Effect of Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.

August 22, 2021 updated by: Maria Karoline de França Richtrmoc, Universidade Federal de Pernambuco

Effect of Spontaneously Breathing Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.

To analyze changes on respiratory muscle strength, peripheral and functional capacity of critically ill patients with clinical and surgical etiology, breathing spontaneously and bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are correlations among these variables. This is an observational study. Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council score (MRC) and hand grip test and functional capacity through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified according to clinical and surgical characteristics. Correlations will be determined using the Pearson test, with significance level of p <0.05.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pernambuco
      • Recife, Pernambuco, Brazil, 52010-902
        • Real Hospital Português de Beneficência

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Breathing spontaneously
  • Length of stay in ICU greater than 24 hours
  • Adherence to study

Exclusion Criteria:

  • Patients with poor prognosis or palliation;
  • Preexisting neuromuscular diseases;
  • Immobility or restriction to bed prior to admission;
  • Nonunions and amputations;
  • Osteomioarticular, cognitive or neurological impairment;
  • Non-cooperation;
  • Specific contraindications to the application of evaluation methods;
  • Hemodynamic or respiratory instability within 48 hours of ICU admission preventing evaluation muscle strength and functional capacity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobilization
Procedure to accelerate the ability of a patient to walk or move about by reducing the time to ambulation. It is characterized by a shorter period of hospitalization or recumbency than is normally practiced.
Other Names:
  • Early mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength
Time Frame: 48 hours
Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
48 hours
Peripheral muscle strength
Time Frame: 48 hours
The peripheral muscle strength will be assessed through the Medical Research Council score (MRC) and hand grip test.
48 hours
Functional capacity
Time Frame: 48 hours
The functional capacity will be assessed through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maria KF Richtrmoc, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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