Status:
COMPLETED
Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Lead Sponsor:
Techniker Krankenkasse
Collaborating Sponsors:
Technical University of Munich
privates Institut für angewandte Versorgungsforschung GmbH
Conditions:
Ischemic Heart Disease Chronic
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT03835923
Start Date
February 12 2019
End Date
April 16 2021
Last Update
November 5 2021
Active Locations (10)
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1
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
Aachen, Germany
2
University Hospital: Charité - Universitätsmedizin Berlin
Berlin, Germany
3
University Hospital: Herzzentrum Dresden
Dresden, Germany
4
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany