Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
LeIKD
2 other identifiers
interventional
502
1 country
10
Brief Summary
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The aim of this program is to reduce cardiovascular risk factors by promoting individual health literacy and a healthy lifestyle, thereby improving metabolism and reducing the progress of the disease as well as mortality. Patients will receive individual exercise prescriptions and nutritional recommendations. This lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose meters and smartphones to allow regional implementation in different areas in Germany. In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. The project examines whether the intervention positively affects metabolic health and lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these high risk patients. Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
February 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2021
CompletedNovember 5, 2021
November 1, 2021
1.8 years
February 1, 2019
November 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
measured in percent (%)
6 months
Secondary Outcomes (15)
Change in HbA1c
12 months
Change in health literacy
6 and 12 months
Change in daily physical activity
6 and 12 months
Change in average steps per day
6 and 12 months
Change in eating behavior
6 and 12 months
- +10 more secondary outcomes
Study Arms (2)
lifestyle intervention
EXPERIMENTALTelemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
usual care
ACTIVE COMPARATORgeneral exercise and nutritional recommendations according to current guidelines
Interventions
intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback. intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback.
Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise)
Eligibility Criteria
You may qualify if:
- ischemic heart disease (ICD-10: I20-I25)
- Diabetes mellitus heart disease (ICD-10: E11)
- insured at participating health insurance
- permission to exercise by the study investigator
- written informed consent
You may not qualify if:
- Mental and behavioral disorders (ICD-10: F0-F99)
- Heart failure NYHA IV (ICD-10: I50.14)
- Malignant neoplasm (ICD-10: C25, C34, C56, C72, C73, C78, C79, C97)
- Parkinson's disease (ICD-10: G20)
- Alzheimer's disease (ICD-10: G30)
- infantile cerebral palsy (ICD-10: G80)
- chronic kidney disease (ICD-10: N18.4 \& N18.5)
- Trisomy 21 (ICD-10: Q90)
- Blindness / visual impairment (ICD-10: H54.0, H54.2, H54.3)
- Hearing loss (ICD-10: H90.0, H90.3, H90.5, H90.6, H90.8)
- Care level 1-5
- Assured in a foreign country
- Inability to exercise or conditions that may interfere with exercise intervention
- No optimal medical treatment within the last 4 weeks
- Not clinically stable within the last 4 weeks
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Techniker Krankenkasselead
- Technical University of Munichcollaborator
- privates Institut für angewandte Versorgungsforschung GmbHcollaborator
- IDS Diagnostic Systems AGcollaborator
- Federal Joint Committeecollaborator
Study Sites (10)
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
Aachen, Germany
University Hospital: Charité - Universitätsmedizin Berlin
Berlin, Germany
University Hospital: Herzzentrum Dresden
Dresden, Germany
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany
University Hospital: Universitätsmedizin Greifswald
Greifswald, Germany
Doctor's Practice: Dr. Rüdell
Kassel, Germany
University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
Leipzig, 04103, Germany
University Hospital: Magdeburg
Magdeburg, Germany
University Hospital: Klinikum rechts der Isar, Technische Universität München
Munich, Germany
Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob
Villingen-Schwenningen, Germany
Related Publications (3)
Mueller S, Dinges SMT, Gass F, Fegers-Wustrow I, Treitschke J, von Korn P, Boscheri A, Krotz J, Freigang F, Dubois C, Winzer EB, Linke A, Edelmann F, Feuerstein A, Wolfram O, Schafer K, Verket M, Wolfarth B, Dorr M, Wachter R, Hackenberg B, Rust S, Nebling T, Amelung V, Halle M. Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial. Nat Med. 2025 Apr;31(4):1203-1213. doi: 10.1038/s41591-025-03498-w. Epub 2025 Feb 7.
PMID: 39920395DERIVEDDinges SM, Krotz J, Gass F, Treitschke J, Fegers-Wustrow I, Geisberger M, Esefeld K, von Korn P, Duvinage A, Edelmann F, Wolfram O, Brandts J, Winzer EB, Wolfarth B, Freigang F, Neubauer S, Nebling T, Hackenberg B, Amelung V, Mueller S, Halle M. Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: Baseline characteristics of the Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes study. Diab Vasc Dis Res. 2022 Jul-Aug;19(4):14791641221113781. doi: 10.1177/14791641221113781.
PMID: 35953083DERIVEDvon Korn P, Sydow H, Neubauer S, Duvinage A, Mocek A, Dinges S, Hackenberg B, Weichenberger M, Schoenfeld J, Amelung V, Mueller S, Halle M. 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. 2021 Feb 8;11(2):e042818. doi: 10.1136/bmjopen-2020-042818.
PMID: 33558354DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Halle, Prof. Dr. med.
Klinikum rechts der Isar Technische Universität München
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med.
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 11, 2019
Study Start
February 12, 2019
Primary Completion
December 16, 2020
Study Completion
April 16, 2021
Last Updated
November 5, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share