Efficacy of Resistance Exercise and an Anti-Inflammatory Diet on Pain, Disease Activity, Functional Status, and Quality of Life in Patients With Rheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Berra Yamuç Tanrıöğen
- Enrollment
- 100
- Primary Endpoint
- Change in Quality of Life
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Quality of Life
Time Frame: Baseline, 6 weeks, 3 months
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)
change in pain score
Time Frame: Baseline, 6 weeks, 3 months
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)
Change in Disease Activity
Time Frame: Baseline, 6 weeks, 3 months
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)
Change in Physical Function
Time Frame: Baseline, 6 weeks, 3 months
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)
Secondary Outcomes
- Change in Physical Function(baseline, 6 weeks, 3 months)
- Anthropometric Measurements(baseline, 6 weeks, 3 months)
- Anthropometric Measurement(Baseline, 6 weeks, 3 months)
Investigators
Berra Yamuç Tanrıöğen
Research Assistant
Balikesir University