Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001245684p
Ethics application status
Submitted, not yet approved
Date submitted
11/10/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Virtual, Comprehensive Care Program Before and After Total Hip and Knee Arthroplasty
Scientific title
Evaluation of a Home-based, Comprehensive Care Program Before and After Total Hip and Knee Arthroplasty
Secondary ID [1] 310721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 331662 0
Joint Replacement 331663 0
Hip Arthroplasty 331851 0
Knee Arthroplasty 331852 0
Condition category
Condition code
Musculoskeletal 328389 328389 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 328595 328595 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the outcomes of an integrated program of patient education and exercise before and after total hip or knee arthroplasty. The program will be home-based and remote-monitored, but will include physiotherapy-led home visits, telehealth consultations and tele-messaging. A program of specific muscle strengthening exercises and cycle ergometry will focus on muscle power as the therapeutic target. The custom-built cycle ergometer and supporting digital application (App) is the 'device' being evaluated in this study. The cycling program will be fully measured (power output and workout adherence) and adjusted based on patient performance and feedback obtained via remote monitoring. Outcomes of the pre-operative phase and early post-operative recovery will be the focus of the study. The pre-operative phase commences 4 weeks before surgery, and post-operative phase starts immediately after surgery until 6 weeks post-surgery. Commencement of post-operative cycle workouts may vary depending on the patients capacity to use the ergometer.
Specifically, the interventions will include:

1. Patient Education – Patient education booklet which has been developed by
the hospital in which patients have their surgery, summarises preparation for surgery, surgery and hospital stay information, and advice on early management at home
2. Exercise program – Guideline-based exercises with an emphasis on range of motion, muscle function and gait re-education as outlined in previous joint arthroplasty studies (Sattler et al 2019). These exercises will be completed at two times each day - usually morning and afternoon. The exercises and repetitions will be standardised for all patients, but modifications may be recommended by the physiotherapist as needed. Exercises will include active range of motion, isometric muscle strengthening (quadriceps and gluteal), dynamic strengthening (1/4 squats, quadriceps in sitting) and muscle stretching (calf and hamstring). Adherence to this part of the exercise program will not be measured specifically but will be monitored by the physiotherapist and patients encouraged to complete the exercises as prescribed
3. Cycle ergometer exercise with measured muscle power and patient feedback. Remote monitoring of muscle power (average and maximum) is obtained for each cycle exercise session from power meters in the cycle pedal cranks. Power data is transferred to a digital application so that it can be viewed by the clinical team on a computer portal. Patient feedback for each ride (pain intensity and effort - 0 to 10 scale) is also transferred to the clinician portal. Modifications to the exercise program are based on both power output and patient feedback, with changes to the prescribed ergometer workouts (workout duration, intensity, workouts per day) being directed by the physiotherapist. The timing of the exercises and cycle workouts will be recommended by the physiotherapist, and may vary between patients.
4. Tele-messaging – patient guidance and support via the digital application messaging system. Messages can be sent to the clinical team at any time if non-urgent assistance is needed or patients have a question related to their exercise or cycling program
5. Home visits from a physiotherapist (approx 1 hour duration) - patient education, exercise prescription, cycle ergometer set-up and education and completing outcome measures. Home visits are scheduled for week 1 (pre-operative) and weeks 1, 4 and 6 post-operative. Patient education will be delivered with reference to the patient information booklet outlined above. Exercises will be demonstrated and corrected by the physiotherapist, in addition to orientation to the cycle ergometer.
6. Physiotherapy telehealth consultations – these will be conducted in weeks 1, 3 and 5 in the post-operative recovery phase. Consultations will review patient progress with the exercise and cycling program and assist with any problems related to the rehabilitation program or recovery more broadly. The duration of the consultation will be between 20 and 30 minutes.
7. Mobility equipment – provision and education in safe use of walking aids, specifically elbow crutches, will be conducted in the first home visit and reviewed prior to discharge from hospital, and in the initial post-operative home visit.
Intervention code [1] 327122 0
Treatment: Other
Intervention code [2] 327123 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336230 0
Joint Pain and Function (Composite score)
Timepoint [1] 336230 0
Baseline, 1 week before surgery and 6 weeks after surgery
Secondary outcome [1] 427447 0
Program Completion
Timepoint [1] 427447 0
Pre-operative (one week before surgery) and Post-operative (6 weeks after surgery
Secondary outcome [2] 427450 0
Pain Intensity (Rest, Walking and at Night)
Timepoint [2] 427450 0
Baseline, one week pre-operative and 6 weeks post-operative
Secondary outcome [3] 427452 0
Joint Pain and Function (assessed using the KOOS and HOOS questionnaires)
Timepoint [3] 427452 0
Baseline, one week pre-operative, 6 weeks post-operative
Secondary outcome [4] 427453 0
Quality of Life
Timepoint [4] 427453 0
Baseline, One week pre-operative and 6 weeks Post-operative
Secondary outcome [5] 427454 0
Independent Living Skills
Timepoint [5] 427454 0
Baseline, one week pre-operative, 6 weeks post-operative
Secondary outcome [6] 427455 0
Walking Speed
Timepoint [6] 427455 0
Baseline, one week pre-operative, 6 weeks Post-operative
Secondary outcome [7] 427456 0
Lower limb muscle power
Timepoint [7] 427456 0
Baseline, one week pre-operative and 6 weeks post-operative
Secondary outcome [8] 428173 0
Hospital Length of Stay
Timepoint [8] 428173 0
Following discharge from hospital
Secondary outcome [9] 428174 0
Hospital Discharge Destination - Home, or Rehabilitation Hospital
Timepoint [9] 428174 0
At time of discharge from hospital
Secondary outcome [10] 428175 0
Hospital readmission
Timepoint [10] 428175 0
6 weeks after discharge from hospital

Eligibility
Key inclusion criteria
Adult participants greater than 45 years of age,

Radiologically identified hip or knee OA as the reason for having a hip or knee arthroplasty

Activity-related joint pain

Scheduled for a THA or TKA procedure by one of the participating surgeons and meeting the criteria for the Short-Stay Joint Surgery Pathway
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are unable to complete the questionnaires and understand instructions
Joint arthroplasty for other reasons (septic arthritis, inflammatory joint disease, gout, fracture, major dysplasia or congenital abnormality, hemochromatosis)
Chronic pain not related to operative hip or knee
Participants who are not physically capable of using the cycling ergometer or participating in an independent rehabilitation program.
Participants with an unstable cardiovascular or respiratory condition
Weight greater than 120kg

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25673 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 41498 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 314945 0
Commercial sector/Industry
Name [1] 314945 0
HBF Insurance
Country [1] 314945 0
Australia
Primary sponsor type
Individual
Name
Dr Mark Hurworth
Address
Murdoch Orthopaedic Clinic, 100 Murdoch Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 316945 0
None
Name [1] 316945 0
Address [1] 316945 0
Country [1] 316945 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313928 0
St John of God Healthcare Human Research Ethics Committee
Ethics committee address [1] 313928 0
Ethics committee country [1] 313928 0
Australia
Date submitted for ethics approval [1] 313928 0
02/11/2023
Approval date [1] 313928 0
Ethics approval number [1] 313928 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129822 0
Dr Mark Hurworth
Address 129822 0
Murdoch Orthopaedic Clinic, 100 Murdoch Drive, Murdoch WA 6150
Country 129822 0
Australia
Phone 129822 0
+61 8 6332 6341
Fax 129822 0
Email 129822 0
[email protected]
Contact person for public queries
Name 129823 0
Stephen Edmondston
Address 129823 0
St John of God Murdoch Hospital, 100 Murdoch Drive, Murdoch WA 6150
Country 129823 0
Australia
Phone 129823 0
+61 8 9438 9011
Fax 129823 0
Email 129823 0
[email protected]
Contact person for scientific queries
Name 129824 0
Stephen Edmondston
Address 129824 0
St John of God Murdoch Hospital, 100 Murdoch Drive, Murdoch WA 6150
Country 129824 0
Australia
Phone 129824 0
+61 8 9438 9011
Fax 129824 0
Email 129824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.