Table 2 Protocol summary
Protocol activities | V1 | V2 | V3 | V4 | V5 | V6 | V7 |
|---|---|---|---|---|---|---|---|
Day −7 | Day 0 | Day 7 | Day 30 | Day 60 | Day 90 | Day 120 | |
Screen | Baseline | End | |||||
Informed consent | x | ||||||
Inclusion/Exclusion | x | ||||||
Medical history and physical exam | x | ||||||
Vital signs/anthropometric measures | x | x | x | x | x | x | x |
Urine pregnancy test | x | x | |||||
Administer and review scales/questionnaires/diaries | x | x | x | x | x | x | x |
Stressor (Udani Stepmill protocol) | x | x | x | x | x | x | x |
Functional measures (6-min timed walk) | x | x | x | x | x | x | x |
Goniometry (range of motion) | x | x | x | x | x | x | |
Review concomitant therapies | x | x | x | x | x | x | x |
Intercurrent medical issues review | x | x | x | x | x | x | |
Compliance assessment (including phone calls) | x | x | x | x | x | x | |
Randomization | x | ||||||
Study supplement preparation & dispensing | x | x | x | x | x |