Changes in Microcirculation and Functional Status During Exacerbation of COPD (COPD-EX)

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; COPD Exacerbation; Retinal Vascular

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Chris Burtin, PhD; Phone Number: 0032499387898; Email: chris.burtin@uhasselt.be
• Study Contact Backup: Name: Martijn Spruit, PhD; Phone Number: +32011269370; Email: martijn.spruit@uhasselt.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Michiel Thomeer, MD, PhD; Phone Number: 003289327038; Email: Michiel.Thomeer@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stable and exacerbated COPD patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
COPD-stable; Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise tolerance	Six minute walk test will be done	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	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.	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	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	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	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	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.	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	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.	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.	COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge

Collaborators and Investigators

• Sponsor: Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COPD-EX HasseltU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No