The Effects of Nutritional on Disease Activity and Functional Status in RA

NCT ID: NCT05227885

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2022-05-31

Brief Summary

Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease.

RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.

The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.

A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity status and physical functional status of the patients included in the study.

Detailed Description

Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease affecting 0.5-1.0% of the population. RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.

The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.

This study will be conducted with 100 patients diagnosed with RA in Balıkesir University, Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation outpatient clinic.

Patients between the ages of 18-75, diagnosed with RA according to the ACR 2010 diagnostic criteria, with a disease duration of 2 or more, using less than 10 mg of prednisolone per day, will be included in the study. Patients with a duration of ≤2 years after the diagnosis of RA, a change in the use of DMARDs and/or biological agents in their medical treatment for the last 8 weeks, using prednisolone more than 10 mg daily, malignancy, pregnant, lactating, and those who cannot understand the information in the questionnaire was not included in the study.

A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity and physical functional status of the patients included in the study.

As a result of this study, it is aimed to help patients with rheumatoid arthritis reach remission with diet programs and recommendations in addition to existing drug treatments.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

questionnaire form

A questionnaire will be applied to all participants. A questionnaire form will be applied to collect data on demographic information, pain, disease activity, nutritional habits, physical activity status and physical functional status of the patients included in the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-75,
• Diagnosed with RA according to ACR 2010 diagnostic criteria,
• RA disease duration at least ≥2 years

Exclusion Criteria

• Pregnant
• During the lactation period,
• Malignancy
• Using more than 10 mg of prednisolone per day,
• The period after the diagnosis of Ra is ≤2 years,
• Changes in medical treatment, DMARD and/or biological agent use in the last 8 weeks,
• Patients who cannot understand the information in the questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

Bilal Uysal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilal UYSAL, MD

Role: PRINCIPAL_INVESTIGATOR

Balikesir University

Locations

Balikesir University

Balıkesir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BalikesirUniversty

Identifier Type: -

Identifier Source: org_study_id