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

NCT03596853 | Unknown

• 1 other identifier: FUBahia Mobilization ICU
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

• Length of ICU stay in days

  Time in days, from baseline to discharge from ICU

  at 28 days or discharge from ICU whichever occurs earlier

Secondary Outcomes (12)

• Muscle mass

  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

• Activity and participation

  Change from baseline up to 1 year post discharge

• Mortality

  At 28 days or discharge from hospital and at 12 months

Study Arms (2)

Experimental: Mobilization

EXPERIMENTAL

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.

Other: Progressive mobilization

Control: Usual care

SHAM COMPARATOR

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

Other: Usual Care

Interventions

Progressive mobilization 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).

Experimental: Mobilization

Usual Care OTHER

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

Control: Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Mansueto Gomes Neto

Salvador, Estado de Bahia, 41950350, Brazil

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking: Triple (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 24, 2018
• Study Start: June 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2022
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

BR (1)