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

Primary Purpose

Intensive Care Unit Syndrome, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Early ambulation
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intensive Care Unit Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Real Hospital Português de Beneficência

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobilization

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 23, 2016
Last Updated
August 22, 2021
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02919085
Brief Title
Effect of Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.
Official Title
Effect of Spontaneously Breathing Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Syndrome, Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Early ambulation
Other Intervention Name(s)
Early mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Time Frame
48 hours
Title
Peripheral muscle strength
Description
The peripheral muscle strength will be assessed through the Medical Research Council score (MRC) and hand grip test.
Time Frame
48 hours
Title
Functional capacity
Description
The functional capacity will be assessed through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s).
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria KF Richtrmoc
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Real Hospital Português de Beneficência
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52010-902
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16132895
Citation
Williams TA, Dobb GJ, Finn JC, Webb SA. Long-term survival from intensive care: a review. Intensive Care Med. 2005 Oct;31(10):1306-15. doi: 10.1007/s00134-005-2744-8. Epub 2005 Aug 24.
Results Reference
result
PubMed Identifier
23153874
Citation
Rossi PJ, Edmiston CE Jr. Patient safety in the critical care environment. Surg Clin North Am. 2012 Dec;92(6):1369-86. doi: 10.1016/j.suc.2012.08.007. Epub 2012 Oct 6.
Results Reference
result
PubMed Identifier
23153875
Citation
Neideen T. Monitoring devices in the intensive care unit. Surg Clin North Am. 2012 Dec;92(6):1387-402. doi: 10.1016/j.suc.2012.08.010. Epub 2012 Oct 13.
Results Reference
result

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

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