CClinicalTrials.gg
CompletedNCT06474858Updated Jun 26, 2024

Effects of Obesity on COPD

An observational study in COPD, Obesity and Chronic Obstructive Pulmonary Disease, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Rijnstate Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
166
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD
  • Obesity
  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Obesity
  • Chronic Obstructive Pulmonary Disease
  • Dyspnea
  • HRQoL
  • Symptoms
  • Dynamic hyperinflation
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 166 is close to the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with a diagnosis of COPD who visit a Pulmonologist at Rijnstate Hospital.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
166 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal weight

    COPD patients with BMI 18.5-24.99

  • Obese

    COPD patients with BMI ≥ 30

06

What researchers measure

Primary outcomes

  1. Dyspnoea - mMRC

    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.

    Time frame: At inclusion

  2. Dyspnoea - NCSI

    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.

    Time frame: At inclusion

  3. Change in dyspnoea

    Level of dyspnoea using the Borg score. The Borg score ranges from grade 0 to 10. Higher scores mean a worse outcome.

    Time frame: Before and after the 6 minute walking test

Secondary outcomes

  1. 6 minute walking test

    distance walked in 6 minutes measured in metres

    Time frame: At inclusion

07

Study locations

1 site
  • Department Of Pulmonology, Rijnstate Hospital, The Netherlands
    Arnhem, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06474858
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 30, 2014
Primary completion
Sep 1, 2016
Completion
Sep 1, 2016
Last update
Jun 26, 2024

Study contacts

Safir Zewari, MD
principal investigator · Rijnstate Hospital, Arnhem, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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