<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/NCT03268421</url>
  </required_header>
  <id_info>
    <org_study_id>CIN001-FIT Teens</org_study_id>
    <secondary_id>R01AR070474</secondary_id>
    <nct_id>NCT03268421</nct_id>
  </id_info>
  <brief_title>Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia</brief_title>
  <acronym>FIT Teens</acronym>
  <official_title>Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</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 whether Fibromyalgia Integrative Training program for Teens (FIT Teens),&#xD;
      a combined cognitive behavioral therapy and neuromuscular exercise training program is more&#xD;
      effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to&#xD;
      cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone.&#xD;
      One third of participants will receive the FIT Teens training; one third will receive CBT&#xD;
      training; and one third of participants will receive the GAE training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically&#xD;
      persists into adulthood for the majority of patients. Whereas medications offer limited and&#xD;
      short-term symptom relief for JFM, our research group has demonstrated that&#xD;
      cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional&#xD;
      disability and depressive symptoms in adolescents with this condition. However, 60% of&#xD;
      patients receiving CBT did not show clinically significant improvement in functional&#xD;
      disability, and pain levels remained in the moderate range despite being reduced overall. Our&#xD;
      multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science&#xD;
      has developed and tested the feasibility of a new Fibromyalgia Integrative Training program&#xD;
      for Teens (FIT Teens), which enhances the established CBT intervention with a novel&#xD;
      neuromuscular exercise training program derived from evidence-based pediatric injury&#xD;
      prevention research. Pilot testing showed excellent patient engagement, no adverse effects&#xD;
      and very promising early results indicating this treatment to have even stronger effects on&#xD;
      disability and pain outcomes than CBT alone. This trial evaluates whether the FIT Teens&#xD;
      intervention is more effective than CBT alone or graded aerobic exercise alone and whether&#xD;
      treatment effects are sustainable over 1 year follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 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>Non-pharmacologic trial comparing behavioral and exercise-based treatments</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in functional disability</measure>
    <time_frame>Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up</time_frame>
    <description>The Functional Disability Inventory (FDI), a 15 item self-report measure will be used to assess participant's perceived difficulty in the performance of daily activities at home, school, recreational, and social domains due to pain. For this primary outcome, data from this questionnaires will be used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs.&#xD;
The main outcome measure for this comparison will be the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity</measure>
    <time_frame>Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up</time_frame>
    <description>A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">420</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Myofascial Pain Syndrome</condition>
  <condition>Muscular Diseases</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Rheumatic Diseases</condition>
  <arm_group>
    <arm_group_label>Fibromyalgia Integrative Training for Teens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graded Aerobic Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fibromyalgia Integrative Training for Teens</intervention_name>
    <description>This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.</description>
    <arm_group_label>Fibromyalgia Integrative Training for Teens</arm_group_label>
    <other_name>FIT Teens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <other_name>CBT</other_name>
    <other_name>coping skills</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Graded Aerobic Exercise</intervention_name>
    <description>This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.</description>
    <arm_group_label>Graded Aerobic Exercise</arm_group_label>
    <other_name>GAE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and&#xD;
             confirmed by 2010 American College of Rheumatology (ACR) criteria modified for&#xD;
             pediatric use&#xD;
&#xD;
          -  Functional Disability Score ≥ 13, indicating at least moderate disability&#xD;
&#xD;
          -  Average pain intensity in the past week ≥ 4 on a 0 -10 cm Visual Analog Scale&#xD;
&#xD;
          -  Stable medications prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)&#xD;
&#xD;
          -  Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of&#xD;
             major depression) or documented developmental delay&#xD;
&#xD;
          -  Any medical condition determined by their physician to be a contraindication for&#xD;
             physical exercise&#xD;
&#xD;
          -  Taking opioid pain medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susmita Kashikar-Zuck, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Children's Hospital-University of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Chilldren's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>juvenile fibromyalgia</keyword>
  <keyword>pain in children</keyword>
  <keyword>musculoskeletal pain</keyword>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>coping skills training</keyword>
  <keyword>neuromuscular exercise</keyword>
  <keyword>graded aerobic exercise</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>Rheumatic Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT03268421
org study id: CIN001-FIT Teens
secondary id: R01AR070474
nct id: NCT03268421
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens),
      a combined cognitive behavioral therapy and neuromuscular exercise training program is more
      effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to
      cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone.
      One third of participants will receive the FIT Teens training; one third will receive CBT
      training; and one third of participants will receive the GAE training.
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically
      persists into adulthood for the majority of patients. Whereas medications offer limited and
      short-term symptom relief for JFM, our research group has demonstrated that
      cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional
      disability and depressive symptoms in adolescents with this condition. However, 60% of
      patients receiving CBT did not show clinically significant improvement in functional
      disability, and pain levels remained in the moderate range despite being reduced overall. Our
      multidisciplinary team of experts in Behavioral Medicine, Rheumatology and Exercise Science
      has developed and tested the feasibility of a new Fibromyalgia Integrative Training program
      for Teens (FIT Teens), which enhances the established CBT intervention with a novel
      neuromuscular exercise training program derived from evidence-based pediatric injury
      prevention research. Pilot testing showed excellent patient engagement, no adverse effects
      and very promising early results indicating this treatment to have even stronger effects on
      disability and pain outcomes than CBT alone. This trial evaluates whether the FIT Teens
      intervention is more effective than CBT alone or graded aerobic exercise alone and whether
      treatment effects are sustainable over 1 year follow-up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-pharmacologic trial comparing behavioral and exercise-based treatments
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in functional disability
time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
description: The Functional Disability Inventory (FDI), a 15 item self-report measure will be used to assess participant's perceived difficulty in the performance of daily activities at home, school, recreational, and social domains due to pain. For this primary outcome, data from this questionnaires will be used to compare baseline response to 3 month follow up to examine whether a reduction in disability occurs.
The main outcome measure for this comparison will be the difference in baseline and primary endpoint (3 month) FDI scores for each of the three interventions (FIT Teens, CBT, and GAE).
measure: Change in pain intensity
time frame: Baseline to 3 month follow up (primary endpoint) and 6, 9 and 12 month follow-up
description: A Visual Analog Scale (VAS) will be used to assess average pain intensity over a one week period
arm group label: Fibromyalgia Integrative Training for Teens
arm group type: Experimental
description: Fibromyalgia Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.
arm group label: Cognitive Behavioral Therapy
arm group type: Active Comparator
description: Cognitive Behavioral Therapy (CBT) is a psychological coping skills training using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem-solving, and using calming self-statements.
arm group label: Graded Aerobic Exercise
arm group type: Active Comparator
description: Graded aerobic exercise (GAE) utilizes a circuit-training approach with short intervals of exercise interspersed with brief rest breaks.
intervention type: Behavioral
intervention name: Fibromyalgia Integrative Training for Teens
description: This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
arm group label: Fibromyalgia Integrative Training for Teens
other name: FIT Teens
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy
description: This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
arm group label: Cognitive Behavioral Therapy
other name: CBT
other name: coping skills
intervention type: Behavioral
intervention name: Graded Aerobic Exercise
description: This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
arm group label: Graded Aerobic Exercise
other name: GAE
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Susmita Kashikar-Zuck, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Rheumatic Diseases
mesh term: Musculoskeletal Diseases
mesh term: Muscular Diseases
mesh term: Collagen Diseases
sharing ipd: No