Efficacy of Resistance Exercise and an Anti-Inflammatory Diet on Pain, Disease Activity, Functional Status, and Quality of Life in Patients With Rheumatoid Arthritis

NCT ID: NCT07262112

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-05-01

Brief Summary

This study aims to examine how resistance exercises and an anti-inflammatory diet affect pain, daily functioning, disease activity, and quality of life in people with rheumatoid arthritis. Participants will follow a structured exercise program and a diet plan designed to reduce inflammation. The study will measure changes in pain levels, mobility, overall health, and disease symptoms over time. The goal is to determine whether combining exercise and an anti-inflammatory diet can help improve the daily lives and well-being of individuals living with rheumatoid arthritis.

Detailed Description

This study examines the combined effects of resistance exercise and an anti-inflammatory diet on clinical outcomes in individuals with rheumatoid arthritis (RA). RA is a chronic inflammatory condition that commonly leads to persistent pain, reduced physical function, and diminished quality of life. Non-pharmacological strategies, including structured exercise and dietary modification, have shown promise as complementary approaches to routine RA management.

Participants in this study will engage in a supervised resistance exercise program along with an anti-inflammatory diet designed to reduce systemic inflammation and support overall musculoskeletal health. The exercise component focuses on improving muscle strength, joint stability, and functional performance, while the dietary intervention emphasizes foods known to lower inflammatory activity.

Outcome assessments will be conducted at baseline (week 0), week 6, and month 3 to evaluate the progression of clinical improvements. Measures will include quality of life, disease activity, functional status, and pain levels. Validated tools and standardized assessment instruments will be used to ensure precise and reliable data collection across all time points.

The aim of this study is to determine whether combining resistance exercise with an anti-inflammatory diet results in meaningful, measurable improvements over time in individuals living with rheumatoid arthritis. The findings may contribute to evidence supporting the integration of multimodal lifestyle interventions into routine RA care.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

exercise

Participants will undergo supervised strengthening exercises using resistance bands in the Physical Medicine and Rehabilitation unit. Sessions will be conducted 3 days per week, each lasting 1 hour, for a total duration of 6 weeks under physician supervision

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Supervised strengthening exercises using resistance bands in the Physical Medicine and Rehabilitation unit, in addition to participants' standard medical treatment for rheumatoid arthritis. Each session lasts 1 hour and is conducted 3 days per week for a total of 6 weeks under physician supervision. The intervention focuses on improving muscular strength and physical function. Every 3 sessions, the resistance will be increased for participants who do not experience pain after the exercise session.

Diet+exercise

Participants will follow a dietitian-supervised anti-inflammatory diet for 3 months. In addition, they will undergo supervised strengthening exercises using resistance bands in the Physical Medicine and Rehabilitation unit. Exercise sessions will be performed 3 days per week, each lasting 1 hour, for a total duration of 6 weeks under physician supervision

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Supervised strengthening exercises using resistance bands in the Physical Medicine and Rehabilitation unit, in addition to participants' standard medical treatment for rheumatoid arthritis. Each session lasts 1 hour and is conducted 3 days per week for a total of 6 weeks under physician supervision. The intervention focuses on improving muscular strength and physical function. Every 3 sessions, the resistance will be increased for participants who do not experience pain after the exercise session.

Diet

Intervention Type: BEHAVIORAL

Dietitian-supervised anti-inflammatory diet followed for 3 months, in addition to participants' standard medical treatment for rheumatoid arthritis. Participants receive individualized dietary counseling and meal plans tailored to reduce inflammation, and adherence to the diet is monitored throughout the study period

diet

Participants will follow a dietitian-supervised anti-inflammatory diet for a duration of 3 months

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Dietitian-supervised anti-inflammatory diet followed for 3 months, in addition to participants' standard medical treatment for rheumatoid arthritis. Participants receive individualized dietary counseling and meal plans tailored to reduce inflammation, and adherence to the diet is monitored throughout the study period

control

Participants will continue to receive standard medical treatment for rheumatoid arthritis as prescribed by their treating physician. No study-specific intervention will be added, and routine RA medications and management will be maintained throughout the study period

Group Type: ACTIVE_COMPARATOR

Medical management/current medications per standard of care by personal physician.

Intervention Type: OTHER

Participants continue standard medical treatment for rheumatoid arthritis as prescribed by their physician. No study-specific intervention is added

Interventions

Exercise

Supervised strengthening exercises using resistance bands in the Physical Medicine and Rehabilitation unit, in addition to participants' standard medical treatment for rheumatoid arthritis. Each session lasts 1 hour and is conducted 3 days per week for a total of 6 weeks under physician supervision. The intervention focuses on improving muscular strength and physical function. Every 3 sessions, the resistance will be increased for participants who do not experience pain after the exercise session.

Intervention Type: BEHAVIORAL

Diet

Dietitian-supervised anti-inflammatory diet followed for 3 months, in addition to participants' standard medical treatment for rheumatoid arthritis. Participants receive individualized dietary counseling and meal plans tailored to reduce inflammation, and adherence to the diet is monitored throughout the study period

Intervention Type: BEHAVIORAL

Medical management/current medications per standard of care by personal physician.

Participants continue standard medical treatment for rheumatoid arthritis as prescribed by their physician. No study-specific intervention is added

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant voluntarily agrees to participate in the study and provides written informed consent.
• Aged 18 years or older.
• Has low to moderate disease activity (e.g., according to DAS28 score)

Exclusion Criteria

• Participants under 18 years of age.
• Uncontrolled diabetes or other metabolic/endocrine disorders.
• Uncontrolled hypertension.
• Any changes in medication within the last 1 month.
• Morbid obesity (BMI > 40).
• Pregnancy.
• Chronic kidney disease.
• Presence of psychiatric disorders.
• Alcoholism.
• Any condition contraindicating exercise, including congestive heart failure, lung disease, cancer, active infection, recent fracture, or recent ligament/tendon injury.

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

Sponsors

Berra Yamuç Tanrıöğen

OTHER

Sponsor Role: lead

Responsible Party

Berra Yamuç Tanrıöğen

Research Assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nilay Şahin, MD

Role: PRINCIPAL_INVESTIGATOR

Balikesir University

Central Contacts

Berra Yamuç Tanrıöğen, MD

Role: CONTACT

berrayamuc96@gmail.com

905071707664

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BAUN-MED-RA-2025

Identifier Type: OTHER

Identifier Source: secondary_id

202405

Identifier Type: -

Identifier Source: org_study_id