Muscle Weakness Clinical Trial
Official title:
Effect of Spontaneously Breathing Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.
NCT number | NCT02919085 |
Other study ID # | 01110031483 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | December 2017 |
Verified date | August 2021 |
Source | Universidade Federal de Pernambuco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Real Hospital Português de Beneficência | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal de Pernambuco |
Brazil,
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. Review. — View 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. Review. — View 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. Epub 2005 Aug 24. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory muscle strength | Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP). | 48 hours | |
Primary | Peripheral muscle strength | The peripheral muscle strength will be assessed through the Medical Research Council score (MRC) and hand grip test. | 48 hours | |
Primary | Functional capacity | The functional capacity will be assessed through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s). | 48 hours |
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