Changes in Microcirculation and Functional Status During Exacerbation of COPD

NCT03250000 | Unknown

• 1 other identifier: COPD-EX HasseltU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; Physical Activity; Retinal Vascular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Functional exercise tolerance

  Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

• Muscle Function

  Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

• Changes in Daily physical activity

  Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

• Impact of the disease

  Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

• Impact of the dyspnea

  Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable and exacerbated COPD patients

You may qualify if:

• 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.

You may not qualify if:

• Inability to walk without support from others

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma samples

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Chris Burtin, PhD

CONTACT

0032499387898; chris.burtin@uhasselt.be

Martijn Spruit, PhD

CONTACT

+32011269370; martijn.spruit@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: August 15, 2017
• Study Start: September 8, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2020
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)