Chronic Heart Failure
Conditions
Keywords
chronic heart failure, exercise training, preferred training, prevention
Brief summary
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.
Interventions
BEHAVIORALexercise training
individualized exercise training
BEHAVIORALAdherence measures
Measures to increase adherence to exercise training
Sponsors
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* women and men * age 30-75 years * chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo * disease duration ≥ 6 month * medical therapy accruing to guidelines (drug, devices, including CRT) * written informed consent
Exclusion criteria
* acute myocarditis * instable angina * heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start * severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start * preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation) * uncorrected valve regurgitation or stenosis (\> second degree) * safety concerns regarding or other reasons against exercise training * severe depression * regular exercise training within the last 6 weeks * life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2@AT | Month 9 | Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Training adherence | 9, 12, 18 and 24 month | Adherence to training sessions |
Other
| Measure | Time frame | Description |
|---|---|---|
| AE | 9, 12, 18 and 24 month | Adverse events, related and unrelated to exercise training |
Countries
Germany
Contacts
Primary ContactMarcus Dörr, MD
Backup ContactStepahn B Felix, MD
Outcome results
None listed