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CARE CR-心血管及心肺对基于常规运动的心脏康复的适应性:一项采用标准方法的社区对照研究方案

CARE CR-Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation: a study protocol for a community-based controlled study with criterion methods.

作者信息

Nichols Simon, Nation Fiona, Goodman Toni, Clark Andrew L, Carroll Sean, Ingle Lee

机构信息

Centre for Sport and Exercise Science, Sheffield Hallam University-Collegiate Crescent Campus, Sheffield, UK.

Department of Sport Health and Exercise Science, University of Hull, Hull, UK.

出版信息

BMJ Open. 2018 Jan 27;8(1):e019216. doi: 10.1136/bmjopen-2017-019216.

Abstract

INTRODUCTION

Cardiac rehabilitation (CR) reduces all-cause and cardiovascular mortality in patients with coronary heart disease (CHD). Much of this improvement has been attributed to the beneficial effects of structured exercise training. However, UK-based studies have not confirmed this. Improvements in survival and cardiovascular health are associated with concurrent improvements in cardiorespiratory fitness (CRF). It is therefore concerning that estimated CRF improvements resulting from UK-based CR are approximately one-third of those reported in international literature. Modest improvements in CRF suggest that UK CR exercise training programmes may require optimisation if long-term survival is to be improved. However, contemporary UK studies lack control data or use estimates of CRF change. Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based CR is a longitudinal, observational, controlled study designed to assess the short-term and long-term effect of CR on CRF, as well cardiovascular and cardiometabolic health.

METHODS AND ANALYSIS

Patients will be recruited following referral to their local CR programme and will either participate in a routine, low-to-moderate intensity, 8-week (16 sessions) exercise-based CR programme or freely abstain from supervised exercise. Initial assessment will be conducted prior to exercise training, or approximately 2 weeks after referral to CR if exercise training is declined. Reassessment will coincide with completion of exercise training or 10 weeks after initial assessment for control participants. Participants will receive a final follow-up 12 months after recruitment. The primary outcome will be peak oxygen consumption determined using maximal cardiopulmonary exercise testing. Secondary outcomes will include changes in subclinical atherosclerosis (carotid intima-media thickness and plaque characteristics), body composition (dual X-ray absorptiometry) and cardiometabolic biomarkers.

ETHICS AND DISSEMINATION

Ethical approval for this non-randomised controlled study has been obtained from the Humber Bridge NHS Research Ethics Committee-Yorkshire and the Humber on the 27th September 2013, (12/YH/0278). Results will be presented at national conferences and published in peer-reviewed journals.

摘要

引言

心脏康复(CR)可降低冠心病(CHD)患者的全因死亡率和心血管死亡率。这种改善很大程度上归因于结构化运动训练的有益效果。然而,英国的研究尚未证实这一点。生存率和心血管健康的改善与心肺适能(CRF)的同时改善相关。因此,令人担忧的是,英国心脏康复带来的CRF改善估计仅为国际文献报道的三分之一左右。CRF的适度改善表明,如果要提高长期生存率,英国的心脏康复运动训练计划可能需要优化。然而,当代英国的研究缺乏对照数据或使用CRF变化的估计值。《心血管和心肺对基于常规运动的心脏康复的适应性》是一项纵向、观察性、对照研究,旨在评估心脏康复对CRF以及心血管和心脏代谢健康的短期和长期影响。

方法与分析

患者将在被转诊至当地心脏康复计划后招募,要么参加常规的低至中等强度、为期8周(16节)的基于运动的心脏康复计划,要么自由选择不参加有监督的运动。初始评估将在运动训练前进行,如果拒绝运动训练,则在转诊至心脏康复计划后约2周进行。重新评估将与运动训练结束时或对照参与者初始评估后10周同时进行。参与者将在招募后12个月接受最终随访。主要结局将是通过最大心肺运动试验确定的峰值耗氧量。次要结局将包括亚临床动脉粥样硬化(颈动脉内膜中层厚度和斑块特征)、身体成分(双能X线吸收法)和心脏代谢生物标志物的变化。

伦理与传播

这项非随机对照研究已于2013年9月27日获得亨伯桥国民保健服务研究伦理委员会 - 约克郡和亨伯地区的伦理批准(12/YH/0278)。研究结果将在全国会议上展示并发表在同行评审期刊上。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c03e/5829840/50f7b60abc28/bmjopen-2017-019216f01.jpg

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