<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/NCT03247348</url>
  </required_header>
  <id_info>
    <org_study_id>1702201230</org_study_id>
    <nct_id>NCT03247348</nct_id>
  </id_info>
  <brief_title>Reducing Sedentary Time in Fibromyalgia Patients</brief_title>
  <acronym>ReSeT-FM</acronym>
  <official_title>Reducing Sedentary Time in Fibromyalgia (ReSeT-FM): A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Richard L. Roudebush VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana 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>
      This study evaluates the feasibility of a behavioral intervention designed to replace&#xD;
      sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will&#xD;
      also evaluate the acceptability of the intervention among veterans and intervention effects&#xD;
      on pain and physical function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in&#xD;
      sedentary behavior and less time in light physical activity experience greater clinical pain&#xD;
      and overall impact of FM, irrespective of time spent in moderate to vigorous physical&#xD;
      activity. To date, no studies have investigated the potential impact of reducing sedentary&#xD;
      behavior on key clinical and physical function outcomes in FM. The overall objective of the&#xD;
      pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention&#xD;
      designed to replace sedentary behavior with light physical activity in veterans with FM.&#xD;
      Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral&#xD;
      intervention, which is based on constructs from social cognitive and self-regulatory theories&#xD;
      that consistently identify important drivers of behavior change as: education, goal-setting,&#xD;
      self-monitoring and behavioral prompts to move via an activity tracker and phone app, and&#xD;
      feedback on behavior via weekly meetings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in minutes of sedentary time per day</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.</time_frame>
    <description>Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in minutes of light physical activity per day.</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.</time_frame>
    <description>Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Impact Questionnaire Revised (FIQ-R)</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks.</time_frame>
    <description>This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI)</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks.</time_frame>
    <description>This 11-item instrument rates the intensity of pain as well as interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Short Form Questionnaire (SF-12)</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks.</time_frame>
    <description>This questionnaire assess physical and mental functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks.</time_frame>
    <description>This physical function test measures functional aerobic capacity. Subjects will walk as far as possible at their usual pace in 6 minutes around a predetermined indoor walking course on a flat surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-second Chair stand test</measure>
    <time_frame>This measure will be assessed at baseline and 8 weeks.</time_frame>
    <description>This physical function test measures lower body muscle strength. Subjects will complete as many sit to stands in a chair as possible in 30 seconds.</description>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Veterans</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ReSeT-FM intervention</intervention_name>
    <description>The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Veterans will be eligible if they have:&#xD;
&#xD;
          -  2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia:&#xD;
             Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater&#xD;
             than 5 or WPI 3-6 and SS greater than 9.&#xD;
&#xD;
          -  Symptoms have been present at a similar level for at least 3 months&#xD;
&#xD;
          -  The subject does not have a disorder that would otherwise explain the pain&#xD;
&#xD;
          -  Moderate pain severity (pain severity score greater than 5)&#xD;
&#xD;
          -  No changes in fibromyalgia medications for last 4 weeks&#xD;
&#xD;
          -  Self-reporting at least 8 hours per day sitting on 5 or more days per week&#xD;
&#xD;
          -  Having access to either an Android or iPhone smart phone with access to internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cardiovascular disease&#xD;
&#xD;
          -  chronic obstructive pulmonary disease (COPD) or asthma needing home oxygen&#xD;
&#xD;
          -  Stroke or transient ischemic attack (TIA) in last 6 months&#xD;
&#xD;
          -  Cancer (other than skin cancer) and receiving treatment for it&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Moderate to severe cognitive impairment&#xD;
&#xD;
          -  Engaging in more than 30 minutes of moderate to vigorous physical activity 3 or more&#xD;
             days per week&#xD;
&#xD;
          -  Currently using an app or activity tracker to track physical activity&#xD;
&#xD;
          -  Enrolled in another research study related to pain or exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly M Naugle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roudebush VA Medical Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Kelly M Naugle, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>


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/NCT03247348
org study id: 1702201230
nct id: NCT03247348
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility of a behavioral intervention designed to replace
      sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will
      also evaluate the acceptability of the intervention among veterans and intervention effects
      on pain and physical function.
Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in
      sedentary behavior and less time in light physical activity experience greater clinical pain
      and overall impact of FM, irrespective of time spent in moderate to vigorous physical
      activity. To date, no studies have investigated the potential impact of reducing sedentary
      behavior on key clinical and physical function outcomes in FM. The overall objective of the
      pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention
      designed to replace sedentary behavior with light physical activity in veterans with FM.
      Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral
      intervention, which is based on constructs from social cognitive and self-regulatory theories
      that consistently identify important drivers of behavior change as: education, goal-setting,
      self-monitoring and behavioral prompts to move via an activity tracker and phone app, and
      feedback on behavior via weekly meetings.
observational model: Case-Only
time perspective: Prospective
measure: Change in minutes of sedentary time per day
time frame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.
description: Participants will wear an Actigraph accelerometer, which provides a well established measure of sedentary time.
measure: Change in minutes of light physical activity per day.
time frame: This measure will be assessed at baseline and 8 weeks. At each time point the accelerometer will be worn for 1 week.
description: Participants will wear an Actigraph accelerometer, which provides a well established measure of light physical activity.
measure: Fibromyalgia Impact Questionnaire Revised (FIQ-R)
time frame: This measure will be assessed at baseline and 8 weeks.
description: This 21-item instrument assesses symptoms, function, and overall impact of fibromyalgia.
measure: Brief Pain Inventory (BPI)
time frame: This measure will be assessed at baseline and 8 weeks.
description: This 11-item instrument rates the intensity of pain as well as interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.
measure: Medical Outcomes Study Short Form Questionnaire (SF-12)
time frame: This measure will be assessed at baseline and 8 weeks.
description: This questionnaire assess physical and mental functioning.
measure: Six minute walk test
time frame: This measure will be assessed at baseline and 8 weeks.
description: This physical function test measures functional aerobic capacity. Subjects will walk as far as possible at their usual pace in 6 minutes around a predetermined indoor walking course on a flat surface.
measure: 30-second Chair stand test
time frame: This measure will be assessed at baseline and 8 weeks.
description: This physical function test measures lower body muscle strength. Subjects will complete as many sit to stands in a chair as possible in 30 seconds.
intervention type: Behavioral
intervention name: ReSeT-FM intervention
description: The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kelly M Naugle, PhD
role: Principal Investigator
affiliation: Indiana University School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Kelly M Naugle, PhD
investigator title: Assistant Professor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No