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

NCT ID: NCT05474209

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

exercise patients with multiple sclerosis

a group that undergoes a "tai-chi" intervention - a special program for patients with multiple sclerosis - once a week with a Tai Chi instructor lasting 90 minutes. At V0, each patient will receive an accurate instructional video for a separate home exercise "tai-chi" at an intensity of twice a week.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

"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

non-exercising patients with multiple sclerosis

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Valkovič, prof.MD.PhD.

Role: STUDY_CHAIR

2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA

Locations

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

Bratislava, Slovak Republic, Slovakia

Countries

Slovakia

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Menkyova 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.

Reference Type: DERIVED

PMID: 37596158 (View on PubMed)

Other Identifiers

EC/0130/2020/UNBKramare

Identifier Type: -

Identifier Source: org_study_id