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OpenTrials
Completed

NCT Number: NCT02919085

Effect of 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.

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Key information

Conditions

Intensive Care Unit Syndrome Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Real Hospital Português de Beneficência

Recife, Pernambuco, 52010-902, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early ambulation

Procedure

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

Primary outcomes

  1. Respiratory muscle strength

    Time frame: 48 hours

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

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2016
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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