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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 sessio
• Поведенческое 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
• Другое 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

Первичные конечные точки

• Change in Quality of Life [Срок оценки: Baseline, 6 weeks, 3 months]
• change in pain score [Срок оценки: Baseline, 6 weeks, 3 months]
• Change in Disease Activity [Срок оценки: Baseline, 6 weeks, 3 months]
• Change in Physical Function [Срок оценки: Baseline, 6 weeks, 3 months]
• Change in Quality of Life [Срок оценки: Baseline, 6 weeks, 3 months]

Вторичные конечные точки (7)

• Change in Physical Function [Срок оценки: Baseline, 6 weeks, 3 months]
• Anthropometric Measurements [Срок оценки: Baseline, 6 weeks, 3 months]
• Change in Physical Function [Срок оценки: baseline, 6 weeks, 3 months]
• Change in Physical Function [Срок оценки: baseline, 6 weeks, 3 months]
• Anthropometric Measurements [Срок оценки: baseline, 6 weeks, 3 months]
• Anthropometric Measurements [Срок оценки: baseline, 6 weeks, 3 months]
• Anthropometric Measurement [Срок оценки: Baseline, 6 weeks, 3 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07262112 · 202405 · BAUN-MED-RA-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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