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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- QRISK-3 Risk Score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
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.
Cardiac Rehabilitation
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.
干预措施: Exercise (Behavioral)
结局指标
主要结局
QRISK-3 Risk Score
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- The Six-Minute Walk Test (6MWT)(0-week, 6-week,12-week,24-week)
- International Physical Activity Questionnaire (IPAQ) - Short Form(0-week, 6-week,12-week,24-week)
- Beck Depression Inventory (BDI)(0-week, 6-week,12-week,24-week)
- The 36-Item Short Form Survey (SF-36)(0-week, 6-week,12-week,24-week)
研究者
Havva Talay Çalış
Professor Doctor
Kayseri City Hospital