An interventional study of Progressive mobilization and Usual Care in Critically Ill, sponsored by Federal University of Bahia. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by Federal University of Bahia · Not applicable, Interventional, and Treatment
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.
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.
1,931 studies on the registry are indexed under Critical Illness; 469 are open to participants now.
This study's planned enrollment of 104 is above the median of 90 across 1,007 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
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.
Other: Progressive mobilization
These patients will receive standard rehabilitation delivered by non-study physiotherapist.
Other: Usual Care
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).
This group will receive standard usual, which will be monitored, but not protocolised.
Length of ICU stay in days
Time in days, from baseline to discharge from ICU
Time frame: at 28 days or discharge from ICU whichever occurs earlier
Muscle mass
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound
Time frame: Change from baseline at 28th day
Change in muscle strength
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
Physical activity: total activity
accelerometry measurement of the total activity
Time frame: At 28 days or discharge from hospital
Activity and participation
Measurement characteristics of World Health Organisation Disability Assessment Schedule II
Time frame: Change from baseline up to 1 year post discharge
Mortality
Mortality
Time frame: At 28 days or discharge from hospital and at 12 months
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)
Time frame: Change from baseline up to 28th day or discharge from hospital
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.'
Time frame: Change from baseline up to 28th day or discharge from hospital
Mobility
Timed up-and-go score
Time frame: Change from baseline up to 28th day or discharge from hospital
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.
Time frame: At 28 days or discharge from hospital and at 12 months
Days with mechanical ventilation
Number of uninterrupted days in use of mechanical ventilation
Time frame: From 3 to 28 days
Length of hospital stay in days
Time in days, from baseline to discharge from hospital
Time frame: Up to 1 month post hospital discharge
Muscle thickness
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm
Time frame: Change from baseline at 28th day
Plan to share: Undecided
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Federal University of Bahia