Clinical trial NCT06220409: Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients
Official title: Effect of Dance Classes on Gut Microbiota Composition, Cognitive Function, and Physical Fitness in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sclerosis, Multiple
Keywords: Physical Activity
Gut Microbiome
Dance
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.)

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: The shift in the mean gut microbiota diversity
timeFrame: Change from baseline at 3 months
measure: Change from baseline in the mean quantitative mobility and leg function performance
timeFrame: Change from baseline at 3 months
measure: Change from baseline in the mean quantitative upper extremity function performance
timeFrame: Change from baseline at 3 months
measure: Differences in the mean quantitative maximal oxygen consumption
timeFrame: Changes from baseline at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Department of Biological and Medical Science, Faculty of Physical Education and Sport, Comenius University
Study officials:
affiliation: Faculty of Physical Education and Sport, Comenius University
name: Viktor Bielik, prof.
role: PRINCIPAL_INVESTIGATOR
References: