<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/NCT04437524</url>
  </required_header>
  <id_info>
    <org_study_id>196481654</org_study_id>
    <nct_id>NCT04437524</nct_id>
  </id_info>
  <brief_title>Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.</brief_title>
  <acronym>FMS</acronym>
  <official_title>Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status, Pain and Strength Parameters in Patients With Fibromyalgia Syndrome (FMS).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul 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, it was aimed to examine the effects of aerobic exercise and&#xD;
      balance-proprioception exercises on pain, functionality and strength parameters of&#xD;
      fibromyalgia patients and to compare the two exercise types.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study planned to evaluate the effect of aerobic and balance-proprioception exercises&#xD;
      on the symptoms of the disease and the superiority of the two exercise models in patients&#xD;
      with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly&#xD;
      divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise&#xD;
      group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a&#xD;
      physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine&#xD;
      Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex&#xD;
      isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will&#xD;
      be evaluated with standardized Mini Mental Test only before the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>6 weeks</time_frame>
    <description>In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (Visual Analogue Scale)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no &quot;0&quot; pain on the 10 cm ruler drawn on paper, &quot;10&quot; is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Strength Evaluation</measure>
    <time_frame>6 weeks</time_frame>
    <description>The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Fibromyalgia Syndrome</condition>
  <arm_group>
    <arm_group_label>balance-proprioception exercises group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>balance-proprioception exercises group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aerobic exercises group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>aerobic exercises group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>therapeutic exercises</intervention_name>
    <description>Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.</description>
    <arm_group_label>aerobic exercises group</arm_group_label>
    <arm_group_label>balance-proprioception exercises group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18 and 60,&#xD;
&#xD;
          -  Symptoms lasting longer than 3 months,&#xD;
&#xD;
          -  According to the 2013 ACR criteria, the Pain Settlement Score (PLI) is ≥17,&#xD;
&#xD;
          -  According to the 2013 ACR criteria, the Symptomatic Impact Scoring (SIQR) is ≥21,&#xD;
&#xD;
          -  Acceptance of treatment that will continue 3 days a week for 6 weeks,&#xD;
&#xD;
          -  The possibility of any change in medical treatment due to FMS during the study is not&#xD;
             foreseen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known central or peripheral nervous system disease, progressive neurological damage,&#xD;
&#xD;
          -  Any serious cardiovascular pathology,&#xD;
&#xD;
          -  Sense, loss of sense of position, unhealed fracture or a surgical wound,&#xD;
&#xD;
          -  Presence of uncontrolled hypertension,&#xD;
&#xD;
          -  Failure to understand or perform simple commands.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female fibromyalgia patients will be admitted to the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gökhan Metin, Professor</last_name>
    <role>Study Director</role>
    <affiliation>İstanbul Univesity, İstanbul Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İstanbul Faculty of Medicine, Department of Sports Medicine</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Hadi Yavuz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength</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>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT04437524
org study id: 196481654
nct id: NCT04437524
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, it was aimed to examine the effects of aerobic exercise and
      balance-proprioception exercises on pain, functionality and strength parameters of
      fibromyalgia patients and to compare the two exercise types.
In the study planned to evaluate the effect of aerobic and balance-proprioception exercises
      on the symptoms of the disease and the superiority of the two exercise models in patients
      with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly
      divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise
      group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a
      physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine
      Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex
      isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will
      be evaluated with standardized Mini Mental Test only before the program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: 6 weeks
description: In order to evaluate the functional status in patients with FMS, FIQ Burchardt et al. It is a specific scale developed by. FIQ consists of 10 items. Calculation is made so that the upper limit of each item is 10 points. The maximum score that can be reached is 100. A high total score indicates that the person is more affected by the disease.
measure: Pain (Visual Analogue Scale)
time frame: 6 weeks
description: Visual Analaog Scale is used to measure the severity of pain in patients. The patient is told that there is no "0" pain on the 10 cm ruler drawn on paper, "10" is the most experienced pain, and the patient is asked to mark on the ruler according to the severity of the pain he/she feels. The distance of the marked point from zero is recorded as the Visual Analogue Scale score in cm.
measure: Muscle Strength Evaluation
time frame: 6 weeks
description: The CSMI Humac Norm 2015 isokinetic dynamometer will be used to evaluate muscle strength.
arm group label: balance-proprioception exercises group
arm group type: Active Comparator
description: balance-proprioception exercises group
arm group label: aerobic exercises group
arm group type: Active Comparator
description: aerobic exercises group
intervention type: Other
intervention name: therapeutic exercises
description: Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
arm group label: aerobic exercises group
arm group label: balance-proprioception exercises group
criteria: 
gender: Female
gender based: Yes
gender description: Only female fibromyalgia patients will be admitted to the study.
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gökhan Metin, Professor
role: Study Director
affiliation: İstanbul Univesity, İstanbul Faculty of Medicine
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Hadi Yavuz
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Syndrome