Lifestyle Intervention in Chronic ischemic heart disease and Diabetes

Lifestyle Intervention in Chronic ischemic heart disease and Diabetes - LeIKD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015140

Enrollment

1500

Registered

2019-01-10

Start date

2019-02-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25 E11

Interventions

Group 1: intervention phase 1 (week 1 – week 26): Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily phys

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Insured at participating health insurance, Chronic ischemic heart disease (ICD-10: I25), Diabetes mellitus type II (ICD-10: E11), Permission to do sports by the study investigator, Written informed consent

Exclusion criteria

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), 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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c (%) within 6 months	—

Secondary

Measure	Time frame
1) Change in HbA1c (%) within 12 months 2) Change in health literacy (European Health Literacy Survey Questionnaire (HLS-EU-Q16)) within 6 and 12 months 3) Change in daily physical activity (International Physical Activity Questionnaire (IPAQ)) within 6 and 12 months 4) Change in average steps per day (7-day average of steps/day measured by pedometers) within 6 and 12 months 5) Change in eating behavior (Fragebogen zum Essverhalten (FEV); German questionnaire on eating behavior) within 6 and 12 months 6) Change in quality of life (Short form health survey (SF-36)) within 6 and 12 months 7) Change in medical care expenses (routine data of health insurance) within 6 and 12 months 8) Change in weight (kg) within 6 and 12 months 9) Change in waist circumference (cm) within 6 and 12 months 10) Change in LDL-cholesterol concentrations (mg/dL) within 6 and 12 months 11) Change in HDL-cholesterol concentrations (mg/dL) within 6 and 12 months 12) Change in triglyceride concentrations (mg/dL) within 6 and 12 months 13) Change in systolic blood pressure (mmHG) within 6 and 12 months 14) Change in diastolic blood pressure (mmHG) within 6 and 12 months 15) Number of the combined endpoint “4P-MACE” (cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris) within 6 and 12 months	—

Measure

Time frame

1) Change in HbA1c (%) within 12 months 2) Change in health literacy (European Health Literacy Survey Questionnaire (HLS-EU-Q16)) within 6 and 12 months 3) Change in daily physical activity (International Physical Activity Questionnaire (IPAQ)) within 6 and 12 months 4) Change in average steps per day (7-day average of steps/day measured by pedometers) within 6 and 12 months 5) Change in eating behavior (Fragebogen zum Essverhalten (FEV); German questionnaire on eating behavior) within 6 and 12 months 6) Change in quality of life (Short form health survey (SF-36)) within 6 and 12 months 7) Change in medical care expenses (routine data of health insurance) within 6 and 12 months 8) Change in weight (kg) within 6 and 12 months 9) Change in waist circumference (cm) within 6 and 12 months 10) Change in LDL-cholesterol concentrations (mg/dL) within 6 and 12 months 11) Change in HDL-cholesterol concentrations (mg/dL) within 6 and 12 months 12) Change in triglyceride concentrations (mg/dL) within 6 and 12 months 13) Change in systolic blood pressure (mmHG) within 6 and 12 months 14) Change in diastolic blood pressure (mmHG) within 6 and 12 months 15) Number of the combined endpoint “4P-MACE” (cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris) within 6 and 12 months

—

Countries

Germany

Contacts

Public ContactAndrè Duvinage

Lehrstuhl für präventive und rehabilitative Sportmedizin, Klinikum rechts der Isar der TU München

leikd.info(at)mri.tum.deDE 089 - 289 24454

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 16, 2026