Effects of Obesity on COPD

Completed

• Conditions: Obesity; Chronic Obstructive Pulmonary Disease; COPD

• Registration Number: NCT06474858
• Lead Sponsor: Rijnstate Hospital

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.

Study Timeline

• Study Start: 2014-06-30
• Study First Submitted: 2016-06-22
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
6 minute walking test	At inclusion	distance walked in 6 minutes measured in metres

Trial Locations

Locations (1)

Department Of Pulmonology, Rijnstate Hospital, The Netherlands; 🇳🇱 Arnhem, Netherlands