None listed
Conditions
Brief summary
It is estimated that 6.9 million Australians have chronic musculoskeletal conditions. More than 550,000 elective surgical procedures are performed each year in Australia for all musculoskeletal conditions and one in seven of these operations is for osteoarthritis of the knee or low back pain. The rising prevalence of these conditions and the ensuing surgical costs mean the quality of care and pricing have been identified for review. Moreover, post-surgical care, including inpatient rehabilitation for the knee and lumbar spine, is currently not standardised, sustainable or evidence-based. This contributes to substantial clinical variation and a wide range of outcomes. The PATHway is a randomised controlled trial designed to evaluate a post-surgical rehabilitation program using disruptive technologies to increase function and physical activity for patients following inpatient rehabilitation after their total knee replacement and lumbar spinal decompression surgeries. The intervention is a post-surgical clinical pathway (standardised, evidence-based, multidisciplinary rehabilitation program) supplemented by a 6-month disruptive technology package composed of 4 components: • an exercise program delivered via a health and fitness app (PhysiApp®) • wearable physical activity tracker (Fitbit®) built-in with motivational reminders and used in combination with the Fitbit app • health-coaching delivered via video calls using the Zoom app and through motivational messages delivered via iMessage • knee joint range of motion (ROM) measuring app (Goniometer Pro®) for total knee replacement participants. The proposed program will be compared to a control group which is akin to usual care. The primary outcome is a change in patient-reported average pain intensity (0-10 on a Numerical Rating Scale, NRS) over the last week from baseline to 3-months. The major secondary outcomes include change of NRS from baseline to 6 and 12 months, change in patient-reported pain-related disability, change in physical activity participation (subjective and objective measures) and physical function from baseline to 3, 6 and 12 months. The study aims to recruit a total of 204 participants (102 participants per arm) of whom 50% will have undergone knee replacement and 50% spinal surgery. Patients will be recruited from multiple study sites (hospitals and private clinics) across Australia.
Interventions
The proposed intervention will consist of the clinical pathway augmented by a 6-months disruptive technology package to optimise engagement and adherence to the post-surgical rehabilitation program. The intervention will be delivered by a study coordinator through apps installed in the study iPad. The technology package will be composed of:
• a daily exercise program (please see details below) delivered via a health fitness app (PhysiApp®) which will be monitored using Physitrack® (the clinician
The proposed intervention will consist of the clinical pathway augmented by a 6-months disruptive technology package to optimise engagement and adherence to the post-surgical rehabilitation program. The intervention will be delivered by a study coordinator through apps installed in the study iPad. The technology package will be composed of: • a daily exercise program (please see details below) delivered via a health fitness app (PhysiApp®) which will be monitored using Physitrack® (the clinician portal) • daily physical activity tracking using a wearable tracker (Fitbit®) built-in with motivational reminders and used in combination with the Fitbit app • a weekly health-coaching delivered by a certified health coach via video-conferencing software (Zoom® app) and motivational text messages via iMessage (Apple®) • a knee joint ROM measuring app (Goniometer Pro®) for total knee replacement participants to measure and record ROM during each health-coaching session Exercise program A 6-month exercise program was created by a physiotherapist after consultation with a surgeon, a rheumatologist and a patient representative using Physitrack®, which is specifically for lumbar decompression and total knee replacement, respectively. The exercise program focused mainly on strengthening, ROM and neural gliding exercises (the latter was limited to lumbar decompression participants). There will be no special equipment needed for the participants except for a chair or exercise mat. Each program is comprised of 3 levels of difficulty with independent progression for strengthening and ROM/neural glide exercises. The exercise program will be delivered to the participant via PhysiApp, which will record the participant’s adherence to the exercises (number sets and repetitions performed). Participants will be asked to rate their pain intensity experienced during exercises. Treatment Adherence Frequency of exercise/physical activity over the last week will be used to assess adherence. Satisfactory adherence to the intervention will be defined as completion of at least 80% of the prescribed intervention. Adherence to the experimental intervention will be measured through a combination of self-reported and objective measures including adherence self-reported questions, data from activity devices, Physitrack app and logs maintained by the study coordinator.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability and willingness to participate in the study 2. Familiarity with the use of the Internet and smart devices 3. Ownership of a smartphone 4. Participants must have at least functional English to be able to understand the study procedures, complete the questionnaires, communicate during the health coaching sessions and consent to participate in the study 5. aged 18 years or older, male or female 6. Admission to one of the study sites for rehabilitation following total knee replacement or lumbar decompression with or without fusion
Exclusion criteria
1. Known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder). 2. Any clinically significant acute or ongoing chronic medical conditions (e.g., uncontrolled diabetes) that could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study. 3. Patients undergoing bilateral knee replacement. 4. Patients undergoing revision for a previous total knee replacement or spinal surgery. 5. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrolment. 6. Current use of any intervention component (activity tracker, exercises app or health coaching) and unwillingness to stop using it for the duration of the study. 7. Spinal surgery beyond two spine levels. 8. Participants beyond 45 days post-op.
Outcome results
None listed