Table 2 Feasibility outcomes
CRITERION | LOWER-LIMB GROUP (n=17) | TRUNK GROUP (n=10) | Proceed | Proceed with amendments | |
|---|---|---|---|---|---|
Recruitment, retention, adherence | |||||
Recruitment rate | > 4 per month | 3 participants per month | No | Strategies to increase recruitment rate | |
Enrolment rate | > 90% | 100% completed baseline assessment, were enrolled and randomised | Yes | ||
Drop-out rate | < 20% | n=2 (12%)a | n=2 (20%)b | Yes | |
Physiotherapy attendance | > 80% | Mean = 89% of intended 8 sessions | Mean = 86% of intended 8 sessions | Yes | |
Exercise adherence | > 80% | 52% of sessions completed | 48% of sessions completed | No | Strategies to increase adherence |
Study protocol acceptability | |||||
Eligibility rate | 1 in 3 | 47% of interested participants were eligible | Yes | ||
Acceptability of intervention to physiotherapists | Descriptive | • Training and supportive material sufficient • Reflected clinical practice, but time allocation insufficient | No | Appointments > 30 min or provide additional more frequent appointments | |
Acceptability of intervention to participants | Descriptive | • Appointment duration/frequency, and facilities appropriate. • Interventions were credible and acceptable | Yes | ||
Barriers to adherence | Descriptive | Work, study and family commitments, lack of motivation, boredom with exercises | No | Strategies to address common barriers | |
Adverse Events | |||||
Injury or illness | < 20% | n=4 (24%) unrelated to interventionc | Nil | Yesd | |
Pain during/after exercise | < 2/10 | Mean pain < 2/10 for each participant (across all sessions) | Yes | ||
Randomisation integrity | |||||
Integrity of blinding | 90% | Assessor unblinded for n=1 | 1 participant (medical professional) knew they were in the “control” group | Yes | |
Group contamination | 0% | Nil | Physiotherapists reported often discussing patient-specific topics | No | Control education difficult to standardise for control groups |
Acceptability of outcomes | |||||
Time to collect data | < 90 min | Baseline and follow-up assessments were completed in 60–90 min | Yes | ||
Completeness of PROs | > 90% | All 23 participants who finished the trial completed PROs, with no missing data | Yes | ||
Completeness of functional performance outcomes | > 90% | 16% (n=4) did not complete follow-upe | 10% (n=1) did not complete follow-up (located internationally) | No | Consider PROs as primary outcome for complete data |
Adherence monitoring | Descriptive | • 23 used PhysiApp© and 2 used paper diaries • Enjoyed the accountability and motivation PhysiApp© provided, and the videos for exercise technique • Inconsistently used PhysiApp© to record adherence (i.e. technical issues, or forgot to use the app as they knew their program) | No | Strategies to increase adherence to data entry (e.g. incentives, interactive features such as benchmarking, education) | |