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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05474209
• Other study ID #: EC/0130/2020/UNBKramare
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• "Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes
"Tai-chi" - a special program for patients with multiple sclerosis - once a week training with a Tai Chi instructor lasting 90 minutes for 12 months

Locations

Country	Name	City	State
Slovakia	2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA	Bratislava	Slovak Republic

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

References & Publications (8)

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 ne — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	V0 visit- Static posturography	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	1. day
Primary	V1 visit- Static posturography	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	3 months after V0 visit
Primary	V2 visit- Static posturography	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	6 months after V0 visit
Primary	V3 visit- Static posturography	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	9 months after V0 visit
Primary	V4 visit- Static posturography	Static posturography- eyes closed on the foam rubber in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	12 months after V0 visit
Primary	V0 visit- Static posturography LI	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.	1. day
Primary	V1 visit- Static posturography LI	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.	3 months after V0 visit
Primary	V2 visit- Static posturography LI	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.	6 months after V0 visit
Primary	V3 visit- Static posturography LI	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.	9 months after V0 visit
Primary	V4 visit- Static posturography LI	Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.	12 months after V0 visit
Primary	V0 visit- Static posturography TA	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	1. day
Primary	V1 visit- Static posturography TA	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	3 months after V0 visit
Primary	V2 visit- Static posturography TA	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	6 months after V0 visit
Primary	V3 visit- Static posturography TA	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	9 months after V0 visit
Primary	V4 visit- Static posturography TA	Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.	12 months after V0 visit
Primary	V0 visit- Static posturography RMS	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.	1. day
Primary	V1 visit- Static posturography RMS	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.	3 months after V0 visit
Primary	V2 visit- Static posturography RMS	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.	6 months after V0 visit
Primary	V3 visit- Static posturography RMS	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.	9 months after V0 visit
Primary	V4 visit- Static posturography RMS	Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.	12 months after V0 visit
Primary	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.	1. day
Primary	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.	3 months after V0 visit
Primary	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.	6 months after V0 visit
Primary	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.	9 months after V0 visit
Primary	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.	12 months after V0 visit
Secondary	V0 visit- EDSS - Expanded disability status scale	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse	1. day
Secondary	V1 visit- EDSS - Expanded disability status scale	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse	3 months after V0 visit
Secondary	V2 visit- EDSS - Expanded disability status scale	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse	6 months after V0 visit
Secondary	V3 visit- EDSS - Expanded disability status scale	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse	9 months after V0 visit
Secondary	V4 visit- EDSS - Expanded disability status scale	EDSS - Expanded disability status scale in points from 0 - 10, Ordinal rating system, The more, the worse	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit
Secondary	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	1. day
Secondary	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	3 months after V0 visit
Secondary	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	6 months after V0 visit
Secondary	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	9 months after V0 visit
Secondary	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	12 months after V0 visit
Secondary	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	1. day
Secondary	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	3 months after V0 visit
Secondary	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	6 months after V0 visit
Secondary	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	9 months after V0 visit
Secondary	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	12 months after V0 visit
Secondary	V0 visit- BAI - The Beck Anxiety Inventory	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse	1. day
Secondary	V1 visit- BAI - The Beck Anxiety Inventory	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse	3 months after V0 visit
Secondary	V2 visit- BAI - The Beck Anxiety Inventory	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse	6 months after V0 visit
Secondary	V3 visit- BAI - The Beck Anxiety Inventory	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse	9 months after V0 visit
Secondary	V4 visit- BAI - The Beck Anxiety Inventory	BAI - The Beck Anxiety Inventory in points from 0 - 63, Questionnaire, The more, the worse	12 months after V0 visit
Secondary	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.	1. day
Secondary	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.	3 months after V0 visit
Secondary	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.	6 months after V0 visit
Secondary	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.	9 months after V0 visit
Secondary	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.	12 months after V0 visit