<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/NCT03799263</url>
  </required_header>
  <id_info>
    <org_study_id>2019001</org_study_id>
    <nct_id>NCT03799263</nct_id>
  </id_info>
  <brief_title>A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease)</brief_title>
  <acronym>COPD</acronym>
  <official_title>A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maugeri Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Università degli Studi di Sassari</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maugeri Foundation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The six minute walking test (6MWT) is a recognized clinical test to evaluate exercise&#xD;
      capacity in different diseases and different conditions. The modalities of performance are&#xD;
      described in International Guidelines. The usually reported measure is the distance in meters&#xD;
      walked in 6 minutes. Despite the report of a single variable during the test is considered as&#xD;
      a limit, changes in monitored variables are seldom analyzed together with the distance&#xD;
      walked. In the past there have been some attempts of multifactorial evaluation of 6MWT,&#xD;
      however up to date, there is no system considering together the changes of different&#xD;
      variables. The investigators wonder whether a multidimensional index based on variables&#xD;
      monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate&#xD;
      exercise capacity in different diseases and different conditions. In COPD patients the 6MWT&#xD;
      is a marker of severity, influenced by the severity of airway obstruction as well as of&#xD;
      comorbidities. This test has been shown as a predictor of survival and need of&#xD;
      hospitalization. The modalities of performance are described in International Guidelines. The&#xD;
      usually reported measure is the distance in meters walked in 6 minutes. However, besides the&#xD;
      pathological conditions, this result is influenced by the individual demographic and&#xD;
      anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects&#xD;
      is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous&#xD;
      year, is a predictor of death risk. During the test some physiological variables should be&#xD;
      monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation&#xD;
      &gt;4% or a SpO2 &lt;90% during the test, are also predictors of increased risk of death or&#xD;
      hospitalization. In addition, also the difference between the HR at baseline and that after&#xD;
      one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of&#xD;
      survival and COPD exacerbation rates. Despite the report of a single variable during the test&#xD;
      is considered as a limit, changes in monitored variables are seldom analyzed together with&#xD;
      the distance walked. In the past there have been some attempts of multifactorial evaluation&#xD;
      of 6MWT, however up to date, there is no system considering together the changes of different&#xD;
      variables. We wonder whether a multidimensional index based on variables monitored during the&#xD;
      6MWT would better predict 24 month exacerbations and mortality in COPD patients.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective: To develop and validate a multidimensional index in COPD subjects with&#xD;
      different grades of severity as assessed by the Global Initiative for Chronic Obstructive&#xD;
      Lung disease as a predictor of 24 month exacerbation rate.&#xD;
&#xD;
      Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the&#xD;
      relationship of this index and other accepted clinical predictors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>COPD Exacerbation</measure>
    <time_frame>24 month</time_frame>
    <description>number of patients with acute exacerbations (treated with antibiotics or steroids)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>24 month</time_frame>
    <description>number of patients died</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalizations</measure>
    <time_frame>24 month</time_frame>
    <description>number of patients hospitalized for COPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>symptoms and anthropometrics characteristics correlation</measure>
    <time_frame>24 month</time_frame>
    <description>Index correlation capacity with dyspnoea (Medical Research Council questionnaire, Barthel Dyspnoea), body weight (kilogram), heart frequency (HR), distance walked (6MWT)</description>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>COPD</condition>
  <condition>Mortality</condition>
  <condition>Disease Exacerbation</condition>
  <condition>Exercise Capacity</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>evaluation group</intervention_name>
    <description>Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stable COPD patients assessed for Pulmonary Rehabilitation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD diagnosis and grades of severity as assessed by the &quot;old&quot; (I to IV) and &quot;new&quot; (A&#xD;
             to D) GOLD guidelines (23)&#xD;
&#xD;
          -  Under inhaler therapy for ≥30 days according to guidelines (23)&#xD;
&#xD;
          -  Smokers or o ex-smokers, smoke history ≥10 pack/years (p/y)&#xD;
&#xD;
          -  Informed Consent Signature.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated Comorbidities with short term severe prognosis&#xD;
&#xD;
          -  Actual Cardiac Arrythmias&#xD;
&#xD;
          -  Pace-maker&#xD;
&#xD;
          -  Other associated respiratory diseases&#xD;
&#xD;
          -  Chronic Heart Failure New York Heart Association classes III, IV.&#xD;
&#xD;
          -  Use of drugs influencing the heart rate&#xD;
&#xD;
          -  Changes in drug therapy in the previous 30 days&#xD;
&#xD;
          -  Use of systemic steroids or antibiotics in the previous 30 days&#xD;
&#xD;
          -  Unscheduled visits or admission to the Emergency Room for symptoms worsening in the&#xD;
             previous 30 days&#xD;
&#xD;
          -  Pneumonia during the previous 60 days&#xD;
&#xD;
          -  Myocardial Infarction in the previous 4 months&#xD;
&#xD;
          -  Subjective and objective inability to perform the 6MWT&#xD;
&#xD;
          -  Inability to carry the oxygen cylinder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Antonio Spanevello, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Maugeri Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maugeri Foundation</name>
      <address>
        <city>Tradate</city>
        <state>VA</state>
        <zip>21049</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.</citation>
    <PMID>6805625</PMID>
  </results_reference>
  <results_reference>
    <citation>Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14.</citation>
    <PMID>20471236</PMID>
  </results_reference>
  <results_reference>
    <citation>ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.</citation>
    <PMID>12091180</PMID>
  </results_reference>
  <results_reference>
    <citation>Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.</citation>
    <PMID>12917227</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17.</citation>
    <PMID>28624883</PMID>
  </results_reference>
  <results_reference>
    <citation>Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11.</citation>
    <PMID>18550610</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maugeri Foundation</investigator_affiliation>
    <investigator_full_name>elisabetta zampogna</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03799263
org study id: 2019001
nct id: NCT03799263
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The six minute walking test (6MWT) is a recognized clinical test to evaluate exercise
      capacity in different diseases and different conditions. The modalities of performance are
      described in International Guidelines. The usually reported measure is the distance in meters
      walked in 6 minutes. Despite the report of a single variable during the test is considered as
      a limit, changes in monitored variables are seldom analyzed together with the distance
      walked. In the past there have been some attempts of multifactorial evaluation of 6MWT,
      however up to date, there is no system considering together the changes of different
      variables. The investigators wonder whether a multidimensional index based on variables
      monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD
      patients.
Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate
      exercise capacity in different diseases and different conditions. In COPD patients the 6MWT
      is a marker of severity, influenced by the severity of airway obstruction as well as of
      comorbidities. This test has been shown as a predictor of survival and need of
      hospitalization. The modalities of performance are described in International Guidelines. The
      usually reported measure is the distance in meters walked in 6 minutes. However, besides the
      pathological conditions, this result is influenced by the individual demographic and
      anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects
      is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous
      year, is a predictor of death risk. During the test some physiological variables should be
      monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation
      >4% or a SpO2 <90% during the test, are also predictors of increased risk of death or
      hospitalization. In addition, also the difference between the HR at baseline and that after
      one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of
      survival and COPD exacerbation rates. Despite the report of a single variable during the test
      is considered as a limit, changes in monitored variables are seldom analyzed together with
      the distance walked. In the past there have been some attempts of multifactorial evaluation
      of 6MWT, however up to date, there is no system considering together the changes of different
      variables. We wonder whether a multidimensional index based on variables monitored during the
      6MWT would better predict 24 month exacerbations and mortality in COPD patients.

      Objectives:

      Primary Objective: To develop and validate a multidimensional index in COPD subjects with
      different grades of severity as assessed by the Global Initiative for Chronic Obstructive
      Lung disease as a predictor of 24 month exacerbation rate.

      Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the
      relationship of this index and other accepted clinical predictors.
observational model: Cohort
time perspective: Prospective
measure: COPD Exacerbation
time frame: 24 month
description: number of patients with acute exacerbations (treated with antibiotics or steroids)
measure: Mortality
time frame: 24 month
description: number of patients died
measure: hospitalizations
time frame: 24 month
description: number of patients hospitalized for COPD
measure: symptoms and anthropometrics characteristics correlation
time frame: 24 month
description: Index correlation capacity with dyspnoea (Medical Research Council questionnaire, Barthel Dyspnoea), body weight (kilogram), heart frequency (HR), distance walked (6MWT)
intervention type: Procedure
intervention name: evaluation group
description: Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
last name: Antonio Spanevello, Prof
role: Study Director
affiliation: Maugeri Foundation
facility: 
country: Italy
citation: Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.
PMID: 6805625
citation: Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14.
PMID: 20471236
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
PMID: 12091180
citation: Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.
PMID: 12917227
citation: Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17.
PMID: 28624883
citation: Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11.
PMID: 18550610
responsible party type: Principal Investigator
investigator affiliation: Maugeri Foundation
investigator full name: elisabetta zampogna
investigator title: Dr
mesh term: Disease Progression
sharing ipd: Undecided