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

Federal Office for Social Security

Status: Completed

Conditions: Ischemic Heart Disease Chronic; Diabetes Mellitus, Type 2

Treatments: Behavioral: lifestyle intervention; Behavioral: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03835923

01NVF17015

DRKS00015140 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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502 participants in 2 patient groups

lifestyle intervention

Experimental group

Description:

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

Treatment:

Behavioral: lifestyle intervention

usual care

Active Comparator group

Description:

general exercise and nutritional recommendations according to current guidelines

Treatment:

Behavioral: usual care