-To determine the presence of changes in the retinal microvasculature and endothelial function in patients with COPD (part 1) -To determine the effect of physical exercise on microvasculare reactivity in patients with COPD and the effect of…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of changes in the retinal microvasculature and endothelial
function in patients with COPD.
Secondary outcome
- The effect of a high-intensity exercise on the reactivity of the retinal
microvasculature in patients with COPD.
- The effect of an 8-week inpatient rehabilitation program on the function of
the retinal microvasculature and endothelial in patients with COPD.
- The association between 1) retinal vessel changes/retinal vascular reactivity
and cardiovascular phenotyping (endothelial function, blood pressure, ankle
brachial index, AFR), 2) retinal vessel changes/retinal vascular reactivity and
relevant outcomes for COPD patients (e.g. lung function, CAT, 6MWT, CPET, CWRT,
smoking status; all included in the routine baseline assessment prior to
rehabilitation).
- Presence of ocular complications (i.e. glaucoma, age dependent macula
degeneration), which are determined by an ophthalmologist.
Background summary
COPD is considered as a complex, heterogeneous, and multicomponent condition,
in which comorbidities are frequently present. Indeed, patients with COPD are
more likely to be diagnosed with (risk factors for) cardiovascular disease.
Smoking is the most important risk factor for the development of COPD and has
negative effects on the airway epithelium, the endothelium and
microvasculature in multiple organs. Retinal image analysis is an unobtrusive
procedure for visualizing the microcirculation. Since similarities exist
between retinal blood vessels and the microvasculature of the heart, lungs, and
brain, retinal imaging can not only be used to identify diseases of the eye but
also to identify cardiovascular diseases and risk factors. To date, little is
known about microvascular changes and endothelial functie and the possible
beneficial effect of physical exercise in patients with COPD.
Study objective
-To determine the presence of changes in the retinal microvasculature and
endothelial function in patients with COPD (part 1)
-To determine the effect of physical exercise on microvasculare reactivity in
patients with COPD and the effect of pulmonary rehabilitation on function of
the retinal microvasculature and endothelial in patients with COPD (part 2).
Study design
prospective observational study.
Study burden and risks
All interventions take place at Ciro+ in Horn as part of regular pulmonary
rehabilitation. In addition, retina photos will be taken in participating
patients and potentially a measurement of endothelial function.
When taking the retina photo, patient will experience a flash of the camera.
The possible inconvenience of this flash will disappear completely after a few
seconds. It takes less than 5 minutes to take the retinal photo.
The EndoPAT is completely safe and harmless, however, the 5 minutes occlusion
of the brachial artery may cause some minor discomfort and tingling in the
fingers.
The risks of participation in the study are almost zero.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
- COPD as a primary diagnosis according to the Global Initiative For Chronic Obstructive Pulmonary Lung Disease (GOLD) definition: *Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases*. COPD is diagnosed by a chest physician.
- Clinically stable on the basis of clinical picture by chest physician .
- Treated according to the current international guidelines.
- Permission for voluntary participation. Patients will be asked during baseline assessment and have to sign an informed consent. Patients have the right to withdraw from the study without any negative consequences on their rehabilitation.
-Attending the regular rehabilitation program in Ciro+ (study part 2)
Exclusion criteria
- Lack of motivation for voluntary participation in this study.
- The presence of abnormalities in the lens (e.g. cataract) or retina (e.g. retinal detachment), which makes it impossible to make an image of the retina.
- The presence of severe retinopathy, which makes it impossible to analyze the microvasculature of the retina.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56813.100.16 |
| OMON | NL-OMON26359 |