- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919085
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
Conditions
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:
|
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.
General Publications
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01110031483
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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