Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial
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 Ischaemi...
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BMJ Publishing Group
2021-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/2/e042818.full |
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| author | Julia Schoenfeld Martin Halle Pia von Korn Hanna Sydow Sarah Neubauer André Duvinage Anja Mocek Sophia Dinges Bjoern Hackenberg Mario Weichenberger Volker Amelung Stephan Mueller |
| author_facet | Julia Schoenfeld Martin Halle Pia von Korn Hanna Sydow Sarah Neubauer André Duvinage Anja Mocek Sophia Dinges Bjoern Hackenberg Mario Weichenberger Volker Amelung Stephan Mueller |
| author_sort | Julia Schoenfeld |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-888dbfade9434bf5a8d55c530e8e1a8a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-888dbfade9434bf5a8d55c530e8e1a8a2024-11-17T07:10:07ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-042818Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trialJulia Schoenfeld0Martin Halle1Pia von Korn2Hanna Sydow3Sarah Neubauer4André Duvinage5Anja Mocek6Sophia Dinges7Bjoern Hackenberg8Mario Weichenberger9Volker Amelung10Stephan Mueller11Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Bavaria, GermanyDepartment of Prevention and Sports Medicine, University Hospital Klinikum Rechts der Isar, Technical University of Munich, Munich, GermanyDepartment of Prevention and Sports Medicine, Technical University of Munich, Munchen, GermanyDepartment of Health Economics and Health Policy, Hannover Medical School, Hannover, GermanyTechniker Krankenkasse, Hamburg, GermanyDepartment of Prevention and Sports Medicine, Technical University of Munich, Munchen, GermanyInstitute for Applied Health Services Research GmbH (INAV), Berlin, GermanyDepartment of Prevention and Sports Medicine, Technical University of Munich, Munchen, GermanyIDS Diagnostic Systems GmbH, Bonn, GermanyDepartment of Prevention and Sports Medicine, Technical University of Munich, Munchen, GermanyInstitute for Applied Health Services Research GmbH (INAV), Berlin, Germany3 Department of Prevention and Sports Medicine, Technical University of Munich, Munchen, GermanyIntroduction 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.https://bmjopen.bmj.com/content/11/2/e042818.full |
| spellingShingle | Julia Schoenfeld Martin Halle Pia von Korn Hanna Sydow Sarah Neubauer André Duvinage Anja Mocek Sophia Dinges Bjoern Hackenberg Mario Weichenberger Volker Amelung Stephan Mueller Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial BMJ Open |
| title | Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial |
| title_full | Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial |
| title_fullStr | Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial |
| title_full_unstemmed | Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial |
| title_short | Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial |
| title_sort | lifestyle intervention in chronic ischaemic heart disease and type 2 diabetes the leikd study study protocol of a prospective multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/2/e042818.full |
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