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

NCT ID: NCT03596853

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-07-31

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.

Conditions

Critically Ill

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: 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.

Group Type: EXPERIMENTAL

Progressive mobilization

Intervention Type: OTHER

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).

Control: Usual care

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

Group Type: SHAM_COMPARATOR

Usual Care

Intervention Type: OTHER

This group will receive standard usual, which will be monitored, but not protocolised.

Interventions

Progressive mobilization

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).

Intervention Type: OTHER

Usual Care

This group will receive standard usual, which will be monitored, but not protocolised.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

Mansueto Gomes Neto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansueto Gomes Neto

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

FUBahia Mobilization ICU

Identifier Type: -

Identifier Source: org_study_id