The Effects of a 12-week Cardiovascular Rehabilitation Exercise Program on Inflammatory Markers and Traditional Coronary Artery Disease Risk Factors in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Framingham risk score
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects approximately 1% of all Canadians. RA is associated with a higher rate of disease and death as well as a decreased life expectancy. Changes in death rates and life expectancy are mainly the result of an increased frequency of cardiovascular disease (CVD). The increase in CVD frequency is primarily attributable to accelerated atherosclerosis. It is believed that elevated levels of inflammation, which are characteristic of RA, play a key role in accelerated rate of CVD in RA patients. Thus, inflammation is considered a primary risk factor for CVD in RA patients. Interestingly, despite a better understanding of the relationship between RA and CVD and improved treatment for RA patients the death rate in RA population continues to increase. Thus, there is an immediate need to develop treatment strategies to reduce the risk of CVD associated with inflammation in the RA population.
Exercise is commonly used to reduce the risk of CVD. Preventative exercise programs are often offered as part of cardiac rehabilitation (CR) programs. These programs help patients modify CVD risk factors, improve physical capacity and decrease CVD risk. Studies also suggest that CR programs decrease levels of inflammation. Since RA patients have an elevated risk for CVD, which is primarily attributed to increased levels of inflammation, they are prime candidates for CR programs. However, RA patients are very rarely referred to CR programs. Thus, there is a lack of information regarding the effects of CR on RA patients. Thus studies are needed to determine whether CR modifies levels of inflammation and decreases CVD risk in RA patients. Therefore, the purpose of this study is to determine the effects of a 12-week standardized cardiac rehabilitation exercise program on systemic inflammation and CVD risk in individuals with RA. Specifically, this study will characterize the effects of a community based CR exercise program on systemic markers of inflammation (proinflammatory cytokines) and global CVD risk (Framingham risk profile) as well as the therapeutic effects of CR exercise on the severity of RA.
This study will help to clarify the mechanism(s) by which exercise impacts CVD risk in patients with inflammatory disease. In addition, the study will show how CR may benefit patients with inflammatory disease with respect to their ability to exercise, global risk for cardiovascular disease and quality of life.
详细描述
Rheumatoid arthritis (RA) is a chronic inflammatory disease that impacts approximately 1% of all Canadians. RA is associated with increased mortality, decreased life expectancy and increased morbidity, which is primarily attributable to an increased risk of cardiovascular disease (CVD). Traditional risk factors (e.g. dyslipidemia, hypertension, physical inactivity, etc.) contribute, in part, to the elevated risk of CVD in individuals with RA. However, the higher incidence of CVD events in RA appears to be independent of the influence of traditional CVD risk factors. Non-traditional risk factors, such as inflammation, also contribute to the increased risk of CVD in RA patients. In fact, when traditional CVD risk factors and co-morbidities are controlled for in people with RA, markers of systemic inflammation confer a significant additional risk for CV death. This suggests that systemic inflammation significantly contributes to the increased risk of CVD in individuals with RA. Thus, there is an immediate need to develop intervention strategies to reduce the inflammatory mediated risk of CVD in the RA population.
One possible intervention that could be used to decrease CVD risk in RA patients is exercise. Exercise can modify both traditional (e.g. dyslipidemia) and non-traditional (e.g. inflammation) risk factors to decrease the risk of CVD. For patients with cardiac disease, clinical guidelines recommend regular exercise. For this, patients are referred to cardiac rehabilitation (CR) programs, where exercise represents the cornerstone of the program. The goal of these programs is modify CVD risk factors, improve physical capacity and decrease CVD risk. Thus, CR programs may offer a suitable therapeutic intervention to help decrease CVD risk in RA patients. However, RA patients are rarely referred to CR despite their increased risk of CVD. Thus, the effects of CR on inflammation and CVD risk in patients with RA remains unclear.
The purpose of this study is to examine the effects of a 12-week cardiac rehabilitation exercise program on systemic inflammation and CVD risk in individuals with RA. The specific objectives of the study are: 1) to determine whether it is feasible for RA patients to complete a 12-week high intensity CR exercise program, 2) examine the effects of a 12-week standardized CR exercise program on systemic markers of inflammation in individuals with RA, 3) to examine the effects of a 12-week standardized CR exercise program on CVD risk in individuals with RA and 4) to characterize the effects a 12-week standardized CR exercise program on the severity of the patient's RA and their functional ability.
This study is meant to be a pilot study that will help provide insight into the therapeutic effects of CR on inflammation and CVD risk in RA patients. Based on the results from this preliminary work, a larger scale study will be developed to evaluate the effects of exercise intensity on cardiovascular risk in patients with inflammatory disease as well as the effects of exercise on decision making for pharmacological intervention (e.g. statin therapy) in this population.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only those patients that 1) have RA fulfilling the American College of Rheumatology criteria, 2) have two or more swollen joints, 3) are receiving stable pharmacotherapy (defined as greater than 3 months of unchanged antirheumatic drugs and greater than 1 month of unchanged nonsteroidal anti-inflammatory drugs), 4) have moderate risk of CVD as identified by the Framingham risk score, 5) are able to walk on treadmill or cycle on a stationary bike for 15 minutes and 6) are able to attend the Community Cardiovascular Hearts in Motion program (held in the Halifax Regional Municipality).
排除标准
- •Patients that are 1) diabetic, 2) have known coronary, cerebral or peripheral artery disease, 3) taking statins, or 4) have one or more arthroplasties of weight bearing joints will not be eligible to participate in the study.
结局指标
主要结局
Framingham risk score
时间窗: Final measure week-13
Equation used to predict global coronary heart disease risk. Factors used in the equation to predict risk include age, total cholesterol or LDL cholesterol, HDL cholesterol, blood pressure, history of diabetes and smoking history.
Levels of systemic inflammation
时间窗: Final measure week-13
Blood samples will be collected from the subjects and used to to quantify serum levels of proinflammatory cytokines (IL-1 alpha and beta, IL-6, IL-17 and TNF alpha) and anti-inflammatory cytokines (IL-4, IL-10).
Severity of rheumatoid arthritis
时间窗: Final measure week-13
Rheumatoid arthritis severity will be determined using the American College of Rheumatology (ACR) response score. The ACR is a composite score based on 7 measures: 3 by an assessor (swollen joint, tender joint count and physician global status), 3 by the patient (function, pain and global status) and blood work to measure rheumatoid factor (RF), anti-citrullinated protein antibodies (ACAP), c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR)).
次要结局
- Weight(Final measure week-13)
- Smoking history(Final measure week-13)
- Waist girth(Final measure week-13)
- Resting blood pressure(Final measure week-13)
- Lipid profile(Final measure week-13)
- Aerobic fitness(Final measure week-13)
- Resting heart rate(Final measure week-13)
- Physical activity level(Final measure week-13)
- Functional ability(Final measure week-13)
- Alcohol consumption(Final measure week-13)