Heinze-Milne Stefan, Bakowsky Volodko, Giacomantonio Nicholas, Grandy Scott A
School of Health and Human Performance, Dalhousie University, Halifax, Canada.
Division of Rheumatology, Department of Medicine, Nova Scotia Health Authority, Halifax, Canada.
BMJ Open. 2017 Dec 22;7(12):e018540. doi: 10.1136/bmjopen-2017-018540.
Patients with systemic inflammatory diseases such as rheumatoid arthritis (RA) have an increased risk of cardiovascular disease (CVD) above the baseline risk attributable to traditional CVD risk factors seen in the general population. Exercise in cardiac rehabilitation (CR) is designed specifically for high-risk primary prevention and those with established CVD. Even though the European League Against Rheumatism guidelines state that exercise is safe for individuals with RA and exercise can reduce CVD risk, patients with RA rarely participate in CR. Thus, little is known about CR's impact on inflammatory and CVD risk in the RA population. The purpose of this trial is to determine the feasibility of a 12-week CR programme for patients with RA and whether it decreases CVD risk without exacerbating RA.
This is a randomised controlled trial whereby 60 participants with RA will be recruited and randomly assigned to either standard of care (SOC) treatment or SOC plus a 12-week CR programme (60 min of education plus two 60 min aerobic exercise sessions/week). Exercise will be performed at 60%-80% of heart rate reserve. Outcome measures (Framingham Risk Score, resting heart rate, blood pressure, blood lipids, markers of systemic inflammation (ie, interleukin (IL) 6 and tumour necrosis factor-α (TNF-α), Clinical Disease Assessment Index, Disease Activity Score-28, physical activity levels and peak cardiorespiratory fitness) will be assessed preintervention (week-0), postintervention (week-13) and 6 months postintervention.
Ethical approval was obtained from the Nova Scotia Health Authority Research Ethics Board. Results will be submitted for publication in an appropriate peer-reviewed journal.
NCT01534871; Pre-results.
患有类风湿关节炎(RA)等全身性炎症疾病的患者,其心血管疾病(CVD)风险高于一般人群中由传统CVD风险因素导致的基线风险。心脏康复(CR)中的运动是专门为高危一级预防人群和已确诊CVD的患者设计的。尽管欧洲抗风湿病联盟指南指出运动对RA患者是安全的,且运动可降低CVD风险,但RA患者很少参与CR。因此,关于CR对RA人群炎症和CVD风险的影响知之甚少。本试验的目的是确定一项为期12周的CR计划对RA患者的可行性,以及该计划是否能在不加重RA的情况下降低CVD风险。
这是一项随机对照试验,将招募60名RA患者,并随机分配至标准治疗(SOC)组或SOC加为期12周的CR计划组(每周60分钟教育课程加两次60分钟有氧运动)。运动将在心率储备的60%-80%强度下进行。在干预前(第0周)、干预后(第13周)和干预后6个月评估结局指标(弗雷明汉风险评分、静息心率、血压、血脂、全身炎症标志物(即白细胞介素(IL)-6和肿瘤坏死因子-α(TNF-α))、临床疾病评估指数、疾病活动评分-28、身体活动水平和心肺适能峰值)。
已获得新斯科舍省卫生局研究伦理委员会的伦理批准。研究结果将提交至合适的同行评审期刊发表。
NCT01534871;预结果。