Study period | |||||
---|---|---|---|---|---|
Enrolment baseline | Intervention period | Post-allocation | |||
Timepoint** | T0 | tr2 | tr7 | T1 | T2 |
Enrollment | |||||
Eligibility screen | X | ||||
Informed consent | X | ||||
Allocation | X | ||||
Study arms | |||||
Intervention group | X | X | X | X | X |
Active control group | X | X | X | ||
Assessments | |||||
Sociodemographic characteristics | X | ||||
Weight/height/BMI | X | X | X | ||
Health parameters (medication, diseases) | X | X | X | ||
Cognitive function (MoCA, TMT A&B) | X | X | X | ||
Performance in the cycle course | X | X | X | ||
Physical performance (SPPB) | X | X | X | ||
Quality of life (EuroQoL-5D + VAS) | X | X | X | ||
Falls/fear of falling (FES-I short form) | X | X | X | ||
Bicycle-related Parameters (cycled distance, self-reported cycling behavior) | X | X | X | ||
Biological specimen | |||||
Saliva samples | X | 3x1 | 3x1 | X | X |
CRP (capillary blood sample) | X | X | X | ||
Hair sample | X | X | X |