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Changes in Microcirculation and Functional Status During Exacerbation of COPD

Changes in Microcirculation and Functional Status During Exacerbation of COPD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03250000
Acronym
COPD-EX
Enrollment
100
Registered
2017-08-15
Start date
2017-09-08
Completion date
2020-07-01
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation, Physical Activity, Retinal Vascular

Brief summary

This study investigates the influence of acute exacerbation of chronic obstructive pulmonary disease (COPD) on retinal microcirculation, on functional status and also investigates the prognostic value of retinal vessel caliber assessment in terms of hospitalization and mortality during 2 years of follow-up.

Detailed description

Recent findings suggest that patients with chronic obstructive pulmonary disease (COPD) are at increased risk for myocardial infarction and stroke during periods of acute exacerbation. These findings might be related to acute endothelial changes associated to increased systemic inflammation. Changes in the microcirculation can be explored noninvasively by studying retinal blood vessels that are visualized in fundus images. The retinal blood vessels have anatomical and physiological features that are comparable with the coronary circulation. Patients with COPD experience quadriceps muscle weakness, which worsens during hospitalization by \ 1% per day. This is the result of physical inactivity, in combination with increased oxidative stress and systemic inflammation. Physical inactivity is induced by the hospital environment, but is also related to symptoms of dyspnea caused by increased work of breathing and oxygen desaturation. Muscle weakness and physical inactivity are associated to poor functional status and recurrent hospital admissions, independent of pulmonary impairment, which makes those patients with frequent exacerbations prone to enter a vicious cycle. Simple functional screening tests during hospital stay might enable us to quantify the impact of a hospitalization on functional status and to identify patients at risk for repeated exacerbations.

Interventions

None listed

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Stable COPD (post-bronchodilator forced expiratory volume / forced vital capacity \< 0.7), no exacerbations in the previous weeks. COPD patients with diagnosis of acute exacerbation, based on the GOLD criteria.

Exclusion criteria

* Inability to walk without support from others

Design outcomes

Primary

MeasureTime frameDescription
Changes in Retinal microcirculationStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeFundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.
Changes in Functional status testsStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeShort physical performance battery (SPPB), which consists of a four meter gait test, a five-repetition sit-to-stand test and a balance test will be done. All the testes ranged from 0 to 4 and the sum of the three components comprised the final SPPB score, with a possible range from 0 to 12.

Secondary

MeasureTime frameDescription
Changes in Daily physical activityStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeActivity level will be assess by an accelerometer, the patient will be worn for 7 days.
Impact of the diseaseStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeThe COPD assessment test will be applied
Impact of the dyspneaStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeThe modified medical research council scale will be applied
Impact of the depressionStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeThe patient health questionnaire will be applied
Functional exercise toleranceStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeSix minute walk test will be done
Body compositionStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeBio-electrical impedance analysis will be used to estimate fat-free body mass based on the assessment of total body water. Body mass index and waist circumference will provide general information about body composition.
Cardiovascular parametersStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeResting ankle and brachial blood pressure will be measured and the ankle brachial pressure index will be calculated by the ratio of ankle to ipsilateral brachial systolic blood pressure
Continuous assessment of oxygen saturationCOPD exacerbated: Day 5-7 in hospital; 4 weeks after dischargeA portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.
Continuous assessment of heart rateCOPD exacerbated: Day 5-7 in hospital; 4 weeks after dischargeA portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.
Impact of the fatigueStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeThe checklist individual strength- fatigue sub-scale will be applied
Muscle FunctionStable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after dischargeHandgrip and Isometric-eccentric quadriceps strength test will be done

Countries

Belgium

Contacts

Primary ContactChris Burtin, PhD
chris.burtin@uhasselt.be0032499387898
Backup ContactMartijn Spruit, PhD
martijn.spruit@uhasselt.be+32011269370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026