The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients
- Conditions
- Cardiac RehabilitationHypertensionRheumatoid Arthritis
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT06295848
- Lead Sponsor
- Kayseri City Hospital
- Brief 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.
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac Rehabilitation Exercise 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.
- Primary Outcome Measures
Name Time Method QRISK-3 Risk Score 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.
DAS28 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.
24-Hour Ambulatory Blood Pressure 0-week, 6-week,12-week,24-week It is the gold standard for hypertension diagnosis and 24-hour blood pressure evaluation.
Maximal oxygen consumption (VO2max) 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.
Framingham Risk Score(FRS) 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.
- Secondary Outcome Measures
Name Time Method The Six-Minute Walk Test (6MWT) 0-week, 6-week,12-week,24-week The Six-Minute Walk Test is a submaximal field test used to monitor exercise capacity and treatment effectiveness in cardiac rehabilitation.
International Physical Activity Questionnaire (IPAQ) - Short Form 0-week, 6-week,12-week,24-week 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.
Beck Depression Inventory (BDI) 0-week, 6-week,12-week,24-week 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.
The 36-Item Short Form Survey (SF-36) 0-week, 6-week,12-week,24-week 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.
Trial Locations
- Locations (1)
Health Sciences University, Kayseri Medicine Faculty
🇹🇷Kayseri, Kocasinan, Turkey