Cardiovascular risk, fitness, autonomic regulation, ability to work, quality of life, health literacy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent. Willingness to participate in physical activity and non-invasive measurements. Availability for follow-up examinations over a period of 6 months.
Exclusion criteria
Exclusion criteria: Manifest cardiovascular diseases (e.g., history of heart attack, bypass, stent, heart valve replacement, pacemaker). Poorly controlled chronic respiratory diseases (asthma/COPD). Severe orthopedic limitations. Pregnancy. Use of performance-influencing medication (e.g., beta blockers). Severe mental illness. Planned extended absences (e.g., sabbatical, secondment). Above-average fitness level (>2x endurance training or >3x sports/week).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Designation: Change in absolute 10-year risk of cardiovascular events (CVD risk). Measurement method: Calculation using the Framingham Risk Score (FRS) based on age, gender, cholesterol (total/HDL), blood pressure, diabetes status, and smoking status. Time point: Comparison of the change from baseline (T0) to post-intervention (T1) and follow-ups after 6 weeks (T2) and 6 months (T3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint 1 Designation: Change in estimated maximum oxygen uptake (VO2max) Measurement method: Non-invasive measurement using seismocardiography (SCG) with the Seismofit® system (CE-certified Class I medical device, manufacturer: Ventrict). A validated algorithm estimates VO2max as a surrogate parameter of cardiorespiratory fitness. Time point: Absolute and relative change from T0 to T1, T2, and T3. Secondary endpoint 2 Designation: Change in vascular stiffness Measurement method: Oscillometric arteriography / pulse wave velocity measurement (PWV) using an upper arm cuff (device: Arteriograph, Tensiomed) Time point: Change from T0 to T1, T2, and T3. Secondary endpoint 3 Designation: Change in vegetative regulation Measurement method: Measurement of heart rate variability (HRV) using an HRV scanner as a marker of the autonomic nervous system. Time point: Change from T0 to T1, T2, and T3. Secondary endpoint 4 Designation: Change in metabolic risk profile (fatty liver index) Measurement method: Calculation of the fatty liver index based on body mass index (BMI), waist circumference, gamma-glutamyltransferase (GGT), and triglycerides from laboratory diagnostics and biometric data. Time point: Change from T0 to T1, T2, and T3. Secondary endpoint 5 Designation: Change in health literacy Measurement method: Assessment using validated questionnaires: HLS19-Q12 (general health literacy), Self-Perceived Food Literacy Scale (nutrition-related literacy), questionnaire on exercise-related health literacy (BGK). Time point: Change from T0 to T1, T2, and T3. Secondary endpoint 6 Designation: Change in health-related quality of life Measurement method: Assessment using SF-12 (Short Form 12 Health Survey) to evaluate physical and mental quality of life. Time point: Change from T0 to T1, T2, and T3. Secondary endpoint 7 Designation: Change in work ability Measurement method: Assessment using the Work Ability Index (WAI), a validated instrumen | — |
Countries
Germany
Contacts
Siemens AG