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/NCT06006507</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar58</org_study_id>
      <nct_id>NCT06006507</nct_id>
    </id_info>
    <brief_title>Examination of Menstruation Symptoms in Women Who Exercise Regularly.</brief_title>
    <official_title>Examination of Menstruation Symptoms in Women Who Exercise Regularly.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        The aim of this study is to contribute to the determination of the relationship between&#xD;
        exercise and menstrual symptoms and to create an alternative for non-pharmacological coping&#xD;
        methods with menstrual symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The type of research is randomized controlled trial. An average of 50 people who do not have&#xD;
        exercise habits will participate in the study, and two randomized groups will be formed as&#xD;
        exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom&#xD;
        Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue&#xD;
        Severity Scale, the International Physical Activity Scale, the Personal Information Form&#xD;
        prepared by us, and the Voluntary and Consent Form during their menstrual period. The&#xD;
        duration of the study will cover 3 (three) menstrual periods of the individuals. At the&#xD;
        beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality&#xD;
        Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form,&#xD;
        Menstruation Symptom Scale and Menstruation Distress Complaint List.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</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>
      <intervention_model_description>Exercise treatments</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue Severity Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as &quot;no fatigue&quot;. If the result is greater than 6.1, it is considered as &quot;chronic fatigue syndrome&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short form of the International Physical Activity Questionnaire</measure>
      <time_frame>14 weeks</time_frame>
      <description>provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Menstruation Symptom Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Menstruation Distress Complaints List</measure>
      <time_frame>14 weeks</time_frame>
      <description>He questions the severity of these symptoms one week before the menstruation, during the last menstruation, and on other days. Complaints are scored from 0 to 4. These are 0: no symptoms, 1: little, 2: moderate, 3: severe, and 4: very severe. The lowest score that can be obtained from the scale is 0 for each term, and the highest score is 188.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Menstrual Problem</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>no exercise will be given</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>exercise training will be given and they will be asked to exercise regularly.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>no exercise will be given</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>In line with the recommendation of the World Health Organization, the exercise group will do 150 minutes of moderate-intensity walking a week and strengthening exercises prepared by the physiotherapist two days a week. Strengthening exercises will be taught by the physiotherapist in a session with the people in the exercise group in groups of five, and then exercise lists will be given to the people on digital exercise platform, where there are video narrations of the exercises. In addition, the participants will be asked to do balance exercises and macular exercise.</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women between the ages of 18-50 whose menstrual cycle continues,&#xD;
  &#xD;
            -  Those who have emotional or physical problems during menstruation periods,&#xD;
  &#xD;
            -  Those whose menstrual cycle is between 21-40 days on average&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with chronic disease&#xD;
  &#xD;
            -  Those with a diagnosed gynecological disease,&#xD;
  &#xD;
            -  Those who receive any medical treatment,&#xD;
  &#xD;
            -  Persons with dysmenorrhea and anemia.&#xD;
  &#xD;
            -  People who exercise regularly.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>menstrual cycle Female only</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Merve KOÇAK</last_name>
      <role>Study Chair</role>
      <affiliation>Bahçeşehir University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Beşiktaş</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
        <phone>+905069787535</phone>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Eccleston CA, Goldenholz SR, Goldenholz DM. Exercise, medication adherence, and the menstrual cycle: How much do these change seizure risk? Epilepsy Res. 2022 Dec;188:107052. doi: 10.1016/j.eplepsyres.2022.107052. Epub 2022 Nov 15.</citation>
      <PMID>36403515</PMID>
    </reference>
    <reference>
      <citation>Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.</citation>
      <PMID>12959622</PMID>
    </reference>
    <reference>
      <citation>Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.</citation>
      <PMID>20199120</PMID>
    </reference>
    <reference>
      <citation>Pereira HM, Larson RD, Bemben DA. Menstrual Cycle Effects on Exercise-Induced Fatigability. Front Physiol. 2020 Jun 26;11:517. doi: 10.3389/fphys.2020.00517. eCollection 2020.</citation>
      <PMID>32670076</PMID>
    </reference>
    <reference>
      <citation>Nie J, Zhang H, Kong Z, Wang C, Liu Y, Shi Q, George K. The impact of exercise modality and menstrual cycle phase on circulating cardiac troponin T. J Sci Med Sport. 2020 Mar;23(3):309-314. doi: 10.1016/j.jsams.2019.10.003. Epub 2019 Oct 10.</citation>
      <PMID>31690491</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>sleep</keyword>
    <keyword>menstruation</keyword>
    <keyword>stress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Menstruation Disturbances</mesh_term>
    </condition_browse>
    <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/NCT06006507
  org study id: Uskudar58
  nct id: NCT06006507
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to contribute to the determination of the relationship between
        exercise and menstrual symptoms and to create an alternative for non-pharmacological coping
        methods with menstrual symptoms.
  The type of research is randomized controlled trial. An average of 50 people who do not have
        exercise habits will participate in the study, and two randomized groups will be formed as
        exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom
        Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue
        Severity Scale, the International Physical Activity Scale, the Personal Information Form
        prepared by us, and the Voluntary and Consent Form during their menstrual period. The
        duration of the study will cover 3 (three) menstrual periods of the individuals. At the
        beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality
        Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form,
        Menstruation Symptom Scale and Menstruation Distress Complaint List.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Exercise treatments
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pittsburgh Sleep Quality Scale
  time frame: 14 weeks
  description: The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality.
  measure: Fatigue Severity Scale
  time frame: 14 weeks
  description: It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as "no fatigue". If the result is greater than 6.1, it is considered as "chronic fatigue syndrome".
  measure: Short form of the International Physical Activity Questionnaire
  time frame: 14 weeks
  description: provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.
  measure: Menstruation Symptom Scale
  time frame: 14 weeks
  description: It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.
  measure: Menstruation Distress Complaints List
  time frame: 14 weeks
  description: He questions the severity of these symptoms one week before the menstruation, during the last menstruation, and on other days. Complaints are scored from 0 to 4. These are 0: no symptoms, 1: little, 2: moderate, 3: severe, and 4: very severe. The lowest score that can be obtained from the scale is 0 for each term, and the highest score is 188.
  arm group label: control group
  arm group type: Active Comparator
  description: no exercise will be given
  arm group label: exercise group
  arm group type: Experimental
  description: exercise training will be given and they will be asked to exercise regularly.
  intervention type: Other
  intervention name: control
  description: no exercise will be given
  arm group label: control group
  intervention type: Other
  intervention name: exercise
  description: In line with the recommendation of the World Health Organization, the exercise group will do 150 minutes of moderate-intensity walking a week and strengthening exercises prepared by the physiotherapist two days a week. Strengthening exercises will be taught by the physiotherapist in a session with the people in the exercise group in groups of five, and then exercise lists will be given to the people on digital exercise platform, where there are video narrations of the exercises. In addition, the participants will be asked to do balance exercises and macular exercise.
  arm group label: exercise group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: menstrual cycle Female only
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Merve KOÇAK
  role: Study Chair
  affiliation: Bahçeşehir University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Eccleston CA, Goldenholz SR, Goldenholz DM. Exercise, medication adherence, and the menstrual cycle: How much do these change seizure risk? Epilepsy Res. 2022 Dec;188:107052. doi: 10.1016/j.eplepsyres.2022.107052. Epub 2022 Nov 15.
  PMID: 36403515
  citation: Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
  PMID: 12959622
  citation: Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.
  PMID: 20199120
  citation: Pereira HM, Larson RD, Bemben DA. Menstrual Cycle Effects on Exercise-Induced Fatigability. Front Physiol. 2020 Jun 26;11:517. doi: 10.3389/fphys.2020.00517. eCollection 2020.
  PMID: 32670076
  citation: Nie J, Zhang H, Kong Z, Wang C, Liu Y, Shi Q, George K. The impact of exercise modality and menstrual cycle phase on circulating cardiac troponin T. J Sci Med Sport. 2020 Mar;23(3):309-314. doi: 10.1016/j.jsams.2019.10.003. Epub 2019 Oct 10.
  PMID: 31690491
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Menstruation Disturbances
  sharing ipd: No