Table 3 Primary outcomes in research progression criteria to inform the definitive randomised controlled trial
Research progression criteria | Evaluation | |
|---|---|---|
Participant recruitment rate (n/month) | 5.6 | Amber (amend) |
Completion of baseline outcome measures | ||
Assessment duration including screening (min, mean ± SD) | 105 ± 9 | Green (go) |
Participants answering acceptable duration (n, %) | 12 (100.0) | Green (go) |
Participant retention | ||
Participants who completed the follow up (n, %) | 12 (100.0) | Green (go) |
Adherence to exercise intervention | ||
Participants adhering to exercise programme (n, %) | 10 (83.3) | Green (go) |
Adverse events | ||
Minor events (n) | 4 (33.3) | Green (go) |
Serious events (n) | 0 | Green (go) |
Participants discontinuing the study (n) | 0 | Green (go) |