Cardiac RehabilitationCARDIRANCT06295848
The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients
A study testing Exercise in people with Cardiac Rehabilitation and Rheumatoid Arthritis, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation, Rheumatoid Arthritis, Hypertension
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Jun 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with RA according to ACR/EULAR 2010 criteria
- Taking regular treatment for at least 1 month according to ACR/EULAR guidelines
- Patients diagnosed with HT according to the 2018 European Society of Hypertension and European Society of Cardiology (ESH/ESC) guideline
Who cannot join
- Refusing to participate in the program
- Severe mental disorder
- Neurological disease or deformity in the lower extremity that would prevent the patient from using the treadmill.
- High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis)
- Uncontrolled HT, Diabetes, cardiac arrhythmia and heart failure
- Symptomatic severe aortic stenosis
- Acute pulmonary embolism or pulmonary infarction and severe pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Kayseri Medicine Faculty
Kayseri, Kocasinan, 38080
About this study
Official title: The Effects of 6-week Cardiac Rehabilitation Programme on Cardiovascular Disease Risk, Systolic and Diastolic Blood Pressure and Disease Activity in Hypertensive Rheumatoid Arthritis Patients : A Randomised Controlled Trial
The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.
Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic auto-immune disease characterized by inflammation and structural damage in synovial joints, but also has extra-articular involvements such as the cardiovascular system. RA patients have higher mortality rates than the general population, and approximately half of premature deaths are due to cardiovascular comorbidities. Traditional risk factors, especially hypertension (HTN), play a key role in the development of cardiovascular diseases (CVD).
In chronic inflammatory diseases such as RA, autoimmunity is a cause of HTN as well as a result of physical damage to the vascular wall. Mild blood pressure elevation caused by specific HTN triggers such as salt retention, angiotensin-II or genetic susceptibility leads to neoantigen release through tissue damage. These neoantigens are recognized by antigen-presenting cells and lead to the differentiation of CD4+ naïve-T lymphocytes into Th1 and Th17 cells. IL-17 and IFN-γ expression causes local inflammation in the vascular wall, endothelial dysfunction, and arterial stiffness. Thus, HTN causes an increase in CVD risk through a common pathogenesis mechanism with RA.
European League Against Rheumatism (EULAR) recommendations emphasize that rheumatologists should be responsible for CVD risk management in RA. However, both RA and HTN treatment is generally administered pharmacologically without focusing on CVD risk. Patients may be recommended regular exercise and lifestyle changes according to EULAR recommendation guide for CVD risk management. One possible intervention that could be used to decrease CVD risk caused by both diseases is cardiac rehabilitation (CR) program in which regular exercise is one of the main components. But RA patients, especially those with cardiovascular comorbidities, are rarely referred to the CR program.
This study will help to clarify the effects of the CR program added to the pharmacological treatment of these patients on cardiovascular mortality risk (Framingham risk score and QRISK-3 score), blood pressure (24-Hour holter monitoring), disease activity (DAS28-CRP), aerobic capacity (VO2max), quality of life (36-Item Short Form Survey) and psychological state (Beck depression inventory).
- Conditions
- Cardiac Rehabilitation, Rheumatoid Arthritis, Hypertension
- Being tested
- Exercise
- Medical subject headings
- Arthritis, Rheumatoid, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
An individual program will be organized for each patient according to the exercise test result. Since the patients have both arthritis and HTN, aerobic exercises will be given at moderate intensity (40-70% VO2 reserve) according to ACMS recommendations. Xrcise Runner Med treadmill and Xrcise Care 2.5.8.3 software will be used for aerobic exercises. Resistant exercises will be given under the supervision of a physiotherapist, calculating 1 repetitation maximum (1-RM) in the main muscle groups.Patients will perform isotonic exercises with 3 sets of 15 repetitions with a resistance of 60% of 1-RM. The education sessions will be conducted by a multidisciplinary team of health professionals (nurse, physiotherapist and dietician) under the leadership of a clinician experienced in CR. Education topics will consist of 60-minute sessions covering heart-healthy eating, setting health-related goal, exercise, diet, healthy weight loss, smoking cessation, and stress/coping.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Experimental | The CR group will receive training for CVD and HT once a week, along with a rehabilitation program consisting of aerobic, resistance, flexibility and stretching exercises 3 days a week for 6 weeks. Receives: Behavioral: Exercise |
| Control | No intervention | Control group will receive treatment for their RA that is considered standard of care treatment (e.g. pharmacotherapy), but will not be participated in the CR program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Framingham Risk Score(FRS)
It is a common tool used to assess a patient's risk level of cardiovascular disease over the next 10 years. There are six coronary risk factors in the FRS calculation, including age, gender, total cholesterol, HDL cholesterol, smoking and systolic blood pressure. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
Measured: 0-week, 6-week,12-week,24-week
QRISK-3 Risk Score
It predicts a patient's risk of developing cardiovascular disease in the next 10 years. It includes many of the traditional risk factors featured in Framingham (such as age, gender, cholesterol/HDL ratio, blood pressure, diabetes and smoking status), but also includes important additional risk factors. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
Measured: 0-week, 6-week,12-week,24-week
24-Hour Ambulatory Blood Pressure
It is the gold standard for hypertension diagnosis and 24-hour blood pressure evaluation.
Measured: 0-week, 6-week,12-week,24-week
DAS28
Rheumatoid arthritis severity will be determined using DAS28 score. The DAS28 score ranges score between 0 and 10, a larger number indicating more active disease. When using the score to assess response to treatment, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement. The score <2.6 suggests disease remission.
Measured: 0-week, 6-week,12-week,24-week
Maximal oxygen consumption (VO2max)
VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min). VO2 max is an objective measurement of cardiorespiratory capacity. Higher values indicate a worse, lower values indicate a better outcome.
Measured: 0-week, 6-week,12-week,24-week
Secondary outcomes (4)
The Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test is a submaximal field test used to monitor exercise capacity and treatment effectiveness in cardiac rehabilitation.
Measured: 0-week, 6-week,12-week,24-week
The 36-Item Short Form Survey (SF-36)
Quality of life will be assessed using the short form of the 36-Item short form survey (SF-36). The SF-36 covers eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: 0-week, 6-week,12-week,24-week
International Physical Activity Questionnaire (IPAQ) - Short Form
The IPAQ short form encompasses questions regarding time spent on walking, moderate-intensity, and high-intensity physical activities besides sitting. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. Total physical activity can be computed as the sum of walking + moderate intensity + high intensity MET-min/week scores. Higher values indicate a worse, lower values indicate a better outcome. There are three levels of physical activity suggested for classifying patients based on total weekly MET score: low, moderate and high. The "minutes" of sitting reported by the IPAQ are asessed independtly and reflect sedentary behaviour measurements.
Measured: 0-week, 6-week,12-week,24-week
Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
Measured: 0-week, 6-week,12-week,24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Nov 2022
- Primary completion15 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- Serap TOMRUK SÜTBEYAZ, PROFESSOR, Study director, KAYSERİ CITY HOSPITALAbdurrahman KUTLUCA, MD, Principal investigator, Health Sciences University, Kayseri Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295848
- Sponsor's protocol ID
- KayseriCH005
- Acronym
- CARDIRA
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chauhan K, Jandu JS, Brent LH, Al-Dhahir MA. Rheumatoid Arthritis. 2023 May 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441999/
PubMed 28723028Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35.
PubMed 25180621Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.
PubMed 33175207Avina-Zubieta JA, Choi HK, Sadatsafavi M, Etminan M, Esdaile JM, Lacaille D. Risk of cardiovascular mortality in patients with rheumatoid arthritis: a meta-analysis of observational studies. Arthritis Rheum. 2008 Dec 15;59(12):1690-7. doi: 10.1002/art.24092.
PubMed 19035419Sokka T, Abelson B, Pincus T. Mortality in rheumatoid arthritis: 2008 update. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S35-61.
PubMed 19026144Hadwen B, Stranges S, Barra L. Risk factors for hypertension in rheumatoid arthritis patients-A systematic review. Autoimmun Rev. 2021 Apr;20(4):102786. doi: 10.1016/j.autrev.2021.102786. Epub 2021 Feb 18.
PubMed 33609791Anyfanti P, Gkaliagkousi E, Triantafyllou A, Koletsos N, Gavriilaki E, Galanopoulou V, Aslanidis S, Douma S. Hypertension in rheumatic diseases: prevalence, awareness, treatment, and control rates according to current hypertension guidelines. J Hum Hypertens. 2021 May;35(5):419-427. doi: 10.1038/s41371-020-0348-y. Epub 2020 May 7.
PubMed 32382031Jagpal A, Navarro-Millan I. Cardiovascular co-morbidity in patients with rheumatoid arthritis: a narrative review of risk factors, cardiovascular risk assessment and treatment. BMC Rheumatol. 2018 Apr 11;2:10. doi: 10.1186/s41927-018-0014-y. eCollection 2018.
PubMed 30886961Panoulas VF, Metsios GS, Pace AV, John H, Treharne GJ, Banks MJ, Kitas GD. Hypertension in rheumatoid arthritis. Rheumatology (Oxford). 2008 Sep;47(9):1286-98. doi: 10.1093/rheumatology/ken159. Epub 2008 May 8.
PubMed 18467370Sahin AA, Ozben B, Sunbul M, Yagci I, Sayar N, Cincin A, Gurel E, Tigen K, Basaran Y. The effect of cardiac rehabilitation on blood pressure, and on left atrial and ventricular functions in hypertensive patients. J Clin Ultrasound. 2020 Dec 1:e22956. doi: 10.1002/jcu.22956. Online ahead of print.
PubMed 33289108Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
PubMed 11926784Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, Kvien TK, Dougados M, Radner H, Atzeni F, Primdahl J, Sodergren A, Wallberg Jonsson S, van Rompay J, Zabalan C, Pedersen TR, Jacobsson L, de Vlam K, Gonzalez-Gay MA, Semb AG, Kitas GD, Smulders YM, Szekanecz Z, Sattar N, Symmons DP, Nurmohamed MT. EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis. 2017 Jan;76(1):17-28. doi: 10.1136/annrheumdis-2016-209775. Epub 2016 Oct 3.
PubMed 27697765Metsios GS, Stavropoulos-Kalinoglou A, Veldhuijzen van Zanten JJ, Treharne GJ, Panoulas VF, Douglas KM, Koutedakis Y, Kitas GD. Rheumatoid arthritis, cardiovascular disease and physical exercise: a systematic review. Rheumatology (Oxford). 2008 Mar;47(3):239-48. doi: 10.1093/rheumatology/kem260. Epub 2007 Nov 28.
PubMed 18045810Peynirci Cersit H, Yagci I, Cersit S. The improvement in aerobic capacity, disease activity, and function in patients with rheumatoid arthritis following cardiac rehabilitation program: A single-center, controlled study. Turk J Phys Med Rehabil. 2019 Apr 26;66(2):121-133. doi: 10.5606/tftrd.2020.3250. eCollection 2020 Jun.
PubMed 32760888Tessler J, Ahmed I, Bordoni B. Cardiac Rehabilitation. 2025 Mar 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537196/
PubMed 30725881
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 6-week Cardiac Rehabilitation Programme on Cardiovascular Disease Risk, Systolic and Diastolic Blood Pressure and Disease Activity in Hypertensive Rheumatoid Arthritis Patients : A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06295848
- Acronym / sponsor ID
- CARDIRA / KayseriCH005
- Conditions
- Cardiac Rehabilitation, Rheumatoid Arthritis, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 6 Mar 2024 (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.
The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.
Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic auto-immune disease characterized by inflammation and structural damage in synovial joints, but also has extra-articular involvements such as the cardiovascular system. RA patients have higher mortality rates than the general population, and approximately half of premature deaths are due to cardiovascular comorbidities. Traditional risk factors, especially hypertension (HTN), play a key role in the development of cardiovascular diseases (CVD).
In chronic inflammatory diseases such as RA, autoimmunity is a cause of HTN as well as a result of physical damage to the vascular wall. Mild blood pressure elevation caused by specific HTN triggers such as salt retention, angiotensin-II or genetic susceptibility leads to neoantigen release through tissue damage. These neoantigens are recognized by antigen-presenting cells and lead to the differentiation of CD4+ naïve-T lymphocytes into Th1 and Th17 cells. IL-17 and IFN-γ expression causes local inflammation in the vascular wall, endothelial dysfunction, and arterial stiffness. Thus, HTN causes an increase in CVD risk through a common pathogenesis mechanism with RA.
European League Against Rheumatism (EULAR) recommendations emphasize that rheumatologists should be responsible for CVD risk management in RA. However, both RA and HTN treatment is generally administered pharmacologically without focusing on CVD risk. Patients may be recommended regular exercise and lifestyle changes according to EULAR recommendation guide for CVD risk management. One possible intervention that could be used to decrease CVD risk caused by both diseases is cardiac rehabilitation (CR) program in which regular exercise is one of the main components. But RA patients, especially those with cardiovascular comorbidities, are rarely referred to the CR program.
This study will help to clarify the effects of the CR program added to the pharmacological treatment of these patients on cardiovascular mortality risk (Framingham risk score and QRISK-3 score), blood pressure (24-Hour holter monitoring), disease activity (DAS28-CRP), aerobic capacity (VO2max), quality of life (36-Item Short Form Survey) and psychological state (Beck depression inventory).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Behavioral: ExerciseThe CR group will receive training for CVD and HT once a week, along with a rehabilitation program consisting of aerobic, resistance, flexibility and stretching exercises 3 days a week for 6 weeks. |
| Control | No intervention | –Control group will receive treatment for their RA that is considered standard of care treatment (e.g. pharmacotherapy), but will not be participated in the CR program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with RA according to ACR/EULAR 2010 criteria
- Taking regular treatment for at least 1 month according to ACR/EULAR guidelines
- Patients diagnosed with HT according to the 2018 European Society of Hypertension and European Society of Cardiology (ESH/ESC) guideline
Key exclusion criteria (7 listed)
- Refusing to participate in the program
- Severe mental disorder
- Neurological disease or deformity in the lower extremity that would prevent the patient from using the treadmill.
- High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis)
- Uncontrolled HT, Diabetes, cardiac arrhythmia and heart failure
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 |
|---|---|---|
| ExerciseAn individual program will be organized for each patient according to the exercise test result. Since the patients have both arthritis and HTN, aerobic exercises will be given at moderate intensity (40-70% VO2 reserve) according to ACMS recommendations. Xrcise Runner Med treadmill and Xrcise Care 2.5.8.3 software will be used for aerobic exercises. Resistant exercises will be given under the supervision of a physiotherapist, calculating 1 repetitation maximum (1-RM) in the main muscle groups.Patients will perform isotonic exercises with 3 sets of 15 repetitions with a resistance of 60% of 1-RM. The education sessions will be conducted by a multidisciplinary team of health professionals (nurse, physiotherapist and dietician) under the leadership of a clinician experienced in CR. Education topics will consist of 60-minute sessions covering heart-healthy eating, setting health-related goal, exercise, diet, healthy weight loss, smoking cessation, and stress/coping. | Behavioural | Cardiac Rehabilitation |
Primary outcome
Framingham Risk Score(FRS)
Time frame: 0-week, 6-week,12-week,24-week
It is a common tool used to assess a patient's risk level of cardiovascular disease over the next 10 years. There are six coronary risk factors in the FRS calculation, including age, gender, total cholesterol, HDL cholesterol, smoking and systolic blood pressure. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
QRISK-3 Risk Score
Time frame: 0-week, 6-week,12-week,24-week
It predicts a patient's risk of developing cardiovascular disease in the next 10 years. It includes many of the traditional risk factors featured in Framingham (such as age, gender, cholesterol/HDL ratio, blood pressure, diabetes and smoking status), but also includes important additional risk factors. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
24-Hour Ambulatory Blood Pressure
Time frame: 0-week, 6-week,12-week,24-week
It is the gold standard for hypertension diagnosis and 24-hour blood pressure evaluation.
DAS28
Time frame: 0-week, 6-week,12-week,24-week
Rheumatoid arthritis severity will be determined using DAS28 score. The DAS28 score ranges score between 0 and 10, a larger number indicating more active disease. When using the score to assess response to treatment, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement. The score <2.6 suggests disease remission.
Maximal oxygen consumption (VO2max)
Time frame: 0-week, 6-week,12-week,24-week
VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min). VO2 max is an objective measurement of cardiorespiratory capacity. Higher values indicate a worse, lower values indicate a better outcome.
4 secondary outcomes
The Six-Minute Walk Test (6MWT)
Time frame: 0-week, 6-week,12-week,24-week
The 36-Item Short Form Survey (SF-36)
Time frame: 0-week, 6-week,12-week,24-week
International Physical Activity Questionnaire (IPAQ) - Short Form
Time frame: 0-week, 6-week,12-week,24-week
Beck Depression Inventory (BDI)
Time frame: 0-week, 6-week,12-week,24-week
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 18 Jun 2026.
- Background: PubMed 28723028Chauhan K, Jandu JS, Brent LH, Al-Dhahir MA. Rheumatoid Arthritis. 2023 May 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441999/
- Background: PubMed 25180621Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35.
- Background: PubMed 33175207Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.
- Background: PubMed 19035419Avina-Zubieta JA, Choi HK, Sadatsafavi M, Etminan M, Esdaile JM, Lacaille D. Risk of cardiovascular mortality in patients with rheumatoid arthritis: a meta-analysis of observational studies. Arthritis Rheum. 2008 Dec 15;59(12):1690-7. doi: 10.1002/art.24092.
- Background: PubMed 19026144Sokka T, Abelson B, Pincus T. Mortality in rheumatoid arthritis: 2008 update. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S35-61.
- Background: PubMed 33609791Hadwen B, Stranges S, Barra L. Risk factors for hypertension in rheumatoid arthritis patients-A systematic review. Autoimmun Rev. 2021 Apr;20(4):102786. doi: 10.1016/j.autrev.2021.102786. Epub 2021 Feb 18.
- Background: PubMed 32382031Anyfanti P, Gkaliagkousi E, Triantafyllou A, Koletsos N, Gavriilaki E, Galanopoulou V, Aslanidis S, Douma S. Hypertension in rheumatic diseases: prevalence, awareness, treatment, and control rates according to current hypertension guidelines. J Hum Hypertens. 2021 May;35(5):419-427. doi: 10.1038/s41371-020-0348-y. Epub 2020 May 7.
- Background: PubMed 30886961Jagpal A, Navarro-Millan I. Cardiovascular co-morbidity in patients with rheumatoid arthritis: a narrative review of risk factors, cardiovascular risk assessment and treatment. BMC Rheumatol. 2018 Apr 11;2:10. doi: 10.1186/s41927-018-0014-y. eCollection 2018.
- Background: PubMed 18467370Panoulas VF, Metsios GS, Pace AV, John H, Treharne GJ, Banks MJ, Kitas GD. Hypertension in rheumatoid arthritis. Rheumatology (Oxford). 2008 Sep;47(9):1286-98. doi: 10.1093/rheumatology/ken159. Epub 2008 May 8.
- Background: PubMed 33289108Sahin AA, Ozben B, Sunbul M, Yagci I, Sayar N, Cincin A, Gurel E, Tigen K, Basaran Y. The effect of cardiac rehabilitation on blood pressure, and on left atrial and ventricular functions in hypertensive patients. J Clin Ultrasound. 2020 Dec 1:e22956. doi: 10.1002/jcu.22956. Online ahead of print.
- Background: PubMed 11926784Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.
- Background: PubMed 27697765Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, Kvien TK, Dougados M, Radner H, Atzeni F, Primdahl J, Sodergren A, Wallberg Jonsson S, van Rompay J, Zabalan C, Pedersen TR, Jacobsson L, de Vlam K, Gonzalez-Gay MA, Semb AG, Kitas GD, Smulders YM, Szekanecz Z, Sattar N, Symmons DP, Nurmohamed MT. EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis. 2017 Jan;76(1):17-28. doi: 10.1136/annrheumdis-2016-209775. Epub 2016 Oct 3.
- 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.
Serap TOMRUK SÜTBEYAZ, PROFESSOR study director
KAYSERİ CITY HOSPITAL
Abdurrahman KUTLUCA, MD principal investigator
Health Sciences University, Kayseri Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiac Rehabilitation and Rheumatoid Arthritis, run by Kayseri City Hospital 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 3 inclusion and 7 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 18 Jun 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?
Framingham Risk Score(FRS) (time frame: 0-week, 6-week,12-week,24-week). 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?
On the ClinicalTrials.gov record for NCT06295848, which also lists 17 linked publications.
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 18 Jun 2026.