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

Effects of the Addition of a Protocol of Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients: Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Critically Ill
• Intervention / Treatment: Other: Progressive mobilization; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41950350
      • Mansueto Gomes Neto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
Sham Comparator: Control: Usual care; These patients will receive standard rehabilitation delivered by non-study physiotherapist.	Other: Usual Care; This group will receive standard usual, which will be monitored, but not protocolised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound	Change from baseline at 28th day
Change in muscle strength	Muscle Strength measured by hand held dynamometer	Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU
Physical activity: total activity	accelerometry measurement of the total activity	At 28 days or discharge from hospital
Activity and participation	Measurement characteristics of World Health Organisation Disability Assessment Schedule II	Change from baseline up to 1 year post discharge
Mortality	Mortality	At 28 days or discharge from hospital and at 12 months
Functional Status	Functional Status Measured Using Functional Status Score for the Intensive Care Unit (involves five functional tasks (rolling, supine to sit transfer, sit to stand transfer, sitting on the edge of bed and walking). Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform at all) to 7 (complete independence)	Change from baseline up to 28th day or discharge from hospital
Surgical Optimal Mobilisation Score (SOMS) level	Surgical Optimal Mobilisation Score (SOMS) level algorithm for goal-directed mobility ranges from '0-No mobility' to '4-Ambulation'. The intermediate steps are '1-Passive Range of Motion,' '2-Sitting,' and '3-Standing.'	Change from baseline up to 28th day or discharge from hospital
Mobility	Timed up-and-go score	Change from baseline up to 28th day or discharge from hospital
Health-Related Quality of Life: SF-36	Health-Related Quality of Life will be measured by a questionnaire 36-item Short Form Health Survey. The SF-36 is a widely used generic instrument for evaluating HRQoL, consisting of eight subscales evaluating specific health status domains and two summary scales, a Physical Component Summary and a Mental Component Summary. Scores on the SF-36 range from 0 to 100, with higher scores indicating better health status.	At 28 days or discharge from hospital and at 12 months
Days with mechanical ventilation	Number of uninterrupted days in use of mechanical ventilation	From 3 to 28 days
Length of hospital stay in days	Time in days, from baseline to discharge from hospital	Up to 1 month post hospital discharge
Muscle thickness	Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm	Change from baseline at 28th day

Collaborators and Investigators

• Sponsor: Federal University of Bahia

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: FUBahia Mobilization ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No