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Completed

NCT Number: NCT03709498

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nutrition and Dietetics, Evaggelismos Hospital

Athens, Kolonaki, 10676, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Phase Angle

    Time frame: 1 month

    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.

Secondary outcomes

  1. Change in Forced vital capacity (FVC)

    Time frame: 1 month

    Secondary endpoint will be the correlation between FVC and muscle mass.

  2. Correlation between phase angle and serum CRP levels.

    Time frame: 1 month

    Detect the serum CRP levels and then analyze the correlation between CRP and phase angle measurement.

  3. Forced expiratory flow volume in one second (FEV1).

    Time frame: 1 month

    Forced expiratory flow volume in one second following standards recommended by European Respiratory Society and correlation with muscle mass.

  4. Length of Hospital Stay (LOS)

    Time frame: 1 month

    Duration of Hospital Stay

  5. Phase Angle

    Time frame: 2 months

    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.

  6. Body Composition

    Time frame: 1 month.

    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

Sponsors and collaborators

Lead sponsor

Evangelismos Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 17, 2018
Registry last updated
Sep 7, 2023

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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