<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/NCT02193906</url>
  </required_header>
  <id_info>
    <org_study_id>MSR-2013</org_study_id>
    <nct_id>NCT02193906</nct_id>
  </id_info>
  <brief_title>Neuropsychological Profile of a Patient's Group With Multiple Sclerosis and Effect of a Cognitive Rehabilitation Program</brief_title>
  <acronym>MS_Rehab</acronym>
  <official_title>Neuropsychological Profile of a Portuguese Patient's Group With Multiple Sclerosis and Results of a Cognitive Rehabilitation Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aveiro University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aveiro University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the effect of an web-based intensive cognitive&#xD;
      rehabilitation program in neuropsychological performance of a population of patients with&#xD;
      multiple sclerosis or clinical isolated syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      1. To determine the effect of an intensive cognitive rehabilitation program in&#xD;
      neuropsychological performance of a population of patients with multiple sclerosis or&#xD;
      clinical isolated syndrome.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. To characterize the neuropsychological profile of a population of patients with multiple&#xD;
           sclerosis or clinical isolated syndrome.&#xD;
&#xD;
        2. To evaluate the relation between Expended Disability Status Scale score and cognitive&#xD;
           dysfunction.&#xD;
&#xD;
        3. To evaluate the impact of depression on neuropsychological performance.&#xD;
&#xD;
        4. To evaluate the relation between cognitive dysfunction and the 9-hole peg test.&#xD;
&#xD;
        5. To evaluate the relation between cognitive dysfunction and the 25-foot walk test.&#xD;
&#xD;
      Population and Sample Patients will be selected from an electronic database that exists in&#xD;
      Centro Hospitalar Entre Douro e Vouga. They will be consecutively convoked and it will be&#xD;
      proposed neuropsychological evaluation and participation in the study.&#xD;
&#xD;
      Every patient will have a baseline neuropsychological evaluation (table 1). After that, they&#xD;
      will be randomized for training (Cogweb® program or Cogweb Monthly Notebooks®) or placebo in&#xD;
      a 2(training):1(placebo) fashion (online program of randomization). After a 3-month period of&#xD;
      tasks (training versus placebo), they will have another neuropsychological evaluation with&#xD;
      the same battery used for baseline.&#xD;
&#xD;
      Patients included in intervention arm that have computer with internet access at home will&#xD;
      perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients included in&#xD;
      intervention arm that don't have computer with internet access at home will perform a minimum&#xD;
      of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months.&#xD;
&#xD;
      Patients included in placebo arm will have to complete a task (send an email with a copy of a&#xD;
      journal/magazine heading) a minimum of 3 times a week.&#xD;
&#xD;
      Every patient included will have an outpatient appointment in the end of the first and second&#xD;
      months of tasks (training versus placebo).&#xD;
&#xD;
      The placebo group is a group of patients with multiple sclerosis, selected according to&#xD;
      inclusion and exclusion criteria, from the same database than those assigned for training.&#xD;
&#xD;
      The neuropsychological evaluation plan comprises: global efficiency (Montreal Cognitive&#xD;
      Assessment test); processing speed (reading task of Stroop test, symbol searching from&#xD;
      Wechsler Adult Intelligence Scale); attention (letter cut of Behavioural Inattention Test,&#xD;
      Trail making test part B); memory (Letter and number sequence of Wechsler Memory Scale, digit&#xD;
      memory, spatial localization of Wechsler Memory Scale, logic memory of Wechsler Memory Scale,&#xD;
      word list from Wechsler Memory Scale); executive functions (colour naming task of Stroop&#xD;
      test, inhibition from INECO frontal screening, verbal initiative from Lisbon Dementia&#xD;
      Evaluating Battery, Zoo Map from Ineco, Matrix from Wechsler Adult Intelligence Scale) and&#xD;
      anxious and depressive symptoms (Hospital Anxiety and Depression Scale).&#xD;
&#xD;
      Sample Size There will be convoked 75 patients (convenience sample).&#xD;
&#xD;
      Design Experimental, single-center study.&#xD;
&#xD;
      Clinical Practice Concomitant medication allowed Any except corticotherapy. Discontinuation&#xD;
      criteria&#xD;
&#xD;
        1. Desire of the patient to end participation in the study.&#xD;
&#xD;
        2. Noncompliance of the intervention plan or fail the appointments predetermined.&#xD;
&#xD;
      Parameters to evaluate de study objectives&#xD;
&#xD;
        1. Neuropsychological battery: performed at baseline and at 3 months after the completion&#xD;
           of study tasks (each test is composed of numerical, continuous variables).&#xD;
&#xD;
        2. Expended Disability Status Scale score: screening at baseline.&#xD;
&#xD;
        3. Stage of the disease: screening from the database.&#xD;
&#xD;
        4. Number of years of disease evolution.&#xD;
&#xD;
        5. 9-hole peg test: performed at baseline and at 3 months after the completion of study&#xD;
           tasks.&#xD;
&#xD;
        6. 25-foot walk test: performed at baseline and at 3 months after the completion of study&#xD;
           tasks.&#xD;
&#xD;
      Efficacy Endpoints Primary: To determine if an intensive cognitive rehabilitation program&#xD;
      changes, in a statistically significant way, the performance on a neuropsychological&#xD;
      evaluation after 3 months of training, comparing to the control group (number of tests scored&#xD;
      more than one standard deviation from the normal value). There will be analyzed the total and&#xD;
      partial scores for each test. The individuals with cognitive deficits at baseline will be&#xD;
      analyzes as rehabilitation group. The others (without cognitive deficits in cognitive&#xD;
      evaluation at baseline) will be analyzed as a separated group of cognitive stimulation.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. To characterize the profile of a population of patients with multiple sclerosis,&#xD;
           according to the performance in a neuropsychological battery, in terms of processing&#xD;
           speed, attention, memory and executive functions.&#xD;
&#xD;
        2. To determine the percentage of patients with Cognitive Dysfunction, defined as&#xD;
           performance &gt;1standard deviation below the median in ≥3 tests of the battery.&#xD;
&#xD;
        3. To correlate the Expended Disability Status Scale score with the Cognitive Dysfunction.&#xD;
&#xD;
        4. To correlate the Hospital Anxiety and Depression Scale score with the Cognitive&#xD;
           Dysfunction.&#xD;
&#xD;
        5. To correlate the 9-hole peg test with the Cognitive Dysfunction.&#xD;
&#xD;
        6. To correlate the 25-foot walk test with the Cognitive Dysfunction.&#xD;
&#xD;
      Safety Endpoints Not applicable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.</measure>
    <time_frame>3 months</time_frame>
    <description>Two neuropsychological assessments were made: at baseline and at 3 months with the same neuropsychological battery to all the patients.&#xD;
After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological profile of a population of patients with multiple sclerosis or clinical isolated syndrome.</measure>
    <time_frame>Baseline</time_frame>
    <description>Characterization of the cognitive profile of deficits in the following domains (percentage of deficits by domain, considering all patients who have done the baseline evaluation): global efficiency, processing speed, attention, memory and executive functions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with Cognitive Dysfunction</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients with performance &gt;1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between Expended Disability Status Scale score and cognitive dysfunction.</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients with performance &gt;1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.&#xD;
Correlation between Expended Disability Status Scale score and Cognitive Dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of depression on neuropsychological performance.</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients with performance &gt;1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.&#xD;
Correlation between Hospital Anxiety and Depression Scale score and Cognitive Dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between cognitive dysfunction and the 9-hole peg test.</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients with performance &gt;1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.&#xD;
Correlation between 9-hole peg test time frame (in seconds) and Cognitive Dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between cognitive dysfunction and the 25-foot walk test.</measure>
    <time_frame>Baseline</time_frame>
    <description>Patients with performance &gt;1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.&#xD;
Correlation between 25-foot walk test time frame (in seconds) and Cognitive Dysfunction.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Long term effects of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with Expended Disability Status Scale.</measure>
    <time_frame>9 months</time_frame>
    <description>Two neuropsychological assessments were made: at baseline and at 9 months with the same neuropsychological battery to all the patients included who performed the 3months cognitive training or placebo tasks.&#xD;
After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive training</intervention_name>
    <description>Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients who have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients who don't have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo task</intervention_name>
    <description>Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients will have to complete a placebo task (send an email with a copy of a journal/magazine heading) a minimum of 3 times a week, for 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with MS diagnosed according to McDonald criteria from 2010 and clinical&#xD;
             isolated syndrome patients.&#xD;
&#xD;
          -  Age ≥18 years old.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease relapse in the last month.&#xD;
&#xD;
          -  Corticotherapy in the last month.&#xD;
&#xD;
          -  Expended Disability Status Scale score &gt;6,0.&#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>Vitor T Cruz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Research Office - Health Sciences Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivânia A Alves, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Office, Health Sciences Department</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 18, 2013</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Universitário de Santiago</investigator_affiliation>
    <investigator_full_name>Ivânia A Alves, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Cognitive training</keyword>
  <keyword>Multiple sclerosis</keyword>
  <keyword>Cognitive deficits</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>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193906
org study id: MSR-2013
nct id: NCT02193906
lead sponsor: 
has dmc: No
The purpose of the study is to determine the effect of an web-based intensive cognitive
      rehabilitation program in neuropsychological performance of a population of patients with
      multiple sclerosis or clinical isolated syndrome.
Objectives

      Primary:

      1. To determine the effect of an intensive cognitive rehabilitation program in
      neuropsychological performance of a population of patients with multiple sclerosis or
      clinical isolated syndrome.

      Secondary:

        1. To characterize the neuropsychological profile of a population of patients with multiple
           sclerosis or clinical isolated syndrome.

        2. To evaluate the relation between Expended Disability Status Scale score and cognitive
           dysfunction.

        3. To evaluate the impact of depression on neuropsychological performance.

        4. To evaluate the relation between cognitive dysfunction and the 9-hole peg test.

        5. To evaluate the relation between cognitive dysfunction and the 25-foot walk test.

      Population and Sample Patients will be selected from an electronic database that exists in
      Centro Hospitalar Entre Douro e Vouga. They will be consecutively convoked and it will be
      proposed neuropsychological evaluation and participation in the study.

      Every patient will have a baseline neuropsychological evaluation (table 1). After that, they
      will be randomized for training (Cogweb® program or Cogweb Monthly Notebooks®) or placebo in
      a 2(training):1(placebo) fashion (online program of randomization). After a 3-month period of
      tasks (training versus placebo), they will have another neuropsychological evaluation with
      the same battery used for baseline.

      Patients included in intervention arm that have computer with internet access at home will
      perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients included in
      intervention arm that don't have computer with internet access at home will perform a minimum
      of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months.

      Patients included in placebo arm will have to complete a task (send an email with a copy of a
      journal/magazine heading) a minimum of 3 times a week.

      Every patient included will have an outpatient appointment in the end of the first and second
      months of tasks (training versus placebo).

      The placebo group is a group of patients with multiple sclerosis, selected according to
      inclusion and exclusion criteria, from the same database than those assigned for training.

      The neuropsychological evaluation plan comprises: global efficiency (Montreal Cognitive
      Assessment test); processing speed (reading task of Stroop test, symbol searching from
      Wechsler Adult Intelligence Scale); attention (letter cut of Behavioural Inattention Test,
      Trail making test part B); memory (Letter and number sequence of Wechsler Memory Scale, digit
      memory, spatial localization of Wechsler Memory Scale, logic memory of Wechsler Memory Scale,
      word list from Wechsler Memory Scale); executive functions (colour naming task of Stroop
      test, inhibition from INECO frontal screening, verbal initiative from Lisbon Dementia
      Evaluating Battery, Zoo Map from Ineco, Matrix from Wechsler Adult Intelligence Scale) and
      anxious and depressive symptoms (Hospital Anxiety and Depression Scale).

      Sample Size There will be convoked 75 patients (convenience sample).

      Design Experimental, single-center study.

      Clinical Practice Concomitant medication allowed Any except corticotherapy. Discontinuation
      criteria

        1. Desire of the patient to end participation in the study.

        2. Noncompliance of the intervention plan or fail the appointments predetermined.

      Parameters to evaluate de study objectives

        1. Neuropsychological battery: performed at baseline and at 3 months after the completion
           of study tasks (each test is composed of numerical, continuous variables).

        2. Expended Disability Status Scale score: screening at baseline.

        3. Stage of the disease: screening from the database.

        4. Number of years of disease evolution.

        5. 9-hole peg test: performed at baseline and at 3 months after the completion of study
           tasks.

        6. 25-foot walk test: performed at baseline and at 3 months after the completion of study
           tasks.

      Efficacy Endpoints Primary: To determine if an intensive cognitive rehabilitation program
      changes, in a statistically significant way, the performance on a neuropsychological
      evaluation after 3 months of training, comparing to the control group (number of tests scored
      more than one standard deviation from the normal value). There will be analyzed the total and
      partial scores for each test. The individuals with cognitive deficits at baseline will be
      analyzes as rehabilitation group. The others (without cognitive deficits in cognitive
      evaluation at baseline) will be analyzed as a separated group of cognitive stimulation.

      Secondary:

        1. To characterize the profile of a population of patients with multiple sclerosis,
           according to the performance in a neuropsychological battery, in terms of processing
           speed, attention, memory and executive functions.

        2. To determine the percentage of patients with Cognitive Dysfunction, defined as
           performance >1standard deviation below the median in ≥3 tests of the battery.

        3. To correlate the Expended Disability Status Scale score with the Cognitive Dysfunction.

        4. To correlate the Hospital Anxiety and Depression Scale score with the Cognitive
           Dysfunction.

        5. To correlate the 9-hole peg test with the Cognitive Dysfunction.

        6. To correlate the 25-foot walk test with the Cognitive Dysfunction.

      Safety Endpoints Not applicable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Effect of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with multiple sclerosis or clinical isolated syndrome.
time frame: 3 months
description: Two neuropsychological assessments were made: at baseline and at 3 months with the same neuropsychological battery to all the patients.
After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.
measure: Neuropsychological profile of a population of patients with multiple sclerosis or clinical isolated syndrome.
time frame: Baseline
description: Characterization of the cognitive profile of deficits in the following domains (percentage of deficits by domain, considering all patients who have done the baseline evaluation): global efficiency, processing speed, attention, memory and executive functions.
measure: Percentage of patients with Cognitive Dysfunction
time frame: Baseline
description: Patients with performance >1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.
measure: Relation between Expended Disability Status Scale score and cognitive dysfunction.
time frame: Baseline
description: Patients with performance >1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.
Correlation between Expended Disability Status Scale score and Cognitive Dysfunction.
measure: Impact of depression on neuropsychological performance.
time frame: Baseline
description: Patients with performance >1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.
Correlation between Hospital Anxiety and Depression Scale score and Cognitive Dysfunction.
measure: Relation between cognitive dysfunction and the 9-hole peg test.
time frame: Baseline
description: Patients with performance >1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.
Correlation between 9-hole peg test time frame (in seconds) and Cognitive Dysfunction.
measure: Relation between cognitive dysfunction and the 25-foot walk test.
time frame: Baseline
description: Patients with performance >1standard deviation below the median in ≥3 tests of the battery of neuropsychological evaluation will be considered as having Cognitive Dysfunction.
Correlation between 25-foot walk test time frame (in seconds) and Cognitive Dysfunction.
measure: Long term effects of an intensive cognitive rehabilitation program in neuropsychological performance of a population of patients with Expended Disability Status Scale.
time frame: 9 months
description: Two neuropsychological assessments were made: at baseline and at 9 months with the same neuropsychological battery to all the patients included who performed the 3months cognitive training or placebo tasks.
After that, the statistically significant differences between the two study groups (comparing the standard deviations from the normative values of each test), will be accessed. The tests will be analysed separately and globally as a battery.
arm group label: Intervention group
arm group type: Experimental
description: Cognitive training.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo task.
intervention type: Other
intervention name: Cognitive training
description: Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients who have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients who don't have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.
arm group label: Intervention group
intervention type: Other
intervention name: Placebo task
description: Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients will have to complete a placebo task (send an email with a copy of a journal/magazine heading) a minimum of 3 times a week, for 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vitor T Cruz, MD
role: Study Director
affiliation: Clinical Research Office - Health Sciences Department
last name: Ivânia A Alves, MD
role: Principal Investigator
affiliation: Clinical Research Office, Health Sciences Department
responsible party type: Principal Investigator
investigator affiliation: Campus Universitário de Santiago
investigator full name: Ivânia A Alves, MD
investigator title: MD
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Cognitive Dysfunction