Clinical trial NCT05474209: Effect of Tai Chi on Balance, Mood, Cognition, and Quality of Life in Patients With Multiple Sclerosis
Official title: The Combined Impact of a Structured Tai Chi Exercise Program on Selected Clinical Aspects and Quality of Life of Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Tai Chi Chuan
balance
non-pharmacological interventions
physical therapy
posturography
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention study will include treated patients with relapsing-remitting MS who meet the 2010 MR McDonald criteria for dissemination in time and space, last month before enrollment without relapse, no severe cognitive impairment, and according to the Kurtz Disability Scale (EDSS). 4.5 for 12 months and exercise intensity three times a week.
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: V0 visit- Static posturography
timeFrame: 1. day
measure: V1 visit- Static posturography
timeFrame: 3 months after V0 visit
measure: V2 visit- Static posturography
timeFrame: 6 months after V0 visit
measure: V3 visit- Static posturography
timeFrame: 9 months after V0 visit
measure: V4 visit- Static posturography
timeFrame: 12 months after V0 visit
measure: V0 visit- Static posturography LI
timeFrame: 1. day
measure: V1 visit- Static posturography LI
timeFrame: 3 months after V0 visit
measure: V2 visit- Static posturography LI
timeFrame: 6 months after V0 visit
measure: V3 visit- Static posturography LI
timeFrame: 9 months after V0 visit
measure: V4 visit- Static posturography LI
timeFrame: 12 months after V0 visit
measure: V0 visit- Static posturography TA
timeFrame: 1. day
measure: V1 visit- Static posturography TA
timeFrame: 3 months after V0 visit
measure: V2 visit- Static posturography TA
timeFrame: 6 months after V0 visit
measure: V3 visit- Static posturography TA
timeFrame: 9 months after V0 visit
measure: V4 visit- Static posturography TA
timeFrame: 12 months after V0 visit
measure: V0 visit- Static posturography RMS
timeFrame: 1. day
measure: V1 visit- Static posturography RMS
timeFrame: 3 months after V0 visit
measure: V2 visit- Static posturography RMS
timeFrame: 6 months after V0 visit
measure: V3 visit- Static posturography RMS
timeFrame: 9 months after V0 visit
measure: V4 visit- Static posturography RMS
timeFrame: 12 months after V0 visit
measure: V0 visit- Mini-BESTest
timeFrame: 1. day
measure: V1 visit- Mini-BESTest
timeFrame: 3 months after V0 visit
measure: V2 visit- Mini-BESTest
timeFrame: 6 months after V0 visit
measure: V3 visit- Mini-BESTest
timeFrame: 9 months after V0 visit
measure: V4 visit- Mini-BESTest
timeFrame: 12 months after V0 visit
Secondary outcomes:
measure: V0 visit- EDSS - Expanded disability status scale
timeFrame: 1. day
measure: V1 visit- EDSS - Expanded disability status scale
timeFrame: 3 months after V0 visit
measure: V2 visit- EDSS - Expanded disability status scale
timeFrame: 6 months after V0 visit
measure: V3 visit- EDSS - Expanded disability status scale
timeFrame: 9 months after V0 visit
measure: V4 visit- EDSS - Expanded disability status scale
timeFrame: 12 months after V0 visit
measure: V0 visit- T25FW - Timed 25-foot walk test
timeFrame: 1. day
measure: V1 visit- T25FW - Timed 25-foot walk test
timeFrame: 3 months after V0 visit
measure: V2 visit- T25FW - Timed 25-foot walk test
timeFrame: 6 months after V0 visit
measure: V3 visit- T25FW - Timed 25-foot walk test
timeFrame: 9 months after V0 visit
measure: V4 visit- T25FW - Timed 25-foot walk test
timeFrame: 12 months after V0 visit
measure: V0 visit- PASAT - Paced Auditory Serial Addition
timeFrame: 1. day
measure: V1 visit- PASAT - Paced Auditory Serial Addition
timeFrame: 3 months after V0 visit
measure: V2 visit- PASAT - Paced Auditory Serial Addition
timeFrame: 6 months after V0 visit
measure: V3 visit- PASAT - Paced Auditory Serial Addition
timeFrame: 9 months after V0 visit
measure: V4 visit- PASAT - Paced Auditory Serial Addition
timeFrame: 12 months after V0 visit
measure: V0 visit- SDMT - Symbol Digit Modalities Test
timeFrame: 1. day
measure: V1 visit- SDMT - Symbol Digit Modalities Test
timeFrame: 3 months after V0 visit
measure: V2 visit- SDMT - Symbol Digit Modalities Test
timeFrame: 6 months after V0 visit
measure: V3 visit- SDMT - Symbol Digit Modalities Test
timeFrame: 9 months after V0 visit
measure: V4 visit- SDMT - Symbol Digit Modalities Test
timeFrame: 12 months after V0 visit
measure: V0 visit- EQ-5D - European Quality of Life Questionnaire
timeFrame: 1. day
measure: V1 visit- EQ-5D - European Quality of Life Questionnaire
timeFrame: 3 months after V0 visit
measure: V2 visit- EQ-5D - European Quality of Life Questionnaire
timeFrame: 6 months after V0 visit
measure: V3 visit- EQ-5D - European Quality of Life Questionnaire
timeFrame: 9 months after V0 visit
measure: V4 visit- EQ-5D - European Quality of Life Questionnaire
timeFrame: 12 months after V0 visit
measure: V0 visit- FES - Falls Efficacy Scale
timeFrame: 1. day
measure: V1 visit- FES - Falls Efficacy Scale
timeFrame: 3 months after V0 visit
measure: V2 visit- FES - Falls Efficacy Scale
timeFrame: 6 months after V0 visit
measure: V3 visit- FES - Falls Efficacy Scale
timeFrame: 9 months after V0 visit
measure: V4 visit- FES - Falls Efficacy Scale
timeFrame: 12 months after V0 visit
measure: V0 visit- ABC - Activities-Specific Balance Confidence Scale
timeFrame: 1. day
measure: V1 visit- ABC - Activities-Specific Balance Confidence Scale
timeFrame: 3 months after V0 visit
measure: V2 visit- ABC - Activities-Specific Balance Confidence Scale
timeFrame: 6 months after V0 visit
measure: V3 visit- ABC - Activities-Specific Balance Confidence Scale
timeFrame: 9 months after V0 visit
measure: V4 visit- ABC - Activities-Specific Balance Confidence Scale
timeFrame: 12 months after V0 visit
measure: V0 visit- BDI-II - The Beck Depression Inventory
timeFrame: 1. day
measure: V1 visit- BDI-II - The Beck Depression Inventory
timeFrame: 3 months after V0 visit
measure: V2 visit- BDI-II - The Beck Depression Inventory
timeFrame: 6 months after V0 visit
measure: V3 visit- BDI-II - The Beck Depression Inventory
timeFrame: 9 months after V0 visit
measure: V4 visit- BDI-II - The Beck Depression Inventory
timeFrame: 12 months after V0 visit
measure: V0 visit- BAI - The Beck Anxiety Inventory
timeFrame: 1. day
measure: V1 visit- BAI - The Beck Anxiety Inventory
timeFrame: 3 months after V0 visit
measure: V2 visit- BAI - The Beck Anxiety Inventory
timeFrame: 6 months after V0 visit
measure: V3 visit- BAI - The Beck Anxiety Inventory
timeFrame: 9 months after V0 visit
measure: V4 visit- BAI - The Beck Anxiety Inventory
timeFrame: 12 months after V0 visit
measure: V0 visit- MoCA - Montreal cognitive assessment
timeFrame: 1. day
measure: V1 visit- MoCA - Montreal cognitive assessment
timeFrame: 3 months after V0 visit
measure: V2 visit- MoCA - Montreal cognitive assessment
timeFrame: 6 months after V0 visit
measure: V3 visit- MoCA - Montreal cognitive assessment
timeFrame: 9 months after V0 visit
measure: V4 visit- MoCA - Montreal cognitive assessment
timeFrame: 12 months after V0 visit
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: 2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
state: Slovak Republic
Study officials:
affiliation: 2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA
name: Peter Valkovič, prof.MD.PhD.
role: STUDY_CHAIR
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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.
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.