Rheumatic DiseasesNCT07504887
Effects of Aerobic Exercise in Rheumatoid Arthritis
A study testing Standard Medical Care (SMC), Patient Education and Aerobic Exercise Group in people with Rheumatic Diseases and Rheumatic Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Rheumatic Diseases, Rheumatic Disorder
- What is being tested?
- Standard Medical Care (SMC), Patient Education and Aerobic Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with RA according to ACR/EULAR 2010 criteria
- Female patients aged 30-70 years
- Low disease activity (DAS-28 < 3.2)
- Voluntary participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43000
About this study
Official 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
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.
Read the 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.
- Conditions
- Rheumatic Diseases, Rheumatic Disorder
- Being tested
- Standard Medical Care (SMC), Patient Education, Aerobic Exercise Group
- Keywords
- RHEUMATIC DISEASE, RHEUMATIC ARTRIT, PAIN, PHYSICAL MEDICINE AND REHABILITATION
- Medical subject headings
- Rheumatic Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical Care (SMC)Other
Standard medical treatment
Patient EducationOther
Patient education
Aerobic Exercise GroupOther
Frequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard medical treatment Patient education Receives: Other: Standard Medical Care (SMC); Other: Patient Education |
| Aerobic Exercise Group | Experimental | Standard medical treatment Patient education Aerobic exercise program Receives: Other: Standard Medical Care (SMC); Other: Patient Education; Other: Aerobic Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis Quality of Life Questionnaire
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.
Measured: Baseline and at the end of 6 weeks (42th day)
Health Assessment Questionnaire (HAQ)
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.
Measured: Baseline and at the end of 6 weeks (42th day)
Functional Capacity (Cardiopulmonary Fitness)
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.
Measured: Baseline and at the end of 6 weeks (42th day)
6-Minute Walk Test (6MWT)
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.
Measured: Baseline and at the end of 6th week (42th day)
Secondary outcomes (6)
Beck Depression Inventory (BDI)
BDI is a 21-item self-reported questionnaire assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating more severe depression.
Measured: Baseline and at the end of 6 weeks (42th day)
Fatigue Severity Scale (FSS)
FSS is a 9-item scale assessing fatigue severity using Likert-type responses. Higher scores indicate greater fatigue severity.
Measured: Baseline and after 6 weeks
Visual analogue Scale for pain
Pain intensity is measured on a 10 cm visual analog scale, where 0 indicates no pain and 10 indicates worst possible pain.
Measured: Baseline and at the end of 6th week (42th day)
Disease Activity Score-28 (DAS-28)
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.
Measured: Baseline and at the end of 6 weeks (42th day)
Inflammatory Markers
C-reactive protein (CRP) Erythrocyte sedimentation rate (ESR) Neutrophil-to-lymphocyte ratio (NLR)
Measured: Baseline and at the end of 6 weeks (42th day)
The Rheumatoid Arthritis Quality of Life Questionnaire
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.
Measured: Baseline and at the end of 6th weeks (42th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2026
- Primary completion24 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Yaman, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504887
- Sponsor's protocol ID
- Busra tez RA
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07504887
- Acronym / sponsor ID
- Busra tez RA
- Conditions
- Rheumatic Diseases, Rheumatic Disorder
- Keywords
- RHEUMATIC DISEASE, RHEUMATIC ARTRIT, PAIN, PHYSICAL MEDICINE AND REHABILITATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Medical Care (SMC), Other: Patient EducationStandard medical treatment Patient education |
| Aerobic Exercise Group | Experimental | Other: Standard Medical Care (SMC), Other: Patient Education, Other: Aerobic Exercise GroupStandard medical treatment Patient education Aerobic exercise program |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with RA according to ACR/EULAR 2010 criteria
- Female patients aged 30-70 years
- Low disease activity (DAS-28 < 3.2)
- Voluntary participation
Key exclusion criteria (8 listed)
- Cardiovascular diseases (CAD, heart failure, etc.)
- Respiratory diseases
- Neurological disorders
- BMI > 35
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Medical Care (SMC)Standard medical treatment | Other | Aerobic Exercise Group, Control Group |
| Patient EducationPatient education | Other | Aerobic Exercise Group, Control Group |
| Aerobic Exercise GroupFrequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down | Other | Aerobic Exercise Group |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Baseline and at the end of 6 weeks (42th day)
Fatigue Severity Scale (FSS)
Time frame: Baseline and after 6 weeks
Visual analogue Scale for pain
Time frame: 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)
Inflammatory Markers
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Care (SMC), Patient Education and Aerobic Exercise Group in people with Rheumatic Diseases and Rheumatic Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoid Arthritis Quality of Life Questionnaire (time frame: Baseline and at the end of 6 weeks (42th day)). The study lists 4 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 27 Aug 2026.