<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/NCT04475874</url>
  </required_header>
  <id_info>
    <org_study_id>DPTPNU</org_study_id>
    <nct_id>NCT04475874</nct_id>
  </id_info>
  <brief_title>Stretching Exercises on Symptoms of Primary Dysmenorrhea</brief_title>
  <official_title>Efficacy of Active Stretching Exercises on Symptoms of Primary Dysmenorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Nourah Bint Abdulrahman University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</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>
      The purpose of this study was to assess the effect of active stretching exercises on reducing&#xD;
      pain and the quality of life during menstrual cycle in young adult females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9&#xD;
      kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were&#xD;
      randomly assigned into three equal groups; two interventions groups (supervised and&#xD;
      non-supervised active stretching exercise program) and one control group. The intervention&#xD;
      group A practiced a 30 to 45-minute supervised active stretching program three times a week&#xD;
      for four weeks, while the other intervention group B practiced non-supervised active&#xD;
      stretching home program and the control group C . Visual Analog Scale (VAS) was used to&#xD;
      measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation&#xD;
      characteristics and the effect of pain on quality of life, before (pre) as well as after&#xD;
      (post) 4 weeks at the end of the study .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">January 12, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>Change from Baseline at pain intensity 4 weeks after</time_frame>
    <description>Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verbal Multidimensional System(VMS)</measure>
    <time_frame>Change from Baseline amenstruation characteristics 4 weeks after</time_frame>
    <description>Verbal Multidimensional System which is a grading system from zero to three and used to evaluate menstruation characteristics including the working ability, the systemic symptoms and analgesia requirement in order to decrease pain with dysmenorrhea</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>supervised stretching exercises :group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-supervised active stretching home program: group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>practiced non-supervised active stretching home program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care: group c</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>supervised stretching exercises</intervention_name>
    <description>30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations</description>
    <arm_group_label>supervised stretching exercises :group A</arm_group_label>
    <other_name>home program stretching exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-supervised active stretching home program</intervention_name>
    <description>non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations</description>
    <arm_group_label>non-supervised active stretching home program: group B</arm_group_label>
    <other_name>home program of stretching exercises</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI of 20-29.9 kg/m2,&#xD;
&#xD;
          -  regular menstrual cycle&#xD;
&#xD;
          -  length 28-30 day&#xD;
&#xD;
          -  cycle bleed from 3 to 7 days,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to stretching exercise&#xD;
&#xD;
          -  taking any hormonal medications:&#xD;
&#xD;
          -  smoker&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zizi Mohammed Ibrahim Ali</name>
      <address>
        <city>Riyadh</city>
        <state>Nnjkjk</state>
        <zip>2136</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Princess Nourah Bint Abdulrahman University</investigator_affiliation>
    <investigator_full_name>ZIZI MOHAMMED IBRAHIM ALI</investigator_full_name>
    <investigator_title>ASSOCIATE PROF</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04475874
org study id: DPTPNU
nct id: NCT04475874
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to assess the effect of active stretching exercises on reducing
      pain and the quality of life during menstrual cycle in young adult females.
Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9
      kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were
      randomly assigned into three equal groups; two interventions groups (supervised and
      non-supervised active stretching exercise program) and one control group. The intervention
      group A practiced a 30 to 45-minute supervised active stretching program three times a week
      for four weeks, while the other intervention group B practiced non-supervised active
      stretching home program and the control group C . Visual Analog Scale (VAS) was used to
      measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation
      characteristics and the effect of pain on quality of life, before (pre) as well as after
      (post) 4 weeks at the end of the study .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Visual Analog Scale (VAS)
time frame: Change from Baseline at pain intensity 4 weeks after
description: Visual Analog Scale measures pain intensity it is a unidimensional measure of pain intensity The classification of VAS was done according to pain scores (mild: 1-3 Moderate: 4-7 Severe: 8-10)
measure: Verbal Multidimensional System(VMS)
time frame: Change from Baseline amenstruation characteristics 4 weeks after
description: Verbal Multidimensional System which is a grading system from zero to three and used to evaluate menstruation characteristics including the working ability, the systemic symptoms and analgesia requirement in order to decrease pain with dysmenorrhea
arm group label: supervised stretching exercises :group A
arm group type: Active Comparator
description: The intervention group A practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks
arm group label: non-supervised active stretching home program: group B
arm group type: Active Comparator
description: practiced non-supervised active stretching home program
arm group label: Standard of care: group c
arm group type: No Intervention
description: control group
intervention type: Other
intervention name: supervised stretching exercises
description: 30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
arm group label: supervised stretching exercises :group A
other name: home program stretching exercises
intervention type: Other
intervention name: non-supervised active stretching home program
description: non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
arm group label: non-supervised active stretching home program: group B
other name: home program of stretching exercises
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Princess Nourah Bint Abdulrahman University
investigator full name: ZIZI MOHAMMED IBRAHIM ALI
investigator title: ASSOCIATE PROF
mesh term: Dysmenorrhea
sharing ipd: No