<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/NCT03805061</url>
  </required_header>
  <id_info>
    <org_study_id>128</org_study_id>
    <nct_id>NCT03805061</nct_id>
  </id_info>
  <brief_title>Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis</brief_title>
  <official_title>Evaluation of the Effects of Aerobic and Isokinetic Exercise Program on Muscle Power Cardiovascular System and Life Quality in Multiple Sclerosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed in this study to measure the muscular strength, cardiovascular system&#xD;
      and quality of life effects of rehabilitation with aerobic and isokinetic exercise program in&#xD;
      MS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 40 patients enrolled in the study from outpatient clinics were included. Two&#xD;
      groups were formed, namely 'aerobic exercise' and 'isokinetic exercise' groups. Using&#xD;
      modified Bruce protocol, effort capacities were measured with Humac Norm Cybex dynamometer, 6&#xD;
      min. walking distance and MSQOL-54 scale were used to assess the quality of life. The aerobic&#xD;
      exercise group by using treadmill their walking speeds were adjusted according to the maximum&#xD;
      speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week,&#xD;
      30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up&#xD;
      exercise was performed before starting to work, 5-10 minutes stretching exercise at the end&#xD;
      of the exercise. Patients in the isokinetic exercise group pedaled a bicycle ergometer for&#xD;
      warming with low resistance for 5 minutes before starting to exercise, and exercise was&#xD;
      applied for 5-10 minutes to cool down at the end of the study. The exercise program was&#xD;
      applied for 8 weeks with 3 repetitions per week.&#xD;
&#xD;
      Assessment of exercise capacity (effort capacity) was performed by applying the Norav&#xD;
      Trackmaster TMX 425 Treadmill Exercise Device by applying Modified Bruce protocol. Patients'&#xD;
      total exercise times were expressed in seconds. Indirect maximum amount of oxygen volume (VO2&#xD;
      max) values were calculated using heart rate obtained with submaximal treadmill exercise.All&#xD;
      the cases participating in the study were compared in terms of the pre-treatment MSQoL-54&#xD;
      scale and the MSQoL-54 scale subscale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2008</start_date>
  <completion_date type="Actual">November 1, 2008</completion_date>
  <primary_completion_date type="Actual">October 30, 2008</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>A total of 40 patients enrolled in the study from outpatient clinics were included. Two groups were formed, namely 'aerobic exercise' and 'isokinetic exercise' groups.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strenght outcomes</measure>
    <time_frame>8 weeks</time_frame>
    <description>The measuring of muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used. The muscle strenght peak torque value was newton-meter (Nm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life outcomes</measure>
    <time_frame>8 weeks</time_frame>
    <description>Quality of life was assesment via Multiple Sclerosis Quality of Life-54 instrument (MSQoL-54). MSQol-54 consists of 54 questions in total. In all cases, they were asked to fill in the questionnaire alone and by reading it themselves. The overall MSQoL-54 scale should be between in 0-100 scores. Higher scores better than lower scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effort capacity outcomes</measure>
    <time_frame>8 weeks</time_frame>
    <description>The effort capacity was performed by applying the Norav Trackmaster TMX 425 Treadmill Exercise Device by Applying Modified Bruce Protocol. The values of the effort capacity were assesment as maximum amount of oxygen volume (ml/kg/min.).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Aerobic exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1 was 'aerobic exercise group'. Patients in this group were included in an aerobic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week, 30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up exercise was performed before starting to work, 5-10 minutes stretching exercise at the end of the exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isokinetic exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 was 'isokinetic exercise group'. Patients in this group were included in an isokinetic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low resistance for 5 minutes before starting to exercise, and exercise was applied for 5-10 minutes to cool down at the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>'aerobic exercise'</intervention_name>
    <description>The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed a period of; 8 weeks, 3 days a week, 30-45 minutes each patient.</description>
    <arm_group_label>Aerobic exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>'isokinetic exercise'</intervention_name>
    <description>Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low exercise and exercise was applied for 5-10 minutes to cool down at the end of the study. were included in a rehabilitation program that they would apply for 3 days per week for 8 weeks.The measuring of isokinetic muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used.</description>
    <arm_group_label>Isokinetic exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Multipl Sclerosis&#xD;
&#xD;
          -  18-65 years old adults&#xD;
&#xD;
          -  Patients signed informed consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-MS musculoskeletal system diseases&#xD;
&#xD;
          -  Congenital anomalies, limb amputations&#xD;
&#xD;
          -  Accompanying neurological diseases (Parkinson, Alzheimer, Polyneuropathy etc.)&#xD;
&#xD;
          -  Vestibular system diseases&#xD;
&#xD;
          -  Chronic diseases (diabetes mellitus, chronic obstructive pulmonary disease,&#xD;
             hypertension, hyperlipidemia, severe cardiac disease, malignancy)&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevgi Atar, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
    <investigator_full_name>Sevgi Atar</investigator_full_name>
    <investigator_title>Director of Administrative, Specialist, M.D.</investigator_title>
  </responsible_party>
  <keyword>Multiple sclerosis</keyword>
  <keyword>aerobic</keyword>
  <keyword>isokinetic</keyword>
  <keyword>exercise</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>No</sharing_ipd>
    <ipd_description>There is any plan to make IPD available to other researchers.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>February 23, 2021</submitted>
    <returned>March 9, 2021</returned>
  </pending_results>
  <!-- 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/NCT03805061
org study id: 128
nct id: NCT03805061
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators aimed in this study to measure the muscular strength, cardiovascular system
      and quality of life effects of rehabilitation with aerobic and isokinetic exercise program in
      MS patients.
A total of 40 patients enrolled in the study from outpatient clinics were included. Two
      groups were formed, namely 'aerobic exercise' and 'isokinetic exercise' groups. Using
      modified Bruce protocol, effort capacities were measured with Humac Norm Cybex dynamometer, 6
      min. walking distance and MSQOL-54 scale were used to assess the quality of life. The aerobic
      exercise group by using treadmill their walking speeds were adjusted according to the maximum
      speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week,
      30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up
      exercise was performed before starting to work, 5-10 minutes stretching exercise at the end
      of the exercise. Patients in the isokinetic exercise group pedaled a bicycle ergometer for
      warming with low resistance for 5 minutes before starting to exercise, and exercise was
      applied for 5-10 minutes to cool down at the end of the study. The exercise program was
      applied for 8 weeks with 3 repetitions per week.

      Assessment of exercise capacity (effort capacity) was performed by applying the Norav
      Trackmaster TMX 425 Treadmill Exercise Device by applying Modified Bruce protocol. Patients'
      total exercise times were expressed in seconds. Indirect maximum amount of oxygen volume (VO2
      max) values were calculated using heart rate obtained with submaximal treadmill exercise.All
      the cases participating in the study were compared in terms of the pre-treatment MSQoL-54
      scale and the MSQoL-54 scale subscale.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 40 patients enrolled in the study from outpatient clinics were included. Two groups were formed, namely 'aerobic exercise' and 'isokinetic exercise' groups.
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Muscle strenght outcomes
time frame: 8 weeks
description: The measuring of muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used. The muscle strenght peak torque value was newton-meter (Nm)
measure: Quality of life outcomes
time frame: 8 weeks
description: Quality of life was assesment via Multiple Sclerosis Quality of Life-54 instrument (MSQoL-54). MSQol-54 consists of 54 questions in total. In all cases, they were asked to fill in the questionnaire alone and by reading it themselves. The overall MSQoL-54 scale should be between in 0-100 scores. Higher scores better than lower scores.
measure: The effort capacity outcomes
time frame: 8 weeks
description: The effort capacity was performed by applying the Norav Trackmaster TMX 425 Treadmill Exercise Device by Applying Modified Bruce Protocol. The values of the effort capacity were assesment as maximum amount of oxygen volume (ml/kg/min.).
arm group label: Aerobic exercise group
arm group type: Active Comparator
description: Group 1 was 'aerobic exercise group'. Patients in this group were included in an aerobic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed for a period of ; 8 weeks, 3 days a week, 30-45 minutes each patient according to the progressive exercise method. 5-10 minutes warm-up exercise was performed before starting to work, 5-10 minutes stretching exercise at the end of the exercise.
arm group label: Isokinetic exercise group
arm group type: Active Comparator
description: Group 2 was 'isokinetic exercise group'. Patients in this group were included in an isokinetic exercise rehabilitation program that they would apply for 3 days per week for 8 weeks. Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low resistance for 5 minutes before starting to exercise, and exercise was applied for 5-10 minutes to cool down at the end of the study.
intervention type: Other
intervention name: 'aerobic exercise'
description: The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed a period of; 8 weeks, 3 days a week, 30-45 minutes each patient.
arm group label: Aerobic exercise group
intervention type: Device
intervention name: 'isokinetic exercise'
description: Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low exercise and exercise was applied for 5-10 minutes to cool down at the end of the study. were included in a rehabilitation program that they would apply for 3 days per week for 8 weeks.The measuring of isokinetic muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used.
arm group label: Isokinetic exercise group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sevgi Atar, M.D.
role: Principal Investigator
affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
responsible party type: Principal Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: Sevgi Atar
investigator title: Director of Administrative, Specialist, M.D.
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No
ipd description: There is any plan to make IPD available to other researchers.
submitted: February 23, 2021
returned: March 9, 2021