Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes (LeIKD)

November 4, 2021 updated by: Prof. Dr. med. Martin Halle, Techniker Krankenkasse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
      • Berlin, Germany
        • University Hospital: Charité - Universitätsmedizin Berlin
      • Dresden, Germany
        • University Hospital: Herzzentrum Dresden
      • Freiburg, Germany
        • University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
      • Greifswald, Germany
        • University Hospital: Universitätsmedizin Greifswald
      • Kassel, Germany
        • Doctor's Practice: Dr. Rüdell
      • Leipzig, Germany, 04103
        • University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
      • Magdeburg, Germany
        • University Hospital: Magdeburg
      • Munich, Germany
        • University Hospital: Klinikum rechts der Isar, Technische Universität München
      • Villingen-Schwenningen, Germany
        • Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lifestyle intervention
Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
Behavioral: 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.
ACTIVE_COMPARATOR: usual care
general exercise and nutritional recommendations according to current guidelines
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 6 months
measured in percent (%)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 12 months
measured in percent (%)
12 months
Change in health literacy
Time Frame: 6 and 12 months
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
6 and 12 months
Change in daily physical activity
Time Frame: 6 and 12 months
International Physical Activity Questionnaire (IPAQ)
6 and 12 months
Change in average steps per day
Time Frame: 6 and 12 months
7-day average of steps/day measured by pedometers
6 and 12 months
Change in eating behavior
Time Frame: 6 and 12 months
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
6 and 12 months
Change in quality of life
Time Frame: 6 and 12 months
Short form health survey (SF-36)
6 and 12 months
Change of medical care expenses
Time Frame: 6 and 12 months
routine data of health insurance company
6 and 12 months
Change in weight
Time Frame: 6 and 12 months
measured in kilograms (kg)
6 and 12 months
Change in waist circumference
Time Frame: 6 and 12 months
measured in centimeters (cm)
6 and 12 months
Change in LDL-cholesterol concentrations
Time Frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
6 and 12 months
Change in HDL-cholesterol concentrations
Time Frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
6 and 12 months
Change in triglyceride concentrations
Time Frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
6 and 12 months
Change in systolic blood pressure
Time Frame: 6 and 12 months
measured in millimeters of mercury (mmHG)
6 and 12 months
Change in diastolic blood pressure
Time Frame: 6 and 12 months
measured in millimeters of mercury (mmHG)
6 and 12 months
Number of the combined endpoint "4P-MACE"
Time Frame: 6 and 12 months
cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Techniker Krankenkasse

Collaborators

Technical University of Munich
Federal Joint Committee
privates Institut für angewandte Versorgungsforschung GmbH
IDS Diagnostic Systems AG

Investigators

  • Principal Investigator: Martin Halle, Prof. Dr. med., Klinikum rechts der Isar Technische Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2019

Primary Completion (ACTUAL)

December 16, 2020

Study Completion (ACTUAL)

April 16, 2021

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (ACTUAL)

February 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01NVF17015
  • DRKS00015140 (REGISTRY: German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on lifestyle intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe