<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/NCT03244696</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0483</org_study_id>
    <nct_id>NCT03244696</nct_id>
  </id_info>
  <brief_title>Behavior and Activity Monitoring in MS</brief_title>
  <official_title>Behavior and Activity Monitoring in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State 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>
      The investigators propose to conduct a randomized 6-month intervention study comparing&#xD;
      cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to&#xD;
      either a physical activity or an active water-intake control group. Individuals will complete&#xD;
      pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventions to increase physical activity through aerobic exercise are some of the only&#xD;
      known treatment options to improve domains of cognition such as executive function. While&#xD;
      increased physical activity is associated with preserved cortical functioning during&#xD;
      exogenous executive functioning tasks in older adults, little is known about the relationship&#xD;
      between physical activity and executive functioning in multiple sclerosis. Thus, the&#xD;
      investigators propose to conduct a randomized 6-month accelerometry-based intervention&#xD;
      designed to increase overall physical activity in sedentary relapsing-remitting multiple&#xD;
      sclerosis with known cognitive challenges. The overall objective is to determine how a&#xD;
      6-month activity tracking intervention impacts the behavioral, neural and mechanistic&#xD;
      associations between physical activity and cognitive functioning. All individuals who contact&#xD;
      the Clinical Neuroscience Laboratory (CNL) with interest in this study will undergo a&#xD;
      phone/online screening assessing inclusion/exclusion criteria. Those participants meeting I/E&#xD;
      criteria will be invited to the lab for 2 pre-assessment sessions, one session at midpoint,&#xD;
      and 2 post-assessment sessions at the completion of the 6 month intervention. Participants&#xD;
      will also be asked to complete a number of online questionnaires following the first&#xD;
      assessment session. The two pre-assessments will involve a through measure of cognitive&#xD;
      functioning, both through the use of neuropsychological batteries and neuroimaging, and&#xD;
      inflammatory markers through collection of a blood sample. Following the pre-assessment&#xD;
      sessions, conducted by blind personnel, participants will be randomized to one of the two&#xD;
      groups. Participants will be asked to self-monitor their assigned health behavior with the&#xD;
      aid of a behavioral tracker (accelerometer or smart water bottle). Via a mobile application&#xD;
      designed by the laboratory, participants will receive daily and weekly summaries of their&#xD;
      health behavior progress, and motivational materials to encourage goal attainment. The&#xD;
      6-month intervention will involve minimal contact from study coordinators. Participants who&#xD;
      do not adhere to study goals will be contacted by a study coordinator via phone who will use&#xD;
      motivational interviewing to promote behavior change. Following the 6-month intervention the&#xD;
      2 assessment sessions will be repeated to obtain post-intervention data for comparison.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2017</start_date>
  <completion_date type="Actual">June 28, 2021</completion_date>
  <primary_completion_date type="Actual">June 28, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>Change in a latent factor of working memory/processing speed will be examined from pre to post intervention. This latent factor will be created using baseline performance on measures from the Minimal Assessment of Cognitive Functioning in Multiple Sclerosis battery (MACFIMS), the NIH Toolbox Cognition Battery (NIHTB-CB), and the processing speed and working memory measures from the Wechsler Adult Intelligence Scale (WAIS-IV) before, during (at midpoint), and after the intervention. Higher scores on this factor represent better working memory/processing speed performance. Investigators hypothesize changes in cognitive performance, specifically in the domains of working memory and processing speed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the Functional Architecture of the MS Brain during Working Memory</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology. Network strength in the working memory connectome during the NBack task will be the primary fMRI-based neuroimaging measure. Higher network strength in the working memory connectome represent greater connections between brain edges associated with high working memory performance. Participants in the physical activity group will show increased network strength in a connectome-based model of working memory performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Functional Architecture of the MS Brain during Processing Speed</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology. Network strength in the processing speed neuromaker during the Symbol Digit Modalities Test will be the outcome variable. Higher network strength in the processing speed neuromarker represent greater connections between brain edges associated with high processing speed performance. Participants in the physical activity group will show increased network strength in this neuromarker of processing speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Depression</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
    <description>Participants will be administered Beck Depression Inventory-II before, at mid-point, and after the intervention. This measure assesses self-reported depressive symptoms with a range of 0-63 with higher scores characterizing higher endorsement of depressive symptoms. Changes in scores will indicate effects of the intervention on symptoms of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Anxiety</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Participants will be administered the Penn State Worry Questionnaire before, at mid-point and after the intervention. This measure assesses self-reported worry symptoms with a range of 16-80. High scores on this measure represent higher levels of chronic worrying. Change on this measure will be assessed to determine the impact of the intervention on symptoms of worry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Perceived Stress</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Participants will be administered the Perceived Stress Scale before, at mid-point and after the intervention. This measure assesses perceived stress with a range of 0-40. High scores on the perceived stress scale represent higher levels of stress. Change on this measure will indicate impact of the intervention on symptoms of stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Quality of Life</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Participants will be administered the Satisfaction with Life Scale and the World Health Organization Quality of Life Scale before, at mid-point, and after the intervention. Standardized scores for the two measures will be merged to create a composite score for quality of life. High scores on this composite measure would represent higher quality of life. Differences in the composite score of quality of life will reveal changes in quality of life as a function of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Sleep Quality</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Participants will be administered the Pittsburgh Sleep Quality Index before, at mid-point, and after the intervention. This measure assesses sleep quality with a range of 0-21. Higher score on this measure represents greater difficulty with sleep. Score changes on this measure will indicate changes in sleep quality as a function of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on a Self-Report Measure of Fatigue</measure>
    <time_frame>Baseline, 3 months and 6 months</time_frame>
    <description>Participants will be administered the Modified Fatigue Impact Scale before, at mid-point and after the intervention. This measure assesses self-reported fatigue with a range of 0-84. High scores on this measure represent higher levels of experienced fatigue. Differences in scores on this measure will indicate changes in fatigue as a function of the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Relapsing-Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Step Tracking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will track their physical activity in steps using an accelerometer for a period of 6 months. Participants will monitor their overall step-count using the accelerometer, and daily and weekly summaries of their progress provided by the experimenters.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water Tracking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will track their water-intake using a smart water bottle for a period of 6 months. Participants will monitor their overall water consumption using a smart water bottle, and daily and weekly summaries of their progress provided by the experimenters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step Tracking</intervention_name>
    <description>The step tracking intervention is designed to increase physical activity through the use of self-monitoring and brief motivational materials. The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.</description>
    <arm_group_label>Step Tracking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Water Tracking</intervention_name>
    <description>The water tracking intervention is designed to increase water intake, to a healthy level, through the use of self-monitoring and brief motivational materials.The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.</description>
    <arm_group_label>Water Tracking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically definite diagnosis of Relapsing-Remitting Multiple Sclerosis&#xD;
&#xD;
          -  Score higher than 23 on the Mini-Mental Status Examination (MMSE)&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) under 5.5&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically isolated syndrome or progressive MS subtype&#xD;
&#xD;
          -  Presence of any other neurological disorders&#xD;
&#xD;
          -  Presence of psychiatric disorder diagnosed by a licensed mental health provider in the&#xD;
             last two years&#xD;
&#xD;
          -  Clinically definite relapse or use of high dose corticosteroids within the last 30&#xD;
             days&#xD;
&#xD;
          -  Recreational drug use in the last 6 months&#xD;
&#xD;
          -  Without access to a smart phone or no access to the internet&#xD;
&#xD;
          -  Current use of accelerometer, pedometer, and/or physical activity monitoring equipment&#xD;
&#xD;
          -  Presence of ferromagnetic implanted devices or self-reported claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruchika S Prakash, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychology, The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Ruchika Prakash</investigator_full_name>
    <investigator_title>Ruchika Prakash, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Sclerosis</keyword>
  <keyword>Demyelinating Autoimmune Diseases, Central Nervous System</keyword>
  <keyword>Autoimmune Diseases of the Nervous System</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Demyelinating Diseases</keyword>
  <keyword>Immune System Diseases</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Walking</keyword>
  <keyword>Hydration</keyword>
  <keyword>Lifestyle Intervention</keyword>
  <keyword>Health Behavior Tracking</keyword>
  <keyword>Inflammatory Biomarkers</keyword>
  <keyword>Neurodegenerative Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</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/NCT03244696
org study id: 2014H0483
nct id: NCT03244696
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose to conduct a randomized 6-month intervention study comparing
      cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to
      either a physical activity or an active water-intake control group. Individuals will complete
      pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.
Interventions to increase physical activity through aerobic exercise are some of the only
      known treatment options to improve domains of cognition such as executive function. While
      increased physical activity is associated with preserved cortical functioning during
      exogenous executive functioning tasks in older adults, little is known about the relationship
      between physical activity and executive functioning in multiple sclerosis. Thus, the
      investigators propose to conduct a randomized 6-month accelerometry-based intervention
      designed to increase overall physical activity in sedentary relapsing-remitting multiple
      sclerosis with known cognitive challenges. The overall objective is to determine how a
      6-month activity tracking intervention impacts the behavioral, neural and mechanistic
      associations between physical activity and cognitive functioning. All individuals who contact
      the Clinical Neuroscience Laboratory (CNL) with interest in this study will undergo a
      phone/online screening assessing inclusion/exclusion criteria. Those participants meeting I/E
      criteria will be invited to the lab for 2 pre-assessment sessions, one session at midpoint,
      and 2 post-assessment sessions at the completion of the 6 month intervention. Participants
      will also be asked to complete a number of online questionnaires following the first
      assessment session. The two pre-assessments will involve a through measure of cognitive
      functioning, both through the use of neuropsychological batteries and neuroimaging, and
      inflammatory markers through collection of a blood sample. Following the pre-assessment
      sessions, conducted by blind personnel, participants will be randomized to one of the two
      groups. Participants will be asked to self-monitor their assigned health behavior with the
      aid of a behavioral tracker (accelerometer or smart water bottle). Via a mobile application
      designed by the laboratory, participants will receive daily and weekly summaries of their
      health behavior progress, and motivational materials to encourage goal attainment. The
      6-month intervention will involve minimal contact from study coordinators. Participants who
      do not adhere to study goals will be contacted by a study coordinator via phone who will use
      motivational interviewing to promote behavior change. Following the 6-month intervention the
      2 assessment sessions will be repeated to obtain post-intervention data for comparison.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed
time frame: Baseline, 3 months, and 6 months
description: Change in a latent factor of working memory/processing speed will be examined from pre to post intervention. This latent factor will be created using baseline performance on measures from the Minimal Assessment of Cognitive Functioning in Multiple Sclerosis battery (MACFIMS), the NIH Toolbox Cognition Battery (NIHTB-CB), and the processing speed and working memory measures from the Wechsler Adult Intelligence Scale (WAIS-IV) before, during (at midpoint), and after the intervention. Higher scores on this factor represent better working memory/processing speed performance. Investigators hypothesize changes in cognitive performance, specifically in the domains of working memory and processing speed.
measure: Changes in the Functional Architecture of the MS Brain during Working Memory
time frame: Baseline and 6 months
description: Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology. Network strength in the working memory connectome during the NBack task will be the primary fMRI-based neuroimaging measure. Higher network strength in the working memory connectome represent greater connections between brain edges associated with high working memory performance. Participants in the physical activity group will show increased network strength in a connectome-based model of working memory performance.
measure: Changes in the Functional Architecture of the MS Brain during Processing Speed
time frame: Baseline and 6 months
description: Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology. Network strength in the processing speed neuromaker during the Symbol Digit Modalities Test will be the outcome variable. Higher network strength in the processing speed neuromarker represent greater connections between brain edges associated with high processing speed performance. Participants in the physical activity group will show increased network strength in this neuromarker of processing speed.
measure: Changes on a Self-Report Measure of Depression
time frame: Baseline, 3 months, and 6 months
description: Participants will be administered Beck Depression Inventory-II before, at mid-point, and after the intervention. This measure assesses self-reported depressive symptoms with a range of 0-63 with higher scores characterizing higher endorsement of depressive symptoms. Changes in scores will indicate effects of the intervention on symptoms of depression.
measure: Changes on a Self-Report Measure of Anxiety
time frame: Baseline, 3 months and 6 months
description: Participants will be administered the Penn State Worry Questionnaire before, at mid-point and after the intervention. This measure assesses self-reported worry symptoms with a range of 16-80. High scores on this measure represent higher levels of chronic worrying. Change on this measure will be assessed to determine the impact of the intervention on symptoms of worry.
measure: Changes on a Self-Report Measure of Perceived Stress
time frame: Baseline, 3 months and 6 months
description: Participants will be administered the Perceived Stress Scale before, at mid-point and after the intervention. This measure assesses perceived stress with a range of 0-40. High scores on the perceived stress scale represent higher levels of stress. Change on this measure will indicate impact of the intervention on symptoms of stress.
measure: Changes on a Self-Report Measure of Quality of Life
time frame: Baseline, 3 months and 6 months
description: Participants will be administered the Satisfaction with Life Scale and the World Health Organization Quality of Life Scale before, at mid-point, and after the intervention. Standardized scores for the two measures will be merged to create a composite score for quality of life. High scores on this composite measure would represent higher quality of life. Differences in the composite score of quality of life will reveal changes in quality of life as a function of the intervention.
measure: Changes on a Self-Report Measure of Sleep Quality
time frame: Baseline, 3 months and 6 months
description: Participants will be administered the Pittsburgh Sleep Quality Index before, at mid-point, and after the intervention. This measure assesses sleep quality with a range of 0-21. Higher score on this measure represents greater difficulty with sleep. Score changes on this measure will indicate changes in sleep quality as a function of the intervention.
measure: Changes on a Self-Report Measure of Fatigue
time frame: Baseline, 3 months and 6 months
description: Participants will be administered the Modified Fatigue Impact Scale before, at mid-point and after the intervention. This measure assesses self-reported fatigue with a range of 0-84. High scores on this measure represent higher levels of experienced fatigue. Differences in scores on this measure will indicate changes in fatigue as a function of the intervention.
arm group label: Step Tracking
arm group type: Experimental
description: Participants will track their physical activity in steps using an accelerometer for a period of 6 months. Participants will monitor their overall step-count using the accelerometer, and daily and weekly summaries of their progress provided by the experimenters.
arm group label: Water Tracking
arm group type: Active Comparator
description: Participants will track their water-intake using a smart water bottle for a period of 6 months. Participants will monitor their overall water consumption using a smart water bottle, and daily and weekly summaries of their progress provided by the experimenters.
intervention type: Behavioral
intervention name: Step Tracking
description: The step tracking intervention is designed to increase physical activity through the use of self-monitoring and brief motivational materials. The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.
arm group label: Step Tracking
intervention type: Behavioral
intervention name: Water Tracking
description: The water tracking intervention is designed to increase water intake, to a healthy level, through the use of self-monitoring and brief motivational materials.The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.
arm group label: Water Tracking
criteria: 
gender: All
minimum age: 30 Years
maximum age: 59 Years
healthy volunteers: No
last name: Ruchika S Prakash, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Ruchika Prakash
investigator title: Ruchika Prakash, Associate Professor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
sharing ipd: No