Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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A cross sectional observation study of body composition in COPD patients consecutively hospitalized with acute exacerbation.

Detailed Description
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Skeletal muscle dysfunction and changes in body composition are important extra-pulmonary manifestations of chronic obstructive pulmonary disease (COPD) that occur in all stages of disease and are associated with poor outcome. In patients with COPD, bioelectrical impedance analysis (BIA) has usually been used to estimate fat-free mass (FFM) and body composition through predictive equations. Very few studies had focused on raw BIA data. The aim of this study is first describe the measurement of phase angle in patients with with acute exacerbation and second to determine the validity of phase angle in this group by assessing its relationship with established markers of function, disease severity and prognosis.

Official Title
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Nutritional Status as a Prognostic Marker of Risk and Outcome in Patients Admitted to Hospital With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous diagnosis of COPD based on history Hospitalization with acute COPD exacerbation Exclusion Criteria: Patients with history of recent surgery (major) and trauma (major) Patients with concomitant disease that might alter nutritional status (heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure, uncontrolled cor pulmonale). Contraindication to BIA including an implanted pacemaker, defibrillator or joint prosthesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase Angle | The evaluation of phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced vital capacity (FVC) | Secondary endpoint will be the correlation between FVC and muscle mass. | 1 month | 
| Correlation between phase angle and serum CRP levels. | Detect the serum CRP levels and then analyze the correlation between CRP and phase angle measurement. | 1 month | 
| Forced expiratory flow volume in one second (FEV1). | Forced expiratory flow volume in one second following standards recommended by European Respiratory Society and correlation with muscle mass. | 1 month | 
| Length of Hospital Stay (LOS) | Duration of Hospital Stay | 1 month | 
| Phase Angle | The evaluation of the phase angle will be performed by means of the electric bioimpedance apparatus. The measurements will be obtained with the patient in dorsal decubitus, barefoot, with the lower limbs slightly apart and without metal objects attached to the body, with electrodes placed on the right hand and foot. | 2 months | 
| Body Composition | Body composition will be assessed using bioelectrical impedance analysis (In Body 720, Biospace) at a standardized time after breakfast. Bioelectrical impedance analysis (BIA) is a simple, safe, non-invasive method to measure assess lean (e.g., muscle) vs. fat body compartments. Fat-free mass will be calculated by using disease-specific equations as described by Schols. Fat mass will then be calculated as total body weight minus fat-free mass. Such BIA measurements are accurate, comparable to other techniques used to assess body composition, and have been validated in patients with acute excerbation of COPD | 1 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Nutritional Status, Acute Exacerbation, Phase Angle