Exercise Capacity in COPD

Reduced Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease -Relevance of Cardiovascular Comorbidities

In this study, cardiopulmonary exercise will be assessed to characterize the relevance of severity of COPD and coexisting cardiovascular comorbidities for exercise capacity.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing

Detailed Description

In patients with chronic obstructive pulmonary disease (COPD) the interpretation of dyspnoea also needs to consider coexisting cardiovascular disease. Cardiopulmonary exercise testing (CPET) is used to characterize pulmonary and cardiac function and limitations during exercise. The investigators hypothesise that cardiopulmonary exercise is reduced in COPD patients with coexisting cardiovascular disease as well as in more symptomatic patients and in patients with frequent exacerbations. For this purpose, 100 patients with with stable COPD are characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Principal Investigator: Stefanie Keymel, MD
    • Contact: Stefanie Keymel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 40 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stabile chronic obstructive pulmonary disease

Description

Inclusion Criteria:

• patients with stable chronic obstructive pulmonary disease, exacerbated or stable
• 40-80 years
• sinus rhythm
• informed written consent

Exclusion Criteria:

• Inability to give written consent
• acute myocardial infarction with ST-segment elevations in last 30 days
• severe acute or chronic renal dysfunction
• severe heart failure-
• atrial fibrillation
• severe valve disease
• severe hypoxemia
• long term oxygen therapy or non invasive ventilation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with stable COPD	Other: Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing; Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Oxygen pulse during cardiopulmonary exercise testing		Baseline
Presence of cardiovascular comorbidities	For the cardiopulmonary characterization clinical characteristics, lung function, blood gases, laboratory investigation, ECG and echocardiography were used in addition to cardiopulmonary exercise testing.	Baseline
measurement of dyspnoea quantified by the COPD assessment test as well as the modified Medical Research Council Scale	For the assessment of the symptoms of the study group and its relation to exercise capacity dyspnoea is assessed by accepted questionnaires typically used for COPD patients at baseline	Baseline
Measurement of FEV1		Baseline
Measurement the capillary pO2 in mmHg and capillary pCO2 at baseline	The blood gases pO2 and pCO2 are taken from the hyperaemic ear lobe to characterize the gas exchange during cardiopulmonary exercise which is a routine procedure	Baseline
N-terminal pro brain natriuretic peptid (NTproBNP) in ng/L from peripheral venous blood at baseline	NTproBNP is analysed from peripheral venous blood to characterize potential heart failure and its relation to exercise capacity of the study subjects	Baseline
Measurement of Maximum wattage during cardiopulmonary exercise testing		Baseline
Measurement of Breathing reserve during cardiopulmonary exercise testing	BThe breathing reserve in % is assessed at the end of the cardiopulmonary exercise testing to characterize a ventilatory limitation of the exercise test. It is calculated as percent from the minute ventilation in relation to the maximum mandatory ventilation. The measurement is a routine measurement during cardiopulmonary exercise testing.	Baseline

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cardiopulmonary exercise testing; cardiopulmonary interaction; cardiovascular comorbidities
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 17-033

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