Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001373763
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
26/10/2022
Date last updated
26/10/2022
Date data sharing statement initially provided
26/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Personalised, Remote- monitored Cycling Rehabilitation program following knee replacement surgery: a feasibility and acceptability trial.
Scientific title
A Personalised, Remote- monitored Cycling Rehabilitation program following Total Knee Arthroplasty: a feasibility and acceptability trial.
Secondary ID [1] 306563 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 325460 0
Knee arthroplasty 325461 0
Condition category
Condition code
Musculoskeletal 322840 322840 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 322921 322921 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 322922 322922 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Name: Feasibility of Personalised Remote-monitored Cycling following TKA

The rationale for the intervention is to evaluate the feasibility of remote-monitored cycling rehabilitation that will commence 2-weeks after total knee replacement surgery. The intervention will continue for 4-weeks, based in the participant's home and monitored remotely by the research team for compliance and patient feedback. Participants will take home a portable cycle ergometer and electronic device with the pre-installed digital application (App) that records and provides real-time feedback during each cycling session, as well as an instruction booklet for the setup and use of the devices. Research personnel have a combined 30 years' experience in musculoskeletal rehabilitation and research to deliver the intervention and have undertaken technical training in use of the App and cycle ergometer from the developer. Participants are recruited from an orthopaedic clinic located in a private hospital where all pre-operative and follow-up visits are conducted.

A familiarisation and information session for each participant will be held during their post-operative appointment at 2-weeks, where participants are shown how to setup and use the cycling ergometer, tablet and app. Average power output will be measured during the session to serve as the baseline exercise prescription. The 4-week home-based intervention involves 20 minute sessions, 5 times per week, with power output in the prescribed 'target' zone. If needed, the prescribed cycling program can be completed over more sessions per day (i.e. 4x5min or 2x10min sessions). Participants then report pain intensity and rate their perceived exertion via the App after each cycling session. Each intervention is personalised based on patient-reported feedback and compliance that is collected and remotely monitored by the research team through the web-based clinician interface.

The exercise compliance and patient feedback is then reviewed by the research team and the power output increased if the baseline level is achieved, and level of perceived exertion is between 3 or 4 (moderate/ sort of hard) on the Borg scale. To progress the exercise dose, the resistance will be increased on the ergometer to achieve an increase in average power output. The participant will be notified of these changes via email or text. If the thresholds are not achieved, the dose may be decreased or remain unchanged, continually adapting to the participants capability to complete the prescribed exercise. Any participants not achieving prescribed exercise targets will be followed-up.

To evaluate the success of the program delivery, feasibility criteria will be used which includes participant recruitment rate, participant retention, dose-goal attainment of the prescribed exercise, and participant adherence to feedback reporting. Key areas of feasibility will be quantitatively assessed from the post-operative feasibility questionnaire completed after the cycling rehabilitation program (6-weeks post-surgery), including acceptability, satisfaction, practicality and safety of the cycling program. Participants will also be completing self-reported outcome measures to assess symptoms and knee function at baseline (pre-surgery), 6-weeks post-surgery (after the intervention) and 12 months post-surgery.


Intervention code [1] 323070 0
Rehabilitation
Intervention code [2] 323071 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330694 0
Intervention adherence as assessed by the proportion of total end-of-session feedback reports out of total sessions completed. The end-of-session report includes a participant rating their pain intensity on an 11-point numerical rating scale and effort on the revised- Borg Rating of Perceived Exertion scale after each cycling session through the study app. This will be collected from the study app.
Timepoint [1] 330694 0
6 weeks post total knee arthroplasty
Primary outcome [2] 332577 0
Dose-goal attainment as assessed by the proportion of cycling sessions completed at the prescribed power output range during the intervention period.

This will be determined by accessing app analytics to identify the number of sessions that were completed at the prescribed power output range out of the total number of sessions.
Timepoint [2] 332577 0
6 weeks post total knee arthroplasty
Primary outcome [3] 332578 0
Participant retention as assessed by the proportion of participants who have completed the 4-week cycling intervention. This is determined by accessing the electronic database that has recorded participant completion of the intervention.
Timepoint [3] 332578 0
6 weeks post total knee arthroplasty
Secondary outcome [1] 407235 0
Perceived exertion measured using a revised Borg Rating of Perceived Exertion (RPE) scale.

An 11-point scale with descriptors anchored at ‘no effort’ and ‘highest effort possible’.
Timepoint [1] 407235 0
After each cycling session during the 4-week intervention post-operatively.
Secondary outcome [2] 407236 0
Knee function measured using the validated Oxford Knee Score (OKS),
Timepoint [2] 407236 0
Baseline, 6 weeks post-operatively and 1 year post-operatively.
Secondary outcome [3] 407237 0
Joint awareness during activities of daily living measured using the validated Forgotten Joint Score.
Timepoint [3] 407237 0
1 year post-operatively
Secondary outcome [4] 413958 0
Knee pain intensity measured using an 11-point numerical rating scale (0 represents "no pain" and a score of 10 represents "worst possible pain")
Timepoint [4] 413958 0
Baseline, after each cycling session (during 4-week intervention), 6 weeks post-operative and 1 year post-operative
Secondary outcome [5] 413959 0
Participant acceptability of the 4-week cycling intervention measured using a feasibility questionnaire.

The questionnaire is based on feasibility focus areas by Bowen et al (2010), assessing the overall feasibility of the intervention.
Timepoint [5] 413959 0
6 week post-operatively
Secondary outcome [6] 413960 0
Participant satisfaction of the 4-week cycling intervention measured using a feasibility questionnaire.

The questionnaire is based on feasibility focus areas by Bowen et al (2010), assessing the overall feasibility of the intervention.
Timepoint [6] 413960 0
6 weeks post-operatively
Secondary outcome [7] 413961 0
Practicality of the 4-week cycling intervention measured using a feasibility questionnaire.

The questionnaire is based on feasibility focus areas by Bowen et al (2010), assessing the overall feasibility of the intervention.
Timepoint [7] 413961 0
6 weeks post-operatively
Secondary outcome [8] 413962 0
Safety of the 4-week cycling intervention measured using a feasibility questionnaire that asks 3 questions related to safety including mounting and stability sitting on the cycling device and injury and adverse events.

The questionnaire is based on feasibility focus areas by Bowen et al (2010), assessing the overall feasibility of the intervention.
Timepoint [8] 413962 0
6 weeks post-operatively
Secondary outcome [9] 415184 0
Knee function measured using the validated Knee Injury and Osteoarthritis Outcome Score (KOOS).
Timepoint [9] 415184 0
Baseline, 6 weeks post-operatively and 1 year post-operatively.

Eligibility
Key inclusion criteria
• Adult participants greater than 45 years of age,
• Radiologically identified knee OA
• Activity-related joint pain
• Scheduled for a TKA procedure by orthopaedic surgeon
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants with poor English who are unable to complete the questionnaires and understand instructions
• Previous significant lower limb surgery i.e High tibial osteotomy
• Secondary OA (septic arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia or congenital abnormality, hemochromatosis)
• Chronic pain not related to operative knee
• Participants who are physically unable to mount the exercise bicycle (severe pain, non-ambulant)
• Participants with a <90 degree knee range of movement or other impairment of knee function which does not permit cycling
• Participants with an unstable cardiovascular or respiratory condition

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size:
As there is no efficacy testing in this study, no formal sample size calculation is required. The sample size recommendation for feasibility studies are between 24 to 50 participants, thus based on these recommendations a sample size of 30 is sufficient for the feasibility objectives of this study.

All participants who completed the study will be included in the data analysis. The number of participants who withdraw or do not complete the study will be recorded. Descriptive statistics will be calculated for demographic variables and patient-reported measures at baseline, and six week follow-up. A paired t-test will be used to test for significant differences in patient-reported measures between baseline and follow-up. The feasibility outcomes will be assessed against the related targets to evaluate the different components of the intervention feasibility. Frequency distributions will be used to summarise the questionnaire responses. For all participants, the mean cycling power output (W/kg) capability at the start and end of the four week intervention will be calculated. A paired t-test will be used to test for significant change in power output during the intervention phase of the study. The criterion for statistical significance will be set at p < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/07/2022
Date of last participant enrolment
Anticipated
12/06/2023
Actual
Date of last data collection
Anticipated
17/06/2024
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21929 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 37011 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 310897 0
Hospital
Name [1] 310897 0
St John of God Murdoch Hospital
Country [1] 310897 0
Australia
Primary sponsor type
Hospital
Name
St John of God Murdoch Hospital
Address
St John of God Murdoch Hospital
100 Murdoch Drive, Murdoch,
WA, 6150
Country
Australia
Secondary sponsor category [1] 312268 0
Individual
Name [1] 312268 0
Mr Mark Hurworth
Address [1] 312268 0
St John of God Murdoch Hospital, 100 Murdoch Drive, Murdoch WA 6105
Country [1] 312268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310457 0
St John of God Healthcare Human Research Ethics Committee
Ethics committee address [1] 310457 0
Ethics committee country [1] 310457 0
Australia
Date submitted for ethics approval [1] 310457 0
10/03/2022
Approval date [1] 310457 0
29/04/2022
Ethics approval number [1] 310457 0

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

Contacts
Principal investigator
Name 117738 0
Dr Mark Hurworth
Address 117738 0
Murdoch Orthopaedic Clinic, St John of God Medical Centre, 100 Murdoch Dr, Murdoch WA 6150
Country 117738 0
Australia
Phone 117738 0
+61400018424
Fax 117738 0
Email 117738 0
[email protected]
Contact person for public queries
Name 117739 0
Zaheerah Haywood
Address 117739 0
Murdoch Centre for Orthopaedic Research, Clinical Trials Office, Cancer Centre South Wing, St John of God Murdoch Hospital, 100 Murdoch Drive, Murdoch WA 6150
Country 117739 0
Australia
Phone 117739 0
+61 894288637
Fax 117739 0
Email 117739 0
[email protected]
Contact person for scientific queries
Name 117740 0
Mark Hurworth
Address 117740 0
Murdoch Orthopaedic Clinic, St John of God Medical Centre, 100 Murdoch Dr, Murdoch WA 6150
Country 117740 0
Australia
Phone 117740 0
+61400018424
Fax 117740 0
Email 117740 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.