<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/NCT03782922</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01954</org_study_id>
    <nct_id>NCT03782922</nct_id>
  </id_info>
  <brief_title>Exercise Training Programm for Physiotherapy Students</brief_title>
  <official_title>Effect of an Exercise Training Programm on Mental and Anatomical Characteristics of Physiotherapy Students - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>THIM - die internationale Hochschule für Physiotherapie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>THIM - die internationale Hochschule für Physiotherapie</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 this study, i.e. randomized controlled trial, the effect of an exercise training program&#xD;
      on mental and anatomical characteristics of physiotherapy students is measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>d2-R-Test</measure>
    <time_frame>Change from baseline attention and concentration at 4 weeks (objective)</time_frame>
    <description>Mental</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AKA-Questionnaire (attention, concentration, learning ability)</measure>
    <time_frame>Change from baseline attention and concentration at 4 weeks (subjective)</time_frame>
    <description>Participants fill out a questionnaire about attention, concentration and learning ability. There are five possible answers for each item from 1 (completely disagree) to 5 (completely agree).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>M360 - physiological parameter of the spine</measure>
    <time_frame>Change from baseline position and mobility of the spine at 4 weeks</time_frame>
    <description>Participants are measured in different positions (upright, flexion, extension; measured in degrees) to assess position, stability and mobility of the spine. The M360 will be guided along the back and the data will be collected electronically (https://www.idiag.ch/idiag-m360/).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (Visual Analogue Scale)</measure>
    <time_frame>Change from baseline pain (back) at 4 weeks</time_frame>
    <description>Participants can use this scale to classify their pain from &quot;No pain&quot; and &quot;Maximum pain imaginable&quot; by means of a slider.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAW-Questionnaire (Actual physical well-being)</measure>
    <time_frame>Change from baseline physical well-being at 4 weeks</time_frame>
    <description>Participants fill out a questionnaire with 58 questions. Each question has five possible answers from 0 (completely disagree) to 4 (completely agree). The highter the score the better the actual physical well-being.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy</condition>
  <condition>Student</condition>
  <condition>Physical Therapy</condition>
  <arm_group>
    <arm_group_label>Exercise Training Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Training Program</intervention_name>
    <description>10min of coordination and strength training (2-3x per week) during 2-6 weeks</description>
    <arm_group_label>Exercise Training Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18&#xD;
&#xD;
          -  signed consent&#xD;
&#xD;
          -  THIM student&#xD;
&#xD;
          -  good health status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  alcohol&#xD;
&#xD;
          -  drugs&#xD;
&#xD;
          -  smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>THIM University of Applied Sciences</name>
      <address>
        <city>Landquart</city>
        <zip>7302</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 9, 2019</last_update_submitted>
  <last_update_submitted_qc>April 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>anatomical</keyword>
  <keyword>mental</keyword>
  <keyword>training program</keyword>
  <!-- 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/NCT03782922
org study id: 2018-01954
nct id: NCT03782922
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, i.e. randomized controlled trial, the effect of an exercise training program
      on mental and anatomical characteristics of physiotherapy students is measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: d2-R-Test
time frame: Change from baseline attention and concentration at 4 weeks (objective)
description: Mental
measure: AKA-Questionnaire (attention, concentration, learning ability)
time frame: Change from baseline attention and concentration at 4 weeks (subjective)
description: Participants fill out a questionnaire about attention, concentration and learning ability. There are five possible answers for each item from 1 (completely disagree) to 5 (completely agree).
measure: M360 - physiological parameter of the spine
time frame: Change from baseline position and mobility of the spine at 4 weeks
description: Participants are measured in different positions (upright, flexion, extension; measured in degrees) to assess position, stability and mobility of the spine. The M360 will be guided along the back and the data will be collected electronically (https://www.idiag.ch/idiag-m360/).
measure: Pain (Visual Analogue Scale)
time frame: Change from baseline pain (back) at 4 weeks
description: Participants can use this scale to classify their pain from "No pain" and "Maximum pain imaginable" by means of a slider.
measure: FAW-Questionnaire (Actual physical well-being)
time frame: Change from baseline physical well-being at 4 weeks
description: Participants fill out a questionnaire with 58 questions. Each question has five possible answers from 0 (completely disagree) to 4 (completely agree). The highter the score the better the actual physical well-being.
arm group label: Exercise Training Program
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Exercise Training Program
description: 10min of coordination and strength training (2-3x per week) during 2-6 weeks
arm group label: Exercise Training Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor