<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/NCT03264612</url>
  </required_header>
  <id_info>
    <org_study_id>10</org_study_id>
    <nct_id>NCT03264612</nct_id>
  </id_info>
  <brief_title>Effect of Swimming on Premenstrual Syndrome</brief_title>
  <official_title>Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Each female sets her experience of 47 manifestations on a 6 point scale separately for the&#xD;
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.&#xD;
      Daily Symptoms Report was filled at the start and at end of the study (before and after&#xD;
      performing swimming exercise) Females in group I were instructed to engage into swimming&#xD;
      exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3&#xD;
      days of menstrual cycle then resumed afterwards.&#xD;
&#xD;
      The exercise included three stages: warming up, swimming and cooling down.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each female sets her experience of 47 manifestations on a 6 point scale separately for the&#xD;
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.&#xD;
      Daily Symptoms Report was filled at the start and at end of the study (before and after&#xD;
      performing swimming exercise) Females in group I were instructed to engage into swimming&#xD;
      exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3&#xD;
      days of menstrual cycle then resumed afterwards.&#xD;
&#xD;
      The exercise included three stages: warming up, swimming and cooling down. Warming up phase&#xD;
      involved 5 minutes of breathing, circulatory and stretching exercises. Breathing&#xD;
      diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was&#xD;
      performed at a convenient position with full relaxation, then she inspires deeply through the&#xD;
      nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that&#xD;
      was repeated 3-5 times.&#xD;
&#xD;
      Costal breathing exercise was done also at the woman favorable position then she inspires&#xD;
      deeply through the nose, opens out her ribs then expires through the mouth with a sigh and&#xD;
      slowly and that was repeated 3-5 times..&#xD;
&#xD;
      Circulatory foot and ankle exercises were done by instructing the woman to point her toes up&#xD;
      and down, doing isometric calf muscle contractions and knee flexion and extension.&#xD;
&#xD;
      Stretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers,&#xD;
      triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar&#xD;
      flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor&#xD;
      fascia latae and quadriceps muscles were performed during warming up phase.&#xD;
&#xD;
      The second phase of treatment was swimming for 20 minutes starting with 5 minutes walking&#xD;
      inside the pool around its edges, then forth and back swimming without reaching fatigue level&#xD;
      for 15 minutes.&#xD;
&#xD;
      The last phase was cooling down phase which was the same exercises of the warming up phase&#xD;
      for 5 minutes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2016</start_date>
  <completion_date type="Actual">August 12, 2017</completion_date>
  <primary_completion_date type="Actual">May 14, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Premenstrual distress questionnaire</measure>
    <time_frame>3 months after start of swimming</time_frame>
    <description>47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Premenstrual Syndrome</condition>
  <arm_group>
    <arm_group_label>Swimming group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.&#xD;
The exercise included three stages: warming up, swimming and cooling down.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non swimming group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.&#xD;
The exercise included three stages: warming up, swimming and cooling down.</description>
    <arm_group_label>Swimming group</arm_group_label>
    <other_name>Swimming</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. virgins.&#xD;
&#xD;
          2. Their age ranged from 18 to 25 years old&#xD;
&#xD;
          3. Their body mass index (BMI) ranged from 18 to 25 kg/m2.&#xD;
&#xD;
          4. They were clinically and medically stable during the study&#xD;
&#xD;
          5. Have regular menstrual cycle of 23 to 35 days duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cardiopulmonary or orthopaedic problems&#xD;
&#xD;
          2. women taking any hormonal drugs or drugs that affect hormones as antidepressnats&#xD;
             during the preceding 3 months before participation in the study&#xD;
&#xD;
          3. any abnormality in ovulation or those with pelvic inflammatory diseases (PID).&#xD;
&#xD;
          4. Women with endocrine abnormality as thyroid, pituitary or ovarian disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>kasr Alainy medical school</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Premenstrual Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03264612
org study id: 10
nct id: NCT03264612
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Each female sets her experience of 47 manifestations on a 6 point scale separately for the
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.
      Daily Symptoms Report was filled at the start and at end of the study (before and after
      performing swimming exercise) Females in group I were instructed to engage into swimming
      exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3
      days of menstrual cycle then resumed afterwards.

      The exercise included three stages: warming up, swimming and cooling down.
Each female sets her experience of 47 manifestations on a 6 point scale separately for the
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.
      Daily Symptoms Report was filled at the start and at end of the study (before and after
      performing swimming exercise) Females in group I were instructed to engage into swimming
      exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3
      days of menstrual cycle then resumed afterwards.

      The exercise included three stages: warming up, swimming and cooling down. Warming up phase
      involved 5 minutes of breathing, circulatory and stretching exercises. Breathing
      diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was
      performed at a convenient position with full relaxation, then she inspires deeply through the
      nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that
      was repeated 3-5 times.

      Costal breathing exercise was done also at the woman favorable position then she inspires
      deeply through the nose, opens out her ribs then expires through the mouth with a sigh and
      slowly and that was repeated 3-5 times..

      Circulatory foot and ankle exercises were done by instructing the woman to point her toes up
      and down, doing isometric calf muscle contractions and knee flexion and extension.

      Stretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers,
      triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar
      flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor
      fascia latae and quadriceps muscles were performed during warming up phase.

      The second phase of treatment was swimming for 20 minutes starting with 5 minutes walking
      inside the pool around its edges, then forth and back swimming without reaching fatigue level
      for 15 minutes.

      The last phase was cooling down phase which was the same exercises of the warming up phase
      for 5 minutes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Premenstrual distress questionnaire
time frame: 3 months after start of swimming
description: 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)
arm group label: Swimming group
arm group type: Active Comparator
description: Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
arm group label: Non swimming group
arm group type: No Intervention
description: no intervention
intervention type: Behavioral
intervention name: Aerobic exercise
description: Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
arm group label: Swimming group
other name: Swimming
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: kasr Alainy medical school
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Professor
mesh term: Syndrome
mesh term: Premenstrual Syndrome
sharing ipd: Undecided