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Rheumatoid ArthritisRED-RANCT07262112

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

A study testing Exercise and Diet in people with Rheumatoid Arthritis, run by Berra Yamuç Tanrıöğen.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Exercise and Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
30 Nov 2025to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Berra Yamuç Tanrıöğen, MD contact

905071707664

berrayamuc96@gmail.com

About this study

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.

Read the 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.

Being tested
Exercise, Diet, Medical management/current medications per standard of care by personal physician.
Keywords
Rheumatoid Arthritis, Anti-inflammatory Diet, Resistance Exercise, Inflammation
Medical subject headings
Arthritis, Rheumatoid, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

  • DietBehavioural

    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

  • 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

Study groups in NCT07262112
Study groupRoleWhat they receive
exerciseExperimentalParticipants 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
Receives: Behavioral: Exercise
Diet+exerciseExperimentalParticipants 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
Receives: Behavioral: Exercise; Behavioral: Diet
dietExperimentalParticipants will follow a dietitian-supervised anti-inflammatory diet for a duration of 3 months
Receives: Behavioral: Diet
controlActive comparatorParticipants 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
Receives: Other: Medical management/current medications per standard of care by personal physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline, 6 weeks, 3 months

  2. 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)

    Measured: Baseline, 6 weeks, 3 months

  3. 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)

    Measured: Baseline, 6 weeks, 3 months

  4. 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)

    Measured: Baseline, 6 weeks, 3 months

  5. 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)

    Measured: Baseline, 6 weeks, 3 months

Secondary outcomes (7)
  1. 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)

    Measured: Baseline, 6 weeks, 3 months

  2. 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

    Measured: Baseline, 6 weeks, 3 months

  3. 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

    Measured: baseline, 6 weeks, 3 months

  4. 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

    Measured: baseline, 6 weeks, 3 months

  5. 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.)

    Measured: baseline, 6 weeks, 3 months

  6. 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%

    Measured: baseline, 6 weeks, 3 months

  7. 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%

    Measured: Baseline, 6 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start30 Nov 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Resistance exercise group Anti-inflammatory diet group diet and resistance exercise group Control group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262112
Sponsor's protocol ID
202405
Other IDs
BAUN-MED-RA-2025
Acronym
RED-RA
Status last verified
Nov 2025
First submitted
16 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Diet in people with Rheumatoid Arthritis, run by Berra Yamuç Tanrıöğen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berra Yamuç Tanrıöğen, MD (905071707664, berrayamuc96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life (time frame: Baseline, 6 weeks, 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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