<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/NCT02199717</url>
  </required_header>
  <id_info>
    <org_study_id>1000039947</org_study_id>
    <nct_id>NCT02199717</nct_id>
  </id_info>
  <brief_title>An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia</brief_title>
  <acronym>HEPS</acronym>
  <official_title>An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Hemophilia Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot project was developed to investigate subjective and objective data related to the&#xD;
      patterns of physical activity participation among hemophilia patients (FVIII or FIX) between&#xD;
      the ages of 5 and 18 years. Physical activity participation among different levels of disease&#xD;
      severity will be compared using accelerometers to calculate the amount of time spent in&#xD;
      moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally,&#xD;
      data will be collected from two validated questionnaires (PedHAL and 3 day physical activity&#xD;
      recall). Current literature that relates level of physical activity to disease severity in&#xD;
      the pediatric hemophilia population is limited. The information gained about the type and&#xD;
      quantity of physical activity participation in children with varying levels of hemophilia&#xD;
      will assist in the development of education and interventions to promote good physical&#xD;
      activity and potentially examine the role of tailored prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        1. To determine if the amount of time spent performing moderate to vigorous physical&#xD;
           activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by&#xD;
           the level of disease severity in the pediatric hemophilia population.&#xD;
&#xD;
        2. To determine if recorded physical activities and intensity of activities from&#xD;
           self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ&#xD;
           according to the severity of hemophilia.&#xD;
&#xD;
        3. To determine if, among patients with hemophilia, there is a relationship between&#xD;
           physical activity level and patient age, weight, and body mass index (BMI).&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
      •Aim # 1: The primary aim of the study is to determine if there are differences in the amount&#xD;
      of time spent in MVPA by level of disease severity of children with hemophilia.&#xD;
&#xD;
      Secondary Aims:&#xD;
&#xD;
        -  Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA&#xD;
           (bouts of exercise) by disease severity of children with hemophilia.&#xD;
&#xD;
        -  Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and&#xD;
           Nutrition Examination Survey) data, recognizing that this survey provides a comparative&#xD;
           healthy normal cohort.&#xD;
&#xD;
        -  Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the&#xD;
           3DPAR (12) by disease severity of children with hemophilia.&#xD;
&#xD;
        -  Aim # 5: The review and determine the relationship between physical activity&#xD;
           participation and timing of prophylaxis factor replacement and whether participation is&#xD;
           limited to days of factor infusion.&#xD;
&#xD;
        -  Aim #6: To investigate the amount of physical activity and how it relates to age,&#xD;
           weight, and patient body mass index (BMI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>MVPA</measure>
    <time_frame>7 days</time_frame>
    <description>To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedentary Time</measure>
    <time_frame>7 days</time_frame>
    <description>To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Hemophilia A</condition>
  <condition>Hemophilia B</condition>
  <condition>Factor VIII Deficiency</condition>
  <condition>Factor IX Deficiency</condition>
  <arm_group>
    <arm_group_label>Boys with Hemophilia</arm_group_label>
    <description>Accelerometer use for 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accelerometer</intervention_name>
    <arm_group_label>Boys with Hemophilia</arm_group_label>
    <other_name>ActiLife</other_name>
    <other_name>Kinesoft</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be 5 to 18 years of age with a diagnosis of hemophilia with no history of&#xD;
        inhibitors or pre-existing co-morbidity (e.g. cerebral palsy, chronic respiratory&#xD;
        conditions, congenital heart defects) that can affect activity participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  5-17 years of age, has a diagnosis of Hemophilia A or B.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Muscle or joint bleed within 4 weeks of study.&#xD;
&#xD;
          -  Pre-existing co-morbidities that would affect physical activity participation.&#xD;
&#xD;
          -  Unable to cooperate with study protocol.&#xD;
&#xD;
          -  Unable to speak, read, or understand English.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa Bouskill, NP, MN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SickKids</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>October 12, 2016</results_first_submitted>
  <results_first_submitted_qc>December 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 14, 2016</results_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Vanessa Bouskill</investigator_full_name>
    <investigator_title>Nurse Practitioner</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Accelerometer</keyword>
  <keyword>Exercise</keyword>
  <keyword>Obesity</keyword>
  <keyword>BMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Hemophilia B</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Boys With Hemophilia</title>
          <description>Use of accelerometer for 1 week</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>42 boys with severe hemophilia 24 boys with moderate/mild hemophilia</population>
      <group_list>
        <group group_id="B1">
          <title>Boys With Hemophilia</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>All male</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>SickKids catchment area</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <population>BMI was grouped by hemophilia severity.</population>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Severe Hemophilia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.05" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild/Moderate Hemophilia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.93" spread="5.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>On demand or Prophylaxis Regimen</title>
          <description>On demand (only treated for bleeds) Prophylaxis (treated to prevent bleeds from occuring)</description>
          <population>Grouped by hemophilia severity.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Severe Hemophilia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>On prophylaxis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>On demand</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild/Moderate Hemophilia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>On prophylaxis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>On demand</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severity of Hemophilia</title>
          <description>Severe &lt;1% FVIII (Factor 8 Deficiency/Hemophilia A) or FIX (Factor 9 Deficiency/Hemophilia B) Moderate/Mild &gt;1% FVIII or FIX</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild/Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>MVPA</title>
        <description>To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
        <time_frame>7 days</time_frame>
        <population>All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Severe Hemophilia</title>
            <description>Severe Hemophilia</description>
          </group>
          <group group_id="O2">
            <title>Mild/Moderate Hemophilia</title>
            <description>Mild/Moderate Hemophilia</description>
          </group>
        </group_list>
        <measure>
          <title>MVPA</title>
          <description>To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
          <population>All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="20"/>
                    <measurement group_id="O2" value="55" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.32</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sedentary Time</title>
        <description>To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
        <time_frame>7 days</time_frame>
        <population>All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Severe Hemophilia</title>
            <description>Severe Hemophilia</description>
          </group>
          <group group_id="O2">
            <title>Mild/Moderate Hemophilia</title>
            <description>Mild/Moderate Hemophilia</description>
          </group>
        </group_list>
        <measure>
          <title>Sedentary Time</title>
          <description>To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.</description>
          <population>All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.</population>
          <units>minutes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="633.4" spread="121.3"/>
                    <measurement group_id="O2" value="327" spread="78.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>306.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>254.8</ci_lower_limit>
            <ci_upper_limit>358</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were documented for the duration of study for each participant (duration being 1 week).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Severe Hemophilia</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vanessa Bouskill NP</name_or_title>
      <organization>Hospital for Sick Children</organization>
      <phone>4168135871</phone>
      <email>vanessa.bouskill@sickkids.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02199717
org study id: 1000039947
nct id: NCT02199717
lead sponsor: 
collaborator: 
has dmc: No
This pilot project was developed to investigate subjective and objective data related to the
      patterns of physical activity participation among hemophilia patients (FVIII or FIX) between
      the ages of 5 and 18 years. Physical activity participation among different levels of disease
      severity will be compared using accelerometers to calculate the amount of time spent in
      moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally,
      data will be collected from two validated questionnaires (PedHAL and 3 day physical activity
      recall). Current literature that relates level of physical activity to disease severity in
      the pediatric hemophilia population is limited. The information gained about the type and
      quantity of physical activity participation in children with varying levels of hemophilia
      will assist in the development of education and interventions to promote good physical
      activity and potentially examine the role of tailored prophylaxis.
Objectives:

        1. To determine if the amount of time spent performing moderate to vigorous physical
           activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by
           the level of disease severity in the pediatric hemophilia population.

        2. To determine if recorded physical activities and intensity of activities from
           self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ
           according to the severity of hemophilia.

        3. To determine if, among patients with hemophilia, there is a relationship between
           physical activity level and patient age, weight, and body mass index (BMI).

      Specific Aims:

      •Aim # 1: The primary aim of the study is to determine if there are differences in the amount
      of time spent in MVPA by level of disease severity of children with hemophilia.

      Secondary Aims:

        -  Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA
           (bouts of exercise) by disease severity of children with hemophilia.

        -  Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and
           Nutrition Examination Survey) data, recognizing that this survey provides a comparative
           healthy normal cohort.

        -  Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the
           3DPAR (12) by disease severity of children with hemophilia.

        -  Aim # 5: The review and determine the relationship between physical activity
           participation and timing of prophylaxis factor replacement and whether participation is
           limited to days of factor infusion.

        -  Aim #6: To investigate the amount of physical activity and how it relates to age,
           weight, and patient body mass index (BMI).
observational model: Cohort
time perspective: Prospective
measure: MVPA
time frame: 7 days
description: To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
measure: Sedentary Time
time frame: 7 days
description: To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
arm group label: Boys with Hemophilia
description: Accelerometer use for 1 week.
intervention type: Device
intervention name: Accelerometer
arm group label: Boys with Hemophilia
other name: ActiLife
other name: Kinesoft
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Vanessa Bouskill, NP, MN
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Vanessa Bouskill
investigator title: Nurse Practitioner
mesh term: Hemophilia A
mesh term: Hemophilia B
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 