Effects of the Addition of a Protocol of Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critically Ill
- Sponsor
- Federal University of Bahia
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Length of ICU stay in days
- Last Updated
- 7 years ago
Overview
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.
Investigators
Mansueto Gomes Neto
Principal Investigator
Federal University of Bahia
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.
Outcomes
Primary Outcomes
Length of ICU stay in days
Time Frame: at 28 days or discharge from ICU whichever occurs earlier
Time in days, from baseline to discharge from ICU
Secondary Outcomes
- Surgical Optimal Mobilisation Score (SOMS) level(Change from baseline up to 28th day or discharge from hospital)
- Muscle mass(Change from baseline at 28th day)
- Muscle thickness(Change from baseline at 28th day)
- Change in muscle strength(Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU)
- Physical activity: total activity(At 28 days or discharge from hospital)
- Mortality(At 28 days or discharge from hospital and at 12 months)
- Days with mechanical ventilation(From 3 to 28 days)
- Length of hospital stay in days(Up to 1 month post hospital discharge)
- Mobility(Change from baseline up to 28th day or discharge from hospital)
- Health-Related Quality of Life: SF-36(At 28 days or discharge from hospital and at 12 months)
- Activity and participation(Change from baseline up to 1 year post discharge)
- Functional Status(Change from baseline up to 28th day or discharge from hospital)