The recruited subjects (n = 300) receive routine medical care on the day of randomization
in our outpatient clinic. Furthermore, an additional blood sample is taken (further blood
samples are taken on month 6 and month 12), which contain 9 ml EDTA (for DNA analysis,
e.g. whole genome sequencing), 5 ml of PaxGene (for RNA analysis), 7.5 ml of plasma (for
example for metabolite and RNA analysis) and 7.5 ml of serum (for example for metabolite
and RNA analysis). A detailed medical history is taken during the basic examination. This
is followed by detailed physical examination and diagnostics. A routine blood sample is
taken to determine the values of electrolytes, NT-ProBNP, hsTnT, creatinine, urea and the
blood count. Finally, the patients answer a questionnaire on Quality of Life (MHLFQ: The
Minnesota Living with Heart Failure Questionnaire) and Depression (PHQ9).
Two thirds of the patients (n = 200; intervention groups) will regularly participate in
an individually designed sports program for a period of 12 months. One third of the
participants (n = 100; control group) will not participate in a sports program. As a
SmartWatch is required for the study. SmartWatches will be made available to all subjects
on the day of recruitment. These are Apple Watches (Series 4), which are provided by
Apple Inc. On the Apple Watch, participants have access to an app, that was especially
developed by us for the study. This app collects important information about the physical
activity and symptoms of the patient (including pulse rate, duration of training, the
number of floors, number of steps and ECGs). The Apple Watch is also used to send
participants of the intervention group regular notifications about their training status
and to remind them of their training.
The participants present themselves 4-6 weeks after recruitment in the department of
sports medicine to perform a spiroergometry and a sports medical evaluation. A
personalized sports program (depending on the severity of the disease) is created for the
subjects of the intervention groups, which consists of strength and endurance training.
The sports program will be carried out over a period of 12 months.
All subjects in the intervention groups receive follow-up visits on month 3, month 6,
month 9 and month 12. The sports program can be adapted on these dates. The subjects who
did not receive a personalized training program presente themselves for the follow-up
examination on month 6 and month 12. Unwanted events during the training (including
syncope, ICD therapy, injuries) are documented during the follow-up visits.
