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/NCT05982210</url>
    </required_header>
    <id_info>
      <org_study_id>FIS-2022-13</org_study_id>
      <nct_id>NCT05982210</nct_id>
    </id_info>
    <brief_title>The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control in Sports Practice.</brief_title>
    <official_title>The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control Parameters in Sports Practice: Application of Breathing Exercises and Manual Therapy of the Diaphragm Muscle and Ribs Protocol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitat Internacional de Catalunya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitat Internacional de Catalunya</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Core stability is maintained mainly by muscle function of abdominal and lumbar region,&#xD;
        including the diaphragm muscle. It is known that exists a connection between trunk's muscle&#xD;
        activity and the movement of lower limb and lower limb and low back injuries are related to&#xD;
        core alterations. Thus, a randomized clinical trial is planned to analyze the effectiveness&#xD;
        of an exercises and manual therapy of the diaphragm and ribs program designed, aiming to&#xD;
        analyze the correlation between rib cage mobility and lower limb neuromuscular control in&#xD;
        young healthy subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the study consists on analysing the correlation between rib cabe mobility and&#xD;
        neuromuscular control parameters of lower limb, as well as pain perception in young healthy&#xD;
        adults sports players. A clinical practice protocol consisting on breathing exercises and&#xD;
        manual therapy of the muscle diaphragm and the ribs will be applied twice a week during eight&#xD;
        weeks. As a result, could be an increasement of the neuromuscular control parameters,&#xD;
        described with the outcome measures of rib cage mobility, lower limb power and stability, and&#xD;
        pain perception. If the results stablish correlation between the rib cage mobility and&#xD;
        neuromuscular control parameters of lower limb, could be helpful in healthcare and sports&#xD;
        science field in order to take in account the diaphragm biomechanics when treating lower limb&#xD;
        injuries and facing its prevention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rib Cage Mobility</measure>
      <time_frame>Week 0, Week 4 and Week 9</time_frame>
      <description>The the rib cage mobility is assessed using a measuring tape. The measuring tape assess the diameter of the rib cage between a maximal inspiration and maximal expiration. Two anatomical marks are described: the superior mark is formed by the third intercostal space, de clavicular line and spinous apophysis of the thoracic vertebra number five; and the inferior mark is formed by xiphoid process and the spinous apophysis of the thoracic vertebra number ten.&#xD;
  The subjects stand with the hands on the head and the evaluator mantains the measuring tape around the rib cage of the subject. The subject inhales by the nose expanding the lungs and exhales by the mouth until the lungs are empty. The measures are taken three times, at the beginning of each inspiratory and expiratory cycle.&#xD;
  The repetition is failed if the subject makes an apnea or cough.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lower Limb Power</measure>
      <time_frame>Week 0, Week 4 and Week 9</time_frame>
      <description>My Jump Lab App is used to asses lower limb power through jump analysis. The device is fixed with a tripod, 50 centimetres away from the floor, focused on the frontal plane of the subject. The subject makes a CounterMovement Jump (CMJ) which is recorded in 240 frames/second. The subject is standing with shoes and knees extended and the hands on the hips. From this position, the subject quickly makes a knee flexion until 90 degrees followed by a quick knee extension before taking a maximum vertical jump.&#xD;
  After de jump is recorded, the take off frame and the landing frame are indicated in the app, and calculates automatically the power of lower limb.&#xD;
  Three repetitions are recorded from each lower limb.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower Limb Stability</measure>
      <time_frame>Week 0, Week 4 and Week 9</time_frame>
      <description>The Star Excursion Balance Test (SEBT) is used to assess lower limb stability. Three tape strips are placed on the floor: anterior (A), posteromedial (PM) and posterolateral (PL), leaving 120 degrees angulation between A and PM/PL, and 90 degrees between PM and PL, converging at the 0 mark.&#xD;
  The participant stands in monopodal position with hands on the hips, without shoes or socks. The anterior part of the foot stays in the 0 mark for the A direction, and the heel por PM and PL. The participant slides the free foot through the tape without touching it until reaching the maximum distance, registrated in centimeters. The repetition is failed if the participant touches the floor, move the baseline foot or touches the tape more than once.&#xD;
  Three repetitions will be recorded for each lower limb and for each direction. The length of the lower limb is measured with the distance between the anterosuperior iliaca spine and the external tibial malleolus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Perception</measure>
      <time_frame>Week 0, Week 4 and Week 9</time_frame>
      <description>The Numeric Rating Scale (NRS) is used to assess pain perception. The NRS is a visual scale composed by 11 different numeric points, within the 0 represents inexistent pain and the 10 represents the maximal pain imaginable.&#xD;
  The subject indicates which number adjusts to the pain intensity experimented related to the lower limb.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Diaphragm; Relaxation</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The Control Group does not have any interventions applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Intervention Group will take part in the experimental process. A clinical practice protocol about breathing exercises and diaphragm and ribs manual therapy will be applied, in a total duration of 15 minutes, twice a week during eight weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol</intervention_name>
      <description>The intervention consists on applying a protocol based on five different exercises, compound by breathing exercises and manual therapy of the muscle diaphragm and the ribs, applied by a physiotherapist.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Physical Activity Practice: at least 150-300min of moderate activity or 75-100min of&#xD;
               intense aerobic activity, twice a week.&#xD;
  &#xD;
            -  Physical activity or sports practice involve mostly lower limb muscles activation.&#xD;
  &#xD;
            -  Core Stability exercises least twice a week. Includes at least 3 of the 6 exercises&#xD;
               listed: bridge exercises, standard plank, lateral plank, superman exercise, mountain&#xD;
               climber and plank variations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Musculoskeletal injury currently or in the past 6 months.&#xD;
  &#xD;
            -  Abdominal or thoracic surgery.&#xD;
  &#xD;
            -  Nervous System disease.&#xD;
  &#xD;
            -  Hiatal Hernia or visceral disease.&#xD;
  &#xD;
            -  Pelvic floor alterations or disease.&#xD;
  &#xD;
            -  Breathing restrictions: disease or infection, asthma, anxiety or other non controlled&#xD;
               alterations.&#xD;
  &#xD;
            -  Treatment of the diaphragm muscle the past 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>María Caridad Bagur</last_name>
      <role>Study Director</role>
      <affiliation>Universitat Internacional de Catalunya</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xantal Borràs</last_name>
      <role>Study Director</role>
      <affiliation>Universitat de Vic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imma Vergara</last_name>
      <phone>+34 637 03 13 54</phone>
      <email>immavergara@uic.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universitat Internacional de Catalunya</name>
        <address>
          <city>Sant Cugat Del Vallès</city>
          <state>Barcelona</state>
          <zip>08195</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Imma Vergara</last_name>
        <phone>+34 637 03 13 54</phone>
        <email>immavergara@uic.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation>
      <investigator_full_name>Imma Vergara Busquets</investigator_full_name>
      <investigator_title>PhD Student</investigator_title>
    </responsible_party>
    <keyword>Core Stability</keyword>
    <keyword>Diaphragm Muscle</keyword>
    <keyword>Rib Cage</keyword>
    <keyword>Breathing Biomechanics</keyword>
    <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/NCT05982210
  org study id: FIS-2022-13
  nct id: NCT05982210
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Core stability is maintained mainly by muscle function of abdominal and lumbar region,
        including the diaphragm muscle. It is known that exists a connection between trunk's muscle
        activity and the movement of lower limb and lower limb and low back injuries are related to
        core alterations. Thus, a randomized clinical trial is planned to analyze the effectiveness
        of an exercises and manual therapy of the diaphragm and ribs program designed, aiming to
        analyze the correlation between rib cage mobility and lower limb neuromuscular control in
        young healthy subjects.
  The aim of the study consists on analysing the correlation between rib cabe mobility and
        neuromuscular control parameters of lower limb, as well as pain perception in young healthy
        adults sports players. A clinical practice protocol consisting on breathing exercises and
        manual therapy of the muscle diaphragm and the ribs will be applied twice a week during eight
        weeks. As a result, could be an increasement of the neuromuscular control parameters,
        described with the outcome measures of rib cage mobility, lower limb power and stability, and
        pain perception. If the results stablish correlation between the rib cage mobility and
        neuromuscular control parameters of lower limb, could be helpful in healthcare and sports
        science field in order to take in account the diaphragm biomechanics when treating lower limb
        injuries and facing its prevention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Rib Cage Mobility
  time frame: Week 0, Week 4 and Week 9
  description: The the rib cage mobility is assessed using a measuring tape. The measuring tape assess the diameter of the rib cage between a maximal inspiration and maximal expiration. Two anatomical marks are described: the superior mark is formed by the third intercostal space, de clavicular line and spinous apophysis of the thoracic vertebra number five; and the inferior mark is formed by xiphoid process and the spinous apophysis of the thoracic vertebra number ten.
  The subjects stand with the hands on the head and the evaluator mantains the measuring tape around the rib cage of the subject. The subject inhales by the nose expanding the lungs and exhales by the mouth until the lungs are empty. The measures are taken three times, at the beginning of each inspiratory and expiratory cycle.
  The repetition is failed if the subject makes an apnea or cough.
  measure: Lower Limb Power
  time frame: Week 0, Week 4 and Week 9
  description: My Jump Lab App is used to asses lower limb power through jump analysis. The device is fixed with a tripod, 50 centimetres away from the floor, focused on the frontal plane of the subject. The subject makes a CounterMovement Jump (CMJ) which is recorded in 240 frames/second. The subject is standing with shoes and knees extended and the hands on the hips. From this position, the subject quickly makes a knee flexion until 90 degrees followed by a quick knee extension before taking a maximum vertical jump.
  After de jump is recorded, the take off frame and the landing frame are indicated in the app, and calculates automatically the power of lower limb.
  Three repetitions are recorded from each lower limb.
  measure: Lower Limb Stability
  time frame: Week 0, Week 4 and Week 9
  description: The Star Excursion Balance Test (SEBT) is used to assess lower limb stability. Three tape strips are placed on the floor: anterior (A), posteromedial (PM) and posterolateral (PL), leaving 120 degrees angulation between A and PM/PL, and 90 degrees between PM and PL, converging at the 0 mark.
  The participant stands in monopodal position with hands on the hips, without shoes or socks. The anterior part of the foot stays in the 0 mark for the A direction, and the heel por PM and PL. The participant slides the free foot through the tape without touching it until reaching the maximum distance, registrated in centimeters. The repetition is failed if the participant touches the floor, move the baseline foot or touches the tape more than once.
  Three repetitions will be recorded for each lower limb and for each direction. The length of the lower limb is measured with the distance between the anterosuperior iliaca spine and the external tibial malleolus.
  measure: Pain Perception
  time frame: Week 0, Week 4 and Week 9
  description: The Numeric Rating Scale (NRS) is used to assess pain perception. The NRS is a visual scale composed by 11 different numeric points, within the 0 represents inexistent pain and the 10 represents the maximal pain imaginable.
  The subject indicates which number adjusts to the pain intensity experimented related to the lower limb.
  arm group label: Control Group
  arm group type: No Intervention
  description: The Control Group does not have any interventions applied.
  arm group label: Intervention Group
  arm group type: Experimental
  description: The Intervention Group will take part in the experimental process. A clinical practice protocol about breathing exercises and diaphragm and ribs manual therapy will be applied, in a total duration of 15 minutes, twice a week during eight weeks.
  intervention type: Other
  intervention name: Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol
  description: The intervention consists on applying a protocol based on five different exercises, compound by breathing exercises and manual therapy of the muscle diaphragm and the ribs, applied by a physiotherapist.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: María Caridad Bagur
  role: Study Director
  affiliation: Universitat Internacional de Catalunya
  last name: Xantal Borràs
  role: Study Director
  affiliation: Universitat de Vic
  last name: Imma Vergara
  phone: +34 637 03 13 54
  email: immavergara@uic.es
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Universitat Internacional de Catalunya
  investigator full name: Imma Vergara Busquets
  investigator title: PhD Student
  sharing ipd: No