NCT05474209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

June 16, 2022

Last Update Submit

July 21, 2022

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisTai Chi Chuanbalancenon-pharmacological interventionsphysical therapyposturography

Outcome Measures

Primary Outcomes (25)

  • 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

  • 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

  • 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

  • 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

  • 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

  • V0 visit- Static posturography LI

    Static posturography- - LI - line integral in mm, Objective test (instrumental), Score interpretation: The more, the worse.

    1. day

  • 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

  • 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

  • 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

  • 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

  • V0 visit- Static posturography TA

    Static posturography- TA - total area in mm2, Objective test (instrumental), Score interpretation: The more, the worse.

    1. day

  • 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

  • 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

  • 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

  • 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

  • V0 visit- Static posturography RMS

    Static posturography- - RMS - root mean square in mm, Objective test (instrumental), Score interpretation: The more, the worse.

    1. day

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (50)

  • V0 visit- EDSS - Expanded disability status scale

    1. day

  • V1 visit- EDSS - Expanded disability status scale

    3 months after V0 visit

  • V2 visit- EDSS - Expanded disability status scale

    6 months after V0 visit

  • V3 visit- EDSS - Expanded disability status scale

    9 months after V0 visit

  • V4 visit- EDSS - Expanded disability status scale

    12 months after V0 visit

  • +45 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

"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

exercise patients with multiple sclerosis

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bratislava, Slovak Republic, 83305, Slovakia

Location

Related Publications (9)

  • 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.

    PMID: 21604009RESULT

  • 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.

    PMID: 21375446RESULT

  • Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.

    PMID: 23669008RESULT

  • Alvarenga-Filho H, Sacramento PM, Ferreira TB, Hygino J, Abreu JEC, Carvalho SR, Wing AC, Alvarenga RMP, Bento CAM. Combined exercise training reduces fatigue and modulates the cytokine profile of T-cells from multiple sclerosis patients in response to neuromediators. J Neuroimmunol. 2016 Apr 15;293:91-99. doi: 10.1016/j.jneuroim.2016.02.014. Epub 2016 Feb 26.

    PMID: 27049568RESULT

  • 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.

    PMID: 26992038RESULT

  • 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.

    PMID: 10484833RESULT

  • 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.

    PMID: 25534298RESULT

  • 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.

    PMID: 25145392RESULT

  • 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.

    PMID: 37596158DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Peter Valkovič, prof.MD.PhD.

    2nd Department of Neurology, Faculty of MedicineCOMENIUS UNIVERSITY BRATISLAVA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

July 26, 2022

Study Start

January 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)