COPDNCT06474858
Effects of Obesity on COPD
An observational study of COPD and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD, Obesity, Chronic Obstructive Pulmonary Disease
- How many people
- 166 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jun 2014to 1 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a diagnosis of COPD who visit a Pulmonologist at Rijnstate Hospital.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department Of Pulmonology, Rijnstate Hospital, The Netherlands
Arnhem
About this study
Official title: A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients
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.
- Conditions
- COPD, Obesity, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Obesity, Chronic Obstructive Pulmonary Disease, Dyspnea, HRQoL, Symptoms, Dynamic hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | COPD patients with BMI 18.5-24.99 | |
| Obese | COPD patients with BMI ≥ 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
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.
Measured: At inclusion
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.
Measured: Before and after the 6 minute walking test
Secondary outcomes (1)
6 minute walking test
distance walked in 6 minutes measured in metres
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start30 Jun 2014
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Safir Zewari, MD, Principal investigator, Rijnstate Hospital, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474858
- Sponsor's protocol ID
- 2014/113
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2016
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients
- ClinicalTrials.gov ID
- NCT06474858
- Acronym / sponsor ID
- 2014/113
- Conditions
- COPD, Obesity, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Obesity, Chronic Obstructive Pulmonary Disease, Dyspnea, HRQoL, Symptoms, Dynamic hyperinflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –COPD patients with BMI 18.5-24.99 |
| Obese | – | –COPD patients with BMI ≥ 30 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of COPD who visit a Pulmonologist at Rijnstate Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
6 minute walking test
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safir Zewari, MD principal investigator
Rijnstate Hospital, Arnhem, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnoea - mMRC (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.