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/NCT06006494</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar53</org_study_id>
      <nct_id>NCT06006494</nct_id>
    </id_info>
    <brief_title>Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome</brief_title>
    <official_title>Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome</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>
        In this study, yoga, aerobic exercise, resistance exercise training in female individuals&#xD;
        with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality&#xD;
        of life and pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled study. Participants will be divided into 3&#xD;
        groups by simple randomization method. groups will be named as aerobic, yoga and resistance&#xD;
        exercise groups. 12-week exercise protocols will be applied to all participants. Participants&#xD;
        before and after treatment; The Fibromyalgia Impact Questionnaire, the McGill Pain&#xD;
        Questionnaire for pain assessment, the Chalder Fatigue Scale to assess their fatigue level,&#xD;
        will be filled in by the participants before and after the study. The data obtained will be&#xD;
        statistically analyzed.&#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 10, 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>Aerobic exercises, resistant exercises and yoga</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fibromyalgia Impact Questionnaire</measure>
      <time_frame>14 weeks</time_frame>
      <description>It assesses the impact of fibromyalgia on the patient's health and functional abilities.&#xD;
  High scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chalder Fatigue Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is an easy, fast and useful scale that evaluates the fatigue felt by the individual during the last 1 month by self-report. High scores indicate that the severity of fatigue is high.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>aerobic group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>only a separate aerobic exercise will be given</description>
    </arm_group>
    <arm_group>
      <arm_group_label>resistant group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>aerobic and resistance exercises will be given</description>
    </arm_group>
    <arm_group>
      <arm_group_label>yoga group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>aerobic exercises will be given and yoga will be done</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>aerobic</intervention_name>
      <description>We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming.&#xD;
  An average of 50 minutes of exercise per day will be required, 3 days a week.</description>
      <arm_group_label>aerobic group</arm_group_label>
      <arm_group_label>resistant group</arm_group_label>
      <arm_group_label>yoga group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>resistant</intervention_name>
      <description>Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.</description>
      <arm_group_label>resistant group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>yoga</intervention_name>
      <description>Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.</description>
      <arm_group_label>yoga group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 18-45&#xD;
  &#xD;
            -  Be woman&#xD;
  &#xD;
            -  Being diagnosed with fibromyalgia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Receiving pharmacological treatment&#xD;
  &#xD;
            -  Having had a surgical operation in the last 6 months&#xD;
  &#xD;
            -  Being pregnant&#xD;
  &#xD;
            -  Having a musculoskeletal injury&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hilal ATASOY</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ömer şevgin</last_name>
      <phone>+90506 978 75 35</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uskudar university</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer Şevgin</last_name>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.</citation>
      <PMID>29291206</PMID>
    </reference>
    <reference>
      <citation>Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.</citation>
      <PMID>21725900</PMID>
    </reference>
    <reference>
      <citation>Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700.</citation>
      <PMID>28636204</PMID>
    </reference>
    <reference>
      <citation>Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, Danyliw A, Sawant A, Dal Bello-Haas V, Rader T, Overend TJ. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013 Dec 20;2013(12):CD010884. doi: 10.1002/14651858.CD010884.</citation>
      <PMID>24362925</PMID>
    </reference>
    <reference>
      <citation>Verma A, Shete SU, Doddoli G. Yoga therapy for fibromyalgia syndrome: A case report. J Family Med Prim Care. 2020 Jan 28;9(1):435-438. doi: 10.4103/jfmpc.jfmpc_816_19. eCollection 2020 Jan.</citation>
      <PMID>32110633</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>women</keyword>
    <keyword>sleep</keyword>
    <keyword>tiredness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</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/NCT06006494
  org study id: Uskudar53
  nct id: NCT06006494
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, yoga, aerobic exercise, resistance exercise training in female individuals
        with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality
        of life and pain.
  The study was planned as a randomized controlled study. Participants will be divided into 3
        groups by simple randomization method. groups will be named as aerobic, yoga and resistance
        exercise groups. 12-week exercise protocols will be applied to all participants. Participants
        before and after treatment; The Fibromyalgia Impact Questionnaire, the McGill Pain
        Questionnaire for pain assessment, the Chalder Fatigue Scale to assess their fatigue level,
        will be filled in by the participants before and after the study. The data obtained will be
        statistically analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Aerobic exercises, resistant exercises and yoga
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Fibromyalgia Impact Questionnaire
  time frame: 14 weeks
  description: It assesses the impact of fibromyalgia on the patient's health and functional abilities.
  High scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.
  measure: Chalder Fatigue Scale
  time frame: 14 weeks
  description: It is an easy, fast and useful scale that evaluates the fatigue felt by the individual during the last 1 month by self-report. High scores indicate that the severity of fatigue is high.
  arm group label: aerobic group
  arm group type: Active Comparator
  description: only a separate aerobic exercise will be given
  arm group label: resistant group
  arm group type: Experimental
  description: aerobic and resistance exercises will be given
  arm group label: yoga group
  arm group type: Experimental
  description: aerobic exercises will be given and yoga will be done
  intervention type: Other
  intervention name: aerobic
  description: We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming.
  An average of 50 minutes of exercise per day will be required, 3 days a week.
  arm group label: aerobic group
  arm group label: resistant group
  arm group label: yoga group
  intervention type: Other
  intervention name: resistant
  description: Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.
  arm group label: resistant group
  intervention type: Other
  intervention name: yoga
  description: Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.
  arm group label: yoga group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Hilal ATASOY
  role: Study Chair
  affiliation: Uskudar University
  last name: ömer şevgin
  phone: +90506 978 75 35
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.
  PMID: 29291206
  citation: Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.
  PMID: 21725900
  citation: Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700.
  PMID: 28636204
  citation: Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, Danyliw A, Sawant A, Dal Bello-Haas V, Rader T, Overend TJ. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013 Dec 20;2013(12):CD010884. doi: 10.1002/14651858.CD010884.
  PMID: 24362925
  citation: Verma A, Shete SU, Doddoli G. Yoga therapy for fibromyalgia syndrome: A case report. J Family Med Prim Care. 2020 Jan 28;9(1):435-438. doi: 10.4103/jfmpc.jfmpc_816_19. eCollection 2020 Jan.
  PMID: 32110633
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst.Prof.Dr.
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No