Internal Medicine Department - CIGES, Universidad de La Frontera, Temuco, Chile
Internal Medicine Department - CIGES, Universidad de La Frontera, Temuco, Chile.
BMJ Open. 2019 Oct 28;9(10):e031213. doi: 10.1136/bmjopen-2019-031213.
Cardiac rehabilitation (CR) programmes are well established, and their effectiveness and cost-effectiveness are proven. In spite of this, CR remains underused, especially in lower-resource settings such as Latin America. There is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme.
A non-inferiority, pragmatic, multicentre, parallel (1:1), prospective, randomised and open with blinded endpoint assessment clinical trial will be conducted. 308 patients with coronary artery disease will be recruited consecutively. Participants will be randomised to hybrid or standard rehabilitation programme. The hybrid CR programme includes 10 supervised exercise sessions and individualised lifestyle counselling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. Intervention in both groups is between 8 and 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalisations due to cardiovascular causes. Secondary outcomes are health-related quality of life, exercise capacity, muscle strength, heart-healthy behaviour, return-to-work, cardiovascular risk factor, adherence, and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months and at 12 months follow-up from recruitment. The primary outcome will be tracked through the end of the trial. Per-protocol and intention-to-treat analysis will be undertaken.Cox regression model will be used to compare primary outcome among study groups.
Ethics committees at the sponsor institution and each centre where participants will be recruited approved the study protocol and the Informed Consent. Research findings will be published in peer-reviewed journals; additionally, results will be disseminated among region stakeholders.
NCT03881150; Pre-results.
01 October 2019.
心脏康复（CR）项目已经成熟，其有效性和成本效益已得到证实。尽管如此，CR 的使用率仍然较低，尤其是在拉丁美洲等资源较少的地区。迫切需要创建更易于获得的 CR 交付模式，以满足所有有需要的患者。本试验旨在评估与标准方案相比，混合 CR 方案在预防复发性心血管事件方面是否不劣效。
将进行一项非劣效性、实用、多中心、平行（1:1）、前瞻性、随机、开放、终点评估盲法临床试验。将连续招募 308 例冠心病患者。参与者将被随机分配到混合或标准康复方案。混合 CR 方案包括 10 次监督下的运动训练和由物理治疗师进行的个性化生活方式咨询，4-6 周后过渡到通过短信和电话进行无人监督的康复。标准 CR 由 18-22 次监督下的运动训练以及关于生活方式的小组教育课程组成。两组的干预时间为 8-12 周。主要结局是心血管死亡率和因心血管原因住院的复合结局。次要结局是健康相关生活质量、运动能力、肌肉力量、心脏健康行为、重返工作岗位、心血管危险因素、依从性和与运动相关的不良事件。在干预结束时、6 个月和招募后 12 个月进行测量。主要结局将在试验结束时进行跟踪。将进行意向治疗和符合方案分析。Cox 回归模型将用于比较研究组之间的主要结局。
赞助机构和每个参与者将被招募的中心的伦理委员会批准了研究方案和知情同意书。研究结果将发表在同行评议的期刊上；此外，还将在区域利益相关者中传播研究结果。
NCT03881150；预试验结果。
2019 年 10 月 1 日。
