NCT02919085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

September 23, 2016

Last Update Submit

August 22, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Respiratory muscle strength

    Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP).

    48 hours

  • Peripheral muscle strength

    The peripheral muscle strength will be assessed through the Medical Research Council score (MRC) and hand grip test.

    48 hours

  • Functional capacity

    The functional capacity will be assessed through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s).

    48 hours

Study Arms (1)

Mobilization

EXPERIMENTAL
Procedure: Early ambulation

Interventions

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.

Also known as: Early mobilization
Mobilization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Real Hospital Português de Beneficência

Recife, Pernambuco, 52010-902, Brazil

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Muscle Weakness

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Maria KF Richtrmoc

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 29, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations