Timepoint | Baseline (t0) | Week 1–12 (t1) | Week 13 (t2) |
---|---|---|---|
Enrollment: | |||
Eligibility screen | × | ||
Informed consent | × | ||
Demographics | × | ||
Medical history | × | ||
Interventions: | |||
Trial group | × | ||
Control group | × | ||
Assessment: | |||
6-MWT | × | × | |
V̇O2 of CET | × | × | |
CAT | × | × | |
SGRQ | × | × | |
Pulmonary function testing | × | × | |
Body fat and muscle composition | × | × | |
HAMD-24 | × | × | |
HAMA | × | × | |
Safety monitoring: | |||
Vital signs | × | × | × |
Adverse event reporting | × | × |