Multiple SclerosisTaiChi-SMNCT05474209
Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis
A study testing "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes in people with Multiple Sclerosis, run by Comenius University at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
Bratislava, Slovak Republic, 83305
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
- Keywords
- Multiple sclerosis, Tai Chi Chuan, balance, non-pharmacological interventions, physical therapy, posturography
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutesOther
"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
| Study group | Role | What they receive |
|---|---|---|
| exercise patients with multiple sclerosis | Active comparator | 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. Receives: Other: "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes |
| non-exercising patients with multiple sclerosis | No intervention | the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
V0 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 1. day
V1 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 3 months after V0 visit
V2 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 6 months after V0 visit
V3 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 9 months after V0 visit
V4 visit- Static posturography
Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 12 months after V0 visit
V0 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 1. day
V1 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 3 months after V0 visit
V2 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 6 months after V0 visit
V3 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 9 months after V0 visit
V4 visit- Static posturography LI
Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 12 months after V0 visit
V0 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 1. day
V1 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 3 months after V0 visit
V2 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 6 months after V0 visit
V3 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 9 months after V0 visit
V4 visit- Static posturography TA
Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 12 months after V0 visit
V0 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 1. day
V1 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 3 months after V0 visit
V2 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 6 months after V0 visit
V3 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 9 months after V0 visit
V4 visit- Static posturography RMS
Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
Secondary outcomes (50)
V0 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Measured: 1. day
V1 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Measured: 3 months after V0 visit
V2 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Measured: 6 months after V0 visit
V3 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Measured: 9 months after V0 visit
V4 visit- EDSS - Expanded disability status scale
EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
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
Measured: 1. day
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
Measured: 3 months after V0 visit
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
Measured: 6 months after V0 visit
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
Measured: 9 months after V0 visit
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
Measured: 12 months after V0 visit
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
Measured: 1. day
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
Measured: 3 months after V0 visit
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
Measured: 6 months after V0 visit
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
Measured: 9 months after V0 visit
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
Measured: 12 months after V0 visit
V0 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Measured: 1. day
V1 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Measured: 3 months after V0 visit
V2 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Measured: 6 months after V0 visit
V3 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Measured: 9 months after V0 visit
V4 visit- BAI - The Beck Anxiety Inventory
BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse
Measured: 12 months after V0 visit
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.
Measured: 1. day
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.
Measured: 3 months after V0 visit
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.
Measured: 6 months after V0 visit
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.
Measured: 9 months after V0 visit
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.
Measured: 12 months after V0 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Valkovič, prof.MD.PhD., Study chair, 2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474209
- Sponsor's protocol ID
- EC/0130/2020/UNBKramare
- Acronym
- TaiChi-SM
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21604009Arnett 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.
PubMed 21375446Latimer-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.
PubMed 23669008Alvarenga-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.
PubMed 27049568Wens 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.
PubMed 26992038Husted 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.
PubMed 10484833Azimzadeh 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.
PubMed 25534298Burschka 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.
PubMed 25145392Menkyova I, Stastna D, Novotna K, Saling M, Lisa I, Vesely T, Slezakova D, Valkovic P. Effect of Tai-chi on balance, mood, cognition, and quality of life in women with multiple sclerosis: A one-year prospective study. Explore (NY). 2024 Mar-Apr;20(2):188-195. doi: 10.1016/j.explore.2023.07.011. Epub 2023 Aug 6.
PubMed 37596158
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05474209
- Acronym / sponsor ID
- TaiChi-SM / EC/0130/2020/UNBKramare
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Tai Chi Chuan, balance, non-pharmacological interventions, physical therapy, posturography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| exercise patients with multiple sclerosis | Active comparator | Other: "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutesa 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. |
| non-exercising patients with multiple sclerosis | No intervention | –the group will be a control group, patients with multiple sclerosis undergo a whole battery of examinations and scales, they will not undergo exercise. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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 | Other | exercise patients with multiple sclerosis |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
50 secondary outcomes
V0 visit- EDSS - Expanded disability status scale
Time frame: 1. day
V1 visit- EDSS - Expanded disability status scale
Time frame: 3 months after V0 visit
V2 visit- EDSS - Expanded disability status scale
Time frame: 6 months after V0 visit
V3 visit- EDSS - Expanded disability status scale
Time frame: 9 months after V0 visit
V4 visit- EDSS - Expanded disability status scale
Time frame: 12 months after V0 visit
V0 visit- T25FW - Timed 25-foot walk test
Time frame: 1. day
V1 visit- T25FW - Timed 25-foot walk test
Time frame: 3 months after V0 visit
V2 visit- T25FW - Timed 25-foot walk test
Time frame: 6 months after V0 visit
V3 visit- T25FW - Timed 25-foot walk test
Time frame: 9 months after V0 visit
V4 visit- T25FW - Timed 25-foot walk test
Time frame: 12 months after V0 visit
V0 visit- PASAT - Paced Auditory Serial Addition
Time frame: 1. day
V1 visit- PASAT - Paced Auditory Serial Addition
Time frame: 3 months after V0 visit
V2 visit- PASAT - Paced Auditory Serial Addition
Time frame: 6 months after V0 visit
V3 visit- PASAT - Paced Auditory Serial Addition
Time frame: 9 months after V0 visit
V4 visit- PASAT - Paced Auditory Serial Addition
Time frame: 12 months after V0 visit
V0 visit- SDMT - Symbol Digit Modalities Test
Time frame: 1. day
V1 visit- SDMT - Symbol Digit Modalities Test
Time frame: 3 months after V0 visit
V2 visit- SDMT - Symbol Digit Modalities Test
Time frame: 6 months after V0 visit
V3 visit- SDMT - Symbol Digit Modalities Test
Time frame: 9 months after V0 visit
V4 visit- SDMT - Symbol Digit Modalities Test
Time frame: 12 months after V0 visit
V0 visit- EQ-5D - European Quality of Life Questionnaire
Time frame: 1. day
V1 visit- EQ-5D - European Quality of Life Questionnaire
Time frame: 3 months after V0 visit
V2 visit- EQ-5D - European Quality of Life Questionnaire
Time frame: 6 months after V0 visit
V3 visit- EQ-5D - European Quality of Life Questionnaire
Time frame: 9 months after V0 visit
V4 visit- EQ-5D - European Quality of Life Questionnaire
Time frame: 12 months after V0 visit
V0 visit- FES - Falls Efficacy Scale
Time frame: 1. day
V1 visit- FES - Falls Efficacy Scale
Time frame: 3 months after V0 visit
V2 visit- FES - Falls Efficacy Scale
Time frame: 6 months after V0 visit
V3 visit- FES - Falls Efficacy Scale
Time frame: 9 months after V0 visit
V4 visit- FES - Falls Efficacy Scale
Time frame: 12 months after V0 visit
V0 visit- ABC - Activities-Specific Balance Confidence Scale
Time frame: 1. day
V1 visit- ABC - Activities-Specific Balance Confidence Scale
Time frame: 3 months after V0 visit
V2 visit- ABC - Activities-Specific Balance Confidence Scale
Time frame: 6 months after V0 visit
V3 visit- ABC - Activities-Specific Balance Confidence Scale
Time frame: 9 months after V0 visit
V4 visit- ABC - Activities-Specific Balance Confidence Scale
Time frame: 12 months after V0 visit
V0 visit- BDI-II - The Beck Depression Inventory
Time frame: 1. day
V1 visit- BDI-II - The Beck Depression Inventory
Time frame: 3 months after V0 visit
V2 visit- BDI-II - The Beck Depression Inventory
Time frame: 6 months after V0 visit
V3 visit- BDI-II - The Beck Depression Inventory
Time frame: 9 months after V0 visit
V4 visit- BDI-II - The Beck Depression Inventory
Time frame: 12 months after V0 visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Results publication: PubMed 21604009Gibson 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 publication: PubMed 21375446Arnett 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 publication: PubMed 23669008Latimer-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 publication: PubMed 27049568Alvarenga-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 publication: PubMed 26992038Wens 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 publication: PubMed 10484833Husted 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 publication: PubMed 25534298Azimzadeh 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 publication: PubMed 25145392Burschka 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.
- Derived from this study: PubMed 37596158Menkyova I, Stastna D, Novotna K, Saling M, Lisa I, Vesely T, Slezakova D, Valkovic P. Effect of Tai-chi on balance, mood, cognition, and quality of life in women with multiple sclerosis: A one-year prospective study. Explore (NY). 2024 Mar-Apr;20(2):188-195. doi: 10.1016/j.explore.2023.07.011. Epub 2023 Aug 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Valkovič, prof.MD.PhD. study chair
2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes in people with Multiple Sclerosis, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
V0 visit- Static posturography (time frame: 1. day). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474209, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.