xml: <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/NCT06026046</url>
    </required_header>
    <id_info>
      <org_study_id>49RC23_0088</org_study_id>
      <secondary_id>2023-A01596-39</secondary_id>
      <nct_id>NCT06026046</nct_id>
    </id_info>
    <brief_title>Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients</brief_title>
    <acronym>EscrimHEMA</acronym>
    <official_title>Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Angers</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In 20 years, the prognosis of hematology patients has improved thanks to the development and&#xD;
        adaptation of treatments and better risk management. However, medium and long-term&#xD;
        complications of intensive treatments are common and remain a real public health problem.&#xD;
        Indeed, intensive treatments associated with room confinement within a protected unit expose&#xD;
        patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this&#xD;
        deconditioning is neglected, response to treatment, tolerance, quality of life and, in the&#xD;
        longer term, survival will be impacted.&#xD;
  &#xD;
        Several teams have demonstrated the feasibility and the benefits of physical support for&#xD;
        patients with prolonged aplasia. These studies focused on peripheral stem cell allograft,&#xD;
        which occur late in the treatment of acute leukemia. On the other hand, studies evaluating&#xD;
        the benefits of physical support as soon as the diagnosis of acute leukemia is made and&#xD;
        intensive treatments are started are rare. Implementing a adapted sport program from the&#xD;
        diagnostic and throughout the course of treatment is therefore a worthwhile subject for&#xD;
        research.&#xD;
  &#xD;
        The adapted sport chosen was fencing because it responds to hematological problems. Fencing&#xD;
        is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair&#xD;
        or in bed, involves praxis and concentration, and involves the whole body. It can be&#xD;
        practiced individually or as part of a team, in a protected room or in a unit corridor.&#xD;
        Fencing is a fighting sport and includes a psychological aspect, with a possible projection&#xD;
        of a fight against the disease. In addition, fencing is carried out by a non-medical or&#xD;
        paramedical practitioner, which can reinforce or recreate an image of normal activity.&#xD;
        Finally, the attention required by listening to the fencing master and the necessary&#xD;
        concentration unconsciously pushes the patient to &quot;get out of his illness&quot;.&#xD;
  &#xD;
        The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an&#xD;
        adapted sport program based on fencing in adult patients with hematological malignancies&#xD;
        receiving intensive treatment, to reduce physical deconditioning.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program</measure>
      <time_frame>1 year</time_frame>
      <description>The proportion of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program will be used to evaluate the feasibility of the adapted sport program based on fencing.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of actual fencing lessons compared to number of scheduled fencing lessons</measure>
      <time_frame>1 year</time_frame>
      <description>The comparison between the number of fencing lessons patients actually attended and the number of fencing lessons theoretically planned will be used to assess adherence to the adapted sport program.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average duration of fencing lessons</measure>
      <time_frame>1 year</time_frame>
      <description>The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average duration of the program</measure>
      <time_frame>1 year</time_frame>
      <description>The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program</measure>
      <time_frame>1 year</time_frame>
      <description>The typology of patients will be described according to pathology, age, co-morbidities, type of intensive chemotherapy, treatment phase (induction, consolidation, allograft, CAR-T cells)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison between the EORTC-QLQC30 score obtained at inclusion and the score obtained at each prolonged hospitalization discharge and at 3 months, 6 months and 1</measure>
      <time_frame>1 year</time_frame>
      <description>The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 is used to assess the quality of life.&#xD;
  The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 comprises 30 items. The 28 first items are constructed on a Likert scale with 4 response modalities (1 &quot;Not at all&quot; / 2 &quot;A little&quot; / 3 &quot;Quite a lot&quot; / 4 &quot;A lot&quot;), the modality 4 representing a high level of symptomatology / problems. The last two items are constructed on a 7-modality scale. These two items respectively assess overall health and overall quality of life, with response modality 1 corresponding to a &quot;very poor&quot; state, and response modality 7 to an &quot;excellent&quot; state.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up</measure>
      <time_frame>6 months</time_frame>
      <description>The 6-minute walk test is used to assess functional exercise capacity of an individual. It measures the distance an individual is able to walk over a 6-minute period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up</measure>
      <time_frame>6 months</time_frame>
      <description>The SPPB test is used to assess the physical performance of an individual. Il is the result of the scores of three criteria: the balance test, the walking speed test and the sit-to-stand test. The sum of the scores of all the tests gives an overall performance score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up</measure>
      <time_frame>6 months</time_frame>
      <description>This test is used to measure muscle strength in the hand and forearm.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Leukemia</condition>
    <condition>Lymphoma</condition>
    <arm_group>
      <arm_group_label>Patients benefiting from the adapted sport program based on fencing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Adapted sport program based on fencing</intervention_name>
      <description>This adapted sport program includes 3 to 5 sessions per week of adapted fencing (excluding weekends and public holidays), carried out either by a fencing master trained in adapted sport, or by an APA teacher trained in adapted fencing by the fencing master.&#xD;
  Sessions can last from 10 to 30 minutes. The course of the session is validated by the fencing master and adapted to each patient. The limiting factors are taken into account, in order to direct towards a specific practice.&#xD;
  The sessions are progressive with very short and varied sequences calling on the imagination and experience of the fencing masters.</description>
      <arm_group_label>Patients benefiting from the adapted sport program based on fencing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patient admitted to a protected unit of the Hematology department of one of the&#xD;
               participating centers&#xD;
  &#xD;
            -  Patient with acute leukemia treated in induction with &quot;3+7&quot; or &quot;5+7&quot; intensive&#xD;
               treatment or by an equivalent treatment (Vyxeos, azacitidine+vénetoclax), or patient&#xD;
               admitted for an allograft or CAR-T cells and not included at the diagnosis of the&#xD;
               disease&#xD;
  &#xD;
            -  Patient eligible for intensive chemotherapy&#xD;
  &#xD;
            -  Patient requiring prolonged hospitalization with room confinement&#xD;
  &#xD;
            -  Signed informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with a neurological or cardiac disease that contraindicates the practice of&#xD;
               fencing&#xD;
  &#xD;
            -  No intensive treatment with prolonged hospitalization&#xD;
  &#xD;
            -  Pregnant, parturient or breastfeeding woman&#xD;
  &#xD;
            -  Person deprived of liberty by judicial or administrative decision&#xD;
  &#xD;
            -  Person under forced psychiatric care&#xD;
  &#xD;
            -  Person under legal protection&#xD;
  &#xD;
            -  Person unable to express consent&#xD;
  &#xD;
            -  Person not covered by or not benefiting from a social security system&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aline MD Schmidt, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Angers</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aline MD Schmidt, PHD</last_name>
      <phone>02 41 35 36 37</phone>
      <phone_ext>33</phone_ext>
      <email>aline.schmidt@chu-angers.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anthéa LOIEZ</last_name>
      <phone>02 41 35 36 37</phone>
      <phone_ext>33</phone_ext>
      <email>Anthea.Loiez@chu-angers.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital, Angers</name>
        <address>
          <city>Angers</city>
          <zip>49000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Aline Schmidt, PHD</last_name>
        <phone>02 41 35 36 37</phone>
        <phone_ext>+33</phone_ext>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Brest Hopspital</name>
        <address>
          <city>Brest</city>
          <zip>29609</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie-Anne COUTURIER, MD</last_name>
        <phone>02 98 22 33 33</phone>
        <phone_ext>+33</phone_ext>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026046
  org study id: 49RC23_0088
  secondary id: 2023-A01596-39
  nct id: NCT06026046
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In 20 years, the prognosis of hematology patients has improved thanks to the development and
        adaptation of treatments and better risk management. However, medium and long-term
        complications of intensive treatments are common and remain a real public health problem.
        Indeed, intensive treatments associated with room confinement within a protected unit expose
        patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this
        deconditioning is neglected, response to treatment, tolerance, quality of life and, in the
        longer term, survival will be impacted.
  
        Several teams have demonstrated the feasibility and the benefits of physical support for
        patients with prolonged aplasia. These studies focused on peripheral stem cell allograft,
        which occur late in the treatment of acute leukemia. On the other hand, studies evaluating
        the benefits of physical support as soon as the diagnosis of acute leukemia is made and
        intensive treatments are started are rare. Implementing a adapted sport program from the
        diagnostic and throughout the course of treatment is therefore a worthwhile subject for
        research.
  
        The adapted sport chosen was fencing because it responds to hematological problems. Fencing
        is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair
        or in bed, involves praxis and concentration, and involves the whole body. It can be
        practiced individually or as part of a team, in a protected room or in a unit corridor.
        Fencing is a fighting sport and includes a psychological aspect, with a possible projection
        of a fight against the disease. In addition, fencing is carried out by a non-medical or
        paramedical practitioner, which can reinforce or recreate an image of normal activity.
        Finally, the attention required by listening to the fencing master and the necessary
        concentration unconsciously pushes the patient to "get out of his illness".
  
        The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an
        adapted sport program based on fencing in adult patients with hematological malignancies
        receiving intensive treatment, to reduce physical deconditioning.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
  time frame: 1 year
  description: The proportion of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program will be used to evaluate the feasibility of the adapted sport program based on fencing.
  measure: Number of actual fencing lessons compared to number of scheduled fencing lessons
  time frame: 1 year
  description: The comparison between the number of fencing lessons patients actually attended and the number of fencing lessons theoretically planned will be used to assess adherence to the adapted sport program.
  measure: Average duration of fencing lessons
  time frame: 1 year
  description: The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .
  measure: Average duration of the program
  time frame: 1 year
  description: The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .
  measure: Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program
  time frame: 1 year
  description: The typology of patients will be described according to pathology, age, co-morbidities, type of intensive chemotherapy, treatment phase (induction, consolidation, allograft, CAR-T cells)
  measure: Comparison between the EORTC-QLQC30 score obtained at inclusion and the score obtained at each prolonged hospitalization discharge and at 3 months, 6 months and 1
  time frame: 1 year
  description: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 is used to assess the quality of life.
  The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 comprises 30 items. The 28 first items are constructed on a Likert scale with 4 response modalities (1 "Not at all" / 2 "A little" / 3 "Quite a lot" / 4 "A lot"), the modality 4 representing a high level of symptomatology / problems. The last two items are constructed on a 7-modality scale. These two items respectively assess overall health and overall quality of life, with response modality 1 corresponding to a "very poor" state, and response modality 7 to an "excellent" state.
  measure: Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up
  time frame: 6 months
  description: The 6-minute walk test is used to assess functional exercise capacity of an individual. It measures the distance an individual is able to walk over a 6-minute period.
  measure: Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up
  time frame: 6 months
  description: The SPPB test is used to assess the physical performance of an individual. Il is the result of the scores of three criteria: the balance test, the walking speed test and the sit-to-stand test. The sum of the scores of all the tests gives an overall performance score.
  measure: Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up
  time frame: 6 months
  description: This test is used to measure muscle strength in the hand and forearm.
  arm group label: Patients benefiting from the adapted sport program based on fencing
  arm group type: Experimental
  intervention type: Other
  intervention name: Adapted sport program based on fencing
  description: This adapted sport program includes 3 to 5 sessions per week of adapted fencing (excluding weekends and public holidays), carried out either by a fencing master trained in adapted sport, or by an APA teacher trained in adapted fencing by the fencing master.
  Sessions can last from 10 to 30 minutes. The course of the session is validated by the fencing master and adapted to each patient. The limiting factors are taken into account, in order to direct towards a specific practice.
  The sessions are progressive with very short and varied sequences calling on the imagination and experience of the fencing masters.
  arm group label: Patients benefiting from the adapted sport program based on fencing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aline MD Schmidt, PHD
  role: Principal Investigator
  affiliation: University Hospital, Angers
  last name: Aline MD Schmidt, PHD
  phone: 02 41 35 36 37
  phone ext: 33
  email: aline.schmidt@chu-angers.fr
  last name: Anthéa LOIEZ
  phone: 02 41 35 36 37
  phone ext: 33
  email: Anthea.Loiez@chu-angers.fr
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No