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Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a
Pia von Korn1,2, Hanna Sydow3,4, Sarah Neubauer5
1Department of Prevention and Sports Medicine, Technical University of Munich, Munchen, Germany.
Insights
This study investigates a telemedical lifestyle intervention for patients with chronic ischemic heart disease and type 2 diabetes. The goal is to improve cardiovascular risk factors and health outcomes compared to usual care.
Area of Science:
- Cardiology
- Endocrinology
- Public Health
Background:
- Lifestyle interventions are recommended for chronic ischemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM).
- Randomized controlled trial evidence is limited for patients with both CIHD and T2DM.
Purpose of the Study:
- To evaluate if a telemedical lifestyle intervention (LS) is superior to usual care (UC) in patients with CIHD and T2DM.
- To assess the impact of LS on cardiovascular risk factors, physical activity, quality of life, and health economics.
Main Methods:
- Prospective, multicenter randomized trial (LeIKD study) comparing LS and UC (1:1 ratio).
- LS includes 6 months of exercise, nutritional counseling, and telemedicine support, followed by 6 months of monitoring.
- Primary endpoint: change in HbA1c from baseline to 6 months.
Main Results:
- Study is ongoing; results are not yet available.
Conclusions:
- The LeIKD trial will provide crucial evidence on the efficacy of telemedical lifestyle interventions for comorbid CIHD and T2DM.
- Findings may inform clinical guidelines and healthcare strategies for managing patients with these combined conditions.
Introduction:
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.
Methods And Analysis:
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 HbA1c from baseline to 6 months.
Ethics And Dissemination:
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.
Trial Registration Number:
Clinical trials.gov identifier: NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.
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