Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients

Federal University of Bahia

Status: Unknown

Conditions: Critically Ill

Treatments: Other: Usual Care; Other: Progressive mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT03596853

FUBahia Mobilization ICU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

Experimental: Mobilization

Experimental group

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.

Treatment:

Other: Progressive mobilization

Control: Usual care

Sham Comparator group

Description:

These patients will receive standard rehabilitation delivered by non-study physiotherapist.

Treatment:

Other: Usual Care