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Trial registered on ANZCTR


Registration number
ACTRN12620000824965p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2020
Date registered
18/08/2020
Date last updated
18/08/2020
Date data sharing statement initially provided
18/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A personalised cycling exercise program for Osteoarthritis patients after surgery
Scientific title
Evaluating the efficacy of a personalised, post-operative cycling exercise regimen for patients with Osteoarthritis (OA) following Total Knee Arthroplasty (TKA)
Secondary ID [1] 301604 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The PROSPECT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 317988 0
Total Knee Arthroplasty 317989 0
Condition category
Condition code
Musculoskeletal 316021 316021 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 316253 316253 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317911 0
Rehabilitation
Comparator / control treatment
Control group: Participants randomised to the non-cycling group. These participants will receive usual care which includes physiotherapist prescribed advice on pain and activity management, and a graduated exercise program.

Prior to discharge from hospital, patients will meet with an orthopaedic physiotherapist who will provide the patient with the hospital joint replacement information brochure ("About your Joint replacement" SGHMHBKS6021 03/19). This covers issues such as pain management, wound care, self-care, household tasks, driving, sleeping

The exercises will consist of a series of weight bearing and non-weight bearing exercises aimed at improving knee joint mobility and lower limb muscle strength. In addition, patients will be encouraged to return to other recreational activities such as walking, swimming or cycling as their pain and mobility allows.

For consistency, the non cycling exercises will be performed at the same frequency as the cycling group ie. 20 minutes per day, 5 days per week for 4 weeks. Each participant will be given a chart of standard exercises .
Control group
Active

Outcomes
Primary outcome [1] 324225 0
The primary treatment outcome will be knee function as measured using the Oxford Knee Score (OKS).
Timepoint [1] 324225 0
Within 1 week pre-operatively, four weeks post-operatively and twelve months post-operatively (primary timepoint)
Secondary outcome [1] 384118 0
Self-reported outcome measures EQ5D5L will be used to assess symptoms, function and quality of life at each time point.
Timepoint [1] 384118 0
Within 1 week pre-operatively, four weeks post-operatively and twelve months post-operatively.
Secondary outcome [2] 384625 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)) will be used to assess symptoms, function and quality of life at each time point.
Timepoint [2] 384625 0
Within 1 week pre-operatively, four weeks post-operatively and twelve months post-operatively.

Eligibility
Key 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
Minimum age
50 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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participant will be randomised by computer generated block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary treatment outcome will be knee function as measured using the OKS. The minimal between-group difference has been set at 6 points on the OKS which has a Minimal Clinical Important Diference (MCID) of 5 points. Based on previous studies in this patient group at SJG Murdoch Hospital, the population standard deviation has been set at 7 OKS points (effect size = 0.85). Based on a two-way repeated measures analysis of variance (ANOVA), a sample size of 50 (25 in each group) will provide 80% power to detect a significant between group difference (a=0.05), while allowing for a 12% dropout rate.

All participants eligible for inclusion in this study will be included in the data analysis. Descriptive statistics will be calculated for baseline demographic and patient-reported variables. The OKS at 12 months will be summarised by treatment group (using mean and SD), and analysed using a linear mixed effects model with repeated measures, adjusting for baseline score and covariates. An interaction between outcome measurement time point and treatment group will be calculated to allow comparison of the treatment effect at each time point. Normal distribution and homogeneity of the variance will be confirmed prior to the analysis. The criterion for statistical significance will be set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 30627 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306035 0
Hospital
Name [1] 306035 0
St John of God Murdoch Hospital
Country [1] 306035 0
Australia
Primary sponsor type
Individual
Name
Mr Mark Hurworth
Address
100 Murdoch Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 306497 0
None
Name [1] 306497 0
Address [1] 306497 0
Country [1] 306497 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306265 0
SJGHC Human Research Ethics Committee
Ethics committee address [1] 306265 0
Suite H203, Level 2
St John of God Subiaco Hospital
12 Salvado Rd
SUBIACO WA 6008
Ethics committee country [1] 306265 0
Australia
Date submitted for ethics approval [1] 306265 0
13/07/2020
Approval date [1] 306265 0
Ethics approval number [1] 306265 0

Summary
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.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103290 0
Dr Mark Hurworth
Address 103290 0
Murdoch Orthopaedic Clinic, St John of God Murdoch Hospital, Suite 10/100 Murdoch Drive, Murdoch, Western Australia, 6150
Country 103290 0
Australia
Phone 103290 0
+61 400018424
Fax 103290 0
Email 103290 0
[email protected]
Contact person for public queries
Name 103291 0
Mark Hurworth
Address 103291 0
Murdoch Orthopaedic Clinic, St John of God Murdoch Hospital, Suite 10/100 Murdoch Drive, Murdoch, Western Australia, 6150
Country 103291 0
Australia
Phone 103291 0
+61 400018424
Fax 103291 0
Email 103291 0
[email protected]
Contact person for scientific queries
Name 103292 0
Mark Hurworth
Address 103292 0
Murdoch Orthopaedic Clinic, St John of God Murdoch Hospital, Suite 10/100 Murdoch Drive, Murdoch, Western Australia, 6150
Country 103292 0
Australia
Phone 103292 0
+61 400018424
Fax 103292 0
Email 103292 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
As discussed and decided within the research team.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8308Study protocol    380058-(Uploaded-23-06-2020-16-23-18)-Study-related document.doc



Results publications and other study-related documents

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