Effects of Obesity on COPD

A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06474858

Enrollment

166

Registered

2024-06-26

Start date

2014-06-30

Completion date

2016-09-01

Last updated

2024-06-26

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

Conditions

Chronic Obstructive Pulmonary Disease, COPD, Obesity

Keywords

COPD, Obesity, Chronic Obstructive Pulmonary Disease, Dyspnea, HRQoL, Symptoms, Dynamic hyperinflation

Brief summary

The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) and Obesity are two major health problems. The prevalence of both is growing and there is a complex interaction between COPD and obesity. On the one hand obesity impairs lung function, with decreasing static lung volumes being the most significant effect. On the other hand there seems a beneficial role of obesity on lung function in COPD patients. This is because obese COPD patients tend to have less hyperinflation than non-obese COPD patients . An interesting question is what the net effect of these changes in lung function is on respiratory symptoms and quality of life. In this observational study, the investigators will compare obese and non-obese COPD patients. Pulmonary function, dyspnea and quality of life will be compared between the two groups.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with COPD by a Pulmonologist defined as an obstructive lung function test with FEV1/FVC \< 0.7 and FEV1 \< 80% predicted * No exacerbation of COPD at time of inclusion * Age \> 18 years * Able to perform lung function tests and fill in the questionnaires.

Exclusion criteria

* Not able to perform lung function tests or fill in the questionnaires * Diagnosis of Asthma * Diagnosis of neuromuscular disease * Diagnosis of heart failure * Treatment for lung Malignancy in the past * Active Malignancy

Design outcomes

Primary

Measure	Time frame	Description
Dyspnoea - mMRC	At inclusion	Level of dyspnoea perceived in daily life measured using the Modified Medical Research Council (mMRC) dyspnoea scale. The mMRC dyspnoea scale ranges from grade 0 to 4. Higher scores mean a worse outcome.
Dyspnoea - NCSI	At inclusion	Level of dyspnoea perceived in daily life measured using the Nijmegen Clinical Screening Instrument (NCSI). The NCSI ranges from grade 0 to 11. Higher scores mean a worse outcome.
Change in dyspnoea	Before and after the 6 minute walking test	Level of dyspnoea using the Borg score. The Borg score ranges from grade 0 to 10. Higher scores mean a worse outcome.

Secondary

Measure	Time frame	Description
6 minute walking test	At inclusion	distance walked in 6 minutes measured in metres

Countries

Netherlands

Outcome results