Background
Methods
Study design
Setting
Participant recruitment and eligibility
Deviations from initial trial protocol
Procedures
Randomisation and blinding
Treating physiotherapists and treatment fidelity
Interventions
What | Lower-limb focussed intervention | Trunk-focussed intervention |
---|---|---|
Who provides | Physiotherapists who have all undergone study-specific training | |
How | 1-to-1 face-to-face sessions to assess and progress unsupervised exercise-therapy program | |
Where | Physiotherapy sessions: Private clinics in Hobart and Melbourne Unsupervised exercise-therapy program: Clinic/public gym, or home | |
When & how much | Physiotherapy 1-to-1 sessions: 30 min duration, weekly for 4 weeks then every 2 to 3 weeks for 12 weeks Unsupervised exercise-therapy program: instructions provided via PhysiApp©, 30 to 45 min duration, minimum 3 sessions per week, unsupervised | |
Tailoring | • Standardised lower-limb exercises (i.e. strength, power, balance), functional retraining (e.g. plyometric, agility) and cardiovascular program • Choice of priority exercisesa (from the standard set) was individualised • Exercise progression was individualised • Individualised education (e.g. exercise rationale, goal setting) • Passive therapy treatment algorithm if appropriate (e.g. taping) | • Standardised, non-specific trunk strengthening exercises • Progression of exercises was individualised • Optional stretching • Standardised education (e.g. rationale for trunk exercises) |
Both groups: exercises progressed based on assessment of pre-defined criteria at each session (i.e., pain, swelling, technique) and resistance training principles | ||
How well | Attendance at physiotherapy recorded by physiotherapists and clinic Unsupervised exercise program adherence recorded by participants in PhysiApp© smartphone app or paper diaries, and monitored by physiotherapists via Physitrack© |
Lower-limb focussed exercise-therapy intervention
Trunk-focussed exercise-therapy (control) intervention
Unsupervised exercise-therapy program (both groups)
Education component (both groups)
Primary outcome: feasibility
Secondary outcomes
Patient-reported outcomes
Functional performance outcomes
Data analysis
Results
Feasibility
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) |
Participant characteristics
Lower-limb focussed group (n=17) | Trunk-focussed group (n=10) | |
---|---|---|
Age, mean±SD years | 34±12 | 33±12 |
Sex, no. (% male) | 6 (35%) | 7 (70%) |
Body mass index, mean±SD kg/m2 | 24.7±2.8 | 25.4±3.8 |
Pre-injury activity levela, no. (%) | ||
Level 1 or 2 | 19 (53%) | 10 (100%) |
Level 3 | 6 (35%) | 0 (0%) |
Level 4 | 2 (12%) | 0 (0%) |
Concomitant meniscal procedureb, no. (%) | 9 (53%) | 3 (30%) |
Ceased supervised PT, median (IQR) months | 7 (6) | 6 (5) |
Patient-reported outcomes
Lower-limb focussed intervention (n=15) | Trunk-focussed intervention (n=8) | Lower-limb vs trunk | Previously published MDC values | |||||
---|---|---|---|---|---|---|---|---|
Baseline | Follow-up^ | Change | Baseline | Follow-up^ | Change | mean difference in change* (95%CI) | ||
ACL-QoL | 45±20 | 64±20 | 20±17 | 56±9 | 78±16 | 22±13 | −2.5 (−18.2 to 13.2) | 12 points (Lafave et al., 2017) |
KOOS-QoL | 39±20 | 62±23 | 23±25 | 52±14 | 67±19 | 16±12 | 7.1 (−12.3 to 26.4) | 8 to 10 points (Roos & Lohmander, 2003) |
KOOS-Symptoms | 68±23 | 74±19 | 7±17 | 81±9 | 90±9 | 9±7 | −2.0 (− 15.7 to 11.6) | 8 to 10 points (Roos & Lohmander, 2003) |
KOOS-Pain | 77±15 | 86±12 | 9±14 | 90±7 | 92±8 | 2±7 | 6.7 (−4.0 to 17.9) | 8 to 10 points (Roos & Lohmander, 2003) |
KOOS-Sport | 57±24 | 77±22 | 20±25 | 76±1 | 83±22 | 8±13 | 12.1 (−7.9 to 32.0) | 8 to 10 points (Roos & Lohmander, 2003) |
KOOS4 | 60±17 | 75±17 | 15±18 | 75±9 | 83±14 | 9±7 | 5.9 (−7.9 to 19.8) | 8 to 10 points (Roos & Lohmander, 2003) |
ACL-RSI | 36±18 | 53±22 | 17±18 | 41±18 | 67±24 | 26±22 | −9.2 (−27.2 to 8.7) | 19 points (Kvist et al., 2013) |
Single-hop | ||||||||
ACLR (cm) | 65±42 | 97±33 | 33±34 | 108±39 | 115±42 | 8±9 | 24.1 (−5.9 to 54.1) | 14 cm (Kockum & Heijne, 2015; Reid et al., 2007) |
Contralateral (cm) | 93±30 | 106±32 | 14±18 | 116±25 | 120±34 | 4±15 | 9.6 (−8.9 to 28.2) | 14 cm (Kockum & Heijne, 2015; Reid et al., 2007) |
LSI (%) | 59±38 | 88±11 | 29±37 | 90±21 | 94±12 | 4±10 | 15.5 (−27.7 to 58.7) | 8% (Kockum & Heijne, 2015; Reid et al., 2007) |
Side-hop | ||||||||
ACLR (reps) | 8±8 | 16±12 | 9±9 | 20±13 | 29±19 | 9±8 | −0.6 (−9.4 to 8.7) | 11 reps (Kockum & Heijne, 2015; Reid et al., 2007) |
Contralateral (reps) | 9±9 | 17±12 | 8±10 | 23±16 | 31±21 | 9±15 | −0.5 (−13.4 to 12.2) | 11 reps (Kockum & Heijne, 2015; Reid et al., 2007) |
LSI (%)a | 71±42 | 82±29 | 11±28 | 73±13 | 94±14 | 21±18 | −10.4 (− 43.1 to 22.2) | ~ 10% (Kockum & Heijne, 2015; Reid et al., 2007) |
One-leg rise | ||||||||
ACLR (reps) | 17±16 | 33±15 | 17±14 | 27±19 | 34±20 | 7±11 | 9.9 (−4.1 to 23.9) | Not available |
Contralateral (reps) | 25±19 | 35±15 | 10±14 | 31±15 | 34±15 | 4±7 | 6.4 (−6.5 to 19.3) | Not available |
LSI (%)b | 67±57 | 98±9 | 31±54 | 68±32 | 83±47 | 16±32 | 15.7 (−40 to 71.5) | Not available |