Proceed with RCT | Proceed, but changes to the protocol need to be discussed | Do not proceed with main trial unless the problem can be solved |
---|---|---|
20 participants recruited in 49 days | Â | Â |
17 out of 20 (85%, 95% CI 62% to 97%) completed the 3-month follow-up | Â | Â |
 | 14 out of 20 (70%, 95% CI 46% to 88%) completed at least half of the exercise sessions and 70% (95% CI 46% to 88%) at least half of the self-management support sessions |  |
16 out of 17 participants (95%, 95%CI 71 to 100%) did not find the questionnaires to burdensome and 100% the assessments | Â | Â |
 | 7 out of 20 participants (35%, 95% CI 15 to 59%) had clinically relevant improvements in quality of life, and 9 out of 20 participants (46%, 95% CI 23 to 68%) in function |  |
No serious intervention-related adverse events were identified | Â | Â |