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A personalised cycling exercise program for Osteoarthritis patients after surgery

Evaluating the efficacy of a personalised, post-operative cycling exercise regimen for patients with Osteoarthritis (OA) following Total Knee Arthroplasty (TKA)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000824965
Acronym
The PROSPECT Study
Enrollment
50
Registered
2020-08-18
Start date
2020-10-01
Completion date
2023-10-01
Last updated
2020-09-14

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 look at a patient-specific, remotely monitored, dose measured cycling exercise program following knee surgery. This new method uses a remotely-monitored bicycle power meter in order to prescribe and modify an exercise regimen. We hypothesize that patients who complete a patient-specific cycling exercise program following this surgery will have better short- and long-term outcomes than those who complete a non-cycling post-operative program.

Interventions

Intervention: A purpose-built cycling device with an inbuilt power meter. Non-drug trial: The exercise device is a purpose build stationary cycle with power meters in the pedal cranks (Infocrank, Australia). The device will be adjusted by a member of the research team to fit the participant who will then be seated to commence familiarisation and establish the initial exercise prescription. This initial exercise is not part of the test, it is to establish the participant's baseline in order for

Intervention: A purpose-built cycling device with an inbuilt power meter. Non-drug trial: The exercise device is a purpose build stationary cycle with power meters in the pedal cranks (Infocrank, Australia). The device will be adjusted by a member of the research team to fit the participant who will then be seated to commence familiarisation and establish the initial exercise prescription. This initial exercise is not part of the test, it is to establish the participant's baseline in order for the exercise program to be prescribed. The resistance and cadence of cycling will be adjusted until the participant can cycle at a comfortable rate. This will be maintained for 20 minutes, with further adjustment as needed based on patient feedback. During the test, a reported level of perceived exertion of between 3 or 4 on the 0 to 10 Borg scale will be the goal. The power output will be monitored during the familiarisation session, and the average power achieved during the trial will be used as the baseline exercise prescription. There is no goal for the amount of power output at baseline. The test will be terminated if the participant reports undue fatigue, or increased pain at any stage. Participants will take the cycle device home along with instructions related to the frequency and duration of their cycling program. The cycling program will commence once the participant is comfortable to do so. They will also have instructions about how to change the resistance of the cycle so the exercise dose can be adjusted. The cycle will have an electronic tablet attached to the handlebars which will provide visual feedback about the power output during the cycling session. This information is collected through a purpose-developed application so that each exercise session can be remotely monitored for compliance by the orthopaedic surgeon and research team. Participants will report their pain and level of perceived exertion at the end of each exercise session. The heartrate during each session will also be monitored using a smartwatch wrist band. The cycling program will continue for 4 weeks, with 5 exercise sessions of 20 minutes duration per week. At the end of each week, the exercise compliance and patient feedback will be reviewed and the power output increased if the baseline level is achieved, and level of perceived exertion falls below the required level. To progress the exercise dose, the resistance will be increased to achieve and increase in average power output of 20W. The participant will be notified of these changes via email or text.

Sponsors

Mr Mark Hurworth
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

•Adult participants greater than or equal to 50 years of age •Radiologically identified knee OA •Scheduled for a TKA procedure by Mr Mark Hurworth

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 dysplasias or congential 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