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/NCT05996692</url>
    </required_header>
    <id_info>
      <org_study_id>39</org_study_id>
      <nct_id>NCT05996692</nct_id>
    </id_info>
    <brief_title>Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions</brief_title>
    <official_title>Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions: a Cross-sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</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>
        Although there are many studies evaluating adherence to supervised walking programs in&#xD;
        patients with fibromyalgia (FM), there are limited studies evaluating adherence to&#xD;
        unsupervised walking programs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Although there are many studies evaluating adherence to supervised walking programs in&#xD;
        patients with fibromyalgia (FM), there are limited studies evaluating adherence to&#xD;
        unsupervised walking programs.&#xD;
  &#xD;
        Purposes of this study were (1) to assess whether walking as exercise was prescribed by their&#xD;
        physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate&#xD;
        the frequency of patients who walk regularly as exercise, (3) to clinically compare patients&#xD;
        who walk regularly as exercise and those who do not, and (4) to determine factors related to&#xD;
        adherence to walking prescriptions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Fibromyalgia Impact Questionnaire is a survey developed to measure functional status in FM patients. This scale measures 10 separate aspects, namely physical impairment, feel good, work missed, do job, pain, fatigue, rested, stiffness, anxiety, and depression. The total score in the questionnaire is between 0 and 100. Higher scores demonstrate higher disease severity and lower functional status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Tampa Scale for Kinesiophobia</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>The Tampa Scale for Kinesiophobia is a reliable survey on fear of movement. In the survey consisting of 17 questions, the total score is between 17 and 68, with higher scores indicating higher kinesiophobia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Overall pain intensity over the last 7 days was assessed with a Visual Analogue Scale (0 = no pain and 10 = the worst pain you can imagine).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Catastrophizing Scale</measure>
      <time_frame>through study completion, an average of one month</time_frame>
      <description>Pain Catastrophizing Scale is made up of 13 items scored on a 5-point Likert scale from 0 (never) to 4 (always). The total score is obtained with the sum of the answers, being able to obtain a maximum score of 52. Higher scores in the scale represent a higher tendency to catastrophize.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>Patients who walked regularly for exercise</arm_group_label>
      <description>Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.&#xD;
  According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients who did not walk regularly for exercise</arm_group_label>
      <description>Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.&#xD;
  According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Evaluation of adherence to walking prescriptions</intervention_name>
      <description>Adherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.</description>
      <arm_group_label>Patients who did not walk regularly for exercise</arm_group_label>
      <arm_group_label>Patients who walked regularly for exercise</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with FM according to the criteria of the American College of&#xD;
          Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  be between 18-70 years old&#xD;
  &#xD;
            -  female gender&#xD;
  &#xD;
            -  Pharmacological therapy has been recommended in the last 1 year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  neurological disease or orthopedic problem presence that may be the reason of&#xD;
               functional impairment&#xD;
  &#xD;
            -  neurological deficit presence&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Since most of the patients with fibromyalgia are women, only female patients were included in the study, since a more homogeneous population was targeted.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ankara Gaziler Physical Medicine and Rehabilitation Hospital</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gaziler Physical Medicine and Rehabilitation Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Yasin Demir</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Fibromyalgia</keyword>
    <keyword>Walking</keyword>
    <keyword>Adherence</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/NCT05996692
  org study id: 39
  nct id: NCT05996692
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although there are many studies evaluating adherence to supervised walking programs in
        patients with fibromyalgia (FM), there are limited studies evaluating adherence to
        unsupervised walking programs.
  Although there are many studies evaluating adherence to supervised walking programs in
        patients with fibromyalgia (FM), there are limited studies evaluating adherence to
        unsupervised walking programs.
  
        Purposes of this study were (1) to assess whether walking as exercise was prescribed by their
        physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate
        the frequency of patients who walk regularly as exercise, (3) to clinically compare patients
        who walk regularly as exercise and those who do not, and (4) to determine factors related to
        adherence to walking prescriptions.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Fibromyalgia Impact Questionnaire (FIQ)
  time frame: through study completion, an average of one month
  description: Fibromyalgia Impact Questionnaire is a survey developed to measure functional status in FM patients. This scale measures 10 separate aspects, namely physical impairment, feel good, work missed, do job, pain, fatigue, rested, stiffness, anxiety, and depression. The total score in the questionnaire is between 0 and 100. Higher scores demonstrate higher disease severity and lower functional status.
  measure: The Tampa Scale for Kinesiophobia
  time frame: through study completion, an average of one month
  description: The Tampa Scale for Kinesiophobia is a reliable survey on fear of movement. In the survey consisting of 17 questions, the total score is between 17 and 68, with higher scores indicating higher kinesiophobia.
  measure: Visual Analogue Scale
  time frame: through study completion, an average of one month
  description: Overall pain intensity over the last 7 days was assessed with a Visual Analogue Scale (0 = no pain and 10 = the worst pain you can imagine).
  measure: Pain Catastrophizing Scale
  time frame: through study completion, an average of one month
  description: Pain Catastrophizing Scale is made up of 13 items scored on a 5-point Likert scale from 0 (never) to 4 (always). The total score is obtained with the sum of the answers, being able to obtain a maximum score of 52. Higher scores in the scale represent a higher tendency to catastrophize.
  arm group label: Patients who walked regularly for exercise
  description: Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
  According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.
  arm group label: Patients who did not walk regularly for exercise
  description: Walking for exercise was explored according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
  According to this criterion, the patients were divided into 2 groups as those who walked regularly for exercise and those who did not walk regularly for exercise.
  intervention type: Other
  intervention name: Evaluation of adherence to walking prescriptions
  description: Adherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
  arm group label: Patients who did not walk regularly for exercise
  arm group label: Patients who walked regularly for exercise
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Since most of the patients with fibromyalgia are women, only female patients were included in the study, since a more homogeneous population was targeted.
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
  investigator full name: Yasin Demir
  investigator title: Associate professor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No