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Effect of Arm Ergometer Exercise Training on Upper Extremity Function in People With Multiple Sclerosis.

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, upper extremity, balance, rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • A relapsing-remitting or secondary progressive type of multiple sclerosis,
  • To be willing to participate in the study.

Exclusion Criteria:

  • Another neurological disorder,
  • Orthopedic surgery history including the elbow, wrist, shoulder, ankle-foot, knee, hip or spine, affecting balance and upper extremity functions,
  • Diagnosed severe cognitive and/or psychiatric impairment,
  • Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
  • Having cardiac disease such as hypertension that would be a contraindication to exercise

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm ergometer-balance training

    arm ergometer

    Arm Description

    Combination of arm ergometer exercise and balance training

    Only arm ergometer exercise training

    Outcomes

    Primary Outcome Measures

    Nine-Hole Peg Test
    The Nine-Hole Peg Test measures finger dexterity.

    Secondary Outcome Measures

    Expanded Disability Status Scale
    Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
    Jamar Hand Dynamometer
    The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
    Arm Function in Multiple Sclerosis Questionnaire
    Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.
    Preference-based Multiple Sclerosis Index
    The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).
    Estimated VO2 Max
    Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.
    Modified Fatigue Impact Scale
    The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. A higher score indicates higher level of fatigue.
    Timed Up and Go test
    The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.
    Activities-Specific Balance Confidence Scale
    The Activities-Specific Balance Confidence Scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.
    Coin Rotation Test
    The coin Rotation Test is developed to assess fine motor skills and speed.

    Full Information

    First Posted
    October 5, 2022
    Last Updated
    October 5, 2022
    Sponsor
    Dokuz Eylul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05571631
    Brief Title
    Effect of Arm Ergometer Exercise Training on Upper Extremity Function in People With Multiple Sclerosis.
    Official Title
    Investigation of the Effect of the Combination of Arm Ergometer Exercise and Balance Training on Upper Extremity Function in People With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2022 (Anticipated)
    Primary Completion Date
    September 15, 2024 (Anticipated)
    Study Completion Date
    November 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dokuz Eylul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will investigate the effects of a 12-week arm ergometer exercise and balance training on upper extremity function in persons with multiple sclerosis.
    Detailed Description
    Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS (pwMS) have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of pwMS, quality of life and participation in activities in the community. Another common symptom that reduces quality of life, independence, and participation in pwMS is balance disorder, seen in 75% of cases. Abnormality in balance control occurs due to lack of postural stability, limitation of stability limits, slowness to return to the starting position during bending and reaching activities. During interaction with the environment in daily life, proprioceptive inputs from the extremities and subsequent proper trunk control enable the person to keep the center of gravity on the support surface at rest and in activity. In this way, proximal stability is provided and tasks that require participation in daily life with distal mobility are performed. It is necessary to manage these progressive symptoms associated with the disease in order to increase the quality of life of pwMS, increase the rate of participation in society and maintain this increase. Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic and quality-of-life outcomes in MS. Current literature reports that aerobic exercise has a positive effect on important parameters such as balance, fatigue, walking, quality of life, and pain in pwMS. At the same time, aerobic exercise training with arm ergometry allows pwMS to improve their upper extremity function. Apart from these, the literature has separately examined the effects of exercise training on upper extremity function and balance in pwMS, and positive effects have been shared separately. However, the relationship between these two important issues and the effect of exercise training on this relationship have not been examined. The aim of the study is to examine the effects of exercise training on upper extremity function and balance in pwMS. Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 30 participants will randomly be divided into 2 groups as arm ergometer-balance training group and arm ergometer training group. Both exercise training will be given by a physiotherapist, supervised 2 days a week for 12 weeks. Assessments will done at baseline and after 12weeks (post-treatment). Assessments will be done by assessors who are blinded to the group allocation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    multiple sclerosis, upper extremity, balance, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm ergometer-balance training
    Arm Type
    Experimental
    Arm Description
    Combination of arm ergometer exercise and balance training
    Arm Title
    arm ergometer
    Arm Type
    Experimental
    Arm Description
    Only arm ergometer exercise training
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    Arm ergometer will aplied as an aerobic exercise. Combination of balance training and arm ergometer exerise program will applied.
    Primary Outcome Measure Information:
    Title
    Nine-Hole Peg Test
    Description
    The Nine-Hole Peg Test measures finger dexterity.
    Time Frame
    Change from Baseline at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Expanded Disability Status Scale
    Description
    Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
    Time Frame
    Baseline
    Title
    Jamar Hand Dynamometer
    Description
    The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Arm Function in Multiple Sclerosis Questionnaire
    Description
    Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Preference-based Multiple Sclerosis Index
    Description
    The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Estimated VO2 Max
    Description
    Estimated VO2max will be calculated Astrand-Rhyming Cycle Ergometer Test.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Modified Fatigue Impact Scale
    Description
    The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. A higher score indicates higher level of fatigue.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Timed Up and Go test
    Description
    The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Activities-Specific Balance Confidence Scale
    Description
    The Activities-Specific Balance Confidence Scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.
    Time Frame
    Change from Baseline at 12 weeks
    Title
    Coin Rotation Test
    Description
    The coin Rotation Test is developed to assess fine motor skills and speed.
    Time Frame
    Change from Baseline at 12 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: A relapsing-remitting or secondary progressive type of multiple sclerosis, To be willing to participate in the study. Exclusion Criteria: Another neurological disorder, Orthopedic surgery history including the elbow, wrist, shoulder, ankle-foot, knee, hip or spine, affecting balance and upper extremity functions, Diagnosed severe cognitive and/or psychiatric impairment, Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD Having cardiac disease such as hypertension that would be a contraindication to exercise
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serkan Ozakbas, MD
    Phone
    +90 232 412 4964
    Email
    serkan.ozakbas@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asiye Tuba Ozdogar, PhD

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Arm Ergometer Exercise Training on Upper Extremity Function in People With Multiple Sclerosis.

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