None listed
Conditions
Brief summary
We are conducting a clinical trial to compare the outcomes of two different treatments: i) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises); and ii) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises) plus the subsequent use of a mobile app for 24 weeks. Participants in both groups will receive exercise-based care by a physiotherapist. This will involve two telehealth consultations with a physiotherapist (using Zoom video-conferencing) over two weeks, for prescription of an individualised strengthening exercise program. Participants in both groups will receive resistance bands for exercising. After completing the physiotherapy consultations, participants will be encouraged to continue with their home exercises for the next 24 weeks. Around half of participants will be randomly allocated to download and engage with a mobile app (on their smartphone or tablet) as well, for the 24 week home exercise period. Outcomes will be collected by web-based survey at baseline and 26 weeks after randomisation, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks after randomisation.
Interventions
All participants (both intervention and control groups) will undergo two one-on-one video (Zoom) consultations with a physiotherapist over 2 weeks, both of which will be 30 minutes duration. The consultations will involve the prescription of a home-based strengthening exercise program. Participants will be provided an information booklet about how to prepare for consultations and a booklet of strength exercises, as well as 4 coloured therabands (red, green, blue, and black) for performing streng
All participants (both intervention and control groups) will undergo two one-on-one video (Zoom) consultations with a physiotherapist over 2 weeks, both of which will be 30 minutes duration. The consultations will involve the prescription of a home-based strengthening exercise program. Participants will be provided an information booklet about how to prepare for consultations and a booklet of strength exercises, as well as 4 coloured therabands (red, green, blue, and black) for performing strengthening exercises at home. 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. During the second physiotherapy consultation, participants will also be advised how to independently progress their exercise program, and encouraged to continue with their strengthening exercises (three times per week) for the next 24 weeks. Participants randomised to the intervention group will receive a call from a researcher who will instruct them how to download and use a free mobile exercise app. Participants will be instructed to commence using the app immediately and to use it for the following 24 weeks to assist them with their home exercise program. Outcomes will be collected by web-based survey at baseline and 26 weeks, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks. No data or analytics from the app will be used as an outcome measure.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator)
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 OA (age at least 45 years; activity-related knee joint pain; morning knee stiffness lasts no more than 30 mins); ii) report history of knee pain for at least 3mths; iii) report knee pain on most days of the past month; iv) report at least mild physical dysfunction (score >20 out of 68 on Western Ontario McMaster Universities (WOMAC) physical function subscale); v) access to a computer/laptop/tablet/smartphone with internet connection for Zoom consultations; vi) own a smartphone with software compatible with the app (for using app if allocated to intervention group); vii) willing to participate in video consultations for physiotherapy appointments; and viii) willing to download and engage with an app regularly (if allocated to intervention group).
Exclusion criteria
i) inability to speak or read English; ii) on waiting list for/planning knee/hip surgery in next 6 months; iii) previous arthroplasty on affected knee; iv) recent knee surgery (past 6 months); v) consulting/ed physiotherapy or doing regular strengthening (at least once per week) exercise for knee (past 6 mths); vi) self-reported inflammatory arthritis (eg rheumatoid arthritis); vii) any neurological condition affecting lower limbs; viii) any unstable/uncontrolled cardiovascular condition; ix) history of fall (past 12 months) and no GP clearance to participate; x) house-bound due to immobility and no GP clearance to participate; and/or xi) fail the 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) and no GP clearance to participate.
Outcome results
None listed