Changes in Microcirculation and Functional Status During Exacerbation of COPD

Physical Activity Clinical Trial

— COPD-EX  

Official title:

Changes in Microcirculation and Functional Status During Exacerbation of COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250000
• Other study ID #: COPD-EX HasseltU
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: September 7, 2017
• Start date: September 8, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2017
• Source: Hasselt University
• Contact: Chris Burtin, PhD
• Phone: 0032499387898
• Email: chris.burtin[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Physical Activity
• Retinal Vascular

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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