<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250000</url>
  </required_header>
  <id_info>
    <org_study_id>COPD-EX HasseltU</org_study_id>
    <nct_id>NCT03250000</nct_id>
  </id_info>
  <brief_title>Changes in Microcirculation and Functional Status During Exacerbation of COPD</brief_title>
  <acronym>COPD-EX</acronym>
  <official_title>Changes in Microcirculation and Functional Status During Exacerbation of COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the influence of acute exacerbation of chronic obstructive pulmonary&#xD;
      disease (COPD) on retinal microcirculation, on functional status and also investigates the&#xD;
      prognostic value of retinal vessel caliber assessment in terms of hospitalization and&#xD;
      mortality during 2 years of follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent findings suggest that patients with chronic obstructive pulmonary disease (COPD) are&#xD;
      at increased risk for myocardial infarction and stroke during periods of acute exacerbation.&#xD;
      These findings might be related to acute endothelial changes associated to increased systemic&#xD;
      inflammation. Changes in the microcirculation can be explored noninvasively by studying&#xD;
      retinal blood vessels that are visualized in fundus images. The retinal blood vessels have&#xD;
      anatomical and physiological features that are comparable with the coronary circulation.&#xD;
&#xD;
      Patients with COPD experience quadriceps muscle weakness, which worsens during&#xD;
      hospitalization by ~1% per day. This is the result of physical inactivity, in combination&#xD;
      with increased oxidative stress and systemic inflammation. Physical inactivity is induced by&#xD;
      the hospital environment, but is also related to symptoms of dyspnea caused by increased work&#xD;
      of breathing and oxygen desaturation.&#xD;
&#xD;
      Muscle weakness and physical inactivity are associated to poor functional status and&#xD;
      recurrent hospital admissions, independent of pulmonary impairment, which makes those&#xD;
      patients with frequent exacerbations prone to enter a vicious cycle.&#xD;
&#xD;
      Simple functional screening tests during hospital stay might enable us to quantify the impact&#xD;
      of a hospitalization on functional status and to identify patients at risk for repeated&#xD;
      exacerbations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Retinal microcirculation</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>Fundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Functional status tests</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional exercise tolerance</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>Six minute walk test will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Function</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>Handgrip and Isometric-eccentric quadriceps strength test will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Daily physical activity</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>Activity level will be assess by an accelerometer, the patient will be worn for 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the disease</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>The COPD assessment test will be applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the dyspnea</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>The modified medical research council scale will be applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the depression</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>The patient health questionnaire will be applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the fatigue</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>The checklist individual strength- fatigue sub-scale will be applied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular parameters</measure>
    <time_frame>Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous assessment of oxygen saturation</measure>
    <time_frame>COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>A portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous assessment of heart rate</measure>
    <time_frame>COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge</time_frame>
    <description>A portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COPD Exacerbation</condition>
  <condition>Physical Activity</condition>
  <condition>Retinal Vascular</condition>
  <arm_group>
    <arm_group_label>COPD-stable</arm_group_label>
    <description>Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD-Ex</arm_group_label>
    <description>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.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Stable and exacerbated COPD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable COPD (post-bronchodilator forced expiratory volume / forced vital capacity &lt;&#xD;
             0.7), no exacerbations in the previous weeks. COPD patients with diagnosis of acute&#xD;
             exacerbation, based on the GOLD criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to walk without support from others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chris Burtin, PhD</last_name>
    <phone>0032499387898</phone>
    <email>chris.burtin@uhasselt.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martijn Spruit, PhD</last_name>
    <phone>+32011269370</phone>
    <email>martijn.spruit@uhasselt.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michiel Thomeer, MD, PhD</last_name>
      <phone>003289327038</phone>
      <email>Michiel.Thomeer@zol.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Martijn Spruit</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250000
org study id: COPD-EX HasseltU
nct id: NCT03250000
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Changes in Retinal microcirculation
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: Fundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.
measure: Changes in Functional status tests
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: 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.
measure: Functional exercise tolerance
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: Six minute walk test will be done
measure: Muscle Function
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: Handgrip and Isometric-eccentric quadriceps strength test will be done
measure: Changes in Daily physical activity
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: Activity level will be assess by an accelerometer, the patient will be worn for 7 days.
measure: Impact of the disease
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: The COPD assessment test will be applied
measure: Impact of the dyspnea
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: The modified medical research council scale will be applied
measure: Impact of the depression
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: The patient health questionnaire will be applied
measure: Impact of the fatigue
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: The checklist individual strength- fatigue sub-scale will be applied
measure: Body composition
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: 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.
measure: Cardiovascular parameters
time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge
description: 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
measure: Continuous assessment of oxygen saturation
time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge
description: A portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.
measure: Continuous assessment of heart rate
time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge
description: A portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.
arm group label: COPD-stable
description: Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk
arm group label: COPD-Ex
description: 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.
Blood plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Burtin, PhD
phone: 0032499387898
email: chris.burtin@uhasselt.be
last name: Martijn Spruit, PhD
phone: +32011269370
email: martijn.spruit@uhasselt.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Martijn Spruit
investigator title: PhD
sharing ipd: No