None listed
Conditions
Brief summary
We are conducting a clinical trial to compare the clinical effectiveness and cost-effectiveness of different modes of delivering physiotherapy care to people with knee OA. Participants will undergo five consultations with a physiotherapist over 3 months (30-45 minutes) for prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education, after which participants will be reassessed remotely via paper or web-based questionnaires at 3 months and 9 months after randomisation.
Interventions
Participants will undergo five one-on-one i) face-to-face or; ii) video consultations with a physiotherapist over 3 months (at approximately weeks 1, 2, 4, 7, 10) each lasting 30 minutes except the first which will be 45 mins. The consultations will involve the prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education.
Physiotherapists will prescribe 5-6 strengthening exercises to be performed at home
Participants will undergo five one-on-one i) face-to-face or; ii) video consultations with a physiotherapist over 3 months (at approximately weeks 1, 2, 4, 7, 10) each lasting 30 minutes except the first which will be 45 mins. The consultations will involve the prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education. Physiotherapists will prescribe 5-6 strengthening exercises to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training. Participants will increase physical activity via a personalised plan developed with the therapist and will use a wearable activity tracker to assist this (for example, monitoring daily step goals). The actual physical activity plan will vary according to an individual's unique needs, preferences and physical capability, including the intensity and frequency of activity. For example, the plan for one person may be to reduce daily sedentary activity and increase incidental physical activity, while for another, the plan may aim to increase the amount of moderate-vigorous physical activity accumulated over the week. Types of physical activity will be negotiated between the physiotherapist and patient and may include any type of activity acceptable to, and feasible for, the patient. For participants allocated to the video consultation group, these 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 elsewhere if preferred). For participants allocated to face to face consultations, the consultations will occur in the physiotherapist’s own clinical rooms. Participants will travel to and from the clinic at their own expense.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) meet National Institute for Health and Care Excellence clinical criteria for knee OA: i. age 45 years or older; ii. activity-related knee joint pain; iii. morning knee stiffness lasting no more than 30 mins, ii) report history of knee pain of at least 3mths duration; iii) report knee pain on most days of the past month; iv) report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week; v) report difficulty walking and climbing stairs; vi) access to a device with internet connection; vii) willing and able to travel to the nearest trial physiotherapist if required, for treatment, and; viii) pass Exercise and Sports Science Australia stage 1 pre-exercise screening questions (consists of seven questions which are answered YES or NO, and are designed to identify individuals with signs or symptoms of underlying disease, or who may be at higher risk of an adverse event during exercise).
Exclusion criteria
i) inability to speak English; ii) on waiting list for/planning knee/hip surgery in next 12 months; iii) previous arthroplasty on affected knee; iv) recent knee surgery (past 6 months); v) consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months); vi) self-reported inflammatory arthritis (e.g. rheumatoid arthritis); vii) any neurological condition affecting lower limbs; and/or viii) any unstable/uncontrolled cardiovascular condition. Clearance to participate from a general practitioner will be required for anyone who i) reported a fall (past 12 months) or is house-bound due to immobility; or ii) who fails the Exercise and Sports Science Australia stage 1 pre-exercise screening questions.
Outcome results
None listed