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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Dimitrios Karayiannis, PhD; Phone Number: 2132045036; Email: jimkar_d@yahoo.com
• Study Contact Backup: Name: Aggeliki Papanikolaou, MD, PhD; Phone Number: 6937158640

Study Locations

• Greece
  • Kolonaki
    • Athens, Kolonaki, Greece, 10676
      • Department of Nutrition and Dietetics, Evaggelismos Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Evangelismos Hospital
• Investigators: Principal Investigator: Sotirios Kakkavas, MD, PhD, Pulmonary Medicine Dept, Evangelismos Hospital,

Publications and helpful links

General Publications

• S. Kakavas, D. Karayiannis, A. Papanikolaou, A. Baschali, M. Sarantidou, A. Karachaliou, A. Karli, Z. Mastora, M. Palavra, G. Boulbasakos. Bioelectrical Impedance Analysis Phase Angle as a Prognostic Marker for Outcome in Patients Admitted in Hospital with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Clinical Nutrition 36:S101, 2017

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diet; Nutritional Status; Acute Exacerbation; Phase Angle
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 53/27-01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No