COPD-EX: Changes in Microcirculation and Functional Status During Exacerbation of COPD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COPD-stable Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk |
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| COPD-Ex Patients admitted to the respiratory ward of ZOL Genk with a diagnosis of acute exacerbation, based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. |
Outcome Measures
Primary Outcome Measures
- Changes in Retinal microcirculation [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Fundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.
- Changes in Functional status tests [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Short 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 Outcome Measures
- Functional exercise tolerance [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Six minute walk test will be done
- Muscle Function [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Handgrip and Isometric-eccentric quadriceps strength test will be done
- Changes in Daily physical activity [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Activity level will be assess by an accelerometer, the patient will be worn for 7 days.
- Impact of the disease [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
The COPD assessment test will be applied
- Impact of the dyspnea [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
The modified medical research council scale will be applied
- Impact of the depression [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
The patient health questionnaire will be applied
- Impact of the fatigue [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
The checklist individual strength- fatigue sub-scale will be applied
- Body composition [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Bio-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 parameters [Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge]
Resting 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 saturation [COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge]
A portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.
- Continuous assessment of heart rate [COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge]
A portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ziekenhuis Oost-Limburg | Genk | Belgium | 3600 |
Sponsors and Collaborators
- Hasselt University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COPD-EX HasseltU