Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients
- Conditions
- Critically Ill
- Interventions
- Other: Progressive mobilizationOther: Usual Care
- Registration Number
- NCT03596853
- Lead Sponsor
- Federal University of Bahia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Mobilization Progressive mobilization 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. Control: Usual care Usual Care These patients will receive standard rehabilitation delivered by non-study physiotherapist.
- Primary Outcome Measures
Name Time Method Length of ICU stay in days at 28 days or discharge from ICU whichever occurs earlier Time in days, from baseline to discharge from ICU
- Secondary Outcome Measures
Name Time Method Surgical Optimal Mobilisation Score (SOMS) level Change from baseline up to 28th day or discharge from hospital 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.'
Muscle mass Change from baseline at 28th day Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound
Muscle thickness Change from baseline at 28th day Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm
Change in muscle strength Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU Muscle Strength measured by hand held dynamometer
Physical activity: total activity At 28 days or discharge from hospital accelerometry measurement of the total activity
Mortality At 28 days or discharge from hospital and at 12 months Mortality
Days with mechanical ventilation From 3 to 28 days Number of uninterrupted days in use of mechanical ventilation
Length of hospital stay in days Up to 1 month post hospital discharge Time in days, from baseline to discharge from hospital
Mobility Change from baseline up to 28th day or discharge from hospital Timed up-and-go score
Health-Related Quality of Life: SF-36 At 28 days or discharge from hospital and at 12 months 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.
Activity and participation Change from baseline up to 1 year post discharge Measurement characteristics of World Health Organisation Disability Assessment Schedule II
Functional Status Change from baseline up to 28th day or discharge from hospital 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)
Trial Locations
- Locations (1)
Mansueto Gomes Neto
🇧🇷Salvador, Bahia, Brazil