Study period | |||||||
---|---|---|---|---|---|---|---|
Time point | tx | t0 | 12 weeks | t1 | t2 | t3 | |
Enrollment | Baseline | Allocation | Treatment | Post-testing | 24 week F-U | 48 week F-U | |
Enrollment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions | |||||||
Physical activity | ←--------→ | ||||||
Recreational activity | ←--------→ | ||||||
Adverse events monitoring | ←--------→ | ||||||
Assessment | |||||||
Medical assessment | X | X | |||||
Anthropometric measurement | X | X | |||||
Demography | X | ||||||
Questionnaires | |||||||
SF-12 | X | X | X | X | |||
BSRS | X | X | X | X | |||
IPAQ | X | X | X | ||||
PHQ-9 | X | X | X | X | |||
SIP-RS | X | X | X | X | |||
NPRS | X | X | X | X | |||
Cognitive testing | |||||||
ACE | X | X | X | X | |||
Physiological testing | |||||||
STS | X | X | |||||
TUG | X | X | |||||
Laboratory tests | |||||||
Glycaemia | X | X | |||||
Total and HDL cholesterol | X | X | |||||
Triglycerides | X | X | |||||
Melatonin | X | X | |||||
IGF-1 | X | X | |||||
ESR | X | X | |||||
CRP | X | X | |||||
IgG, IgA, IgM | X | X | |||||
PHA test | X | X | |||||
T-helper Th1, Th2, Th17 | X | X |