Department of Prevention and Sports Medicine, Technical University of Munich, Munchen, Germany.
DZHK (German Centre for Cardiovascular Research), partner site Munich, Munich Heart Alliance, Munich, Germany.
BMJ Open. 2021 Feb 8;11(2):e042818. doi: 10.1136/bmjopen-2020-042818.
Guidelines recommend lifestyle intervention in chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). However, evidence from randomised controlled trials is scarce in patients with combined entities.
The Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (LeIKD) trial is a prospective, multicentre study that will randomise (1:1) patients with CIHD (ICD-10: I20-I25) and T2DM (ICD-10: E11) from one health insurance company into a lifestyle intervention (LS) or usual care (UC). Active LS consists of an individual combined exercise programme of strength and endurance training and nutritional counselling with regular feedback for 6 months. Intervention is supported by telemedicine. Follow-up without individualised feedback will continue for 6 months. The study aims to investigate whether an individualised telemedical supported LS intervention is superior to UC in improving cardiovascular risk factors, physical activity, quality of life, health literacy, major cardiovascular events and health economics in patients with both CIHD and T2DM. Primary endpoint is the change in HbA from baseline to 6 months.
The study has been approved by the ethics committee of the Technical University of Munich (registration number: 144/18-S) and at each study site. The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. It is funded by the Federal Joint Committee (www.innovationsfonds.g-ba.de), reference number 01NVF17015, which has no impact on data collection, analysis or interpretation. Dissemination is independent of the funding source.
Clinical trials.gov identifier: NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.
指南建议对慢性缺血性心脏病（CIHD）和 2 型糖尿病（T2DM）患者进行生活方式干预。然而，在合并症患者中，随机对照试验的证据很少。
慢性缺血性心脏病和 2 型糖尿病的生活方式干预（LeIKD）试验是一项前瞻性、多中心研究，将从一家健康保险公司中随机（1:1）选择患有 CIHD（ICD-10：I20-I25）和 T2DM（ICD-10：E11）的患者分为生活方式干预（LS）或常规护理（UC）组。积极的 LS 包括个体化的综合运动计划，包括力量和耐力训练以及营养咨询，并定期反馈，持续 6 个月。干预措施由远程医疗支持。没有个体化反馈的随访将继续进行 6 个月。该研究旨在调查个体化远程医疗支持的 LS 干预是否优于 UC，以改善合并 CIHD 和 T2DM 患者的心血管危险因素、身体活动、生活质量、健康素养、主要心血管事件和健康经济学。主要终点是从基线到 6 个月时 HbA 的变化。
该研究已获得慕尼黑工业大学伦理委员会（注册号：144/18-S）和每个研究地点的批准。该研究将按照世界医学协会《赫尔辛基宣言》进行，并将结果发表在文章和报告中。该研究由联邦联合委员会（www.innovationsfonds.g-ba.de）资助，参考号 01NVF17015，该委员会对数据收集、分析或解释没有影响。传播独立于资金来源。
临床试验.gov 标识符：NCT03835923。德国临床试验注册处（DRKS）：DRKS00015140。
