An observational study in COPD Exacerbation, Physical Activity and Retinal Vascular, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by Hasselt University · Observational
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.
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.
Stable and exacerbated COPD patients
Exclusion Criteria:
Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk
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.
Changes in Retinal microcirculation
Fundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Changes in Functional status tests
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.
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Functional exercise tolerance
Six minute walk test will be done
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Muscle Function
Handgrip and Isometric-eccentric quadriceps strength test will be done
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Changes in Daily physical activity
Activity level will be assess by an accelerometer, the patient will be worn for 7 days.
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Impact of the disease
The COPD assessment test will be applied
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Impact of the dyspnea
The modified medical research council scale will be applied
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Impact of the depression
The patient health questionnaire will be applied
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Impact of the fatigue
The checklist individual strength- fatigue sub-scale will be applied
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Body composition
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.
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Cardiovascular parameters
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
Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
Continuous assessment of oxygen saturation
A portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.
Time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge
Continuous assessment of heart rate
A portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.
Time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hasselt University