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/NCT06015451</url>
    </required_header>
    <id_info>
      <org_study_id>468196</org_study_id>
      <nct_id>NCT06015451</nct_id>
    </id_info>
    <brief_title>Exercise in Postconcussion Symptoms and Posttraumatic Headache</brief_title>
    <official_title>Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Olavs Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>St. Olavs Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare two models of delivery of guided exercise in&#xD;
        patients with exercise intolerance after mild head injury.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        • Is a program that includes elements of in-house exercise and follow-up sessions, and&#xD;
        repeated treadmill testing, superior to a program with telephone-based follow-up only?&#xD;
  &#xD;
        Participants will undergo a treadmill test to determine eligibility for the study, and to&#xD;
        determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they&#xD;
        will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to&#xD;
        be the symptom threshold. One group will receive face-to-face folllow-up and repeated&#xD;
        testing, one group will receive telephone-based follow-up only .&#xD;
  &#xD;
        Researchers will compare these two groups to see if closer follow-up is superior when it&#xD;
        comes to recovery from exercise intolerance after 12 weeks of exercise.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with self-reported symptom exacerbation in relation to physical activity will be&#xD;
        screened for inclusion with Buffalo Concussion Treadmill test (BCTT), an incremental&#xD;
        treadmill exercise test according to a standard Balke protocol, to the first sign of symptom&#xD;
        exacerbation or submaximal exertion. Heart rate and perceived exertion (Borg scale) are&#xD;
        measured every minute. Patients who demonstrate symptom exacerbation according to predefined&#xD;
        criteria will receive an individually tailored program for workouts with self-selected&#xD;
        aerobic activites, of 15-20 minutes duration, 4-5 times per week at 85-90% (measured with HR&#xD;
        monitor) of the HR at test termination, and they are randomised to either:&#xD;
  &#xD;
        A. Every week the first three weeks, participants will exercise one individual session at the&#xD;
        hospital, and the BCTT will be performed every 3rd week at the hospital to be able to shape&#xD;
        the intervention.&#xD;
  &#xD;
        B. The participants will only exercise at home, and will be contacted by telephone/video&#xD;
        call, every week during the first three weeks, thereafter less often, up to every third week.&#xD;
  &#xD;
        After 12 weeks, there will be a repeated BCTT, performed by a blinded assessor.&#xD;
  &#xD;
        Patient reported outcomes are collected using electronic questionnaires before and after the&#xD;
        intervention and 6 months after inclusion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2025</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>Single (Outcomes Assessor)</masking>
      <masking_description>The treadmill test after completion of intervention is performed by an assessor that is blinded for group membership.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Exercise tolerance</measure>
      <time_frame>3 months</time_frame>
      <description>Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Headache burden</measure>
      <time_frame>6 months</time_frame>
      <description>Change in days of headache of at least moderate intensity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change on self-selected area of function.</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported amount of physical activity</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life after head injury (QOL)</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Quality of life after brain injury - Overall Scale (QOLIBRI - OS). Six items rated on an ordinal scale, higher score indicate better QOL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of headaches</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>6 months</time_frame>
      <description>Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to training</measure>
      <time_frame>6 months</time_frame>
      <description>The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Brain Concussion</condition>
    <condition>Post-Concussion Syndrome</condition>
    <condition>Post-Traumatic Headache</condition>
    <condition>Craniocerebral Trauma</condition>
    <arm_group>
      <arm_group_label>Follow-up face-to face</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Home-based and in-house exercise, supervised both by telephone and face-to-face.&#xD;
  Every week the first three weeks participants will exercise one session at the hospital, and the BCTT/BCCT will be performed every 3rd week, at the hospital in order to be able to shape the intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Follow-up over the phone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Home-based exercise only, supervised by telephone. The participants will exercise solely in the home setting and will be contacted by telephone, every week during the first three weeks, thereafter every third week. Based on the therapist's evaluation during these calls, the intervention is shaped.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sub-symptom threshold exercise</intervention_name>
      <description>Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.</description>
      <arm_group_label>Follow-up face-to face</arm_group_label>
      <arm_group_label>Follow-up over the phone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-65 years&#xD;
  &#xD;
            -  Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks&#xD;
               ago.&#xD;
  &#xD;
            -  At least one postconcussion symptoms, of at least moderate degree, occurring within&#xD;
               the first week after the head injury.&#xD;
  &#xD;
            -  Intolerance for physical activity (self-reported and measured; including symptom&#xD;
               exacerbation later on the test day).&#xD;
  &#xD;
            -  Capable of giving informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  More than 2 years since last injury.&#xD;
  &#xD;
            -  The symptoms are better explained by other conditions.&#xD;
  &#xD;
            -  Severe communication problems, typically due to poor knowledge of Norwegian.&#xD;
  &#xD;
            -  Severe psychiatric, neurological, somatic, or substance abuse disorders that will make&#xD;
               it problematic to function in a group and/or will complicate follow-up and outcome&#xD;
               assessment.&#xD;
  &#xD;
            -  Safety concerns according to the study medical checklist.&#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>Britt-Elin Lurud, MD</last_name>
      <role>Study Director</role>
      <affiliation>Clinic of Rehabilitation, St. Olavs Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Toril Skandsen, PhD</last_name>
      <phone>+4792692780</phone>
      <email>toril.skandsen@ntnu.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Janne-Birgitte BB Børke, MSc</last_name>
      <email>janne.borke@stolav.no</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>St. Olavs Hospital, Clinic of Rehabilitation</name>
        <address>
          <city>Trondheim</city>
          <zip>7050</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Toril Skandsen, PhD</last_name>
        <phone>+47 92692780</phone>
        <email>toril.skandsen@ntnu.no</email>
      </contact>
      <contact_backup>
        <last_name>Janne-Birgitte BB Børke, Msc</last_name>
        <email>janne.borke@stolav.no</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>exercise intolerance</keyword>
    <keyword>exercise</keyword>
    <keyword>Thread mill test</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Concussion Syndrome</mesh_term>
      <mesh_term>Post-Traumatic Headache</mesh_term>
      <mesh_term>Brain Concussion</mesh_term>
      <mesh_term>Craniocerebral Trauma</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>October 10, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT06015451/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06015451
  org study id: 468196
  nct id: NCT06015451
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare two models of delivery of guided exercise in
        patients with exercise intolerance after mild head injury.
  
        The main question it aims to answer is:
  
        • Is a program that includes elements of in-house exercise and follow-up sessions, and
        repeated treadmill testing, superior to a program with telephone-based follow-up only?
  
        Participants will undergo a treadmill test to determine eligibility for the study, and to
        determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they
        will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to
        be the symptom threshold. One group will receive face-to-face folllow-up and repeated
        testing, one group will receive telephone-based follow-up only .
  
        Researchers will compare these two groups to see if closer follow-up is superior when it
        comes to recovery from exercise intolerance after 12 weeks of exercise.
  Patients with self-reported symptom exacerbation in relation to physical activity will be
        screened for inclusion with Buffalo Concussion Treadmill test (BCTT), an incremental
        treadmill exercise test according to a standard Balke protocol, to the first sign of symptom
        exacerbation or submaximal exertion. Heart rate and perceived exertion (Borg scale) are
        measured every minute. Patients who demonstrate symptom exacerbation according to predefined
        criteria will receive an individually tailored program for workouts with self-selected
        aerobic activites, of 15-20 minutes duration, 4-5 times per week at 85-90% (measured with HR
        monitor) of the HR at test termination, and they are randomised to either:
  
        A. Every week the first three weeks, participants will exercise one individual session at the
        hospital, and the BCTT will be performed every 3rd week at the hospital to be able to shape
        the intervention.
  
        B. The participants will only exercise at home, and will be contacted by telephone/video
        call, every week during the first three weeks, thereafter less often, up to every third week.
  
        After 12 weeks, there will be a repeated BCTT, performed by a blinded assessor.
  
        Patient reported outcomes are collected using electronic questionnaires before and after the
        intervention and 6 months after inclusion.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The treadmill test after completion of intervention is performed by an assessor that is blinded for group membership.
  measure: Exercise tolerance
  time frame: 3 months
  description: Change in heart rate at test termination (the Buffalo Concussion Treadmill Test)
  measure: Headache burden
  time frame: 6 months
  description: Change in days of headache of at least moderate intensity
  measure: Change on self-selected area of function.
  time frame: 6 months
  description: Change on the Patient-specific Function Scale (PSFS), the first 3 items, range 0-30, highest is worst.
  measure: Self-reported amount of physical activity
  time frame: 6 months
  description: Change on the International Physical Activity Questionnaire (IPAQ), higher total values indicate more physical activity.
  measure: Quality of life after head injury (QOL)
  time frame: 6 months
  description: Change on the Quality of life after brain injury - Overall Scale (QOLIBRI - OS). Six items rated on an ordinal scale, higher score indicate better QOL.
  measure: Depressive symptoms
  time frame: 6 months
  description: Change on the Patient Health Questionnaire (PHQ-9). Nine items range 0-3, higher score indicates more severe depressive symptoms.
  measure: Anxiety
  time frame: 6 months
  description: Change on the Generalized Anxiety Disorder Scale (GAD-7). Seven items range 0-3, higher score indicates more severe symptoms of anxiety.
  measure: Impact of headaches
  time frame: 6 months
  description: Change on the Headache Impact Test (HIT)-6. Six items, Total score ranges from 36-78, higher score indicates higher impact.
  measure: Fatigue
  time frame: 6 months
  description: Change on the Fatigue Severity Scale (FSS). Nina items, total score range 9-63, higher score indicates more severe fatigue.
  measure: Adherence to training
  time frame: 6 months
  description: The Problematic Experience of Therapy scale (PETS). 12 questions with responses on a Likert scale. No total score.
  arm group label: Follow-up face-to face
  arm group type: Active Comparator
  description: Home-based and in-house exercise, supervised both by telephone and face-to-face.
  Every week the first three weeks participants will exercise one session at the hospital, and the BCTT/BCCT will be performed every 3rd week, at the hospital in order to be able to shape the intervention.
  arm group label: Follow-up over the phone
  arm group type: Active Comparator
  description: Home-based exercise only, supervised by telephone. The participants will exercise solely in the home setting and will be contacted by telephone, every week during the first three weeks, thereafter every third week. Based on the therapist's evaluation during these calls, the intervention is shaped.
  intervention type: Other
  intervention name: Sub-symptom threshold exercise
  description: Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.
  arm group label: Follow-up face-to face
  arm group label: Follow-up over the phone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Britt-Elin Lurud, MD
  role: Study Director
  affiliation: Clinic of Rehabilitation, St. Olavs Hospital
  last name: Toril Skandsen, PhD
  phone: +4792692780
  email: toril.skandsen@ntnu.no
  last name: Janne-Birgitte BB Børke, MSc
  email: janne.borke@stolav.no
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Norway
  responsible party type: Sponsor
  mesh term: Post-Concussion Syndrome
  mesh term: Post-Traumatic Headache
  mesh term: Brain Concussion
  mesh term: Craniocerebral Trauma
  mesh term: Headache
  provided document: 