Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
- Conditions
- Ischemic Heart Disease ChronicDiabetes Mellitus, Type 2
- Interventions
- Behavioral: usual careBehavioral: lifestyle intervention
- Registration Number
- NCT03835923
- Lead Sponsor
- Techniker Krankenkasse
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description usual care usual care general exercise and nutritional recommendations according to current guidelines lifestyle intervention lifestyle intervention Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
- Primary Outcome Measures
Name Time Method Change in HbA1c 6 months measured in percent (%)
- Secondary Outcome Measures
Name Time Method Change in HbA1c 12 months measured in percent (%)
Change in health literacy 6 and 12 months European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Change in average steps per day 6 and 12 months 7-day average of steps/day measured by pedometers
Change in quality of life 6 and 12 months Short form health survey (SF-36)
Change in LDL-cholesterol concentrations 6 and 12 months measured in milligram/deciliter (mg/dL)
Number of the combined endpoint "4P-MACE" 6 and 12 months cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Change in daily physical activity 6 and 12 months International Physical Activity Questionnaire (IPAQ)
Change in eating behavior 6 and 12 months Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Change in triglyceride concentrations 6 and 12 months measured in milligram/deciliter (mg/dL)
Change of medical care expenses 6 and 12 months routine data of health insurance company
Change in weight 6 and 12 months measured in kilograms (kg)
Change in waist circumference 6 and 12 months measured in centimeters (cm)
Change in HDL-cholesterol concentrations 6 and 12 months measured in milligram/deciliter (mg/dL)
Change in systolic blood pressure 6 and 12 months measured in millimeters of mercury (mmHG)
Change in diastolic blood pressure 6 and 12 months measured in millimeters of mercury (mmHG)
Trial Locations
- Locations (10)
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
🇩🇪Aachen, Germany
University Hospital: Herzzentrum Dresden
🇩🇪Dresden, Germany
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪Freiburg, Germany
University Hospital: Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
University Hospital: Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Doctor's Practice: Dr. Rüdell
🇩🇪Kassel, Germany
University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
🇩🇪Leipzig, 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