Clinical trial NCT03596853: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length of ICU stay in days
timeFrame: at 28 days or discharge from ICU whichever occurs earlier
Secondary outcomes:
measure: Muscle mass
timeFrame: Change from baseline at 28th day
measure: Change in muscle strength
timeFrame: Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU
measure: Physical activity: total activity
timeFrame: At 28 days or discharge from hospital
measure: Activity and participation
timeFrame: Change from baseline up to 1 year post discharge
measure: Mortality
timeFrame: At 28 days or discharge from hospital and at 12 months
measure: Functional Status
timeFrame: Change from baseline up to 28th day or discharge from hospital
measure: Surgical Optimal Mobilisation Score (SOMS) level
timeFrame: Change from baseline up to 28th day or discharge from hospital
measure: Mobility
timeFrame: Change from baseline up to 28th day or discharge from hospital
measure: Health-Related Quality of Life: SF-36
timeFrame: At 28 days or discharge from hospital and at 12 months
measure: Days with mechanical ventilation
timeFrame: From 3 to 28 days
measure: Length of hospital stay in days
timeFrame: Up to 1 month post hospital discharge
measure: Muscle thickness
timeFrame: Change from baseline at 28th day
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Mansueto Gomes Neto
state: Bahia
Study officials:
References: