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Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis (TaiChi-SM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05474209
Recruitment Status : Completed
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Comenius University

Brief Summary:
Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system (CNS). The clinical picture is very variable, ultimately resulting in disability. Disease attacks manifest themselves depending on the location of the CNS damaged by inflammation, demyelination, axonal loss and gliosis. The most common manifestations include motor disorders with the development of stiffness, balance and coordination, cognition, fatigue and depression. In the long term, most patients with MS will achieve significant and irreversible incapacitation. Immunomodulatory therapy is designed to reduce disease activity, slowing progression, but only to a certain extent. A significant benefit, but little researched, is physical exercise. Tai Chi has a positive effect on various neurological diseases. In recent studies, Tai Chi has shown improvements in coordination and balance, depression, anxiety, cognition and overall quality of life in patients with MS. The aim of the project is to assess the therapeutic value of structured Tai Chi exercise based on published clinical work.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes Not Applicable

Detailed Description:
Multiple sclerosis (MS) is a chronic disease that mainly affects young people with a maximum incidence in working age. Demyelination, axial damage, inflammation and gliosis affect the brain, spinal cord and optic nerves. The resulting symptoms are both physical and mental, and are closely related. The degree of disability in MS can range from relatively benign to malignant forms leading to severe disability in patients over several years. The most common symptoms of MS are impaired motor and sensitive functions, imbalances and coordination. Loss of balance leads to falls, in patients with MS they occur with a prevalence of 34-64%. The result is injuries, fractures, soft tissue damage, restricted activities and reduced mobility. The psychological aspect is loss of independence, social isolation, reduced quality of life. The clinical picture of MS also includes cognitive dysfunction (more than half of patients with MS) and a number of neurobehavioral disorders, especially fatigue (53-90%), depression (with a prevalence of 40-60%), anxiety disorders (35%). They are conditioned not only by reactivity, but indeed by the pathophysiology of the disease itself. Cognitive and affective symptoms associated with MS are a serious psychosocial factor limiting the course of the disease. MS is an incurable disease. Immunomodulatory therapy, which is continuously modified according to the patient's condition, is essentially a variety of effective prevention of progression of disability. At present, there is not enough knowledge about the right combination and structure of programmed physical exercise, which would significantly alleviate the symptoms of MS. While in the past it has not been recommended to patients in the traditional sense of MS, recent findings integrate physical exercise into the treatment of MS as an essential component. Current research points to significant benefits of physical activity in patients with MS: improved aerobic capacity and muscle strength, mobility, fatigue, and quality of life. Even the potential of physical exercise for the pathology of SM itself is expected, namely anti-inflammatory - by modulating the cytokine profile of T-cells and neuroprotective - by increasing the level of serum BDNF (brain-derived neurotrophic factor). Tai Chi Chuan - The inner art of Taoist Tai Chi is not practiced as a martial art technique or in a competitive spirit. A characteristic feature of Tai Chi is stretching and rotation in every movement. Another aspect is the emphasis on sitting and getting up, which helps to improve balance, strengthen legs, tendons and ligaments. Tai Chi also has a spiritual dimension associated with physical exercise. The primary goal is relaxation of body and soul, for Tai Chi are characterized by slow and controlled movements, deep relaxed breathing and correct posture through a state of awareness and concentration. Tai Chi improves flexibility, range of motion, muscle strength and balance and therefore could be beneficial for MS patients. As many of the basic principles of Tai Chi are directly related to postural control, initial smaller studies have begun to show that improvements in depression, quality of life and balance have improved.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention study will include treated patients with relapsing-remitting MS who meet the 2010 MR McDonald criteria for dissemination in time and space, last month before enrollment without relapse, no severe cognitive impairment, and according to the Kurtz Disability Scale (EDSS). 4.5 for 12 months and exercise intensity three times a week.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Combined Impact of a Structured Tai Chi Exercise Program on Selected Clinical Aspects and Quality of Life of Patients With Multiple Sclerosis
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: exercise patients with multiple sclerosis
a group that undergoes a "tai-chi" intervention - a special program for patients with multiple sclerosis - once a week with a Tai Chi instructor lasting 90 minutes. At V0, each patient will receive an accurate instructional video for a separate home exercise "tai-chi" at an intensity of twice a week.
Other: "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes for 12 months

No Intervention: non-exercising patients with multiple sclerosis
the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise.



Primary Outcome Measures :
  1. V0 visit- Static posturography [ Time Frame: 1. day ]
    Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  2. V1 visit- Static posturography [ Time Frame: 3 months after V0 visit ]
    Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  3. V2 visit- Static posturography [ Time Frame: 6 months after V0 visit ]
    Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  4. V3 visit- Static posturography [ Time Frame: 9 months after V0 visit ]
    Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  5. V4 visit- Static posturography [ Time Frame: 12 months after V0 visit ]
    Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  6. V0 visit- Static posturography LI [ Time Frame: 1. day ]
    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  7. V1 visit- Static posturography LI [ Time Frame: 3 months after V0 visit ]
    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  8. V2 visit- Static posturography LI [ Time Frame: 6 months after V0 visit ]
    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  9. V3 visit- Static posturography LI [ Time Frame: 9 months after V0 visit ]
    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  10. V4 visit- Static posturography LI [ Time Frame: 12 months after V0 visit ]
    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  11. V0 visit- Static posturography TA [ Time Frame: 1. day ]
    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  12. V1 visit- Static posturography TA [ Time Frame: 3 months after V0 visit ]
    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  13. V2 visit- Static posturography TA [ Time Frame: 6 months after V0 visit ]
    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  14. V3 visit- Static posturography TA [ Time Frame: 9 months after V0 visit ]
    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  15. V4 visit- Static posturography TA [ Time Frame: 12 months after V0 visit ]
    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

  16. V0 visit- Static posturography RMS [ Time Frame: 1. day ]
    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  17. V1 visit- Static posturography RMS [ Time Frame: 3 months after V0 visit ]
    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  18. V2 visit- Static posturography RMS [ Time Frame: 6 months after V0 visit ]
    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  19. V3 visit- Static posturography RMS [ Time Frame: 9 months after V0 visit ]
    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  20. V4 visit- Static posturography RMS [ Time Frame: 12 months after V0 visit ]
    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

  21. V0 visit- Mini-BESTest [ Time Frame: 1. day ]

    Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.

    The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.


  22. V1 visit- Mini-BESTest [ Time Frame: 3 months after V0 visit ]

    Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.

    The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.


  23. V2 visit- Mini-BESTest [ Time Frame: 6 months after V0 visit ]

    Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.

    The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.


  24. V3 visit- Mini-BESTest [ Time Frame: 9 months after V0 visit ]

    Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.

    The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.


  25. V4 visit- Mini-BESTest [ Time Frame: 12 months after V0 visit ]

    Mini-BESTest - Balance Evaluation Systems Test measure in points from 0 - 28. Objective test (clinical), The less, the worse.

    The Mini-BESTest consists of 14 tasks that assess static, proactive, and reactive balance. This balance measure is a shorter version of the original 27-item BESTest and takes only 15 minutes to administer. The mini-BESTest may be more appropriate and effective for ambulatory people with MS with relatively few walking disabilities. Higher scores mean better outcome.



Secondary Outcome Measures :
  1. V0 visit- EDSS - Expanded disability status scale [ Time Frame: 1. day ]
    EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse

  2. V1 visit- EDSS - Expanded disability status scale [ Time Frame: 3 months after V0 visit ]
    EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse

  3. V2 visit- EDSS - Expanded disability status scale [ Time Frame: 6 months after V0 visit ]
    EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse

  4. V3 visit- EDSS - Expanded disability status scale [ Time Frame: 9 months after V0 visit ]
    EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse

  5. V4 visit- EDSS - Expanded disability status scale [ Time Frame: 12 months after V0 visit ]
    EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse

  6. V0 visit- T25FW - Timed 25-foot walk test [ Time Frame: 1. day ]

    T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.


  7. V1 visit- T25FW - Timed 25-foot walk test [ Time Frame: 3 months after V0 visit ]

    T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.


  8. V2 visit- T25FW - Timed 25-foot walk test [ Time Frame: 6 months after V0 visit ]

    T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.


  9. V3 visit- T25FW - Timed 25-foot walk test [ Time Frame: 9 months after V0 visit ]

    T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.


  10. V4 visit- T25FW - Timed 25-foot walk test [ Time Frame: 12 months after V0 visit ]

    T25FW - Timed 25-foot walk test in seconds, Objective test (clinical), The more, the worse.

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score for the T25-FW is the average of the two completed trials. Higher scores mean worse outcome.


  11. V0 visit- PASAT - Paced Auditory Serial Addition [ Time Frame: 1. day ]

    PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.

    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.


  12. V1 visit- PASAT - Paced Auditory Serial Addition [ Time Frame: 3 months after V0 visit ]

    PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.

    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.


  13. V2 visit- PASAT - Paced Auditory Serial Addition [ Time Frame: 6 months after V0 visit ]

    PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.

    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.


  14. V3 visit- PASAT - Paced Auditory Serial Addition [ Time Frame: 9 months after V0 visit ]

    PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.

    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.


  15. V4 visit- PASAT - Paced Auditory Serial Addition [ Time Frame: 12 months after V0 visit ]

    PASAT - Paced Auditory Serial Addition in correct items from 0 - 60, Scale, The less, the worse.

    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. The score for the PASAT is the total number correct out of 60 possible answers. Higher scores mean better outcome.


  16. V0 visit- SDMT - Symbol Digit Modalities Test [ Time Frame: 1. day ]

    SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.

    The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.


  17. V1 visit- SDMT - Symbol Digit Modalities Test [ Time Frame: 3 months after V0 visit ]

    SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.

    The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.


  18. V2 visit- SDMT - Symbol Digit Modalities Test [ Time Frame: 6 months after V0 visit ]

    SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.

    The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.


  19. V3 visit- SDMT - Symbol Digit Modalities Test [ Time Frame: 9 months after V0 visit ]

    SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.

    The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.


  20. V4 visit- SDMT - Symbol Digit Modalities Test [ Time Frame: 12 months after V0 visit ]

    SDMT - Symbol Digit Modalities Test in correct items from 0 - 110, Scale, The less, the worse.

    The Symbol Digit Modalities Test (SDMT) is the most sensitive screening metric of neurocognitive function in multiple sclerosis (MS) and is consistently interpreted as a measure of information processing speed (IPS), attention and working memory. It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key. Higher scores mean better outcome.


  21. V0 visit- EQ-5D - European Quality of Life Questionnaire [ Time Frame: 1. day ]
    The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.

  22. V1 visit- EQ-5D - European Quality of Life Questionnaire [ Time Frame: 3 months after V0 visit ]
    The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.

  23. V2 visit- EQ-5D - European Quality of Life Questionnaire [ Time Frame: 6 months after V0 visit ]
    The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.

  24. V3 visit- EQ-5D - European Quality of Life Questionnaire [ Time Frame: 9 months after V0 visit ]
    The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.

  25. V4 visit- EQ-5D - European Quality of Life Questionnaire [ Time Frame: 12 months after V0 visit ]
    The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Higher scores mean worse outcome. Part II is scored from 0 to 100. The score from Part II can be used to track changes in health, on an individual or group level, over time. Higher scores mean better outcome.

  26. V0 visit- FES - Falls Efficacy Scale [ Time Frame: 1. day ]
    FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  27. V1 visit- FES - Falls Efficacy Scale [ Time Frame: 3 months after V0 visit ]
    FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  28. V2 visit- FES - Falls Efficacy Scale [ Time Frame: 6 months after V0 visit ]
    FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  29. V3 visit- FES - Falls Efficacy Scale [ Time Frame: 9 months after V0 visit ]
    FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  30. V4 visit- FES - Falls Efficacy Scale [ Time Frame: 12 months after V0 visit ]
    FES - Falls Efficacy Scale in points from 0 - 100, Questionnaire, The more, the worse The FES is a questionnaire assessing the confidence level individuals have in performing daily activities without falling. The FES is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Higher scores mean worse outcome. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.

  31. V0 visit- ABC - Activities-Specific Balance Confidence Scale [ Time Frame: 1. day ]
    ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of > 80% indicates high level of functioning

  32. V1 visit- ABC - Activities-Specific Balance Confidence Scale [ Time Frame: 3 months after V0 visit ]
    ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of > 80% indicates high level of functioning

  33. V2 visit- ABC - Activities-Specific Balance Confidence Scale [ Time Frame: 6 months after V0 visit ]
    ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of > 80% indicates high level of functioning

  34. V3 visit- ABC - Activities-Specific Balance Confidence Scale [ Time Frame: 9 months after V0 visit ]
    ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of > 80% indicates high level of functioning

  35. V4 visit- ABC - Activities-Specific Balance Confidence Scale [ Time Frame: 12 months after V0 visit ]
    ABC - Activities-Specific Balance Confidence Scale in points from 0 - 150, Questionnaire, The less, the worse Perceived balance confidence was evaluated by Activity Balance Confidence scale (ABC). This test assesses the self-reported patient´s level of confidence while performing a continuum of less and more challenging 16 common daily activities. Higher scores mean better outcome. A score of > 80% indicates high level of functioning

  36. V0 visit- BDI-II - The Beck Depression Inventory [ Time Frame: 1. day ]
    BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome

  37. V1 visit- BDI-II - The Beck Depression Inventory [ Time Frame: 3 months after V0 visit ]
    BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome

  38. V2 visit- BDI-II - The Beck Depression Inventory [ Time Frame: 6 months after V0 visit ]
    BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome

  39. V3 visit- BDI-II - The Beck Depression Inventory [ Time Frame: 9 months after V0 visit ]
    BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome

  40. V4 visit- BDI-II - The Beck Depression Inventory [ Time Frame: 12 months after V0 visit ]
    BDI-II - The Beck Depression Inventory in points from 0 - 63, Questionnaire, The more, the worse The Beck Depression Inventory (BDI-II) is a widely clinically used 21-item self-reported scale to evaluate the severity of depression. The Beck Anxiety Inventory (BAI) is self-reported 21-scale to evaluate the level of anxiety. Both of scales minimum value is 0 and maximum value is 63. Higher scores mean worse outcome

  41. V0 visit- BAI - The Beck Anxiety Inventory [ Time Frame: 1. day ]
    BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse

  42. V1 visit- BAI - The Beck Anxiety Inventory [ Time Frame: 3 months after V0 visit ]
    BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse

  43. V2 visit- BAI - The Beck Anxiety Inventory [ Time Frame: 6 months after V0 visit ]
    BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse

  44. V3 visit- BAI - The Beck Anxiety Inventory [ Time Frame: 9 months after V0 visit ]
    BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse

  45. V4 visit- BAI - The Beck Anxiety Inventory [ Time Frame: 12 months after V0 visit ]
    BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse

  46. V0 visit- MoCA - Montreal cognitive assessment [ Time Frame: 1. day ]

    MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.

    MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.


  47. V1 visit- MoCA - Montreal cognitive assessment [ Time Frame: 3 months after V0 visit ]

    MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.

    MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.


  48. V2 visit- MoCA - Montreal cognitive assessment [ Time Frame: 6 months after V0 visit ]

    MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.

    MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.


  49. V3 visit- MoCA - Montreal cognitive assessment [ Time Frame: 9 months after V0 visit ]

    MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.

    MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.


  50. V4 visit- MoCA - Montreal cognitive assessment [ Time Frame: 12 months after V0 visit ]

    MoCA - Montreal cognitive assessment in points from 0 - 30, Scale, The less, the worse.

    MoCA is a widely used screening assessment for detecting cognitive impairment. This test consists of 30 points and takes part in 10 minutes from the individual. The Montreal test is performed in seven steps, which may change in some countries dependent on education and culture. The basics of this test include short-term memory, executable performance, attention and focus. Higher scores mean better outcome.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinically defined MS,
  2. age from 20 to 60 years,
  3. and the ability to stand and walk independently at least 200 meters without an assistive device.

Exclusion Criteria:

  1. clinical MS exacerbation during the study,
  2. disease-modifying drug change during the study,
  3. pregnancy,
  4. involvement in any other exercise programme,
  5. severe cognitive deficit (defined by Montreal Cognitive Assessment score ≤19), and
  6. any other health condition that would interfere with an exercise programme (such as musculoskeletal disorder, lung, or heart disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05474209


Locations
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Slovakia
2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
Bratislava, Slovak Republic, Slovakia, 83305
Sponsors and Collaborators
Comenius University
Investigators
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Study Chair: Peter Valkovič, prof.MD.PhD. 2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
Publications of Results:

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Responsible Party: Comenius University
ClinicalTrials.gov Identifier: NCT05474209    
Other Study ID Numbers: EC/0130/2020/UNBKramare
First Posted: July 26, 2022    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Comenius University:
Multiple sclerosis
Tai Chi Chuan
balance
non-pharmacological interventions
physical therapy
posturography
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases