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

NCT ID: NCT06220409

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-15

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.

Conditions

Sclerosis, Multiple

Study Design

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

Study Groups

Dance

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

Group Type: EXPERIMENTAL

Dance classes

Intervention Type: OTHER

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

Passive

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy subjects

The subjects engage in sports recreationally

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dance classes

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Viktor Bielik

prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Bielik, prof.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Education and Sport, Comenius University

Locations

Department of Biological and Medical Science, Faculty of Physical Education and Sport, Comenius University

Bratislava, , Slovakia

Countries

Slovakia

Other Identifiers

1/0260/21

Identifier Type: -

Identifier Source: org_study_id