Table 2 Study objectives, success criteria and results of the feasibility study
Predefined Success Criteria | Results |
|---|---|
Recruitment process | |
> 50% of the eligible patients willing to participate in the study | 18 patients screened eligible. 13 accepted invitation. Consent rate was 72% |
Outcome assessments | |
Appropriate selection of PROMs | Removal of Dizziness Handicap Inventory. Replaced QOLIBRI with QOLIBRI-Overall Scale. Added Problematic Experience of Therapy Scale. |
Max 40 min completing the PROMs | 12 of 13 patients (92%) completed the PROMs in < 40 min |
< 10% missing PROM items | 0.3% of total items missing |
≥ 80% of patients have exercise intolerance confirmed with the BCTT | 12 of 13 patients (92%) had exercise intolerance according to BCTT. One patient had normal test but increased symptoms in the next 24 h. 11 patients with mean age of 36.9 (SD 11.4) were included and were invited for retest |
Assessment of primary and secondary outcome for RCT 1. Symptom burden: Rivermead Post-Concussion Symptoms (RPQ) 2. Test for exercise intolerance: Buffalo Concussion Treadmill Test (BCTT) | 9 patients received the intervention and were retested The primary outcome measuring symptom burden (RPQ) captured reduction in PPCS.BCTT showed increased exercise tolerance. See Supplementary file for figure |
Retention rates | |
< 20% drop out | 2 of 11 included patients (18%) were lost to follow-up |
Adherence to the intervention | |
> 67% attendance rate of introductory therapy sessions of the intervention | Attendance rate of 90% |
Patients adhere to min. 3 weekly prescribed unsupervised exercise sessions | 75% performed exercise according to prescription |
> 67% of the patients maintains exercise diary | 8 of 9 patients (89%) maintained exercise diary |
Ancillary non-predefined objectives | |
Patients that report increased PPCS next 24-h after test was included | Patients requires 3-point symptom increase during BCTT to be included |
Stop criteria for the BCTT: The patients continued the test until voluntary exhaustion or Borg RPE > 18 | Stop criteria BCTT added: 90% estimated max HR (211–0.64*age) |
Multiple NRS score per symptom | Overall PPCS NRS, that includes all symptoms that patients relate to PPCS |