<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/NCT01696851</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-10-8276-GZ-CTIL</org_study_id>
    <nct_id>NCT01696851</nct_id>
  </id_info>
  <brief_title>Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs</brief_title>
  <official_title>Physiological and Psycho-social Variables of People With a Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with Spinal cord injury with tetraplegia suffer from respiratory problem due to&#xD;
      weakness of the muscles and because the autonomic system dysfunction.&#xD;
&#xD;
      Exercise is one way of preserving and improving physical fitness and directly and indirectly&#xD;
      reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects&#xD;
      with spinal cord injury with tetraplegia have limited options for exercise: table tennis,&#xD;
      gym, pool and more. Because of the nature of the injury which includes the sympathetic&#xD;
      failure, they can not easily get the desired pulse to improve physical fitness.&#xD;
&#xD;
      Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could&#xD;
      not participate in wheelchair basketball. The game combines short, quick races with different&#xD;
      aerobic capabilities. Previous studies have shown that participants in wheelchair rugby&#xD;
      Improve anaerobic power, oxygen consumption, physical fitness and daily functioning.&#xD;
      Wheelchair rugby improves self-confidence and as a result it affects other areas of life.&#xD;
      Another study examined sense of self-efficacy, saw improvement in this index for rugby&#xD;
      players in a wheelchair at high levels.&#xD;
&#xD;
      In the present study the investigators aim to examine whether regular participation in&#xD;
      wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym,&#xD;
      swimming).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no more interested in this issue&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lung function during rest using a spirometer</measure>
    <time_frame>one minute</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional testing</measure>
    <time_frame>5 minutes</time_frame>
    <description>getting on a 6 meters long ramp adapted to the ability of people with tetraplegia (this takes up to 30 seconds). And opening and closing a sliding door.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>5 minutes</time_frame>
    <description>Beck questionnaire assessing depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self efficacy</measure>
    <time_frame>5 minutes</time_frame>
    <description>Sense of self efficacy questionnaire assessing self efficacy.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Wheelchair Rugby Players With Tetraplegia</condition>
  <arm_group>
    <arm_group_label>wheelchair rugby players with tetraplegia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>other routine sport participants with tetraplegia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tests and questionnaires</intervention_name>
    <description>lung test, depression and self-efficacy questionnaires and Functional testing.</description>
    <arm_group_label>other routine sport participants with tetraplegia</arm_group_label>
    <arm_group_label>wheelchair rugby players with tetraplegia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Wheelchair rugby players with SCI with four limbs paralyzed playing and practicing&#xD;
        regularly. Season lasts about six months.&#xD;
&#xD;
        Belonging to this group are training and playing regularly twice a week about 3 hours at a&#xD;
        time, total of 6 hours per week under the supervision of two coaches who attend every&#xD;
        practice and game.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with tetraplegia who play wheelchair rugby&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffering from a medical condition that prevents from performing the tests required by&#xD;
             the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabi Zeilig, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of Physical Education Wingate</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Quadriplegia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01696851
org study id: SHEBA-10-8276-GZ-CTIL
nct id: NCT01696851
lead sponsor: 
has dmc: No
People with Spinal cord injury with tetraplegia suffer from respiratory problem due to
      weakness of the muscles and because the autonomic system dysfunction.

      Exercise is one way of preserving and improving physical fitness and directly and indirectly
      reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects
      with spinal cord injury with tetraplegia have limited options for exercise: table tennis,
      gym, pool and more. Because of the nature of the injury which includes the sympathetic
      failure, they can not easily get the desired pulse to improve physical fitness.

      Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could
      not participate in wheelchair basketball. The game combines short, quick races with different
      aerobic capabilities. Previous studies have shown that participants in wheelchair rugby
      Improve anaerobic power, oxygen consumption, physical fitness and daily functioning.
      Wheelchair rugby improves self-confidence and as a result it affects other areas of life.
      Another study examined sense of self-efficacy, saw improvement in this index for rugby
      players in a wheelchair at high levels.

      In the present study the investigators aim to examine whether regular participation in
      wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym,
      swimming).
observational model: Case-Control
time perspective: Prospective
measure: lung function during rest using a spirometer
time frame: one minute
measure: Functional testing
time frame: 5 minutes
description: getting on a 6 meters long ramp adapted to the ability of people with tetraplegia (this takes up to 30 seconds). And opening and closing a sliding door.
measure: Depression
time frame: 5 minutes
description: Beck questionnaire assessing depression
measure: Self efficacy
time frame: 5 minutes
description: Sense of self efficacy questionnaire assessing self efficacy.
arm group label: wheelchair rugby players with tetraplegia
arm group label: other routine sport participants with tetraplegia
intervention type: Other
intervention name: tests and questionnaires
description: lung test, depression and self-efficacy questionnaires and Functional testing.
arm group label: other routine sport participants with tetraplegia
arm group label: wheelchair rugby players with tetraplegia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabi Zeilig, Dr.
role: Principal Investigator
affiliation: Sheba Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Quadriplegia