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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
Sponsored by
Comenius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Tai Chi Chuan, balance, non-pharmacological interventions, physical therapy, posturography

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • 2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

exercise patients with multiple sclerosis

non-exercising patients with multiple sclerosis

Arm Description

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.

the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise.

Outcomes

Primary Outcome Measures

V0 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V1 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V2 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V3 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V4 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
V0 visit- Mini-BESTest
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.
V1 visit- Mini-BESTest
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.
V2 visit- Mini-BESTest
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.
V3 visit- Mini-BESTest
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.
V4 visit- Mini-BESTest
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

V0 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V1 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V2 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V3 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V4 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
V0 visit- T25FW - Timed 25-foot walk test
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.
V1 visit- T25FW - Timed 25-foot walk test
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.
V2 visit- T25FW - Timed 25-foot walk test
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.
V3 visit- T25FW - Timed 25-foot walk test
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.
V4 visit- T25FW - Timed 25-foot walk test
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.
V0 visit- PASAT - Paced Auditory Serial Addition
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.
V1 visit- PASAT - Paced Auditory Serial Addition
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.
V2 visit- PASAT - Paced Auditory Serial Addition
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.
V3 visit- PASAT - Paced Auditory Serial Addition
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.
V4 visit- PASAT - Paced Auditory Serial Addition
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.
V0 visit- SDMT - Symbol Digit Modalities Test
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.
V1 visit- SDMT - Symbol Digit Modalities Test
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.
V2 visit- SDMT - Symbol Digit Modalities Test
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.
V3 visit- SDMT - Symbol Digit Modalities Test
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.
V4 visit- SDMT - Symbol Digit Modalities Test
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.
V0 visit- EQ-5D - European Quality of Life Questionnaire
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.
V1 visit- EQ-5D - European Quality of Life Questionnaire
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.
V2 visit- EQ-5D - European Quality of Life Questionnaire
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.
V3 visit- EQ-5D - European Quality of Life Questionnaire
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.
V4 visit- EQ-5D - European Quality of Life Questionnaire
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.
V0 visit- FES - Falls Efficacy Scale
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.
V1 visit- FES - Falls Efficacy Scale
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.
V2 visit- FES - Falls Efficacy Scale
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.
V3 visit- FES - Falls Efficacy Scale
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.
V4 visit- FES - Falls Efficacy Scale
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.
V0 visit- ABC - Activities-Specific Balance Confidence Scale
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
V1 visit- ABC - Activities-Specific Balance Confidence Scale
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
V2 visit- ABC - Activities-Specific Balance Confidence Scale
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
V3 visit- ABC - Activities-Specific Balance Confidence Scale
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
V4 visit- ABC - Activities-Specific Balance Confidence Scale
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
V0 visit- BDI-II - The Beck Depression Inventory
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
V1 visit- BDI-II - The Beck Depression Inventory
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
V2 visit- BDI-II - The Beck Depression Inventory
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
V3 visit- BDI-II - The Beck Depression Inventory
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
V4 visit- BDI-II - The Beck Depression Inventory
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
V0 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V1 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V2 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V3 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V4 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
V0 visit- MoCA - Montreal cognitive assessment
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.
V1 visit- MoCA - Montreal cognitive assessment
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.
V2 visit- MoCA - Montreal cognitive assessment
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.
V3 visit- MoCA - Montreal cognitive assessment
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.
V4 visit- MoCA - Montreal cognitive assessment
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.

Full Information

First Posted
June 16, 2022
Last Updated
July 21, 2022
Sponsor
Comenius University
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1. Study Identification

Unique Protocol Identification Number
NCT05474209
Brief Title
Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis
Acronym
TaiChi-SM
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comenius 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Tai Chi Chuan, balance, non-pharmacological interventions, physical therapy, posturography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise patients with multiple sclerosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
non-exercising patients with multiple sclerosis
Arm Type
No Intervention
Arm Description
the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise.
Intervention Type
Other
Intervention Name(s)
"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
Intervention Description
"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
Primary Outcome Measure Information:
Title
V0 visit- Static posturography
Description
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
1. day
Title
V1 visit- Static posturography
Description
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
3 months after V0 visit
Title
V2 visit- Static posturography
Description
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
6 months after V0 visit
Title
V3 visit- Static posturography
Description
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
9 months after V0 visit
Title
V4 visit- Static posturography
Description
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
12 months after V0 visit
Title
V0 visit- Static posturography LI
Description
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
1. day
Title
V1 visit- Static posturography LI
Description
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
3 months after V0 visit
Title
V2 visit- Static posturography LI
Description
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
6 months after V0 visit
Title
V3 visit- Static posturography LI
Description
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
9 months after V0 visit
Title
V4 visit- Static posturography LI
Description
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
12 months after V0 visit
Title
V0 visit- Static posturography TA
Description
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
1. day
Title
V1 visit- Static posturography TA
Description
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
3 months after V0 visit
Title
V2 visit- Static posturography TA
Description
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
6 months after V0 visit
Title
V3 visit- Static posturography TA
Description
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
9 months after V0 visit
Title
V4 visit- Static posturography TA
Description
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
12 months after V0 visit
Title
V0 visit- Static posturography RMS
Description
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
1. day
Title
V1 visit- Static posturography RMS
Description
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
3 months after V0 visit
Title
V2 visit- Static posturography RMS
Description
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
6 months after V0 visit
Title
V3 visit- Static posturography RMS
Description
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
9 months after V0 visit
Title
V4 visit- Static posturography RMS
Description
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Time Frame
12 months after V0 visit
Title
V0 visit- Mini-BESTest
Description
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.
Time Frame
1. day
Title
V1 visit- Mini-BESTest
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- Mini-BESTest
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- Mini-BESTest
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- Mini-BESTest
Description
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.
Time Frame
12 months after V0 visit
Secondary Outcome Measure Information:
Title
V0 visit- EDSS - Expanded disability status scale
Description
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Time Frame
1. day
Title
V1 visit- EDSS - Expanded disability status scale
Description
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Time Frame
3 months after V0 visit
Title
V2 visit- EDSS - Expanded disability status scale
Description
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Time Frame
6 months after V0 visit
Title
V3 visit- EDSS - Expanded disability status scale
Description
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Time Frame
9 months after V0 visit
Title
V4 visit- EDSS - Expanded disability status scale
Description
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Time Frame
12 months after V0 visit
Title
V0 visit- T25FW - Timed 25-foot walk test
Description
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.
Time Frame
1. day
Title
V1 visit- T25FW - Timed 25-foot walk test
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- T25FW - Timed 25-foot walk test
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- T25FW - Timed 25-foot walk test
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- T25FW - Timed 25-foot walk test
Description
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.
Time Frame
12 months after V0 visit
Title
V0 visit- PASAT - Paced Auditory Serial Addition
Description
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.
Time Frame
1. day
Title
V1 visit- PASAT - Paced Auditory Serial Addition
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- PASAT - Paced Auditory Serial Addition
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- PASAT - Paced Auditory Serial Addition
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- PASAT - Paced Auditory Serial Addition
Description
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.
Time Frame
12 months after V0 visit
Title
V0 visit- SDMT - Symbol Digit Modalities Test
Description
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.
Time Frame
1. day
Title
V1 visit- SDMT - Symbol Digit Modalities Test
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- SDMT - Symbol Digit Modalities Test
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- SDMT - Symbol Digit Modalities Test
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- SDMT - Symbol Digit Modalities Test
Description
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.
Time Frame
12 months after V0 visit
Title
V0 visit- EQ-5D - European Quality of Life Questionnaire
Description
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.
Time Frame
1. day
Title
V1 visit- EQ-5D - European Quality of Life Questionnaire
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- EQ-5D - European Quality of Life Questionnaire
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- EQ-5D - European Quality of Life Questionnaire
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- EQ-5D - European Quality of Life Questionnaire
Description
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.
Time Frame
12 months after V0 visit
Title
V0 visit- FES - Falls Efficacy Scale
Description
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.
Time Frame
1. day
Title
V1 visit- FES - Falls Efficacy Scale
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- FES - Falls Efficacy Scale
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- FES - Falls Efficacy Scale
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- FES - Falls Efficacy Scale
Description
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.
Time Frame
12 months after V0 visit
Title
V0 visit- ABC - Activities-Specific Balance Confidence Scale
Description
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
Time Frame
1. day
Title
V1 visit- ABC - Activities-Specific Balance Confidence Scale
Description
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
Time Frame
3 months after V0 visit
Title
V2 visit- ABC - Activities-Specific Balance Confidence Scale
Description
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
Time Frame
6 months after V0 visit
Title
V3 visit- ABC - Activities-Specific Balance Confidence Scale
Description
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
Time Frame
9 months after V0 visit
Title
V4 visit- ABC - Activities-Specific Balance Confidence Scale
Description
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
Time Frame
12 months after V0 visit
Title
V0 visit- BDI-II - The Beck Depression Inventory
Description
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
Time Frame
1. day
Title
V1 visit- BDI-II - The Beck Depression Inventory
Description
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
Time Frame
3 months after V0 visit
Title
V2 visit- BDI-II - The Beck Depression Inventory
Description
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
Time Frame
6 months after V0 visit
Title
V3 visit- BDI-II - The Beck Depression Inventory
Description
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
Time Frame
9 months after V0 visit
Title
V4 visit- BDI-II - The Beck Depression Inventory
Description
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
Time Frame
12 months after V0 visit
Title
V0 visit- BAI - The Beck Anxiety Inventory
Description
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Time Frame
1. day
Title
V1 visit- BAI - The Beck Anxiety Inventory
Description
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Time Frame
3 months after V0 visit
Title
V2 visit- BAI - The Beck Anxiety Inventory
Description
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Time Frame
6 months after V0 visit
Title
V3 visit- BAI - The Beck Anxiety Inventory
Description
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Time Frame
9 months after V0 visit
Title
V4 visit- BAI - The Beck Anxiety Inventory
Description
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Time Frame
12 months after V0 visit
Title
V0 visit- MoCA - Montreal cognitive assessment
Description
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.
Time Frame
1. day
Title
V1 visit- MoCA - Montreal cognitive assessment
Description
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.
Time Frame
3 months after V0 visit
Title
V2 visit- MoCA - Montreal cognitive assessment
Description
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.
Time Frame
6 months after V0 visit
Title
V3 visit- MoCA - Montreal cognitive assessment
Description
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.
Time Frame
9 months after V0 visit
Title
V4 visit- MoCA - Montreal cognitive assessment
Description
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.
Time Frame
12 months after V0 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinically defined MS, age from 20 to 60 years, and the ability to stand and walk independently at least 200 meters without an assistive device. Exclusion Criteria: clinical MS exacerbation during the study, disease-modifying drug change during the study, pregnancy, involvement in any other exercise programme, severe cognitive deficit (defined by Montreal Cognitive Assessment score ≤19), and any other health condition that would interfere with an exercise programme (such as musculoskeletal disorder, lung, or heart disease).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Valkovič, prof.MD.PhD.
Organizational Affiliation
2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
Official's Role
Study Chair
Facility Information:
Facility Name
2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
City
Bratislava
State/Province
Slovak Republic
ZIP/Postal Code
83305
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21604009
Citation
Gibson JC, Summers GD. Bone health in multiple sclerosis. Osteoporos Int. 2011 Dec;22(12):2935-49. doi: 10.1007/s00198-011-1644-8. Epub 2011 May 21.
Results Reference
result
PubMed Identifier
21375446
Citation
Arnett PA, Strober LB. Cognitive and neurobehavioral features in multiple sclerosis. Expert Rev Neurother. 2011 Mar;11(3):411-24. doi: 10.1586/ern.11.12.
Results Reference
result
PubMed Identifier
23669008
Citation
Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
Results Reference
result
PubMed Identifier
27049568
Citation
Alvarenga-Filho H, Sacramento PM, Ferreira TB, Hygino J, Abreu JEC, Carvalho SR, Wing AC, Alvarenga RMP, Bento CAM. Combined exercise training reduces fatigue and modulates the cytokine profile of T-cells from multiple sclerosis patients in response to neuromediators. J Neuroimmunol. 2016 Apr 15;293:91-99. doi: 10.1016/j.jneuroim.2016.02.014. Epub 2016 Feb 26.
Results Reference
result
PubMed Identifier
26992038
Citation
Wens I, Keytsman C, Deckx N, Cools N, Dalgas U, Eijnde BO. Brain derived neurotrophic factor in multiple sclerosis: effect of 24 weeks endurance and resistance training. Eur J Neurol. 2016 Jun;23(6):1028-35. doi: 10.1111/ene.12976. Epub 2016 Mar 16.
Results Reference
result
PubMed Identifier
10484833
Citation
Husted C, Pham L, Hekking A, Niederman R. Improving quality of life for people with chronic conditions: the example of t'ai chi and multiple sclerosis. Altern Ther Health Med. 1999 Sep;5(5):70-4.
Results Reference
result
PubMed Identifier
25534298
Citation
Azimzadeh E, Hosseini MA, Nourozi K, Davidson PM. Effect of Tai Chi Chuan on balance in women with multiple sclerosis. Complement Ther Clin Pract. 2015 Feb;21(1):57-60. doi: 10.1016/j.ctcp.2014.09.002. Epub 2014 Nov 27.
Results Reference
result
PubMed Identifier
25145392
Citation
Burschka JM, Keune PM, Oy UH, Oschmann P, Kuhn P. Mindfulness-based interventions in multiple sclerosis: beneficial effects of Tai Chi on balance, coordination, fatigue and depression. BMC Neurol. 2014 Aug 23;14:165. doi: 10.1186/s12883-014-0165-4.
Results Reference
result

Learn more about this trial

Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis

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