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Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

NCT ID: NCT03835923

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2021-04-16

Brief Summary

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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.

Detailed Description

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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 combined endpoint of death and myocardial infarction reaches up to 30% within four years. A lifestyle intervention with exercise training and dietary change can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of lifestyle interventions in the population is insufficient.

This prospective randomized controlled trial examines whether a structured, individual and telemedicine-supported lifestyle intervention improves health literacy and reduces cardiovascular risk factors compared to a guideline-based recommendation (usual care). Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.

In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. After randomization (1:1), the 750 patients of the intervention group will receive individual exercise prescriptions and nutritional recommendations based on a maximum exercise stress test and a multi-day nutrition protocol. The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and smartphones as well as regular oral and written feedback.

Conditions

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Ischemic Heart Disease Chronic Diabetes Mellitus, Type 2

Keywords

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lifestyle intervention chronic ischemic heart disease diabetes mellitus type 2 cardiovascular risk factors health literacy telemedicine cross-sectoral care HbA1c individual exercise training dietary change sustainability heart disease nutrition exercise physical activity coronary artery disease coronary heart disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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lifestyle intervention

Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations

Group Type EXPERIMENTAL

lifestyle intervention

Intervention Type BEHAVIORAL

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.

usual care

general exercise and nutritional recommendations according to current guidelines

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type BEHAVIORAL

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)

Interventions

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lifestyle intervention

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.

Intervention Type BEHAVIORAL

usual care

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Participation in another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role collaborator

privates Institut für angewandte Versorgungsforschung GmbH

UNKNOWN

Sponsor Role collaborator

IDS Diagnostic Systems AG

UNKNOWN

Sponsor Role collaborator

Federal Joint Committee

OTHER_GOV

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Martin Halle

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Halle, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar Technische Universität München

Locations

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University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen

Aachen, , Germany

Site Status

University Hospital: Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

University Hospital: Herzzentrum Dresden

Dresden, , Germany

Site Status

University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau, , Germany

Site Status

University Hospital: Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status

Doctor's Practice: Dr. Rüdell

Kassel, , Germany

Site Status

University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

University Hospital: Magdeburg

Magdeburg, , Germany

Site Status

University Hospital: Klinikum rechts der Isar, Technische Universität München

Munich, , Germany

Site Status

Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob

Villingen-Schwenningen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39920395 (View on PubMed)

Dinges 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.

Reference Type DERIVED
PMID: 35953083 (View on PubMed)

von 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.

Reference Type DERIVED
PMID: 33558354 (View on PubMed)

Other Identifiers

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DRKS00015140

Identifier Type: REGISTRY

Identifier Source: secondary_id

01NVF17015

Identifier Type: -

Identifier Source: org_study_id