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Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
'aerobic exercise'
'isokinetic exercise'
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple sclerosis, aerobic, isokinetic, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Multipl Sclerosis
  • 18-65 years old adults
  • Patients signed informed consent forms

Exclusion Criteria:

  • Non-MS musculoskeletal system diseases
  • Congenital anomalies, limb amputations
  • Accompanying neurological diseases (Parkinson, Alzheimer, Polyneuropathy etc.)
  • Vestibular system diseases
  • Chronic diseases (diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hyperlipidemia, severe cardiac disease, malignancy)
  • Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Aerobic exercise group

    Isokinetic exercise group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Muscle strenght outcomes
    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)
    Quality of life outcomes
    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.
    The effort capacity outcomes
    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.).

    Secondary Outcome Measures

    Full Information

    First Posted
    December 25, 2018
    Last Updated
    January 13, 2019
    Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03805061
    Brief Title
    Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis
    Official Title
    Evaluation of the Effects of Aerobic and Isokinetic Exercise Program on Muscle Power Cardiovascular System and Life Quality in Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 30, 2008 (Actual)
    Primary Completion Date
    October 30, 2008 (Actual)
    Study Completion Date
    November 1, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple sclerosis, aerobic, isokinetic, exercise

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aerobic exercise group
    Arm Type
    Active Comparator
    Arm 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 Title
    Isokinetic exercise group
    Arm Type
    Active Comparator
    Arm 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(s)
    'aerobic exercise'
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    'isokinetic exercise'
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Muscle strenght outcomes
    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)
    Time Frame
    8 weeks
    Title
    Quality of life outcomes
    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.
    Time Frame
    8 weeks
    Title
    The effort capacity outcomes
    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.).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Multipl Sclerosis 18-65 years old adults Patients signed informed consent forms Exclusion Criteria: Non-MS musculoskeletal system diseases Congenital anomalies, limb amputations Accompanying neurological diseases (Parkinson, Alzheimer, Polyneuropathy etc.) Vestibular system diseases Chronic diseases (diabetes mellitus, chronic obstructive pulmonary disease, hypertension, hyperlipidemia, severe cardiac disease, malignancy) Pregnancy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sevgi Atar, M.D.
    Organizational Affiliation
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is any plan to make IPD available to other researchers.

    Learn more about this trial

    Effects of Aerobic and Isokinetic Exercise in Multiple Sclerosis

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