Sclerosis, MultipleMSDANCENCT06220409
Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients
A study testing Dance classes in people with Sclerosis, Multiple, run by Comenius University at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Sclerosis, Multiple
- What is being tested?
- Dance classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Mar 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Department of Biological and Medical Science, Faculty of Physical Education and Sport, Comenius University
Bratislava, 814 69
About this study
Official title: Effect of Dance Classes on Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients
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.
- Conditions
- Sclerosis, Multiple
- Being tested
- Dance classes
- Keywords
- Physical Activity, Gut Microbiome, Dance
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance classesOther
A 12-week dance class training program two times a week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | The patients persuading dance classes two times a wek for 3 months . Receives: Other: Dance classes |
| Passive | No intervention | The patients engage in no structured or self-induced physical exercise or activity (sedentary individuals) |
| Healthy subjects | No intervention | The subjects engage in sports recreationally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 3 months
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.
Measured: Change from baseline at 3 months
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.
Measured: Change from baseline at 3 months
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.
Measured: Changes from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Mar 2022
- Primary completion30 Aug 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Bielik, Comenius University
- Investigators
- Viktor Bielik, prof., Principal investigator, Faculty of Physical Education and Sport, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220409
- Sponsor's protocol ID
- 1/0260/21
- Acronym
- MSDANCE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dance Classes on Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06220409
- Acronym / sponsor ID
- MSDANCE / 1/0260/21
- Conditions
- Sclerosis, Multiple
- Keywords
- Physical Activity, Gut Microbiome, Dance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: Dance classesThe patients persuading dance classes two times a wek for 3 months . |
| Passive | No intervention | –The patients engage in no structured or self-induced physical exercise or activity (sedentary individuals) |
| Healthy subjects | No intervention | –The subjects engage in sports recreationally |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance classesA 12-week dance class training program two times a week for 3 months | Other | Dance |
Primary outcome
The shift in the mean gut microbiota diversity
Time frame: Change from baseline at 3 months
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.
Change from baseline in the mean quantitative mobility and leg function performance
Time frame: Change from baseline at 3 months
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.
Change from baseline in the mean quantitative upper extremity function performance
Time frame: Change from baseline at 3 months
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.
Differences in the mean quantitative maximal oxygen consumption
Time frame: Changes from baseline at 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Bielik, prof. principal investigator
Faculty of Physical Education and Sport, Comenius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance classes in people with Sclerosis, Multiple, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The shift in the mean gut microbiota diversity (time frame: Change from baseline at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.