None listed
Conditions
Brief summary
Participants will be randomly allocated in a 1:1 ratio to receive the same home strength program prescribed either i) once a week or ii) three times a week. Participants in both exercise groups will receive one videoconferencing consultation with a physiotherapist (within one week post-randomisation, 30 minutes). The physiotherapist will prescribe the same 5 standardised exercises to all participants at a standardised dosage of 3 sets of 12 repetitions per exercise. The physiotherapist will instruct the participants to perform their exercise program unsupervised at home, at their allocated weekly frequency, until the 3-month reassessment. The time point for re-assessment will be 3 months post-randomisation. The primary outcome measure will be the change in average walking pain over the past week on an NRS. Secondary outcome measures will include WOMAC pain and function; quality-of-life; arthritis and exercise self-efficacy; global rating of change; patient specific functional scale; patient acceptance of symptoms; sit to stand test; calf raise test; and willingness for joint replacement. We hypothesise that a strengthening exercise program prescribed once a week is non-inferior to the same home program prescribed three times a week in people with knee OA.
Interventions
Participants will be randomly assigned a physiotherapist (stratified by group allocation—‘once’ or ‘three’ times weekly exercise group using random permuted block sizes), and research staff will book one consultation appointment on behalf of the participant.
Each participant will have one online consultation (within 1-week post-randomisation, 30 minutes each) with the randomly allocated physiotherapist to prescribe a home strength program that participants will be asked to undertake for 3 mont
Participants will be randomly assigned a physiotherapist (stratified by group allocation—‘once’ or ‘three’ times weekly exercise group using random permuted block sizes), and research staff will book one consultation appointment on behalf of the participant. Each participant will have one online consultation (within 1-week post-randomisation, 30 minutes each) with the randomly allocated physiotherapist to prescribe a home strength program that participants will be asked to undertake for 3 months. Physiotherapists will prescribe the same five exercises to each participant. These exercises reflect the typical home strength exercises prescribed in the literature for knee osteoarthritis (OA) and by physiotherapists in Australia. Ahead of the physiotherapy consultations, the research team will post all participants two exercise resistance bands of different strengths (green and blue) along with an exercise booklet. The trial arms differ in the frequency of exercise prescribed across the week (once versus three times per week). Other dosage parameters will be identical across the treatment groups. Prescription of each home strength program will be the same five standardised exercises, each to be performed as 3 sets of 12 reps, with 1-3 minutes rest between sets. The days home exercises are performed each week are up to the participants discretion. The physiotherapist will individualise the colour of the exercise band (green or blue) for the seated knee extension exercise and the side leg raises in standing exercise to ensure the participant is working as close as possible to an intensity of 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion Scale for strength training. Based on the Borg scale, the physiotherapist may also decide that an exercise band is not needed for one or both of these exercises. Physiotherapists will verbally advise participants whether they should perform their prescribed program once or three times per week (based on allocation), and this information will also be included in the participant’s exercise booklet. After the consultation, the physiotherapist will instruct the participant to perform the exercise program until their follow-up assessment at 3 months post-randomisation. Participants will be permitted to continue with their usual joint pain medications during that time. Consultations will occur via the video-conferencing facility of Zoom, a commercial cloud-based system accessible from any internet-connected computer, laptop or mobile device. Physiotherapists will consult from their clinic with participants based at home or wherever is suitable (e.g., work). Physiotherapists will be provided access to a website containing a video library of exercises to allow them to provide real-time demonstrations of exercises to participants. This will be shared with participants via a shared-screen feature on Zoom, allowing them to view a demonstration of the exercise during the consultation. Semi-structured electronic consultation notes will be recorded by the physiotherapist and submitted to the research staff after the consultation. Notes will be scrutinised by research staff for physiotherapist fidelity to allocated exercise frequency. Participants will complete a one week log book recording their exercises in weeks 4, 8 and 12 with the data submitted to the researchers.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) meet the National Institute for Health and Care Excellence clinical criteria for OA i. age 45 years or older; ii. activity-related knee joint pain; iii. no morning knee stiffness or morning knee stiffness duration of less than 30 mins; ii) report history of knee pain for 3 months or more; iii) report knee pain on most days of the past month; iv) report knee pain on walking over the past week of at least 4 on an 11-point (0-10 range) NRS; v) report difficulty walking or climbing stairs; vi) have an email address and access to a computer/laptop/tablet/smartphone with webcam and internet connection for Zoom consultation and; vii) willing to participate in a videoconferencing consultation for their physiotherapy appointment.
Exclusion criteria
i) inability to speak or read English; ii) on waiting list for/planning any knee/hip surgery in the next 6 months; iii) previous arthroplasty on the affected knee; iv) undergone knee surgery in either knee in the past 6 months; v) is undertaking/has undertaken regular strengthening exercise (at least once per week) for knee problems at any stage in the past 6 months; vi) intending to/planning to commence regular strengthening exercise (at least once per week) for knee problems in the next 3 months; vii) self-reports (at screening) any inflammatory arthritis (e.g., rheumatoid arthritis); viii) self-reports (at screening) any neurological condition that impacts their lower limb function; ix) self-reports (at screening) any unstable/uncontrolled cardiovascular condition that could make exercise unsafe. x) previously participated in a CHESM clinical trial in the prior four years, or is currently participating in another research study at CHESM or elsewhere.
Outcome results
None listed