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/NCT06042244</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00149742</org_study_id>
      <nct_id>NCT06042244</nct_id>
    </id_info>
    <brief_title>Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis</brief_title>
    <official_title>Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Kansas Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kansas Medical Center</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>
        Study Significance: This proposed investigation is designed to examine the feasibility of an&#xD;
        exercise-based intervention to reduce frailty in people living with MS. The proposed research&#xD;
        will be the first to establish the feasibility of targeting frailty in pwMS and will begin to&#xD;
        examine the dynamic nature of frailty in MS. These advances will pave the way for planned&#xD;
        prospective studies toward effective targets for diagnostics, and rehabilitation of frailty&#xD;
        in MS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Outcome</measure>
      <time_frame>6 weeks</time_frame>
      <description>Preliminary efficacy of multimodal exercise in improving frailty [Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multimodal Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Multimodal Exercise Group</intervention_name>
      <description>Listed in arm/ group descriptions</description>
      <arm_group_label>Multimodal Exercise Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Waitlist</intervention_name>
      <description>listed in arm/group description</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must be aged 40-65 years old to be enrolled in this study.&#xD;
  &#xD;
            -  Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness;&#xD;
               slowness; inactivity) to be considered.&#xD;
  &#xD;
            -  Subjects must have a confirmed diagnosis of MS by the treating neurologist&#xD;
  &#xD;
            -  be free from MS relapses in the last 30 days&#xD;
  &#xD;
            -  have an Expanded Disability Status Scale (EDSS) score ≤ 6.0&#xD;
  &#xD;
            -  be fluent in spoken and written English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to walk unassisted for at least ten meters&#xD;
  &#xD;
            -  are diagnosed with other clinically important neurological conditions (such as&#xD;
               Parkinson's Disease, epilepsy, etc.)&#xD;
  &#xD;
            -  exhibit severe cognitive impairment (as determined by a Mini-Cog score &lt;3)&#xD;
  &#xD;
            -  are diagnosed with active psychiatric problems.&#xD;
  &#xD;
            -  unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral&#xD;
               stenosis, clinically severe left ventricular outflow obstruction, critical proximal&#xD;
               coronary artery stenosis)&#xD;
  &#xD;
            -  arthritis of the lower limbs&#xD;
  &#xD;
            -  acute lower back or lower limbs pain&#xD;
  &#xD;
            -  rheumatic and/or severe orthopedic problems that may interfere with resistance&#xD;
               training.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tobia Zanotto, PhD</last_name>
      <phone>217-721-4852</phone>
      <email>tzanotto@kumc.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- 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/NCT06042244
  org study id: STUDY00149742
  nct id: NCT06042244
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Study Significance: This proposed investigation is designed to examine the feasibility of an
        exercise-based intervention to reduce frailty in people living with MS. The proposed research
        will be the first to establish the feasibility of targeting frailty in pwMS and will begin to
        examine the dynamic nature of frailty in MS. These advances will pave the way for planned
        prospective studies toward effective targets for diagnostics, and rehabilitation of frailty
        in MS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Primary Outcome
  time frame: 6 weeks
  description: Preliminary efficacy of multimodal exercise in improving frailty [Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).
  arm group label: Control Group
  arm group type: Other
  description: Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.
  arm group label: Multimodal Exercise Group
  arm group type: Experimental
  description: Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.
  intervention type: Other
  intervention name: Multimodal Exercise Group
  description: Listed in arm/ group descriptions
  arm group label: Multimodal Exercise Group
  intervention type: Other
  intervention name: Waitlist
  description: listed in arm/group description
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Tobia Zanotto, PhD
  phone: 217-721-4852
  email: tzanotto@kumc.edu
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  mesh term: Frailty