An interventional study of Exercise and Diet in Rheumatoid Arthritis, sponsored by Berra Yamuç Tanrıöğen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Berra Yamuç Tanrıöğen · Not applicable, Interventional, and Treatment
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.
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 100 is close to the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
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Exclusion Criteria:
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
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
Participants will follow a dietitian-supervised anti-inflammatory diet for a duration of 3 months
Behavioral: Diet
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.
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.
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
Participants continue standard medical treatment for rheumatoid arthritis as prescribed by their physician. No study-specific intervention is added
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6 weeks, 3 months
Change in Physical Function
Functional status will be assessed using validated physical performance tests, including handgrip strength. These assessments will be conducted at baseline, Week 6, and Month 3 to evaluate changes in participants' ability to perform daily activities under the study interventions, in addition to standard medical treatment for rheumatoid arthritis. Maximal voluntary grip force measured in kilograms using a hand dynamometer to assess overall muscle strength. Higher values indicate greater muscle strength. Units of Measure: kilograms (kg) Minimum Value: 0 kg Maximum Value: \~100 kg (depending on population)
Time frame: Baseline, 6 weeks, 3 months
Anthropometric Measurements
Body mass index (BMI) will be measured at baseline, Week 6, and Month 3 to evaluate changes in participants' overall body weight relative to height, in response to the study interventions, alongside standard medical treatment for rheumatoid arthritis. BMI calculated as weight in kilograms divided by height in meters squared (kg/m²) to assess overall body weight relative to height. Lower or higher BMI may indicate underweight or overweight status. Units of Measure: kg/m² Minimum Value: \~10 kg/m² Maximum Value: \~60 kg/m²
Time frame: Baseline, 6 weeks, 3 months
Change in Physical Function
Functional status will be assessed using validated physical performance tests, including 30-second sit-to-stand test. These assessments will be conducted at baseline, Week 6, and Month 3 to evaluate changes in participants' ability to perform daily activities under the study interventions, in addition to standard medical treatment for rheumatoid arthritis. Number of full stands completed from a seated position in 30 seconds to assess lower body muscle strength and functional performance. Higher values indicate better muscle function. Units of Measure: repetitions Minimum Value: 0 repetitions Maximum Value: 60 repetitions
Time frame: baseline, 6 weeks, 3 months
Change in Physical Function
Functional status will be evaluated using a validated physical performance measure, the 6-minute walk test (6MWT). Assessments will be performed at baseline, Week 6, and Month 3 to monitor changes in participants' ability to carry out daily activities in response to the study interventions, in addition to standard medical treatment for rheumatoid arthritis. Distance walked in meters during 6 minutes to assess functional exercise capacity. Higher values indicate better functional capacity. Units of Measure: meters (m) Minimum Value: 0 m Maximum Value: \~1000 m
Time frame: baseline, 6 weeks, 3 months
Anthropometric Measurements
Waist circumference will be assessed at baseline, Week 6, and Month 3 to monitor changes in central adiposity associated with the study interventions, in addition to standard medical care for rheumatoid arthritis Measurement of abdominal circumference in centimeters to assess central adiposity. Lower values indicate less abdominal fat. Units of Measure: centimeters (cm) Minimum Value: 40 cm (approx.) Maximum Value: 150 cm (approx.)
Time frame: baseline, 6 weeks, 3 months
Anthropometric Measurements
Body fat percentage will be measured at baseline, Week 6, and Month 3 to evaluate alterations in participants' total body fat under the study interventions, alongside their standard medical treatment for rheumatoid arthritis. Percentage of body mass composed of fat, measured by validated methods such as bioelectrical impedance analysis. Lower values indicate less body fat. Units of Measure: percent (%) Minimum Value: 5% Maximum Value: 60%
Time frame: baseline, 6 weeks, 3 months
Anthropometric Measurement
Muscle mass percentage will be assessed at baseline, Week 6, and Month 3 to examine changes in lean body mass resulting from the study interventions, in addition to participants' standard medical care. Percentage of body mass composed of skeletal muscle, measured by validated methods such as bioelectrical impedance analysis. Higher values indicate greater muscle mass. Units of Measure: percent (%) Minimum Value: 20% Maximum Value: 60%
Time frame: Baseline, 6 weeks, 3 months
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