arm Description
These patients will receive standard rehabilitation delivered by non-study physiotherapist. In addition, the patients will undergo a protocol of progressive mobilization with individualized dose control and training load stratified according to functional levels and performance.
Arm Title
Control: Usual care
Arm Type
Sham Comparator
Arm Description
These patients will receive standard rehabilitation delivered by non-study physiotherapist.
Intervention Type
Other
Intervention Name(s)
Progressive mobilization
Intervention Description
Will be applied once a day, 5x/ week, performed into 4 levels: N1 (bridge and rolling for both sides); N2 (transfer training from lying down to sitting on both sides); N3 (sit and stand up from a chair); N4 (running training). According to their functional level, patients will perform, once a day, 8 sets of each movement, alternating 20 seconds of execution with 10 seconds of rest. Patients will be stimulated constantly to perform the movements with the highest possible speed.
If the patient performs adequately within of your level functional level, can will progress in level, if can not progress, there will be an increase in training volume within the level itself. Adequate performance within the functional level means that the patient is able to complete more than eight sets of exercise and does not present increased sensation of pain, present sensation of perceived exertion within the safety limit of the protocol (Borg ≤ 6).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
This group will receive standard usual, which will be monitored, but not protocolised.
Primary Outcome Measure Information:
Title
Length of ICU stay in days
Description
Time in days, from baseline to discharge from ICU
Time Frame
at 28 days or discharge from ICU whichever occurs earlier
Secondary Outcome Measure Information:
Title
Muscle mass
Description
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound
Time Frame
Change from baseline at 28th day
Title
Change in muscle strength
Description
Muscle Strength measured by hand held dynamometer
Time Frame
Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU
Title
Physical activity: total activity
Description
accelerometry measurement of the total activity
Time Frame
At 28 days or discharge from hospital
Title
Activity and participation
Description
Measurement characteristics of World Health Organisation Disability Assessment Schedule II
Time Frame
Change from baseline up to 1 year post discharge
Title
Mortality
Description
Mortality
Time Frame
At 28 days or discharge from hospital and at 12 months
Title
Functional Status
Description
Functional Status Measured Using Functional Status Score for the Intensive Care Unit (involves five functional tasks (rolling, supine to sit transfer, sit to stand transfer, sitting on the edge of bed and walking). Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform at all) to 7 (complete independence)
Time Frame
Change from baseline up to 28th day or discharge from hospital
Title
Surgical Optimal Mobilisation Score (SOMS) level
Description
Surgical Optimal Mobilisation Score (SOMS) level algorithm for goal-directed mobility ranges from '0-No mobility' to '4-Ambulation'. The intermediate steps are '1-Passive Range of Motion,' '2-Sitting,' and '3-Standing.'
Time Frame
Change from baseline up to 28th day or discharge from hospital
Title
Mobility
Description
Timed up-and-go score
Time Frame
Change from baseline up to 28th day or discharge from hospital
Title
Health-Related Quality of Life: SF-36
Description
Health-Related Quality of Life will be measured by a questionnaire 36-item Short Form Health Survey. The SF-36 is a widely used generic instrument for evaluating HRQoL, consisting of eight subscales evaluating specific health status domains and two summary scales, a Physical Component Summary and a Mental Component Summary. Scores on the SF-36 range from 0 to 100, with higher scores indicating better health status.
Time Frame
At 28 days or discharge from hospital and at 12 months
Title
Days with mechanical ventilation
Description
Number of uninterrupted days in use of mechanical ventilation
Time Frame
From 3 to 28 days
Title
Length of hospital stay in days
Description
Time in days, from baseline to discharge from hospital
Time Frame
Up to 1 month post hospital discharge
Title
Muscle thickness
Description
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm
Time Frame
Change from baseline at 28th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being able to roll in the bed and bridge.
Barthel score of at least 70 weeks before admission to the ICU
Ability to interact with the researcher
Exclusion Criteria:
Mortality rate in excess of 50% according to Acute Physiology and Chronic Health Disease Classification System II (APACHEII)
Present intracranial pressure increase
Cardiorespiratory arrest,
Has unstable fractures that hamper progression in levels of mobilization,
Severe lower limb injury or amputation
Neuromuscular disease
Underwent radiotherapy and / or chemotherapy in the last 6 months.
Facility Information:
Facility Name
Mansueto Gomes Neto
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950350
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients
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