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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03709498
Enrollment
60
Registered
2018-10-17
Start date
2016-01-31
Completion date
2020-01-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Diet, Nutritional Status, Acute Exacerbation, Phase Angle

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

Evangelismos Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Phase Angle1 monthThe 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

MeasureTime frameDescription
Correlation between phase angle and serum CRP levels.1 monthDetect the serum CRP levels and then analyze the correlation between CRP and phase angle measurement.
Forced expiratory flow volume in one second (FEV1).1 monthForced expiratory flow volume in one second following standards recommended by European Respiratory Society and correlation with muscle mass.
Change in Forced vital capacity (FVC)1 monthSecondary endpoint will be the correlation between FVC and muscle mass.
Phase Angle2 monthsThe 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.
Body Composition1 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
Length of Hospital Stay (LOS)1 monthDuration of Hospital Stay

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026