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/NCT06028776</url>
    </required_header>
    <id_info>
      <org_study_id>MS_Ballroom_Fit</org_study_id>
      <nct_id>NCT06028776</nct_id>
    </id_info>
    <brief_title>Effects of MS Ballroom Fitness on Balance, Walking Capacity, and Well-being in Multiple Sclerosis</brief_title>
    <official_title>MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Danish MS Society</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Aarhus</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 goal of the present study is to evaluate the effects of a dance-based concept entitled MS&#xD;
        Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple&#xD;
        sclerosis (pwMS). A total of 66 pwMS will be enrolled and equally randomized into an&#xD;
        intervention group or a control-waitlist group. Those in the intervention group will&#xD;
        undertake 7 weeks of MS Ballroom Fitness, with 2 sessions per week.&#xD;
  &#xD;
        The investigators assume that balance, walking capacity as well as well-being will be&#xD;
        improved.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the&#xD;
        central nervous system (CNS) causing demyelination of axons within the CNS as well as loss of&#xD;
        axons and neurons. While a wide range of symptoms potentially develops due to the pathology&#xD;
        of MS, lower extremity motor function appears preferentially affected. It is therefore not&#xD;
        surprising that substantial impairments in balance and walking capacity have been reported in&#xD;
        pwMS, based on both subjective (patient perspectives) and objective assessments. This is&#xD;
        problematic as balance and walking capacity are rated among the most important bodily&#xD;
        functions, and furthermore associated with mental well-being and quality of life.&#xD;
  &#xD;
        In pwMS, balance can be comprehensively assessed by the mini balance evaluation systems test&#xD;
        (miniBEST), specifically evaluating dynamic balance, functional mobility, and gait. As for&#xD;
        walking capacity, this can be comprehensively assessed by using a 'simple' short distance&#xD;
        walk test (e.g., the timed 25 foot maximal walk test (T25FWT)), a 'complex' short distance&#xD;
        walk test (e.g., the six spot step test (SSST)) that involves challenging components of&#xD;
        coordination and dynamic balance, alongside a long distance 'endurance' walk test (e.g., the&#xD;
        6-minute maximal walk test (6MWT)) that can also help capture motor fatigability. In addition&#xD;
        to these, the 12-item MS Walking Scale (MSWS-12) are commonly used to assess the&#xD;
        patient-reported impact of MS on different aspects of walking ability.&#xD;
  &#xD;
        Different modalities of exercise therapy have been shown effective in counteracting the&#xD;
        deterioration of balance and walking capacity observed in pwMS, with improvements reported&#xD;
        across all the tests outlined above. Interestingly, dance (including mixed modalities with a&#xD;
        predominant dance-based content) appear particularly potent in terms of targeting impairments&#xD;
        in balance AND walking capacity. Whilst some pilot/exploratory studies involving pwMS exist,&#xD;
        the summarized evidence appear sparse and contain three major limitations. First, the&#xD;
        majority of pwMS studies are small exploratory non-controlled studies lacking sample size&#xD;
        calculations. Second, none of the identified dance studies provide a personalized approach,&#xD;
        i.e., by designing interventions that embrace the needs and physical functional level of each&#xD;
        participant. Third, none of the identified dance studies have assessed whether dance-induced&#xD;
        adaptations in balance and walking capacity are accompanied by - or even translates into -&#xD;
        improvements in mental well-being and quality of life.&#xD;
  &#xD;
        Physiotherapist Elisabeth Dalsgaard has developed a dance-based concept entitled MS Ballroom&#xD;
        FitnessTM (abbreviated MSB-Fit) with a specific focus on joy of life and inclusion. It is&#xD;
        specifically adapted to pwMS, having three difficulty levels that correspond to three overall&#xD;
        disability categories (sitting, standing, and walking pwMS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 22, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 22, 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>The investigators will use a classic RCT approach, although participants randomized into the control group will be offered the intervention afterwards (hence, termed control-waitlist group).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Six spot step test (SSST)</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures walking coordination and balance. Unit: seconds.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHO5 wellbeing</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Static balance</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures static balance (total score based on 5 different tests; 10s parallel foot stand, 10s semi-parallel foot stand, 10s tandem foot stand, 20s right leg foot stand, 20s left leg foot stand). Unit: seconds (0-70s; 70s is better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional reach test</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified functional reach test</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures how far a person can reach (forward, left, right) with one arm in sitting position. Unit: cm.&#xD;
  NB: This test is used for wheel-chair users only.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Four square step test</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures dynamic stability and co-ordination. Unit: s.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6-minute walk test</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Objective test that measures walking endurance. Unit: meters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ottawa sitting scale</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Rater-evaluated test that measures the level of trunk impairments and sitting balance. Unit: score (0-24; 24 is better).&#xD;
  NB: This test is used for wheel-chair users only.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient determined disease steps</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multiple Sclerosis Walking Scale</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Quality of life - 5 Dimensions (EuroQOL5D)</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures quality of life. Unit: score (0-100; 0 is better).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified fatigue impact scale</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Falls-efficacy scale - international</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Falls</measure>
      <time_frame>Change from Baseline to 7 weeks</time_frame>
      <description>Number of falls in the past year</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will be offered 2 weekly sessions (45-60 min) of MS Ballroom Fitness for a period of 7 weeks. All other 'usual care' are allowed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will continue their habitual living, also including whatever 'usual care' they participate in.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MS Ballroom Fitness</intervention_name>
      <description>A personalized dance-based concept focusing on balance, walking capacity, and well-being.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  self-reported MS diagnosis&#xD;
  &#xD;
            -  patient-determined disease steps (PDDS) ≤ 7 (7 correspond to use a wheelchair for most&#xD;
               daily activities)&#xD;
  &#xD;
            -  able to independently attend the testing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  self-reported comorbidities excluding participation in the intervention&#xD;
  &#xD;
            -  substantial cognitive impairments hindering participation&#xD;
  &#xD;
            -  recent fractures (6 months)&#xD;
  &#xD;
            -  critical physical impairments hindering participation in the described training study&#xD;
  &#xD;
            -  participation in structured exercise therapy (including dancing) for the past 3 months&#xD;
               (≥ 2 session per week of moderate-to-high intensity)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lars Hvid, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Aarhus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lars Hvid</last_name>
      <phone>93508717</phone>
      <email>lhvid@ph.au.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Aarhus University, Exercise Biology</name>
        <address>
          <city>Aarhus C</city>
          <state>Jutland</state>
          <zip>8000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lars Hvid</last_name>
        <phone>93508717</phone>
        <email>lhvid@ph.au.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.</ipd_description>
    </patient_data>
    <!-- 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/NCT06028776
  org study id: MS_Ballroom_Fit
  nct id: NCT06028776
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the present study is to evaluate the effects of a dance-based concept entitled MS
        Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple
        sclerosis (pwMS). A total of 66 pwMS will be enrolled and equally randomized into an
        intervention group or a control-waitlist group. Those in the intervention group will
        undertake 7 weeks of MS Ballroom Fitness, with 2 sessions per week.
  
        The investigators assume that balance, walking capacity as well as well-being will be
        improved.
  Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the
        central nervous system (CNS) causing demyelination of axons within the CNS as well as loss of
        axons and neurons. While a wide range of symptoms potentially develops due to the pathology
        of MS, lower extremity motor function appears preferentially affected. It is therefore not
        surprising that substantial impairments in balance and walking capacity have been reported in
        pwMS, based on both subjective (patient perspectives) and objective assessments. This is
        problematic as balance and walking capacity are rated among the most important bodily
        functions, and furthermore associated with mental well-being and quality of life.
  
        In pwMS, balance can be comprehensively assessed by the mini balance evaluation systems test
        (miniBEST), specifically evaluating dynamic balance, functional mobility, and gait. As for
        walking capacity, this can be comprehensively assessed by using a 'simple' short distance
        walk test (e.g., the timed 25 foot maximal walk test (T25FWT)), a 'complex' short distance
        walk test (e.g., the six spot step test (SSST)) that involves challenging components of
        coordination and dynamic balance, alongside a long distance 'endurance' walk test (e.g., the
        6-minute maximal walk test (6MWT)) that can also help capture motor fatigability. In addition
        to these, the 12-item MS Walking Scale (MSWS-12) are commonly used to assess the
        patient-reported impact of MS on different aspects of walking ability.
  
        Different modalities of exercise therapy have been shown effective in counteracting the
        deterioration of balance and walking capacity observed in pwMS, with improvements reported
        across all the tests outlined above. Interestingly, dance (including mixed modalities with a
        predominant dance-based content) appear particularly potent in terms of targeting impairments
        in balance AND walking capacity. Whilst some pilot/exploratory studies involving pwMS exist,
        the summarized evidence appear sparse and contain three major limitations. First, the
        majority of pwMS studies are small exploratory non-controlled studies lacking sample size
        calculations. Second, none of the identified dance studies provide a personalized approach,
        i.e., by designing interventions that embrace the needs and physical functional level of each
        participant. Third, none of the identified dance studies have assessed whether dance-induced
        adaptations in balance and walking capacity are accompanied by - or even translates into -
        improvements in mental well-being and quality of life.
  
        Physiotherapist Elisabeth Dalsgaard has developed a dance-based concept entitled MS Ballroom
        FitnessTM (abbreviated MSB-Fit) with a specific focus on joy of life and inclusion. It is
        specifically adapted to pwMS, having three difficulty levels that correspond to three overall
        disability categories (sitting, standing, and walking pwMS).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators will use a classic RCT approach, although participants randomized into the control group will be offered the intervention afterwards (hence, termed control-waitlist group).
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Six spot step test (SSST)
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures walking coordination and balance. Unit: seconds.
  measure: WHO5 wellbeing
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).
  measure: Static balance
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures static balance (total score based on 5 different tests; 10s parallel foot stand, 10s semi-parallel foot stand, 10s tandem foot stand, 20s right leg foot stand, 20s left leg foot stand). Unit: seconds (0-70s; 70s is better)
  measure: Functional reach test
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.
  measure: Modified functional reach test
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures how far a person can reach (forward, left, right) with one arm in sitting position. Unit: cm.
  NB: This test is used for wheel-chair users only.
  measure: Four square step test
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures dynamic stability and co-ordination. Unit: s.
  measure: 6-minute walk test
  time frame: Change from Baseline to 7 weeks
  description: Objective test that measures walking endurance. Unit: meters.
  measure: Ottawa sitting scale
  time frame: Change from Baseline to 7 weeks
  description: Rater-evaluated test that measures the level of trunk impairments and sitting balance. Unit: score (0-24; 24 is better).
  NB: This test is used for wheel-chair users only.
  measure: Patient determined disease steps
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).
  measure: Multiple Sclerosis Walking Scale
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).
  measure: European Quality of life - 5 Dimensions (EuroQOL5D)
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures quality of life. Unit: score (0-100; 0 is better).
  measure: Modified fatigue impact scale
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)
  measure: Falls-efficacy scale - international
  time frame: Change from Baseline to 7 weeks
  description: Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)
  measure: Falls
  time frame: Change from Baseline to 7 weeks
  description: Number of falls in the past year
  arm group label: Intervention
  arm group type: Experimental
  description: This group will be offered 2 weekly sessions (45-60 min) of MS Ballroom Fitness for a period of 7 weeks. All other 'usual care' are allowed.
  arm group label: Control
  arm group type: No Intervention
  description: This group will continue their habitual living, also including whatever 'usual care' they participate in.
  intervention type: Behavioral
  intervention name: MS Ballroom Fitness
  description: A personalized dance-based concept focusing on balance, walking capacity, and well-being.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lars Hvid, PhD
  role: Principal Investigator
  affiliation: University of Aarhus
  last name: Lars Hvid
  phone: 93508717
  email: lhvid@ph.au.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: No
  ipd description: By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.