<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/NCT02253693</url>
  </required_header>
  <id_info>
    <org_study_id>H14-23641</org_study_id>
    <nct_id>NCT02253693</nct_id>
  </id_info>
  <brief_title>Exploratory Pilot Study of Physical Activity Monitoring in Adult Patients With Haemophilia A by Means of Accelerometry</brief_title>
  <official_title>Descriptive Pilot Study of Monitoring of Physical Activity in Adult Patients With Haemophilia A Arthropathy by Means of Accelerometry, Image Tests and Physical Condition Parameters. Benefits Associated With That Monitoring&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research Question: Does an specific and pre-defined physical exercise prescribed by a&#xD;
      specialist provide any benefit on haemophilic arthropathy, the quality of life or the&#xD;
      physical condition of patients with haemophilia A and haemophilic arthropathy? Does adherence&#xD;
      to physical exercise improve when monitoring patients with an accelerometer? Do compliant&#xD;
      patients find higher benefit on haemophilic arthropathy, quality of life or the physical&#xD;
      condition than non-compliant patients?&#xD;
&#xD;
      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a&#xD;
      prescribed and specific physical exercise monitored by an accelerometer is producing any&#xD;
      change in the following domains: progress of haemophilic arthropathy; health-related quality&#xD;
      of life; physical condition.&#xD;
&#xD;
      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia&#xD;
      A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients&#xD;
      achieve higher improvement in these 3 domains than non-complaint patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific details of Treatment/Intervention:&#xD;
&#xD;
      Physical exercises that are part of the specific medical program prescribed for each patient.&#xD;
      The exercise program for each patient will depend of the haemophilic arthropathy, the level&#xD;
      of physical condition and the preferences of the patient.&#xD;
&#xD;
      Monitoring of physical activity will be made by means of accelerometers. Its use does not&#xD;
      alter the daily activities and does not require any change of the patients' individual&#xD;
      habits. The assessment of the patients' cardiovascular condition will be made using pulse&#xD;
      monitors. Normal examinations in clinical practice will be revised as well as those specific&#xD;
      to each patient reference health centre, muscle strength and joint use testing which will be&#xD;
      validated with force measurement devices. Assess by means of an ultrasound system the&#xD;
      baseline situation of the joints used for daily activities for injury control. Determine the&#xD;
      likelihood of fracture and assess the bone quality by means of densitometry. Thermal cameras&#xD;
      will allow to analyse the characteristics of Joint inflammation. It may be suitable for&#xD;
      bleeding evolution control. Measurements given by densitometers will allows to determine the&#xD;
      state of bones of the participants in the study (osteoporosis measurement). Number of&#xD;
      bleeding events/hemarthrosis during the period of study. Determine the activity of&#xD;
      hemarthros/synovitis using thermal images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>2 Years</target_duration>
  <primary_outcome>
    <measure>Change from baseline in the physiotherapy treatment compliance. Parameters: Intensity, duration, type of exercise and % of compliance.</measure>
    <time_frame>After 6, 12, 18 and 24 months.</time_frame>
    <description>Level of treatment compliance assessed by the intensity (counts/min), duration (m) and type of exercise measured with triaxial accelerometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Age (years).</measure>
    <time_frame>In month 0, and month 24.</time_frame>
    <description>Age of patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (Kg).</measure>
    <time_frame>In month 0, and month 24.</time_frame>
    <description>Weight of patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemistry and haemogram tests. The parameters to be reported are: Leukocyte (mil/mm3), Lymphocyte (mil/mm3), Haemoglobin (g/dl), Glucose (mg/dl), Total, HDL and LDL cholesterol (mg/dl), Triglyceride (mg/dl) and Creatine phosphokinase (CPK) (UI/L).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prophylactic treatment with Factor VIII. Parameters: Trough levels of FVIII in blood (% FVIII) and type of FVIII and dose (UI/ week).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition of patient. Parameters: BMI (Kg/m^2) and % of body fat.</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular condition. Parameters: Beats/minute and distance covered (metres).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Beats/minute measured with a pulse monitor and distance covered in Six-minute walk test (6MWT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Measured with Cuff- stethoscope; Manometer; manual meter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength in kilos (peak force and time to reach peak force).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Measured with Lafayette device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State of joints and injury control (HJHS 2.1. score).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Evaluated by ultrasound system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint inflammation. Parameters: Thermal imaging (ºC) and joint perimeter (cm).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Measured with thermal camera and tape measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone density. Parameter: Bone Quality Index (BQI).</measure>
    <time_frame>In Baseline and in month 24.</time_frame>
    <description>Densitometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding/ hemarthrosis. Parameter: Bleeding Rate (BR).</measure>
    <time_frame>In Baseline and after 6, 12, 18 and 24 months.</time_frame>
    <description>Registered in patient's diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life. Parameters: General questionnaire (EQ-5D EuroQoL) and specific questionnaire (A36 Hemophilia QoL).</measure>
    <time_frame>In Baseline and in 12 and 24 month.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Hemophilia A, Congenital</condition>
  <arm_group>
    <arm_group_label>Patients with haemophilia</arm_group_label>
    <description>Adult patients with haemophilia A presenting joint disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with haemophilia A presenting joint disease (haemophilic arthropathy) and&#xD;
        who are under prophylaxis treatment with FVIII&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients over 18&#xD;
&#xD;
          -  Patients diagnosed with haemophilia A and under prophylaxis treatment with the same&#xD;
             FVIII for 2 years prior to the inclusion in the study.&#xD;
&#xD;
          -  Patients with haemophilic arthropathy in, at least, one of the four load-bearing&#xD;
             joints (knees and ankles), according to clinical and/or radiographic criteria (at&#xD;
             least 3 in the Gilbert scale and /or at least 3 in the Pettersson scale) and/or&#xD;
             Chronic synovitis evidenced by ultrasound.&#xD;
&#xD;
          -  Patients with signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have developed an inhibitor antibody (≥5 Bethesda units), at the moment&#xD;
             of the inclusion in the study.&#xD;
&#xD;
          -  Development of inhibitors&#xD;
&#xD;
          -  Modification, during follow-up, of FVIII with which the patient started the study.&#xD;
&#xD;
          -  The patient decides to withdraw voluntarily from the study.&#xD;
&#xD;
          -  Major orthopaedic surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felipe Querol-Fuentes</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Rodríguez-Merchan EC, Goddard NJ, Lee CA, editors. Musculoskeletal Aspects of Haemophilia. Oxford: Blackwell Sciencie Ltd; 2000.</citation>
  </reference>
  <reference>
    <citation>Gonzalez LM, Peiro-Velert C, Devis-Devis J, Valencia-Peris A, Perez-Gimeno E, Perez-Alenda S, Querol F. Comparison of physical activity and sedentary behaviours between young haemophilia A patients and healthy adolescents. Haemophilia. 2011 Jul;17(4):676-82. doi: 10.1111/j.1365-2516.2010.02469.x. Epub 2011 Feb 7.</citation>
    <PMID>21299746</PMID>
  </reference>
  <reference>
    <citation>Hendelman D, Miller K, Baggett C, Debold E, Freedson P. Validity of accelerometry for the assessment of moderate intensity physical activity in the field. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S442-9. doi: 10.1097/00005768-200009001-00002.</citation>
    <PMID>10993413</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Felipe Querol Fuentes</investigator_full_name>
    <investigator_title>Full Lecturer</investigator_title>
  </responsible_party>
  <keyword>Hemophilia A</keyword>
  <keyword>Hemophilic arthropathy</keyword>
  <keyword>Accelerometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <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/NCT02253693
org study id: H14-23641
nct id: NCT02253693
lead sponsor: 
collaborator: 
has dmc: Yes
Research Question: Does an specific and pre-defined physical exercise prescribed by a
      specialist provide any benefit on haemophilic arthropathy, the quality of life or the
      physical condition of patients with haemophilia A and haemophilic arthropathy? Does adherence
      to physical exercise improve when monitoring patients with an accelerometer? Do compliant
      patients find higher benefit on haemophilic arthropathy, quality of life or the physical
      condition than non-compliant patients?

      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a
      prescribed and specific physical exercise monitored by an accelerometer is producing any
      change in the following domains: progress of haemophilic arthropathy; health-related quality
      of life; physical condition.

      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia
      A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients
      achieve higher improvement in these 3 domains than non-complaint patients.
Specific details of Treatment/Intervention:

      Physical exercises that are part of the specific medical program prescribed for each patient.
      The exercise program for each patient will depend of the haemophilic arthropathy, the level
      of physical condition and the preferences of the patient.

      Monitoring of physical activity will be made by means of accelerometers. Its use does not
      alter the daily activities and does not require any change of the patients' individual
      habits. The assessment of the patients' cardiovascular condition will be made using pulse
      monitors. Normal examinations in clinical practice will be revised as well as those specific
      to each patient reference health centre, muscle strength and joint use testing which will be
      validated with force measurement devices. Assess by means of an ultrasound system the
      baseline situation of the joints used for daily activities for injury control. Determine the
      likelihood of fracture and assess the bone quality by means of densitometry. Thermal cameras
      will allow to analyse the characteristics of Joint inflammation. It may be suitable for
      bleeding evolution control. Measurements given by densitometers will allows to determine the
      state of bones of the participants in the study (osteoporosis measurement). Number of
      bleeding events/hemarthrosis during the period of study. Determine the activity of
      hemarthros/synovitis using thermal images.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in the physiotherapy treatment compliance. Parameters: Intensity, duration, type of exercise and % of compliance.
time frame: After 6, 12, 18 and 24 months.
description: Level of treatment compliance assessed by the intensity (counts/min), duration (m) and type of exercise measured with triaxial accelerometer.
measure: Age (years).
time frame: In month 0, and month 24.
description: Age of patient.
measure: Weight (Kg).
time frame: In month 0, and month 24.
description: Weight of patient.
measure: Biochemistry and haemogram tests. The parameters to be reported are: Leukocyte (mil/mm3), Lymphocyte (mil/mm3), Haemoglobin (g/dl), Glucose (mg/dl), Total, HDL and LDL cholesterol (mg/dl), Triglyceride (mg/dl) and Creatine phosphokinase (CPK) (UI/L).
time frame: In Baseline and after 6, 12, 18 and 24 months.
measure: Prophylactic treatment with Factor VIII. Parameters: Trough levels of FVIII in blood (% FVIII) and type of FVIII and dose (UI/ week).
time frame: In Baseline and after 6, 12, 18 and 24 months.
measure: Body composition of patient. Parameters: BMI (Kg/m^2) and % of body fat.
time frame: In Baseline and after 6, 12, 18 and 24 months.
measure: Cardiovascular condition. Parameters: Beats/minute and distance covered (metres).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Beats/minute measured with a pulse monitor and distance covered in Six-minute walk test (6MWT).
measure: Blood pressure (mmHg).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Measured with Cuff- stethoscope; Manometer; manual meter.
measure: Muscle strength in kilos (peak force and time to reach peak force).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Measured with Lafayette device.
measure: State of joints and injury control (HJHS 2.1. score).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Evaluated by ultrasound system.
measure: Joint inflammation. Parameters: Thermal imaging (ºC) and joint perimeter (cm).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Measured with thermal camera and tape measure.
measure: Bone density. Parameter: Bone Quality Index (BQI).
time frame: In Baseline and in month 24.
description: Densitometry.
measure: Bleeding/ hemarthrosis. Parameter: Bleeding Rate (BR).
time frame: In Baseline and after 6, 12, 18 and 24 months.
description: Registered in patient's diary.
measure: Health-related quality of life. Parameters: General questionnaire (EQ-5D EuroQoL) and specific questionnaire (A36 Hemophilia QoL).
time frame: In Baseline and in 12 and 24 month.
arm group label: Patients with haemophilia
description: Adult patients with haemophilia A presenting joint disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Felipe Querol-Fuentes
role: Principal Investigator
affiliation: University of Valencia
facility: 
facility: 
country: Spain
citation: Rodríguez-Merchan EC, Goddard NJ, Lee CA, editors. Musculoskeletal Aspects of Haemophilia. Oxford: Blackwell Sciencie Ltd; 2000.
citation: Gonzalez LM, Peiro-Velert C, Devis-Devis J, Valencia-Peris A, Perez-Gimeno E, Perez-Alenda S, Querol F. Comparison of physical activity and sedentary behaviours between young haemophilia A patients and healthy adolescents. Haemophilia. 2011 Jul;17(4):676-82. doi: 10.1111/j.1365-2516.2010.02469.x. Epub 2011 Feb 7.
PMID: 21299746
citation: Hendelman D, Miller K, Baggett C, Debold E, Freedson P. Validity of accelerometry for the assessment of moderate intensity physical activity in the field. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S442-9. doi: 10.1097/00005768-200009001-00002.
PMID: 10993413
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Felipe Querol Fuentes
investigator title: Full Lecturer
mesh term: Hemophilia A
sharing ipd: No