<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/NCT04452760</url>
  </required_header>
  <id_info>
    <org_study_id>UCAM-CE071923</org_study_id>
    <nct_id>NCT04452760</nct_id>
  </id_info>
  <brief_title>Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis</brief_title>
  <official_title>Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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 (ME) is a degenerative, inflammatory and autoimmune demyelinating disease&#xD;
      of the central nervous system, characterized by demyelination due to inflammation and&#xD;
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,&#xD;
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic&#xD;
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.&#xD;
      Strength training has been shown to improve strength and mobility in persons with MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease&#xD;
      of the central nervous system, characterized by demyelination due to inflammation and&#xD;
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,&#xD;
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic&#xD;
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.&#xD;
      Resistance training has been shown to improve strength, sleep quality and mobility in persons&#xD;
      with MS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal Voluntary Isometric Contraction of Knee Extension</measure>
    <time_frame>Before the program training</time_frame>
    <description>the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Voluntary Isometric Contraction of Knee Extension</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Force Development</measure>
    <time_frame>Before the program training</time_frame>
    <description>Rate of force development in knee extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Force Development</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Rate of force development in knee extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central Activation Ratio</measure>
    <time_frame>Before the program training</time_frame>
    <description>The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central Activation Ratio</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spasticity</measure>
    <time_frame>Before the program training</time_frame>
    <description>Pendulum test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spasticity</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Pendulum test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Before the program training</time_frame>
    <description>Test 10 m-walks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Test 10 m-walks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Balance</measure>
    <time_frame>Before the program training</time_frame>
    <description>Romberg Test with eyes open and closed. Analysis with force plates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Balance</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Romberg Test with eyes open and closed. Analysis with force plates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>Before the program training</time_frame>
    <description>Sit-to-Stand Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Sit-to-Stand Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>Before the program training</time_frame>
    <description>Sleeping Heart Rate Variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Sleeping Heart Rate Variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Before the program training</time_frame>
    <description>Acelerometry and Karolinska Sleep Diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>After 10 weeks</time_frame>
    <description>Acelerometry and Karolinska Sleep Diary</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only testing sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Progressive resistance training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Physical exercise intervention</description>
    <arm_group_label>Progressive resistance training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Testing sessions</intervention_name>
    <description>Testing sessions</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Progressive resistance training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild or moderate disability with clinical mild spastic-ataxic gait disorder.&#xD;
&#xD;
          -  stable phase of the disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) &lt; 6.&#xD;
&#xD;
          -  relapsing disease within the preceding 12 months.&#xD;
&#xD;
          -  corticosteroid treatment within the last months before study inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacobo Á Rubio-Arias, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Politécnica de Madrid.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Católica San Antonio</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Jacobo Á. Rubio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>neurological disorders</keyword>
  <keyword>resistance training</keyword>
  <keyword>strength training</keyword>
  <keyword>sleep quality</keyword>
  <keyword>neuromuscular performance</keyword>
  <keyword>functional capacity</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be published in a journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After the completion of study</ipd_time_frame>
    <ipd_access_criteria>The data will be published in a journal</ipd_access_criteria>
  </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/NCT04452760
org study id: UCAM-CE071923
nct id: NCT04452760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Strength training has been shown to improve strength and mobility in persons with MS.
Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Resistance training has been shown to improve strength, sleep quality and mobility in persons
      with MS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Maximal Voluntary Isometric Contraction of Knee Extension
time frame: Before the program training
description: the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
measure: Maximal Voluntary Isometric Contraction of Knee Extension
time frame: After 10 weeks
description: the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
measure: Rate of Force Development
time frame: Before the program training
description: Rate of force development in knee extension
measure: Rate of Force Development
time frame: After 10 weeks
description: Rate of force development in knee extension
measure: Central Activation Ratio
time frame: Before the program training
description: The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
measure: Central Activation Ratio
time frame: After 10 weeks
description: The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
measure: Spasticity
time frame: Before the program training
description: Pendulum test
measure: Spasticity
time frame: After 10 weeks
description: Pendulum test
measure: Walking speed
time frame: Before the program training
description: Test 10 m-walks
measure: Walking speed
time frame: After 10 weeks
description: Test 10 m-walks
measure: Static Balance
time frame: Before the program training
description: Romberg Test with eyes open and closed. Analysis with force plates
measure: Static Balance
time frame: After 10 weeks
description: Romberg Test with eyes open and closed. Analysis with force plates
measure: Functional capacity
time frame: Before the program training
description: Sit-to-Stand Test
measure: Functional capacity
time frame: After 10 weeks
description: Sit-to-Stand Test
measure: Heart Rate Variability
time frame: Before the program training
description: Sleeping Heart Rate Variability
measure: Heart Rate Variability
time frame: After 10 weeks
description: Sleeping Heart Rate Variability
measure: Sleep Quality
time frame: Before the program training
description: Acelerometry and Karolinska Sleep Diary
measure: Sleep Quality
time frame: After 10 weeks
description: Acelerometry and Karolinska Sleep Diary
arm group label: Control group
arm group type: Active Comparator
description: Only testing sessions
arm group label: Progressive resistance training group
arm group type: Experimental
description: 10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.
intervention type: Other
intervention name: Physical exercise
description: Physical exercise intervention
arm group label: Progressive resistance training group
intervention type: Other
intervention name: Testing sessions
description: Testing sessions
arm group label: Control group
arm group label: Progressive resistance training group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jacobo Á Rubio-Arias, Dr
role: Principal Investigator
affiliation: Universidad Politécnica de Madrid.
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Jacobo Á. Rubio
investigator title: Principal Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: The data will be published in a journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: After the completion of study
ipd access criteria: The data will be published in a journal