Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in left ventricular mass
研究概览
简要总结
The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.
详细描述
80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.
After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 and <70 years
- •Informed consent
- •Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment
- •Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) <=3.2
- •An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology
- •Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:
- •Vasectomized partner
- •Bilateral tubal occlusion
- •Sexual abstinence
- •Intrauterine device
- •Hormonal contraception
- •Females who are considered to have no childbearing potential are
- •Bilateral tubal ligation
- •Bilateral oophorectomy
- •Complete hysterectomy
- •Postmenopausal defined as 12 months with no menses without an alternative medical cause
排除标准
- •Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
- •Subjects who cannot undergo MRI scans (metallic implants or claustrophobia)
- •Corticosteroid use per os > 10 mg/day within seven days of study enrollment
- •Intramuscular corticosteroid within 3 weeks of the study enrollment
- •Grade 2 hypertension (systolic BP > 160 mmHg and/or diastolic BP >100 mmHg) despite the use of antihypertensive drugs.
- •Pregnancy
- •Subjects with insulin dependent Diabetes
结局指标
主要结局
Change in left ventricular mass
时间窗: 12 weeks
measured by MRI scan
次要结局
- Visceral adipose tissue mass(12 weeks)
- Global longitudinal strain(12 weeks)
- Intramyocardial triglyceride content(12 weeks)
- Whole body plethysmography(12 weeks)
- Left ventricular and atrial end-diastolic volume(12 weeks)
- Left atrial volume index(12 weeks)
- Interventricular septum thickness(12 weeks)
- Oral glucose tolerance test(12 weeks)
- Axial accelerometer-based physical activity monitors(5 days in week 6 of the intervention/control)
- RA disease specific outcomes 6(12 weeks)
- Stroke volume(12 weeks)
- E/A ratio(12 weeks)
- Cardiorespiratory fitness(12 weeks)
- Dynamic spirometry(12 weeks)
- Body composition(12 weeks)
- Dietary intake(3 days in the week 6 of intervention/control)
- LVEF(12 weeks)
- E/é(12 weeks)
- Left ventricular and atrial end-systolic volume(12 weeks)
- Aortic and pulmonary distensibility and pulse wave velocity(12 weeks)
- RA disease specific outcomes 3(12 weeks)
- RA disease specific outcomes 8(12 weeks)
- Left ventricular posterior wall thickness(12 weeks)
- Subcutaneous, visceral and epicardial adipose tissue(12 weeks)
- Diffusion capacity(12 weeks)
- RA disease specific outcomes 5(12 weeks)
- RA disease specific outcomes 1(12 weeks)
- RA disease specific outcomes 2(12 weeks)
- RA disease specific outcomes 7(12 weeks)
- RA disease specific outcomes 4(12 weeks)
- Blood sample(12 weeks)
研究者
Regitse Christensen
Principal investigator
Rigshospitalet, Denmark