Background
Methods
Study design
Participants
Procedures overview
Randomisation, blinding and allocation concealment
Physiotherapy care
Physiotherapists
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Current registration to practice as a physiotherapist;
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Have a receptionist at their clinical practice to facilitate patient bookings and communication with research staff;
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Have access to a desktop or laptop computer with internet connection and suitable work-space for private video consultations in their clinical rooms;
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Have an Australian Business Number;
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Have some previous experience and confidence using video conferencing software (e.g. Skype, Zoom, FaceTime);
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Willing to undertake trial training requirements; and
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Be willing and available to participate in the RCT until end of 2021.
Physiotherapist training
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Bespoke self-directed e-learning modules (delivered on the University of Melbourne Learning Management System) about best-practice OA management, telehealth (including delivery of care via Zoom video-conferencing) and trial procedures, including the structured physiotherapy treatment protocol. Physiotherapists were told it would take approximately 5 h to work through all e-learning modules, which they were encouraged to complete at their own pace, ideally over 4 weeks. The PEAK Training Program e-learning modules have since been adapted, and released, for widespread use by clinicians outside of the trial and access is available to users from all over the globe via https://healthsciences.unimelb.edu.au/departments/physiotherapy/about-us/chesm/news-and-events/peak-training-program/);
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A mock initial consultation via video-conferencing with a researcher acting as a patient, who provided immediate feedback on performance;
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Four video consultations, with two pilot patients with knee pain recruited by research staff (an initial and a follow-up call for each patient), to practice video consultation skills. Physiotherapists completed a self-reflection exercise upon completion of the pilot consultations (What went well? What didn’t go so well? What would I do differently in future?). Research staff conducted “spot” checks of consultation recordings and provided feedback to individual physiotherapists regarding performance after all pilot consultations were complete;
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A video-conference with research staff to answer any questions about trial procedures.
Participant resources
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Four information booklets:
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“Preparing for your consultations” (information about consultations, instructions on how to use Zoom video-conferencing and activity tracker);
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“Osteoarthritis Information” (information about knee OA, common management options, exercise and physical activity, weight loss, pain management, sleep and success stories);
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“Exercise Booklet” (strengthening exercise instructions and photos, including information on progressing exercises, managing flare-ups and dealing with set-backs); and
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“Knee Plan and Log Book” (templates to record details of management plans agreed upon at each consultation and monitor progress with exercise and physical activity goals).
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Four coloured elastic resistance bands (red, green, blue, and black) for home-based strengthening exercises; and
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A wearable activity tracker to facilitate physical activity plans (Mi Band 4, Anhui Huami Information Technology Co. Ltd., China) or pedometer (Omron Healthcare, USA).
Consultations
Initial consultation (45 mins)- WEEK 1 | Consultation 2 (30 mins)- WEEK 2 | Consultation 3 (30 mins)- WEEK 4 | Consultation 4 (30 mins)- WEEK 7 | Consultation 5 (30 mins)- WEEK 10 | |
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Assessment | 15 mins | 5 mins | 5 mins | 5 mins | 5 mins |
Introduction and setting expectations | Checking in … . | Checking in … . | Checking in … . | Checking in … . | |
Review pre-consultation survey- choose questions for future reassessment. | - changes in knee pain | - changes in knee pain | - changes in knee pain | - changes in knee pain | |
- how they have managed with strengthening exercises | - how they have managed with overall program | - how they have managed with overall program | - how they have managed with overall program | ||
Subjective information as relevant. | - adverse events? | - adverse events? | - adverse events? | - adverse events? | |
Functional observation: walking, squatting, sit to stand, single leg standing balance, anything else as relevant. | - comments/questions arising from discussions last time. | - comments/questions arising from discussions last time. | - comments/questions arising from discussions last time. | - comments/question s arising from discussions last time. | |
Reassess questions from pre-consultation survey. | Reassess questions from pre-consultation survey. | ||||
Re-assess sit to stand and any other functional tasks as required. | |||||
Re-assess sit to stand and any other functional tasks as required. | |||||
Check progress with goals. | |||||
Education | 10 mins | ||||
Understanding OA. | |||||
Benefits of exercise/physical activity. | |||||
Strengthening exercises | 15 mins | 10 mins | 10–15 min | 10–15 min | 15 mins |
Choose a program of 3 exercises from booklet (1 quadriceps; 1 hip/gluteal; 1 hamstrings/gluteal) | Review progress. | Review progress. | Review progress. | Review progress. | |
Check adherence in Log Book. | Check adherence in Log Book. | Check adherence in Log Book. | Check adherence in Log Book. | ||
- Congratulate adherence. | - Congratulate adherence. | - Congratulate adherence. | - Congratulate adherence. | ||
Prescribe variation (if necessary) and dosage. | - Discuss reasons for non-adherence & troubleshoot. | - Discuss reasons for non-adherence & troubleshoot. | - Discuss reasons for non-adherence & troubleshoot. | - Discuss reasons for non-adherence & troubleshoot. | |
Watch patient perform one set of each exercise & ensure they are working at hard to very hard level. | |||||
Review current exercises & modify/progress as required & add 2–3 more to program (max 6 in total; 2 quadriceps; 1 hip/gluteal; 1 hamstrings/gluteal; 1 calf; 1 optional extra). | Review current exercises & modify/progress as required. | Review current exercises & modify/progress as required. | Review current exercises & modify/progress as required. | ||
Discuss exercising with pain/flare-ups. | Watch patient perform one set of any new exercises & ensure they are working hard to very hard. | Watch patient perform one set of any new exercises & ensure they are working hard to very hard. | Watch patient perform one set of any new exercises & ensure they are working hard to very hard. | ||
Instruct use of Log Book. | |||||
Check patient knows how to change/progress their program over the next 6 months. | |||||
Watch patient perform one set of each new exercise & ensure they are working hard to very hard). | |||||
Advise patient to continue exercise program for next 6 months. | |||||
Education | 5 mins | ||||
Physical activity. Activity pacing. | |||||
Physical activity | 5 mins | 10 mins | 5–10 min | 5–10 min | 5 mins |
Check patient has activity tracker set up and can use it. | Review daily step count recorded in Log Book. | Review daily step count recorded in Log Book. | Review daily step count recorded in Log Book. | Review daily step count recorded in Log Book. | |
Instruct patient to wear activity tracker every day for next week and record daily steps as a baseline for developing a daily step goal at the next visit. | Set daily step goal (may be maintain or increase from baseline). | Review progress with physical activity plan. | Review progress with physical activity plan. | Review progress with physical activity plan. | |
- Congratulate adherence. | |||||
Agree on physical activity plan to achieve steps and/or increase/maintain intensity of activity. | - Congratulate adherence. | - Congratulate adherence. | - Discuss reasons for non-adherence & troubleshoot. | ||
- Discuss reasons for non-adherence & troubleshoot. | - Discuss reasons for non-adherence & troubleshoot. | ||||
Set an ongoing physical activity plan that patient can manage in daily life (may/may not include step goals & use of activity tracker based on patient choice). | |||||
Instruct use of Log Book. | Ask patient to identify potential barriers & plan strategies for overcoming them. | Set daily step goal for coming weeks (may be to maintain or increase from previous weeks). Agree on physical activity plan to achieve step goal and/or increase/maintain intensity of activity. | Set daily step goal for coming weeks (may be to maintain or increase from previous weeks). Agree on physical activity plan to achieve step goal and/or increase/maintain intensity of activity. | ||
Check patient knows how to change/progress their program as required. | |||||
Advise patient to continue physical activity for next 6 months. | |||||
Education | 5 mins | 5 mins | 5 mins | ||
Understanding & managing your pain. | Weight loss for OA (relevant for all patients, even those of healthy body weight) | Dealing with lapses & set-backs. | |||
Encourage ongoing use of Log Book and activity tracker where possible. | |||||
Participant ‘homework’ | Pre-reading: | Pre-reading: | Pre-reading: | Pre-reading: | Encourage reading of: |
Physical activity. | Barriers to exercise and physical activity. | Weight loss for OA- if appropriate for the individual. | Modifying your exercise program. | Success stories. | |
Activity pacing. | Understanding & managing pain. | Dealing with lapses & set-backs. |
Behaviours: | |||
- Undertake strengthening exercise program | |||
- Undertake negotiated physical activity plan | |||
Behaviour change technique | Written information | Physiotherapist discussion | Other |
Consequences of behaviour | |||
Explanation of benefits of exercise & physical activity. | ✓ OA Info booklet | ✓ Consult #1 | |
Explanation that exercise & physical activity will not make joint structural damage worse. | ✓ OA Info booklet | ✓ Consult #1 | |
Goal setting & action planning | |||
Use of a plan stating how often to exercise & which exercises to do (including dosage). | ✓ Knee plan & log book | ✓ Consults #1–5 | |
Development of specific goals related to patient’s knee problems. | ✓ Consult #1 & 5 | ✓ Pre-consultation survey | |
Development of specific physical activity & step goals. | ✓ Knee plan & log book | ✓ Consults #2–5 | |
Barrier identification/planning | |||
Information & discussion about barriers to exercise & physical activity adherence, including problem-solving. | ✓ OA Info booklet | ✓ Consults #1–5 | |
✓ Knee plan & log book | |||
✓ Exercise booklet | |||
Behavioural grading & instruction | |||
Strengthening exercises are graded in number, intensity and/or difficulty to get progressively harder over time. | ✓ Knee plan & log book | ✓ Consults #1–5 | ✓ Four graded resistance bands |
✓ Exercise booklet | |||
Physical activity is graded in duration, intensity and/or frequency to get progressively harder over time. | ✓ OA Info booklet | ✓ Consults #1–5 | |
✓ Knee plan & log book | |||
Instruction in where, when and how to perform physical activity | ✓ Knee plan & log book | ✓ Consults #2–5 | |
Instruction in where, when and how to perform strengthening exercises | ✓ Knee plan & log book | ✓ Consults #1–5 | ✓ Four graded resistance bands |
✓ Exercise booklet | |||
Demonstration of how to perform strengthening exercises | ✓ Consults #1–5 | ✓ Online video library | |
Encouragement to join group exercise classes. | ✓ OA Info booklet | ✓ Consults #2–5 | |
Encouraged to involve partner or family to join in with exercising & physical activity. | ✓ OA Info booklet | ✓ Consults #2–5 | |
Self-monitoring & feedback | |||
Encouraged to self-monitor exercise & physical activity | ✓ Knee plan & log book | ✓ Consults #1–5 | ✓ Activity monitor |
Physiotherapist review of & and feedback on exercise & physical activity recorded | ✓ Knee plan & log book | ✓ Consults #2–5 | ✓ Activity monitor |
Relapse prevention | |||
Instruction on how to modify exercise & physical activity during flare-ups | ✓ Exercise booklet | ✓ Consults #1–5 | |
Planning for set-backs in physical activity & how to overcome them | ✓ Consult #2 | ||
Dealing with lapses & set-backs with exercise & physical activity; use of constructive self-talk | ✓ Exercise booklet | ✓ Consult #5 | |
Pain & emotional control | |||
Encouragement to use activity pacing & pain coping activities (eg relaxation, pleasant imagery, mindfulness) | ✓ OA Info booklet | ✓ Consults #2 & 3 | |
Tips for healthy sleep | ✓ OA Info booklet | ✓ Consult #3 | |
Prompts | |||
Encouraged to use reminders to exercise. | ✓ OA Info booklet | ||
Rewards | |||
Patient encouraged to use self-rewards for achieving exercise & physical activity goals | ✓ OA Info booklet | ✓ Consults #2–5 | |
Physiotherapist congratulates adherence to exercise & physical activity | ✓ Consults #2–5 | ||
Social comparison | |||
Encourage reading of patient success stories | ✓ OA Info booklet | ✓ Consult #5 | |
Review | |||
Review of behavioural goals (exercise & physical activity) at follow-up. | ✓ Consults #2–5 | ||
Review of outcomes (pain and function) at follow-up. | ✓ Consults #2–5 | ||
Review, supervision and correction of strengthening exercise technique. | ✓ Consults #1–5 |
Maximum of 6 exercises at any one time, performed three times/week | |||
2 quadriceps strengthening exercises | |||
1 hip abduction/gluteal strengthening exercise | |||
1 hamstring/gluteal strengthening exercise | |||
1 calf strengthening exercise | |||
1 other exercise as appropriate | |||
1. Quads strengthening | |||
Knee extension | Non weight-bearing | Q1. Seated knee extension | Progression: Increase resistance with elastic band – red through to black |
Non weight-bearing | Q2. Inner range quads over roll | ||
Sit-to-stand | Weight-bearing | Q3. Sit to stand without using hands | Progression: lower chair height, hover above the seat without touching down, add resistance band around knees and push outwards while performing sit to stand |
Weight-bearing | Q4. Asymmetrical chair stands (with more weight on arthritis leg) | ||
Steps | Weight-bearing | Q5. Step-ups | Progression: Increase step height |
Weight-bearing | Q6. Forward touch-downs from a step | Progression: Increase step height, don’t touch floor | |
Weight-bearing | Q7. Step-ups with weight | Progression: Increase step height, increase weight | |
Weight-bearing | Q8. Forward touch-downs with weight | Progression: Increase step height, increase weight | |
Wall squats | Weight-bearing | Q9. Partial wall squats | Progression: Halfway hold in bent-knee position, increase the amount of body weight taken through the arthritis knee. |
Weight-bearing | Q10. Split leg wall squats | ||
Controlled squats | Weight-bearing | Q11. Controlled squats (with back of chair support) | |
Controlled knee flexion/extension | Weight-bearing | Q12. Controlled knee flexion/extension with forwards/backwards sliding of opposite leg | |
Weight-bearing | Q13. Controlled knee flexion/extension with forwards/backwards sliding of opposite leg with elastic band | Progression: Increase resistance by changing elastic band colour – red through to black | |
Weight-bearing | Q16. Controlled knee flexion/extension with sideways sliding of opposite leg | ||
Weight-bearing | Q17. Controlled knee flexion/extension with elastic band and sideways sliding of opposite leg | Progression: Increase resistance by changing elastic band colour – red through to black | |
Step to single leg balance | Weight-bearing | Q14. Step to standing balance on semi-flexed knee | |
Weight-bearing | Q15. Step to standing balance on semi-flexed knee with arm movements | ||
2. Hip abductor/gluteal strengthening | |||
Standing hip abduction | Non weight-bearing | HA1. Side leg raises in standing with elastic band. | Progression: Increase resistance by changing elastic band colour – red through to black, add halfway hold |
Weight- bearing | HA3. Wall push with opposite leg, standing on straight arthritis leg | Progression: Hold weight in hand, increase the hold time | |
Weight- bearing | HA4. Wall push with opposite leg, standing on arthritis leg with deeper knee bending | ||
Side stepping | Weight-bearing | HA2. Crab walking with elastic band | Progression: Increase resistance by changing elastic band colour – red through to black |
3. Hamstring/gluteal strengthening | |||
Supine bridging | Weight-bearing | HG1. Bridge with hold | |
Weight-bearing | HG2. Split leg bridge with hold | ||
Weight-bearing | HG3. Single-leg bridge with hold | ||
Standing knee flexion | Non weight-bearing | HG4. Hamstring curls standing over bench | |
Non weight-bearing | HG5. Hamstring curls standing over bench with elastic band | Progression: Increase resistance by changing elastic band colour – red through to black | |
Seated knee flexion | Non weight-bearing | HG6. Seated knee flexion with elastic band | Progression: Increase resistance by changing elastic band colour – red through to black |
Standing hip extension | Non weight-bearing | HG7. Hip extension with knee bent (90°) standing over a bench | |
Non weight-bearing | HG8. Hip extension with knee straight standing over a bench | ||
Non weight-bearing | HG9. Hip extension with knee straight with elastic band standing over a bench | Progression: Increase resistance by changing elastic band colour – red through to black | |
4. Calf strengthening | |||
Standing plantar-flexion | Weight-bearing | C1. Double leg calf raises | |
Weight-bearing | C2. Single leg calf raises | ||
Weight-bearing | C3. Double leg calf raises over edge of step | ||
Weight-bearing | C4. Single leg calf raises over edge of step | ||
5. Balance (if appropriate) | |||
Tandem stance | Weight- bearing | B1. Maintain balance in tandem stance | Progression: remove hand support (if required), slowly raise arms in the air, eyes closed |
Natural stance | Weight- bearing | B2. Maintain balance whilst tapping opposite foot forwards & backwards | |
Single leg stance | Weight- bearing | B3. Maintain balance in single leg stance | Progression: Increase hold time up, slowly raise arms up and down, eyes closed |