Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis

NCT05777629 | Unknown

• 1 other identifier: nol
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is an autoimmune disease characterized by inflammation, demyelination and axon damage. Affecting approximately 2.5 million individuals around the world and seen mostly in young adults, MS can cause different levels of disability in functional activities, cause limitations in social and professional life, and impair quality of life. Multiple sclerosis is thought to be an autoimmune disease that develops on the basis of genetic predisposition and environmental factors. Nutritional habits and physical activity are important environmental factors. These can be effective in the course of MS and change the quality of life. Compatibility of nutrition with the Mediterranean diet and providing adequate physical activity may be beneficial in increasing physical and mental well-being in general, and therefore the quality of life of the person. In our country, there is not enough information about the ongoing nutritional habits and physical activity levels of MS patients in their daily lives, and quality of life studies are limited. Our limited knowledge on these issues narrows the possibility of movement in an area that can be corrected in MS patients and thus have a positive impact on their quality of life. The aim of this study is to determine compliance with the Mediterranean diet, the tendency to use various nutritional supplements, physical activity habits, walking-related problems and quality of life in MS patients and to evaluate whether there is a significant relationship between these parameters.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Mediterranean Diet; Quality of Life; Walking

Outcome Measures

Primary Outcomes (4)

• Mediterranean Diet Compliance Status

  The 14-item Mediterranean Diet Adaptation Scale (PREDIMED) will be used to determine the adaptation status of individuals to the Mediterranean diet. In this scale, there are a total of 14 questions, 12 of which are about food consumption frequency and 2 are about food consumption habits. The score given for each question is 0 or 1 point. Then the scores are summed and the score is evaluated as ≤5 (low agreement), 6-9 (moderate agreement), and ≥10 (high agreement).

  1 year

• Quality of Life Of Multiple Sclerosis Patients

  The quality of life of individuals will be determined by the Multiple Sclerosis International Quality of Life Scale. It is evaluated between 0-124 points in total. An increase in the total score is associated with a higher quality of life.

  1 months

• Impacts on Walking

  The 12-item Ms Gait Scale will be used to determine the gait impact. 12-item MS Gait Scale: It is a 12-item questionnaire that questions the effect of walking in MS. The difficulties experienced by individuals during walking activity in the last 2 weeks are questioned. Each item contains 5 points (1; not at all impressed, 5; totally impressed). Lower scores indicate better gait impairment

  2 months

• Expanded Disability Status Scale

  The disability status of the patients will be determined using the Expanded Disability Status Scale (EDSS). The EDSS scale measures disability and neurological symptoms in MS patients. A score between 0 and 10 is given on the scale. 0 indicates no disability or disorder, 10 indicates MS-related death

  1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with MS between the ages of 18-65

You may qualify if:

• Being between the ages of 18-65
• Having been diagnosed with multiple sclerosis
• Having voluntarily agreed to participate in the research

You may not qualify if:

• Being under the age of 18 and over the age of 65
• Being pregnant or in the postpartum period during the research
• Having an attack during the research
• Active infection
• Having another disease that prevents him from doing physical activity
• Having a disease that requires a special diet

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

UGaziantep

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yasemin EKMEKYAPAR FIRAT

  Sanko University

  PRINCIPAL INVESTIGATOR

• Münife NEYAL

  Sanko University

  PRINCIPAL INVESTIGATOR

• İpek KATİRCİ KİRMACİ

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Nezihe OTAY LULE

  Gaziiantep University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 21, 2023
• Study Start: February 28, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 1, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)