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CompletedNCT06220409MSDANCEUpdated Jan 24, 2024

Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients

An interventional study of Dance classes in Sclerosis, Multiple, sponsored by Comenius University. Completed at 1 site in Slovakia. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-01-24.

Sponsored by Comenius University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

The evidence suggests that multiple sclerosis (MS) induces a decline in motor and cognitive function and provokes a shift in gut microbiome composition in patients. Therefore, the purpose of this study is to explore the effect of a 12-week dance class training program on the gut microbiota composition, motor function, and cognitive function of patients with MS.

The investigators will also study the following:

  • The impact of organised physical activity on quality of life
  • The impact of organised physical activity on body composition and metabolic parameters (e.g., insulin sensitivity, lipid profile, ect.)
  • The impact of organised physical activity on physical fitness (e.g., VO2max, Power, ect.)
Read the detailed description

Progressive loss of lower extremity mobility and physical function is one of the most important and well-researched effects of MS. Additionally, there is evidence that MS patients have a moderate dysbiosis in the gut microbiota structure compared to healthy subjects, whereas recent studies have demonstrated the critical role the gut microbiome plays in preserving general health, including its potential impact on neurological disorders and the immune system. Even though research is still in its early stages, the gut microbiome may have a significant impact on MS. A plethora of physical exercise strategies are available in the literature to help MS patients with fatigue, motor function, and health-related quality of life. Despite the scarcity of specific research, embracing dancing courses for MS patients has promising potential health benefits. Importantly, apart from improved physical fitness and motor function, patients with MS may also experience dancing with various other advantages, such as emotional well-being and social interaction.

Objective: This proposal aims to investigate the effects of regular physical exercise, such as dancing classes, on the health of individuals with MS. MSDANCE will investigate the impact that a dancing class training program lasting twelve weeks had on the makeup of the microbiota in the gut, as well as the motor and cognitive functioning, physical fitness, quality of life, body composition, and metabolic parameters of patients with MS. Consequently, these observations will be compared with those of healthy subjects.

Hypothesis: The investigators hypothesize that regular physical exercise (dance class training program) will improve motor and cognitive functions, with an additional positive effect on the microbial composition in patients with MS. The investigators further hypothesize the improvement in the following variables: physical fitness, quality of life, body composition, metabolic parameters, etc.

02

Conditions studied

  • Sclerosis, Multiple

Keywords

  • Physical Activity
  • Gut Microbiome
  • Dance
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Comenius University is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with multiple sclerosis, diagnosed according to official diagnostic criteria according to McDonald 2010
  • Consent ability and written consent
  • The expanded disability status scale (EDSS) \<5.5
  • age 30 - 50

Exclusion criteria

Exclusion Criteria:

  • serious comorbidities including psychiatric diseases
  • Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
  • Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
  • Nicotine consumption of > 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting.
  • Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
  • Malignant disease
  • Insufficient mental possibility of cooperation Eating disorder
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Dance

    The patients persuading dance classes two times a wek for 3 months .

    Other: Dance classes

  • No intervention
    Passive

    The patients engage in no structured or self-induced physical exercise or activity (sedentary individuals)

  • No intervention
    Healthy subjects

    The subjects engage in sports recreationally

Interventions

  • OtherDance classes

    A 12-week dance class training program two times a week for 3 months

06

What researchers measure

Primary outcomes

  1. The shift in the mean gut microbiota diversity

    Influence of the interventions on the Shannon index. The higher the index, the more diverse the species are in the habitat. The value of the Shannon-Weaver diversity index usually ranges from 1.5 to 3.5 and only rarely exceeds 4.5.

    Time frame: Change from baseline at 3 months

  2. Change from baseline in the mean quantitative mobility and leg function performance

    Influence of the interventions on a time in 25-Foot Walk. The longer the duration, the worse the outcome. Normal values: less than 4 seconds; Mild impairment: 4-5.99 seconds; Moderate impairment: 6-9.99 seconds; Severe impairment: 10 seconds or more.

    Time frame: Change from baseline at 3 months

  3. Change from baseline in the mean quantitative upper extremity function performance

    Influence of the interventions on a 9-hole Peg Test. The longer the duration, the worse the outcome. Values: 0 (completed without any delays) or more.

    Time frame: Change from baseline at 3 months

  4. Differences in the mean quantitative maximal oxygen consumption

    Comparison of maximal oxygen consumption (VO2max) within groups (MS pre-intervention vs. post-intervention) and between groups (healthy subjects vs. MS pre- and post-intervention). The higher the values, the better the outcome. The general ranges for VO2max in healthy adults are: Average Values: Men: 35-40 ml/kg/min, and Women: 27-31 ml/kg/min; Good Fitness Level: Men: 45-50 ml/kg/min and Women: 38-42 ml/kg/min; Excellent Fitness Level: Men: 55-60 ml/kg/min or higher, and Women: 47-52 ml/kg/min or higher.

    Time frame: Changes from baseline at 3 months

07

Study locations

1 site
  • Department of Biological and Medical Science, Faculty of Physical Education and Sport, Comenius University
    Bratislava, 814 69, Slovakia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06220409
Lead sponsor
Comenius University
Responsible party
Viktor Bielik (prof., Comenius University) — Principal investigator
First posted
Jan 24, 2024
Start date
Mar 1, 2022
Primary completion
Aug 30, 2023
Completion
Dec 15, 2023
Last update
Jan 24, 2024

Study contacts

Viktor Bielik, prof.
principal investigator · Faculty of Physical Education and Sport, Comenius University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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