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OpenTrials
Completed

NCT Number: NCT06474858

Effects of Obesity on COPD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dyspnoea - mMRC

    Time frame: 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.

  2. Dyspnoea - NCSI

    Time frame: 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.

  3. Change in dyspnoea

    Time frame: 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 outcomes

  1. 6 minute walking test

    Time frame: At inclusion

    distance walked in 6 minutes measured in metres

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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