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A Personalised, Remote- monitored Cycling Rehabilitation program following knee replacement surgery: a feasibility and acceptability trial.

A Personalised, Remote- monitored Cycling Rehabilitation program following Total Knee Arthroplasty: a feasibility and acceptability trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001373763
Enrollment
6
Registered
2022-10-26
Start date
2022-07-21
Completion date
2023-06-12
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess the feasibility of delivering a novel remotely monitored, dose measured cycling exercise rehabilitation program to patients following total knee arthroplasty (TKA). This new method uses a mobile cycling device with an in-built power meter remotely monitored by clinicians to prescribe and modify the post-operative exercise regimen, tailoring it specifically to the patient. The feasibility outcomes from this study will inform the acceptability and efficacy of a post-operative cycling exercise program and a larger randomised controlled trial on knee muscle strength, function and post-operative recovery outcomes of a cycling based protocol versus a standard exercise regimen post TKA.

Interventions

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

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.

Sponsors

St John of God Murdoch Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026