<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/NCT04496804</url>
  </required_header>
  <id_info>
    <org_study_id>300005111</org_study_id>
    <nct_id>NCT04496804</nct_id>
  </id_info>
  <brief_title>Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis</brief_title>
  <acronym>BIPAMS-Brain</acronym>
  <official_title>BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of&#xD;
      irreversible neurological disability among young women and the second leading cause of&#xD;
      disability among young men in the United States. This disease results in the progressive loss&#xD;
      of walking mobility and substantial worsening of cognition, symptoms, and quality of life&#xD;
      over time. There is evidence that physical activity is beneficially associated with aerobic&#xD;
      fitness and brain structure and function in persons with MS. Nevertheless, this population is&#xD;
      strikingly sedentary and physically inactive. This highlights a vital opportunity to improve&#xD;
      aerobic fitness and brain health by developing behavioral interventions that increase&#xD;
      physical activity. To that end, this project is a Phase-II randomized control trial for&#xD;
      examining the efficacy of a behavioral intervention that is based on social-cognitive theory&#xD;
      and delivered through the Internet for increasing physical activity and, secondarily,&#xD;
      improving aerobic fitness and brain structure and function in persons with MS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Minutes of moderate to vigorous physical activity - Baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minutes of moderate to vigorous physical activity - Post intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiorespiratory fitness; oxygen consumption during exercise - baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiorespiratory fitness; oxygen consumption during exercise - post intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distance walked - baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distance walked - post-intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>information processing speed; cognitive function - baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>information processing speed; cognitive function - post intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of subcortical grey matter brain structures - baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>An MRI will be conducted to measure brain structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of subcortical grey matter brain structures - post intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>An MRI will be conducted to measure brain structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting state functional brain connectivity - baseline</measure>
    <time_frame>Assessment will be conducted before the intervention</time_frame>
    <description>An MRI will be conducted to measure brain function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting state functional brain connectivity - post intervention</measure>
    <time_frame>Assessment will be conducted immediately after the intervention</time_frame>
    <description>An MRI will be conducted to measure brain function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Behavioral Intervention for Physical Activity in MS (BIPAMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The current behavioral intervention consists of two primary components; an Internet website and one-on-one video chats with a behavioral coach. The Internet website involves content delivered through interactive video courses. The interactive video courses are based on elements of social cognitive theory. Each courses consists of an introduction, the primary content, and a take home message. The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic. A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention, discussion of website material, supportive accountability, and reporting of adverse events/injuries. The chats are conducted face-to-face through Skype. The chats occur 7 times during the first 2 months, 4 times during the second 2 months, and twice during the final 2 months of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness for MS (WellMS)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Provides an Internet website and one-on-one video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity. The materials are transformations of brochures provided by the National MS Society, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Intervention for Physical Activity in MS (BIPAMS)</intervention_name>
    <description>A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.</description>
    <arm_group_label>Behavioral Intervention for Physical Activity in MS (BIPAMS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness for MS (WellMS)</intervention_name>
    <description>A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.</description>
    <arm_group_label>Wellness for MS (WellMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of multiple sclerosis&#xD;
&#xD;
          -  relapse free in the last 30 days&#xD;
&#xD;
          -  being non-active defined as not engaging in regular activity (30 minutes accumulated&#xD;
             per day) on more than 2 days of the week during the previous 6 months&#xD;
&#xD;
          -  ambulate without assistance&#xD;
&#xD;
          -  low risk for contraindications for MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate or high risk for undertaking strenuous or maximal exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Motl, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Robert W Motl</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT04496804
org study id: 300005111
nct id: NCT04496804
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of
      irreversible neurological disability among young women and the second leading cause of
      disability among young men in the United States. This disease results in the progressive loss
      of walking mobility and substantial worsening of cognition, symptoms, and quality of life
      over time. There is evidence that physical activity is beneficially associated with aerobic
      fitness and brain structure and function in persons with MS. Nevertheless, this population is
      strikingly sedentary and physically inactive. This highlights a vital opportunity to improve
      aerobic fitness and brain health by developing behavioral interventions that increase
      physical activity. To that end, this project is a Phase-II randomized control trial for
      examining the efficacy of a behavioral intervention that is based on social-cognitive theory
      and delivered through the Internet for increasing physical activity and, secondarily,
      improving aerobic fitness and brain structure and function in persons with MS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Minutes of moderate to vigorous physical activity - Baseline
time frame: Assessment will be conducted before the intervention
description: Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
measure: Minutes of moderate to vigorous physical activity - Post intervention
time frame: Assessment will be conducted immediately after the intervention
description: Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
measure: cardiorespiratory fitness; oxygen consumption during exercise - baseline
time frame: Assessment will be conducted before the intervention
description: A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.
measure: cardiorespiratory fitness; oxygen consumption during exercise - post intervention
time frame: Assessment will be conducted immediately after the intervention
description: A graded exercise test on a treadmill. Participants will walk at a quick pace on the treadmill and the incline will increase every 2 minutes until the participant is no longer able to keep pace with the treadmill.
measure: distance walked - baseline
time frame: Assessment will be conducted before the intervention
description: The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
measure: distance walked - post-intervention
time frame: Assessment will be conducted immediately after the intervention
description: The six-minute walk test will be used to measure walking endurance. The test involves walking for 6 minutes without stopping.
measure: information processing speed; cognitive function - baseline
time frame: Assessment will be conducted before the intervention
description: The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
measure: information processing speed; cognitive function - post intervention
time frame: Assessment will be conducted immediately after the intervention
description: The symbol digit modalities test will be used to measure information processing speed. The test involves matching numbers to symbols.
measure: volume of subcortical grey matter brain structures - baseline
time frame: Assessment will be conducted before the intervention
description: An MRI will be conducted to measure brain structure.
measure: volume of subcortical grey matter brain structures - post intervention
time frame: Assessment will be conducted immediately after the intervention
description: An MRI will be conducted to measure brain structure.
measure: resting state functional brain connectivity - baseline
time frame: Assessment will be conducted before the intervention
description: An MRI will be conducted to measure brain function.
measure: resting state functional brain connectivity - post intervention
time frame: Assessment will be conducted immediately after the intervention
description: An MRI will be conducted to measure brain function.
arm group label: Behavioral Intervention for Physical Activity in MS (BIPAMS)
arm group type: Experimental
description: The current behavioral intervention consists of two primary components; an Internet website and one-on-one video chats with a behavioral coach. The Internet website involves content delivered through interactive video courses. The interactive video courses are based on elements of social cognitive theory. Each courses consists of an introduction, the primary content, and a take home message. The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic. A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention, discussion of website material, supportive accountability, and reporting of adverse events/injuries. The chats are conducted face-to-face through Skype. The chats occur 7 times during the first 2 months, 4 times during the second 2 months, and twice during the final 2 months of the intervention.
arm group label: Wellness for MS (WellMS)
arm group type: Sham Comparator
description: Provides an Internet website and one-on-one video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity. The materials are transformations of brochures provided by the National MS Society, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided.
intervention type: Behavioral
intervention name: Behavioral Intervention for Physical Activity in MS (BIPAMS)
description: A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
arm group label: Behavioral Intervention for Physical Activity in MS (BIPAMS)
intervention type: Behavioral
intervention name: Wellness for MS (WellMS)
description: A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
arm group label: Wellness for MS (WellMS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Robert Motl, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Robert W Motl
investigator title: Primary Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis