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/NCT06009536</url>
    </required_header>
    <id_info>
      <org_study_id>EK-402 /22b</org_study_id>
      <nct_id>NCT06009536</nct_id>
    </id_info>
    <brief_title>Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?</brief_title>
    <official_title>Does Resistance Training Protocol Change Micromorphology in Achilles Tendinopathy?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Motol</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Motol</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>
        This work is designed as a prospective cohort study, in which the effects of a protocol of&#xD;
        12-week resistance training loading the Achilles tendon in patients with Achilles&#xD;
        tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will&#xD;
        participate. In addition, there will be a small control group of healthy participants which&#xD;
        will not complete the same protocol, but will be monitored for natural changes in same&#xD;
        objectives. Group of patients will be instructed to perform a training protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research within one participant will last a total of 26 weeks from the initial to the&#xD;
        final examination and will include control measurements at 6 and 12 weeks from the beginning&#xD;
        of therapy. Potential participants will be selected based on the recommendation of a&#xD;
        specialist doctor and their suitability will be assessed according to the inclusion criteria.&#xD;
        They will then be invited to an initial examination. This will include an objective&#xD;
        examination by a physiotherapist, a subjective assessment by the patient and an&#xD;
        ultrasonographic (USG) examination followed by a micromorphological analysis using special&#xD;
        software. At the end of the initial examination, the participant will be informed about&#xD;
        training protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Peak Spatial Frequency Radius at the site of Pathology</measure>
      <time_frame>Change of initial values at 26 weeks follow up after beginning of the therapy.</time_frame>
      <description>Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Tendon Diameter at the Place of Maximum Tendon Width</measure>
      <time_frame>Change of initial values at 26 weeks follow up after beginning of the therapy.</time_frame>
      <description>Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in VISA-A Questionnaire Score</measure>
      <time_frame>Change of initial values at 39 weeks follow up after beginning of the therapy.</time_frame>
      <description>The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Achilles Tendinopathy</condition>
    <arm_group>
      <arm_group_label>Resistance training protocol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants with healthy tendons</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group are considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Achilles tendon.&#xD;
  In this group, no specific treatment will be performed, only Achilles tendon will be monitored through time.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Achilles Tendon Loading Exercise Protocol According to Silbernagel</intervention_name>
      <description>It is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day.</description>
      <arm_group_label>Resistance training protocol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in&#xD;
               the area of Achilles tendon), which at least partially limit his quality of life&#xD;
               during normal or sporting activities,&#xD;
  &#xD;
            -  the patient is in the age group of 18-60 years,&#xD;
  &#xD;
            -  the patient has difficulties in only one lower limb; the second, asymptomatic limb&#xD;
               will be considered the reference,&#xD;
  &#xD;
            -  the patient is not aware of any mechanical damage to the tendon in symptomatic limb in&#xD;
               the past (e.g. partial or complete rupture as a result of an injury),&#xD;
  &#xD;
            -  the patient has not undergone any treatment aimed at AS in the last 3 months (surgery,&#xD;
               corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US&#xD;
               examination of AS shows structural changes (expansion, neovascularization, focal&#xD;
               hypoechoic areas, etc.).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient has been diagnosed with a rheumatic disease or a disease of the central&#xD;
               nervous system&#xD;
  &#xD;
            -  patient is aware of mechanical damage to the Achilles tendon as a result of an injury&#xD;
               in the past.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stanislav Machac, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University Hospital Motol and 2nd Faculty of Medicine, Charles University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University Hospital Motol and 2nd Faculty of Medicine, Charles University</name>
        <address>
          <city>Prague</city>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Motol</investigator_affiliation>
      <investigator_full_name>Stanislav Machač, Ph.D</investigator_full_name>
      <investigator_title>Academic woorker</investigator_title>
    </responsible_party>
    <keyword>Achilles Tendinopathy</keyword>
    <keyword>Ultrasonography</keyword>
    <keyword>Resistance Training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
    </condition_browse>
    <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/NCT06009536
  org study id: EK-402 /22b
  nct id: NCT06009536
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This work is designed as a prospective cohort study, in which the effects of a protocol of
        12-week resistance training loading the Achilles tendon in patients with Achilles
        tendinopathy (AT) will be monitored. It is estimated that at least 20 patients will
        participate. In addition, there will be a small control group of healthy participants which
        will not complete the same protocol, but will be monitored for natural changes in same
        objectives. Group of patients will be instructed to perform a training protocol.
  The research within one participant will last a total of 26 weeks from the initial to the
        final examination and will include control measurements at 6 and 12 weeks from the beginning
        of therapy. Potential participants will be selected based on the recommendation of a
        specialist doctor and their suitability will be assessed according to the inclusion criteria.
        They will then be invited to an initial examination. This will include an objective
        examination by a physiotherapist, a subjective assessment by the patient and an
        ultrasonographic (USG) examination followed by a micromorphological analysis using special
        software. At the end of the initial examination, the participant will be informed about
        training protocol.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in Peak Spatial Frequency Radius at the site of Pathology
  time frame: Change of initial values at 26 weeks follow up after beginning of the therapy.
  description: Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
  measure: Change in Tendon Diameter at the Place of Maximum Tendon Width
  time frame: Change of initial values at 26 weeks follow up after beginning of the therapy.
  description: Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
  measure: Change in VISA-A Questionnaire Score
  time frame: Change of initial values at 39 weeks follow up after beginning of the therapy.
  description: The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
  arm group label: Resistance training protocol
  arm group type: Experimental
  description: Participants in this group will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
  arm group label: Participants with healthy tendons
  arm group type: No Intervention
  description: Participants in this group are considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Achilles tendon.
  In this group, no specific treatment will be performed, only Achilles tendon will be monitored through time.
  intervention type: Other
  intervention name: Achilles Tendon Loading Exercise Protocol According to Silbernagel
  description: It is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day.
  arm group label: Resistance training protocol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stanislav Machac, PhD
  role: Study Chair
  affiliation: University Hospital Motol and 2nd Faculty of Medicine, Charles University
  facility: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Motol
  investigator full name: Stanislav Machač, Ph.D
  investigator title: Academic woorker
  mesh term: Tendinopathy
  sharing ipd: No