<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/NCT03006900</url>
  </required_header>
  <id_info>
    <org_study_id>2918</org_study_id>
    <nct_id>NCT03006900</nct_id>
  </id_info>
  <brief_title>Multiple Sclerosis and Pilates</brief_title>
  <official_title>Determining the Impact of a Pilates Program in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Multiple Sclerosis Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to&#xD;
      the more traditional exercise programs. Although somewhat limited, previous research has&#xD;
      suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded,&#xD;
      randomized controlled study has one intervention group (Pilates and massage therapy) and one&#xD;
      control group (massage therapy only). The primary outcome of interest is the change in&#xD;
      walking ability between groups. Secondary outcomes include other measures of physical&#xD;
      performance and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the recent 2015 MS Society of Canada MS Wellness Survey almost 25% of people indicated&#xD;
      that they think physical activity is the most important area of wellness, yet physical&#xD;
      inactivity is still common in individuals with multiple sclerosis (MS). While some of this&#xD;
      may be due to factors related to MS such as fatigue, pain, and physical restrictions,&#xD;
      research has shown that exercise has beneficial effects on mobility, strength, balance, and&#xD;
      overall quality of life. However, because the symptoms of MS vary, there is not one optimal&#xD;
      exercise program that exists. Pilates may be a good exercise option for MS. Pilates focuses&#xD;
      on body positions and movement, with specific attention on the core (stomach or trunk)&#xD;
      muscles. Very few researchers have studied Pilates in MS, but those that have, noticed some&#xD;
      improvements in walking, balance, and strength. There were no negative effects reported from&#xD;
      the Pilates exercises, and the exercises can be adapted for all levels of ability in MS. We&#xD;
      are interested in studying the effect of Pilates in MS. To do this, we will recruit 30 people&#xD;
      with MS to participate in this study. Participants will be randomly put into either the&#xD;
      Pilates group or the control group. Those individuals in the Pilates group will attend two&#xD;
      50-minute Pilates classes twice weekly, plus receive a weekly 1-hour massage therapy session.&#xD;
      Individuals in the control group will only receive the weekly massage therapy session. At the&#xD;
      end of the study (12 weeks), we will look to see if there are any differences between the two&#xD;
      groups in walking ability. We will also compare other important outcomes such as muscle&#xD;
      strength, balance, and quality of life between the two groups. Results from this study may&#xD;
      provide individuals with another exercise option to help manage their MS and improve their&#xD;
      wellness. Results will also be useful for organizations such as the MS Society to help make&#xD;
      decisions about which programs and services to offer to individuals with MS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Change from baseline in distance during the 6-minute walk test</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in balance score for the Fullerton Advanced Balance Scale</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sit and reach test score for flexibility</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in timed up and go test score</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in physical activity level</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in maximal isometric knee extension strength</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ability to recruit motor units</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ability to recruit motor units in a fatigued state</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in trunk muscular endurance</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in lean tissue mass</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fat mass</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline for score from the MS International Quality of Life questionnaire</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in adverse events</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Pilates and massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pilates (twice per week for 50 minutes) and massage (once per week for one hour)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Massage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Massage (once per week for one hour)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates</intervention_name>
    <description>Pilates</description>
    <arm_group_label>Pilates and massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage</intervention_name>
    <description>Massage</description>
    <arm_group_label>Massage</arm_group_label>
    <arm_group_label>Pilates and massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expanded Disability Status Scale of 8 or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charity Evans, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of Kinesiology, University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 5B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Phil Chilibeck</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
  </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/NCT03006900
org study id: 2918
nct id: NCT03006900
lead sponsor: 
collaborator: 
has dmc: No
Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to
      the more traditional exercise programs. Although somewhat limited, previous research has
      suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded,
      randomized controlled study has one intervention group (Pilates and massage therapy) and one
      control group (massage therapy only). The primary outcome of interest is the change in
      walking ability between groups. Secondary outcomes include other measures of physical
      performance and quality of life.
In the recent 2015 MS Society of Canada MS Wellness Survey almost 25% of people indicated
      that they think physical activity is the most important area of wellness, yet physical
      inactivity is still common in individuals with multiple sclerosis (MS). While some of this
      may be due to factors related to MS such as fatigue, pain, and physical restrictions,
      research has shown that exercise has beneficial effects on mobility, strength, balance, and
      overall quality of life. However, because the symptoms of MS vary, there is not one optimal
      exercise program that exists. Pilates may be a good exercise option for MS. Pilates focuses
      on body positions and movement, with specific attention on the core (stomach or trunk)
      muscles. Very few researchers have studied Pilates in MS, but those that have, noticed some
      improvements in walking, balance, and strength. There were no negative effects reported from
      the Pilates exercises, and the exercises can be adapted for all levels of ability in MS. We
      are interested in studying the effect of Pilates in MS. To do this, we will recruit 30 people
      with MS to participate in this study. Participants will be randomly put into either the
      Pilates group or the control group. Those individuals in the Pilates group will attend two
      50-minute Pilates classes twice weekly, plus receive a weekly 1-hour massage therapy session.
      Individuals in the control group will only receive the weekly massage therapy session. At the
      end of the study (12 weeks), we will look to see if there are any differences between the two
      groups in walking ability. We will also compare other important outcomes such as muscle
      strength, balance, and quality of life between the two groups. Results from this study may
      provide individuals with another exercise option to help manage their MS and improve their
      wellness. Results will also be useful for organizations such as the MS Society to help make
      decisions about which programs and services to offer to individuals with MS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in distance during the 6-minute walk test
time frame: 12 weeks
measure: Change from baseline in balance score for the Fullerton Advanced Balance Scale
time frame: 12 weeks
measure: Change in sit and reach test score for flexibility
time frame: 12 weeks
measure: Change from baseline in timed up and go test score
time frame: 12 weeks
measure: Change from baseline in physical activity level
time frame: 12 weeks
measure: Change from baseline in maximal isometric knee extension strength
time frame: 12 weeks
measure: Change from baseline in ability to recruit motor units
time frame: 12 weeks
measure: Change from baseline in ability to recruit motor units in a fatigued state
time frame: 12 weeks
measure: Change from baseline in trunk muscular endurance
time frame: 12 weeks
measure: Change from baseline in lean tissue mass
time frame: 12 weeks
measure: Change from baseline in fat mass
time frame: 12 weeks
measure: Change from baseline for score from the MS International Quality of Life questionnaire
time frame: 12 weeks
measure: Change from baseline in adverse events
time frame: 12 weeks
arm group label: Pilates and massage
arm group type: Experimental
description: Pilates (twice per week for 50 minutes) and massage (once per week for one hour)
arm group label: Massage
arm group type: Active Comparator
description: Massage (once per week for one hour)
intervention type: Other
intervention name: Pilates
description: Pilates
arm group label: Pilates and massage
intervention type: Other
intervention name: Massage
description: Massage
arm group label: Massage
arm group label: Pilates and massage
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Charity Evans, PhD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Phil Chilibeck
investigator title: Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No