Effects of Aerobic Exercise in Rheumatoid Arthritis

March 26, 2026 updated by: Fatima Yaman, Kutahya Health Sciences University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Kütahya, Turkey (Türkiye), 43000
        • Kutahya Health Sciences University
        • Contact:
        • Sub-Investigator:
          • Fatima YAMAN, Assoc. Prof.
        • Principal Investigator:
          • Vural KAVUNCU, Prof. Dr.
        • Sub-Investigator:
          • Busra ARI, MD.
        • Sub-Investigator:
          • Mehmet Ali ASTARCIOGLU, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Standard medical treatment Patient education
Other: Standard Medical Care (SMC)
Standard medical treatment
Other: Patient Education
Patient education
Experimental: Aerobic Exercise Group
Standard medical treatment Patient education Aerobic exercise program
Other: Standard Medical Care (SMC)
Standard medical treatment
Other: Patient Education
Patient education
Other: Aerobic Exercise Group
Frequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at the end of 6 weeks (42th day)
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.
Baseline and at the end of 6 weeks (42th day)
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.
Baseline and at the end of 6 weeks (42th day)
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.
Baseline and at the end of 6th week (42th day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at the end of 6 weeks (42th day)
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.
Baseline and after 6 weeks
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.
Baseline and at the end of 6th week (42th day)
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.
Baseline and at the end of 6 weeks (42th day)
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)
Baseline and at the end of 6 weeks (42th day)
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.
Baseline and at the end of 6th weeks (42th day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Busra tez RA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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