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NCT Number: NCT07504887

Effects of Aerobic Exercise in Rheumatoid Arthritis

This study aims to evaluate the effects of aerobic exercise therapy on quality of life, functional capacity, mood, and fatigue in patients with rheumatoid arthritis. Additionally, the study investigates the impact of aerobic exercise on inflammatory markers, pain, and disease activity.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43000, Turkey (Türkiye)

About this study

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by joint inflammation, pain, and functional limitations. Exercise therapy is widely used in rehabilitation to improve functional capacity and quality of life in RA patients.

In this study, patients with low disease activity RA will be divided into two groups:

Standard medical treatment + education Standard medical treatment + education + aerobic exercise

The aerobic exercise program will be conducted 5 days per week for 6 weeks. Outcomes including functional capacity (VO2 max), quality of life, fatigue, mood, and inflammatory markers will be assessed before and after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with RA according to ACR/EULAR 2010 criteria
  • Female patients aged 30-70 years
  • Low disease activity (DAS-28 < 3.2)
  • Voluntary participation

Exclusion criteria

  • Cardiovascular diseases (CAD, heart failure, etc.)
  • Respiratory diseases
  • Neurological disorders
  • BMI > 35
  • Malignancy
  • Pregnancy or breastfeeding
  • Recent medication change (last 3 months)
  • Musculoskeletal conditions preventing exercise

Treatment and study plan

Standard Medical Care (SMC)

Other

Standard medical treatment

Patient Education

Other

Patient education

Aerobic Exercise Group

Other

Frequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down

Primary outcomes

  1. Rheumatoid Arthritis Quality of Life Questionnaire

    Time frame: Baseline and at the end of 6 weeks (42th day)

    RAQoL is a disease-specific instrument consisting of 30 items scored as yes/no. Total scores range from 0 to 30, with higher scores indicating poorer quality of life. The Turkish version has established validity and reliability.

  2. Health Assessment Questionnaire (HAQ)

    Time frame: Baseline and at the end of 6 weeks (42th day)

    HAQ evaluates functional ability in daily living activities using 20 items. Each item is scored from 0 (no difficulty) to 3 (unable to perform). The final score is calculated as the average of item scores, ranging from 0 to 3, with higher scores indicating worse functional status.

  3. Functional Capacity (Cardiopulmonary Fitness)

    Time frame: Baseline and at the end of 6 weeks (42th day)

    VO₂ max (mL/kg/min) is measured using cardiopulmonary exercise testing (CPET) on a cycle ergometer. It is considered the gold standard for assessing aerobic capacity.

  4. 6-Minute Walk Test (6MWT)

    Time frame: Baseline and at the end of 6th week (42th day)

    The 6MWT evaluates submaximal exercise capacity. Participants are instructed to walk as far as possible within 6 minutes on a 30-meter corridor. Total walking distance (meters) is recorded. Higher distances indicate better functional capacity.

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: Baseline and at the end of 6 weeks (42th day)

    BDI is a 21-item self-reported questionnaire assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating more severe depression.

  2. Fatigue Severity Scale (FSS)

    Time frame: Baseline and after 6 weeks

    FSS is a 9-item scale assessing fatigue severity using Likert-type responses. Higher scores indicate greater fatigue severity.

  3. Visual analogue Scale for pain

    Time frame: Baseline and at the end of 6th week (42th day)

    Pain intensity is measured on a 10 cm visual analog scale, where 0 indicates no pain and 10 indicates worst possible pain.

  4. Disease Activity Score-28 (DAS-28)

    Time frame: Baseline and at the end of 6 weeks (42th day)

    DAS-28 is a composite index including tender/swollen joint count, ESR or CRP levels, and patient global assessment. Lower scores indicate lower disease activity.

  5. Inflammatory Markers

    Time frame: Baseline and at the end of 6 weeks (42th day)

    C-reactive protein (CRP) Erythrocyte sedimentation rate (ESR) Neutrophil-to-lymphocyte ratio (NLR)

  6. The Rheumatoid Arthritis Quality of Life Questionnaire

    Time frame: Baseline and at the end of 6th weeks (42th day)

    RAQoL is a disease-specific questionnaire consisting of 30 yes/no items. Scores range from 0 to 30, with higher scores indicating poorer quality of life.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Evaluation of the Effects of Aerobic Exercise Therapy on Quality of Life, Functional Capacity, Mood, Fatigue, and Inflammatory Markers in Patients With Rheumatoid Arthritis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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