<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/NCT03042806</url>
  </required_header>
  <id_info>
    <org_study_id>ICSMaugeri</org_study_id>
    <nct_id>NCT03042806</nct_id>
  </id_info>
  <brief_title>Validation of a Questionnaire for Physical Activity in COPD: Maugeri Physical Activity Questionnaire (MaPAct)</brief_title>
  <acronym>MaPAct</acronym>
  <official_title>Validation of a Questionnaire Evaluating the Physical Activities in COPD Patients: the Maugeri Physical Activity Questionnaire - MaPAct</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elisabetta Zampogna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione Salvatore Maugeri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione Salvatore Maugeri</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>
      Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary&#xD;
      rehabilitation in terms of exercise capacity, symptoms and health-related quality of life&#xD;
      whereas the effect on physical activity is still not clear. Some studies have investigated&#xD;
      the effect of exercise training on daily physical activity. However, there is considerable&#xD;
      variability in study findings, data are discordant and the effect of exercise training on&#xD;
      physical activity is unclear. There are probably a number of reasons to account for this.&#xD;
&#xD;
      First of all, the choice of the method for evaluating physical activity. Although direct&#xD;
      observation, double-labelled water and calorimetry are considered the gold standard for&#xD;
      assessing physical activity, they are too time consuming and expensive to be used in large&#xD;
      population studies .The Physical Activity (PA) of patients with COPD can be assessed using&#xD;
      questionnaires. A variety of questionnaires exist that capture different aspects of physical&#xD;
      activity such as amount, type, intensity, symptom experience and limitations in the&#xD;
      performance of ''activities of daily life''. Up to now, it still does not exist an instrument&#xD;
      that evaluates the physical activity of COPD patients in Italian language that takes in&#xD;
      account Italian people' lifestyle. Since this is strongly influenced by the environment,&#xD;
      cultural and social conditions in which we live, it is essential to have an instrument&#xD;
      specifically tailored for the population under study.&#xD;
&#xD;
      Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD&#xD;
      patients pointing to assess self-perceived physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods The study will be approved by the Internal Review Board and Ethics Committee of the&#xD;
      Salvatore Maugeri Foundation, Institute of Care and Scientific Research Rehabilitation of&#xD;
      Tradate and Lumezzane, Italy and Malcantonese Hospital, Castelrotto, Switzerland. The&#xD;
      procedures will be performed between September 2016 to September 2018.&#xD;
&#xD;
      Study design A team of experts, (1 pulmonologist, 1 bioengineer, 4 physiotherapists, 1&#xD;
      psychologist and 1 psychometrist) elaborated the instruments and defined the instructions to&#xD;
      administer the MaPAct to self-evaluate the physical activity during daily life. This phase&#xD;
      distinguishes three steps.&#xD;
&#xD;
      Subjects A total of 195 in-hospital patients (15 in a first step, 50 in a second step and 130&#xD;
      in the third) with diagnosis of COPD, will be enrolled. Will be excluded from the study all&#xD;
      the patients that were hospitalized in the 30 days before admission, patients with&#xD;
      degenerative neuromuscular disease, subjects with motor disabilities limiting ambulation,&#xD;
      subjects with memory or comprehension problems, with dementia, Parkinson disease, and&#xD;
      subjects that do not give their consent to the participation to the study. All subjects&#xD;
      receive a consent informed.&#xD;
&#xD;
      Step 1 A focus group of 15 patients will be arranged and patients will be asked to fill in&#xD;
      the preliminary version of the questionnaire and to offer their impression. In this pilot&#xD;
      step patients will be also asked to discuss on the relevance for the study population and&#xD;
      comprehensiveness of the items describing them generically as 'clear' or 'unclear',&#xD;
      &quot;appropriate&quot; or &quot;not appropriate&quot; to themselves (16-17), the aim being to achieve consensus&#xD;
      for each item. Where items were described as &quot;not appropriate&quot; or &quot;unclear&quot;, participants&#xD;
      should explain their reasons. Some items should be removed at this stage, or reworded if&#xD;
      necessary. The objective was to include all items judged to be relevant to COPD patients.&#xD;
      These items will form the Item Set.&#xD;
&#xD;
      Step 2 The patient-perceived comprehensibility will be tested on a sample of 50 patients.&#xD;
      Patients will be asked to rank their perceived comprehensibility of the questionnaire on a&#xD;
      4-point Likert scale, between 0 and 3 (0 =Easy, 1 =Quite easy, 2 = Quite difficult, and 3 =&#xD;
      Difficult). Some items should be removed at this stage, or reworded if necessary.&#xD;
&#xD;
      Step 3 The definitive version of MaPAct will be administered to a sample of 130 patients to&#xD;
      evaluate the psychometric properties of MaPAct.&#xD;
&#xD;
      A complete Rasch analysis will be performed, along with an evaluation of internal consistency&#xD;
      and test-retest reliability in a sub-sample of subjects.&#xD;
&#xD;
      Finally, since skeletal muscle weakness, reduced exercise capacity, slow gait and reduced&#xD;
      physical activity levels are well-known systemic effects in COPD, in order to estimate MaPAct&#xD;
      criterion validity with COPD status, the correlations between MaPAct with Global Initiative&#xD;
      for Chronic Obstructive Lung Disease (GOLD) stage (18), hospital admissions or exacerbations&#xD;
      as defined by the GOLD and symptoms as derived by mMRC and CAT scales will be evaluated.&#xD;
&#xD;
      Time for completing the MaPAct will be also assessed. In order to provide an estimate of the&#xD;
      reliability of the MaPAct to describe objective physical activity, in a sub group of 30&#xD;
      patients a metabolic holter (SenseWear armband - 48 hours) will be used to measure daily&#xD;
      calories, number of steps and Metabolic Equivalents (METS) that will be correlated with the&#xD;
      MapAct.&#xD;
&#xD;
      Timeline On day 1 of the study, all the COPD patients will perform medical evaluation&#xD;
      (medical history, physical examination and history of COPD exacerbations within 12 month),&#xD;
      pulmonary function tests, blood gas analysis and MaPAct. On the subsequent day, while 40&#xD;
      consecutive patients will complete again MaPAct (+ 24 h) for intrarater variability&#xD;
      determination, all subjects will perform a 6-minute walking test (6MWT) and evaluate&#xD;
      perceived exertion (CR-10; modified Borg Scale; 19). In all subjects modified Medical&#xD;
      Research Council- (mMRC Dyspnea Index; 20, 21), and COPD Assessment Test (CAT, 22) will be&#xD;
      carried on.&#xD;
&#xD;
      The GOLD spirometric classification will be used to determine the severity of the disease:&#xD;
      mild COPD, forced expiratory volume in one second (FEV1) ≥80% predicted; moderate COPD,&#xD;
      50%≤FEV1&lt;80% predicted; and severe-to-very severe COPD, FEV1&lt;50% predicted.&#xD;
&#xD;
      Statistical analysis Internal consistency&#xD;
&#xD;
      The internal consistency of the MaPAct will be assessed by calculating:&#xD;
&#xD;
        1. Cronbach's coefficient alpha: the closer this is to 1.0 the greater the internal&#xD;
           consistency of the items in the scale. An alpha of 0.8 is a reasonable goal. Rules of&#xD;
           thumb are: &quot;Alpha &gt; 0.9 Excellent; &gt; 0.8 Good; &gt; 0.7 Acceptable&quot; (23);&#xD;
&#xD;
        2. Item-remainder correlation through the Spearman's rank correlation (ρ) coefficient to&#xD;
           examine the correlations between each item and the sum of the remaining items, omitting&#xD;
           that item from the total: a Spearman coefficient ρ &gt; 0.40 will be considered as the&#xD;
           minimum value for satisfactory item-to-total correlation (24).&#xD;
&#xD;
      Reproducibility Reliability coefficient will be estimated with intraclass correlation&#xD;
      coefficient (ICC). Expecting to obtain ICC values of about .90, with a 95% confidence&#xD;
      interval (CI) of .20, at least 32 subjects are required (25).&#xD;
&#xD;
      Rasch Analysis For Rasch analysis, a sample size of more than 100 persons will estimate item&#xD;
      difficulty with an alpha of 0.05 within ± 0.5 logits (26).&#xD;
&#xD;
      The steps of analysis will be as follows:&#xD;
&#xD;
        1. Rating scale diagnostic. We will investigate whether the rating scale is being used in&#xD;
           the expected manner. We evaluated the response categories as suggested by Linacre (27).&#xD;
&#xD;
        2. Validity, assessed by evaluating the goodness of fit of the real data to the modelled&#xD;
           data, to test if there were items that do not fit the model expectations. We will&#xD;
           consider mean-square (MnSq) &gt; 0.7 and &lt; 1.3 as an indicator of acceptable fit (28).&#xD;
           Items outside this range will be considered underacting (MnSq &gt; 1.3, suggesting the&#xD;
           presence of unexpectedly high variability), or overfitting (MnSq &lt; 0.7, indicating a too&#xD;
           predictable pattern).&#xD;
&#xD;
        3. Reliability, evaluated in terms of separation, defined as the ratio of the person (or&#xD;
           item) &quot;true&quot; standard deviation to the error standard deviation (29). Item separation is&#xD;
           used to verify the item hierarchy and reflects the number of &quot;strata&quot; of measures that&#xD;
           are statistically discernible. A separation of 2.0 is considered good and sufficient to&#xD;
           allow stratification into 3 groups (30). A related index is the reliability of these&#xD;
           separation indexes, which provides the degree of confidence that can be placed in the&#xD;
           reproducibility of these estimates; the value of the coefficient varies from 0 to 1&#xD;
           (values &gt; 0.80 are considered good, and &gt; 0.90 excellent) (31).&#xD;
&#xD;
        4. Principal component analysis (PCA) on the standardized residuals will be used to&#xD;
           investigate:&#xD;
&#xD;
      4.1. The dimensionality of the scale. In this case &quot;unidimensionality&quot; assumes that, after&#xD;
      the removal of the trait that the scale intended to measure (the &quot;Rasch factor&quot;), the&#xD;
      residuals will be uncorrelated and normally distributed (i.e. there are no principal&#xD;
      components). The following criteria will be used to determine whether additional factors are&#xD;
      likely to be present in the residuals: at least 50% of the variance explained by the Rasch&#xD;
      factor, eigenvalue of the first contrast smaller than 3, and variance explained by each&#xD;
      contrast smaller than 5%.&#xD;
&#xD;
      4.2. The local independence of items. High correlation (&gt; 0.30) of residuals for 2 items&#xD;
      indicates that they may not be locally independent or that there is a subsidiary dimension in&#xD;
      the measurement that is not accounted for by the main Rasch dimension (32).&#xD;
&#xD;
      Criterion validity Spearman's rank correlation (ρ) coefficient will be used to examine the&#xD;
      correlations between the MaPAct and the COPD status as indicated by GOLD stage, CAT and mMRC&#xD;
      scores. The effect size for the correlation is expected medium to high (r ~ 0.4). In order to&#xD;
      detect departure from the hypothesis (i.e. small effect size, r &lt;= .2), the sample size&#xD;
      required is 130 subjects (alpha = 0.05, beta = 0.8, one sided test).&#xD;
&#xD;
      Comparison with Objective Physical Activity&#xD;
&#xD;
      Spearman's rank correlation (ρ) coefficient will be used to examine the correlations between&#xD;
      the MaPAct and the daily calories, number of steps and METS as measured with the metabolic&#xD;
      holter:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Anticipated">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire validity</measure>
    <time_frame>six months</time_frame>
    <description>Numeric score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire reliability</measure>
    <time_frame>six months</time_frame>
    <description>Numeric score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">195</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>COPD patients will be asked to fill in the Maugeri Physical Activity Questionnaire (MaPAct) to assess self perceived physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>all the COPD patients will be ask to complete the questionnaire</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD diagnosis in stable state, able to read and to write, that accept to sign&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  will be excluded all patients that were hospitalized in the 30 days before evaluation,&#xD;
             patients with degenerative neuromuscular diseases, subjects with motor disabilities&#xD;
             limiting deambulation, subjects with memory or comprehension problems, with dementia,&#xD;
             parkinson disease, cognitive impairment, and subject that do not give their consent&#xD;
             for the participation to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Spanevello, professor</last_name>
    <role>Study Director</role>
    <affiliation>Insubria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabetta Zampogna, MSc</last_name>
    <phone>+390331829599</phone>
    <email>elisabetta.zampogna@icsmaugeri.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Zanini, MD</last_name>
    <phone>+390331829222</phone>
    <email>azanini67@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ICS Maugeri</name>
      <address>
        <city>Tradate</city>
        <state>Va</state>
        <zip>21049</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabetta Zampogna, MSc</last_name>
      <phone>+390331829599</phone>
      <email>elisabetta.zampogna@icsmaugeri.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.</citation>
    <PMID>24127811</PMID>
  </reference>
  <reference>
    <citation>Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.</citation>
    <PMID>24603844</PMID>
  </reference>
  <reference>
    <citation>Cindy Ng LW, Mackney J, Jenkins S, Hill K. Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. Chron Respir Dis. 2012 Feb;9(1):17-26. doi: 10.1177/1479972311430335. Epub 2011 Dec 22.</citation>
    <PMID>22194629</PMID>
  </reference>
  <reference>
    <citation>Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Quantifying physical activity in daily life with questionnaires and motion sensors in COPD. Eur Respir J. 2006 May;27(5):1040-55. doi: 10.1183/09031936.06.00064105.</citation>
    <PMID>16707399</PMID>
  </reference>
  <reference>
    <citation>Dobbels F, de Jong C, Drost E, Elberse J, Feridou C, Jacobs L, Rabinovich R, Frei A, Puhan MA, de Boer WI, van der Molen T, Williams K, Pinnock H, Troosters T, Karlsson N, Kulich K, Rudell K; PROactive consortium; PROactive consortium. The PROactive innovative conceptual framework on physical activity. Eur Respir J. 2014 Nov;44(5):1223-33. doi: 10.1183/09031936.00004814. Epub 2014 Jul 17.</citation>
    <PMID>25034563</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Salvatore Maugeri</investigator_affiliation>
    <investigator_full_name>Elisabetta Zampogna</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Questionnaire</keyword>
  <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/NCT03042806
org study id: ICSMaugeri
nct id: NCT03042806
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients affected from Chronic Obstructive Pulmonary Disease (COPD) benefit from pulmonary
      rehabilitation in terms of exercise capacity, symptoms and health-related quality of life
      whereas the effect on physical activity is still not clear. Some studies have investigated
      the effect of exercise training on daily physical activity. However, there is considerable
      variability in study findings, data are discordant and the effect of exercise training on
      physical activity is unclear. There are probably a number of reasons to account for this.

      First of all, the choice of the method for evaluating physical activity. Although direct
      observation, double-labelled water and calorimetry are considered the gold standard for
      assessing physical activity, they are too time consuming and expensive to be used in large
      population studies .The Physical Activity (PA) of patients with COPD can be assessed using
      questionnaires. A variety of questionnaires exist that capture different aspects of physical
      activity such as amount, type, intensity, symptom experience and limitations in the
      performance of ''activities of daily life''. Up to now, it still does not exist an instrument
      that evaluates the physical activity of COPD patients in Italian language that takes in
      account Italian people' lifestyle. Since this is strongly influenced by the environment,
      cultural and social conditions in which we live, it is essential to have an instrument
      specifically tailored for the population under study.

      Aim of this study is to validate the Maugeri Physical Activity questionnaire (MaPAct) in COPD
      patients pointing to assess self-perceived physical activity.
Methods The study will be approved by the Internal Review Board and Ethics Committee of the
      Salvatore Maugeri Foundation, Institute of Care and Scientific Research Rehabilitation of
      Tradate and Lumezzane, Italy and Malcantonese Hospital, Castelrotto, Switzerland. The
      procedures will be performed between September 2016 to September 2018.

      Study design A team of experts, (1 pulmonologist, 1 bioengineer, 4 physiotherapists, 1
      psychologist and 1 psychometrist) elaborated the instruments and defined the instructions to
      administer the MaPAct to self-evaluate the physical activity during daily life. This phase
      distinguishes three steps.

      Subjects A total of 195 in-hospital patients (15 in a first step, 50 in a second step and 130
      in the third) with diagnosis of COPD, will be enrolled. Will be excluded from the study all
      the patients that were hospitalized in the 30 days before admission, patients with
      degenerative neuromuscular disease, subjects with motor disabilities limiting ambulation,
      subjects with memory or comprehension problems, with dementia, Parkinson disease, and
      subjects that do not give their consent to the participation to the study. All subjects
      receive a consent informed.

      Step 1 A focus group of 15 patients will be arranged and patients will be asked to fill in
      the preliminary version of the questionnaire and to offer their impression. In this pilot
      step patients will be also asked to discuss on the relevance for the study population and
      comprehensiveness of the items describing them generically as 'clear' or 'unclear',
      "appropriate" or "not appropriate" to themselves (16-17), the aim being to achieve consensus
      for each item. Where items were described as "not appropriate" or "unclear", participants
      should explain their reasons. Some items should be removed at this stage, or reworded if
      necessary. The objective was to include all items judged to be relevant to COPD patients.
      These items will form the Item Set.

      Step 2 The patient-perceived comprehensibility will be tested on a sample of 50 patients.
      Patients will be asked to rank their perceived comprehensibility of the questionnaire on a
      4-point Likert scale, between 0 and 3 (0 =Easy, 1 =Quite easy, 2 = Quite difficult, and 3 =
      Difficult). Some items should be removed at this stage, or reworded if necessary.

      Step 3 The definitive version of MaPAct will be administered to a sample of 130 patients to
      evaluate the psychometric properties of MaPAct.

      A complete Rasch analysis will be performed, along with an evaluation of internal consistency
      and test-retest reliability in a sub-sample of subjects.

      Finally, since skeletal muscle weakness, reduced exercise capacity, slow gait and reduced
      physical activity levels are well-known systemic effects in COPD, in order to estimate MaPAct
      criterion validity with COPD status, the correlations between MaPAct with Global Initiative
      for Chronic Obstructive Lung Disease (GOLD) stage (18), hospital admissions or exacerbations
      as defined by the GOLD and symptoms as derived by mMRC and CAT scales will be evaluated.

      Time for completing the MaPAct will be also assessed. In order to provide an estimate of the
      reliability of the MaPAct to describe objective physical activity, in a sub group of 30
      patients a metabolic holter (SenseWear armband - 48 hours) will be used to measure daily
      calories, number of steps and Metabolic Equivalents (METS) that will be correlated with the
      MapAct.

      Timeline On day 1 of the study, all the COPD patients will perform medical evaluation
      (medical history, physical examination and history of COPD exacerbations within 12 month),
      pulmonary function tests, blood gas analysis and MaPAct. On the subsequent day, while 40
      consecutive patients will complete again MaPAct (+ 24 h) for intrarater variability
      determination, all subjects will perform a 6-minute walking test (6MWT) and evaluate
      perceived exertion (CR-10; modified Borg Scale; 19). In all subjects modified Medical
      Research Council- (mMRC Dyspnea Index; 20, 21), and COPD Assessment Test (CAT, 22) will be
      carried on.

      The GOLD spirometric classification will be used to determine the severity of the disease:
      mild COPD, forced expiratory volume in one second (FEV1) ≥80% predicted; moderate COPD,
      50%≤FEV1<80% predicted; and severe-to-very severe COPD, FEV1<50% predicted.

      Statistical analysis Internal consistency

      The internal consistency of the MaPAct will be assessed by calculating:

        1. Cronbach's coefficient alpha: the closer this is to 1.0 the greater the internal
           consistency of the items in the scale. An alpha of 0.8 is a reasonable goal. Rules of
           thumb are: "Alpha > 0.9 Excellent; > 0.8 Good; > 0.7 Acceptable" (23);

        2. Item-remainder correlation through the Spearman's rank correlation (ρ) coefficient to
           examine the correlations between each item and the sum of the remaining items, omitting
           that item from the total: a Spearman coefficient ρ > 0.40 will be considered as the
           minimum value for satisfactory item-to-total correlation (24).

      Reproducibility Reliability coefficient will be estimated with intraclass correlation
      coefficient (ICC). Expecting to obtain ICC values of about .90, with a 95% confidence
      interval (CI) of .20, at least 32 subjects are required (25).

      Rasch Analysis For Rasch analysis, a sample size of more than 100 persons will estimate item
      difficulty with an alpha of 0.05 within ± 0.5 logits (26).

      The steps of analysis will be as follows:

        1. Rating scale diagnostic. We will investigate whether the rating scale is being used in
           the expected manner. We evaluated the response categories as suggested by Linacre (27).

        2. Validity, assessed by evaluating the goodness of fit of the real data to the modelled
           data, to test if there were items that do not fit the model expectations. We will
           consider mean-square (MnSq) > 0.7 and < 1.3 as an indicator of acceptable fit (28).
           Items outside this range will be considered underacting (MnSq > 1.3, suggesting the
           presence of unexpectedly high variability), or overfitting (MnSq < 0.7, indicating a too
           predictable pattern).

        3. Reliability, evaluated in terms of separation, defined as the ratio of the person (or
           item) "true" standard deviation to the error standard deviation (29). Item separation is
           used to verify the item hierarchy and reflects the number of "strata" of measures that
           are statistically discernible. A separation of 2.0 is considered good and sufficient to
           allow stratification into 3 groups (30). A related index is the reliability of these
           separation indexes, which provides the degree of confidence that can be placed in the
           reproducibility of these estimates; the value of the coefficient varies from 0 to 1
           (values > 0.80 are considered good, and > 0.90 excellent) (31).

        4. Principal component analysis (PCA) on the standardized residuals will be used to
           investigate:

      4.1. The dimensionality of the scale. In this case "unidimensionality" assumes that, after
      the removal of the trait that the scale intended to measure (the "Rasch factor"), the
      residuals will be uncorrelated and normally distributed (i.e. there are no principal
      components). The following criteria will be used to determine whether additional factors are
      likely to be present in the residuals: at least 50% of the variance explained by the Rasch
      factor, eigenvalue of the first contrast smaller than 3, and variance explained by each
      contrast smaller than 5%.

      4.2. The local independence of items. High correlation (> 0.30) of residuals for 2 items
      indicates that they may not be locally independent or that there is a subsidiary dimension in
      the measurement that is not accounted for by the main Rasch dimension (32).

      Criterion validity Spearman's rank correlation (ρ) coefficient will be used to examine the
      correlations between the MaPAct and the COPD status as indicated by GOLD stage, CAT and mMRC
      scores. The effect size for the correlation is expected medium to high (r ~ 0.4). In order to
      detect departure from the hypothesis (i.e. small effect size, r <= .2), the sample size
      required is 130 subjects (alpha = 0.05, beta = 0.8, one sided test).

      Comparison with Objective Physical Activity

      Spearman's rank correlation (ρ) coefficient will be used to examine the correlations between
      the MaPAct and the daily calories, number of steps and METS as measured with the metabolic
      holter:
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Questionnaire validity
time frame: six months
description: Numeric score
measure: Questionnaire reliability
time frame: six months
description: Numeric score
arm group label: experimental group
arm group type: Other
description: COPD patients will be asked to fill in the Maugeri Physical Activity Questionnaire (MaPAct) to assess self perceived physical activity.
intervention type: Behavioral
intervention name: questionnaire
description: all the COPD patients will be ask to complete the questionnaire
arm group label: experimental group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Antonio Spanevello, professor
role: Study Director
affiliation: Insubria University
last name: Elisabetta Zampogna, MSc
phone: +390331829599
email: elisabetta.zampogna@icsmaugeri.it
last name: Andrea Zanini, MD
phone: +390331829222
email: azanini67@gmail.com
facility: 
status: Recruiting
contact: 
country: Italy
citation: Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
PMID: 24127811
citation: Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
PMID: 24603844
citation: Cindy Ng LW, Mackney J, Jenkins S, Hill K. Does exercise training change physical activity in people with COPD? A systematic review and meta-analysis. Chron Respir Dis. 2012 Feb;9(1):17-26. doi: 10.1177/1479972311430335. Epub 2011 Dec 22.
PMID: 22194629
citation: Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Quantifying physical activity in daily life with questionnaires and motion sensors in COPD. Eur Respir J. 2006 May;27(5):1040-55. doi: 10.1183/09031936.06.00064105.
PMID: 16707399
citation: Dobbels F, de Jong C, Drost E, Elberse J, Feridou C, Jacobs L, Rabinovich R, Frei A, Puhan MA, de Boer WI, van der Molen T, Williams K, Pinnock H, Troosters T, Karlsson N, Kulich K, Rudell K; PROactive consortium; PROactive consortium. The PROactive innovative conceptual framework on physical activity. Eur Respir J. 2014 Nov;44(5):1223-33. doi: 10.1183/09031936.00004814. Epub 2014 Jul 17.
PMID: 25034563
responsible party type: Sponsor-Investigator
investigator affiliation: Fondazione Salvatore Maugeri
investigator full name: Elisabetta Zampogna
investigator title: Principal Investigator
sharing ipd: Undecided