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

NCT07262112 | Not Yet Recruiting

• 2 other identifiers: 202405BAUN-MED-RA-2025
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Anti-inflammatory Diet; Resistance Exercise; Inflammation

Outcome Measures

Primary Outcomes (5)

• Change in Quality of Life

  Health-related quality of life will be assessed using Arthritis Impact Measurement Scales 2 (AIMS2) at baseline, 6 weeks, and 3 months. This outcome measure the effect of the study interventions, in addition to participants' standard medical treatment for rheumatoid arthritis A patient-reported questionnaire assessing the physical, emotional, and social impact of arthritis. Scores are calculated for each subscale and overall. Higher scores indicate greater disability or worse health status. Units of Measure: points (scale-specific) Minimum Value: 0 points (no impact) Maximum Value: 10 points per subscale (worst impact; total score depends on number of subscales)

  Baseline, 6 weeks, 3 months

• change in pain score

  Pain will be assessed using the Visual Analog Scale (VAS) at baseline, 6 weeks, and 3 months. This outcome measures the effect of the interventions (Exercise, Diet, Diet+Exercise) in addition to standard medical treatment on patient-reported pain intensity. Self-reported measure of pain intensity using a 100-mm horizontal line, where 0 mm represents "no pain" and 100 mm represents "worst imaginable pain." Higher scores indicate greater pain intensity. Units of Measure: millimeters (mm) Minimum Value: 0 mm (no pain) Maximum Value: 100 mm (worst imaginable pain)

  Baseline, 6 weeks, 3 months

• Change in Disease Activity

  Rheumatoid arthritis disease activity will be measured using the Disease Activity Score 28 (DAS28) at baseline, 6 weeks, and 3 months. This outcome evaluates the effect of the interventions combined with standard medical treatment on disease progression and inflammation levels Composite index measuring rheumatoid arthritis disease activity based on the number of tender and swollen joints (28 joints), patient global assessment of health, and either erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Higher scores indicate higher disease activity. Units of Measure: points Minimum Value: 0 (no disease activity) Maximum Value: \~10 (high disease activity)

  Baseline, 6 weeks, 3 months

• Change in Physical Function

  Functional status will be assessed using the Health Assessment Questionnaire (HAQ) at baseline, 6 weeks, and 3 months. This outcome measures improvement in patient functionality and ability to perform daily activities under the combined interventions and standard medical treatment A patient-reported questionnaire assessing functional ability in daily activities, including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Scores range from 0 to 3, with higher scores indicating greater disability or worse functional status. Units of Measure: points Minimum Value: 0 points (no disability) Maximum Value: 3 points (severe disability)

  Baseline, 6 weeks, 3 months

• Change in Quality of Life

  Health-related quality of life will be assessed using Short Form 36 (SF-36) at baseline, 6 weeks, and 3 months. This outcome measure the effect of the study interventions, in addition to participants' standard medical treatment for rheumatoid arthritis A patient-reported questionnaire assessing overall health-related quality of life across 8 domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status or quality of life. Units of Measure: points Minimum Value: 0 points (worst health/quality of life) Maximum Value: 100 points (best health/quality of life)

  Baseline, 6 weeks, 3 months

Secondary Outcomes (7)

• Change in Physical Function

  Baseline, 6 weeks, 3 months

• Anthropometric Measurements

  Baseline, 6 weeks, 3 months

• Change in Physical Function

  baseline, 6 weeks, 3 months

• Change in Physical Function

  baseline, 6 weeks, 3 months

• Anthropometric Measurements

  baseline, 6 weeks, 3 months

Study Arms (4)

exercise

EXPERIMENTAL

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

Behavioral: Exercise

Diet+exercise

EXPERIMENTAL

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

Behavioral: Exercise; Behavioral: Diet

diet

EXPERIMENTAL

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

Behavioral: Diet

control

ACTIVE COMPARATOR

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

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

Interventions

Exercise 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; exercise

Diet 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+exercise; diet

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

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

control

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Berra Yamuç Tanrıöğen: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nilay Şahin, MD

  Balikesir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berra Yamuç Tanrıöğen, MD

CONTACT

905071707664; berrayamuc96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is applied in this study. Both participants and investigators are aware of the assigned interventions, as the study involves exercise and dietary programs that cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: Resistance exercise group Anti-inflammatory diet group diet and resistance exercise group Control group

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 3, 2025
• Study Start: November 30, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11