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

NCT06220409 | Completed

• 1 other identifier: 1/0260/21
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.)

Conditions

Sclerosis, Multiple

Keywords

Physical Activity; Gut Microbiome; Dance

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Changes from baseline at 3 months

Study Arms (3)

Dance

EXPERIMENTAL

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

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

Interventions

Dance classes OTHER

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

Dance

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Malignant disease
• Insufficient mental possibility of cooperation Eating disorder

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

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

Bratislava, 814 69, Slovakia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Viktor Bielik, prof.

  Faculty of Physical Education and Sport, Comenius University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 24, 2024
• Study Start: March 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: December 15, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

SL (1)