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Trial registered on ANZCTR


Registration number
ACTRN12618001167257
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
13/07/2018
Date last updated
22/04/2024
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
My Knee Exercise: a 6 month electronically delivered intervention to support self-management for people with knee osteoarthritis: A pragmatic randomised controlled trial.
Scientific title
My Knee Exercise: The effectiveness of a 6 month electronically delivered intervention, for people with knee osteoarthritis, on pain and function: A pragmatic randomised controlled trial.
Secondary ID [1] 295042 0
Nil Known
Universal Trial Number (UTN)
U1111-1214-8770
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 308082 0
Chronic Knee Pain 308083 0
Condition category
Condition code
Musculoskeletal 307128 307128 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
My Knee Exercise Intervention
Participants will be provided a URL to access “My Knee Exercise”, a website containing information to assist in the self-management of knee pain. Over 24 weeks they will be asked to access the website at home, on their own device, read the educational information provided and complete a self-directed, home-based, exercise program. Participants can view the website as often as they require.
Specifically, they will be asked to access the 4 website sections. All sections can be accessed concurrently. These sections are:
1) My Knee Education. This section contains information about knee OA and exercise benefits. Participants will be directed to view the written and visual educational material prior to commencing a home-based exercise program. The material provided has been specifically developed for this study.
2) My Knee Strength. This section prescribes a 24-week, self-directed, home-based, exercise program. Over the 24 weeks participants will complete three consecutive exercise programs, each eight-week duration. Each program will contain five-six strength based exercises for the hip, knee and ankle, for example seated knee extension, walk squats, hip abduction, calf raises. The prescribed exercises in each program will vary to increase the exercise challenge overtime and add variety. Prescription of each exercise is: ten repetitions; three sets; three times a week; at an exercise intensity of hard (5-6) in program one and very hard (7-8) in program two and three, as rated on a 11-point scale of Rated Perceived Exertion (RPE). Intensity will be increased for each exercise by adding ankle weights and/or changing body position. Each exercise session is estimated to be 20-30 minutes duration.
Written instructions will be provided for each exercise as well as photographic and video demonstrations.
Participants will be encouraged to purchase their own ankle weights to progress their exercises throughout the 24-week intervention, following detailed instructions.
During the intervention, adherence to the strength based program will be encouraged via mobile phone text message support. Participants will receive both facilitator and barrier to exercise participation text messages. Facilitator messages will come from a standard set. Barrier messages will be semi-personalised and address participants self-selected barrier to exercise participation if low adherence is reported for the previous week (less than 3 exercise sessions/week). Participants will select the barrier from a pre-determined list of common barriers including lack of time, forgetfulness, pain. Text messages will also be personalised using participants first names. Participants will be encouraged, but not mandated, to keep an exercise log book to record their weekly exercise practice.
3) My Knee Physical Activity. This section contains information and guidance to assist participants to increase their general physical activity over the 24-week intervention period.
4) My Knee Tools: This section contains a range of resources to help participants complete their strength based exercise program and increase their physical activity. Resources include downloadable templates of exercise logbooks, action plan development and goal setting.
Intervention code [1] 301377 0
Rehabilitation
Comparator / control treatment
Participants will be provided a URL to access “My Knee Education”, a website containing only the My Knee Education section of the My Knee Exercise website (intervention). The material provided has been specifically developed for this study.
General exercise and physical activity recommendations will also be provided, similar to those available in current Internet-based Australian OA consumers resources.
Over 24 weeks they will be asked to access the website at home, on their own device, read the educational information provided and implement the exercise and physical activity recommendations as they see fit. Participants can view the website as often as they require.
Control group
Active

Outcomes
Primary outcome [1] 306100 0
Average overall knee pain severity in past week using a Numeric Rating Scale (NRS)
Timepoint [1] 306100 0
Baseline and 24 weeks after intervention commencement (primary time-point)
Primary outcome [2] 306101 0
The physical function sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be extracted from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire.

Updated from
Physical function sub scale of the Knee Osteoarthritis Outcome Score  
Reason: The purpose of the update is to provide a further detailed description. The decision to report the WOMAC physical function sub-scale was made during study design, prior to participant enrollment, at the time of the studies sample size calculation.
Updated on 6/06/2019 9:03:42 AM
Timepoint [2] 306101 0
Baseline and 24 weeks after intervention commencement (primary time-point)
Secondary outcome [1] 347574 0
Pain sub scale of the Knee Osteoarthritis Outcome Score
Timepoint [1] 347574 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [2] 347575 0
Function in Sport and Recreation sub scale of the Knee Osteoarthritis Outcome Score
Timepoint [2] 347575 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [3] 347576 0
Knee related Quality of Life sub scale of the Knee Osteoarthritis Outcome Score
Timepoint [3] 347576 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [4] 347577 0
Participant perceived global rating of change scale (GRC) (7-point Likert where 1=much worse, 7=much better)
Timepoint [4] 347577 0
24 weeks after intervention commencement (primary time-point)
Secondary outcome [5] 347578 0
Assessment of Quality of Life (AQoL)
Timepoint [5] 347578 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [6] 347579 0
Physical Activity scale for the Elderly (PASE)
Timepoint [6] 347579 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [7] 347580 0
Self-efficacy pain sub-scale of the Arthritis self-efficacy scale
Updated from
Arthritis self-efficacy scale  
Reason: To clarify the sub-scales of the Arthritis self-efficacy scale that will be collected
Updated on 23/07/2018 9:00:12 AM
Timepoint [7] 347580 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [8] 347581 0
Self-efficacy For Exercise (SEE) Scale
Timepoint [8] 347581 0
Baseline and 24 weeks after intervention commencement
Secondary outcome [9] 347582 0
Overall Satisfaction on a 7 point Likert scale
Timepoint [9] 347582 0
24 weeks after intervention commencement
Secondary outcome [10] 349825 0
Self-efficacy function sub-scale of the Arthritis self-efficacy scale
Inserted
 
Reason: To clarify the sub-scales of the Arthritis self-efficacy scale that will be collected
Updated on 23/07/2018 9:00:12 AM
Timepoint [10] 349825 0
Baseline and 24 weeks after intervention commencement
Inserted
 
Reason: To clarify the sub-scales of the Arthritis self-efficacy scale that will be collected
Updated on 23/07/2018 9:00:12 AM

Eligibility
Key inclusion criteria
a) Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria:
- aged 45 years and over
- activity related knee joint pain
- morning stiffness of 30 minutes or less;

b) History of knee pain on most days for 3 months or more;

c) Overall average knee pain in past week self-rated as equal to or greater than 4 out of 10 on an 11-point numeric rating scale (NRS);

d) Able to give informed consent and to participate fully in the interventions and assessment procedures;

d) Have a mobile phone with text message functioning and be willing to use it during the study to receive and send text messages;

e)Have a home Internet connection and a device that enables access to the Internet.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
· Booked for knee joint replacement surgery;

· Have had a knee joint replacement in the most painful knee;

· Have participated in a structured knee exercise program within the past 6 months;

· Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis;

· Have had a fall within the last 12 months and do not receive clearance from a General Practitioner to participate in an unsupervised home exercise program;

· Are housebound requiring assistance from another person to leave the house in the previous month and do not receive medical clearance from a General Practitioner to participate in an unsupervised home exercise program by a General Practitioner;

· Fail pre-exercise screening (Adult Pre-exercise Screening Questionnaire) and do not receive medical clearance from a General Practitioner to participate in an unsupervised home exercise program;

· Unable to speak or read English;

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)
To conceal allocation, the randomisation schedule will be accessed via a password-protected, computer program by a researcher not involved in participant recruitment scheduling or assessment.

The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. Another researcher will access the randomisation schedule via computer, concealed in a password protected database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur according to a 1: 1 allocation.
The randomisation schedule will be computer generated, using random permuted blocks of varying sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: For an effect size of 0.4, with a correlation between pre- and post- measurements of 0.35, power 80% (using ANCOVA for analysis) and allowing for a 15% loss to follow up, 103 participants per arm are required, for a total of 206. These estimates are based on data from our previously published RCT investigating home exercise with a comparable patient population (Bennell, 2017, Annals of Internal Medicine).

Statistical Analysis Plan: Analyses comparing the two groups will be performed by the statistician in a blinded fashion using all available data from all randomised participants. Demographic and baseline characteristics of participants will be summarised as appropriate (means and standard deviations for continuous variables that appear to be distributed approximately symmetrically, medians and interquartile ranges for other continuous variables, counts and percentages for categorical variables) and will be inspected to assess baseline comparability of treatment groups. For continuous outcomes, differences in change will be compared between groups using linear regression models adjusted for baseline levels of these outcomes. Model assumptions will be assessed using standard diagnostic plots. For binary outcomes, differences between groups will be compared using relative risks, calculated from logistic regression models. Should the amount of missing data for an outcome be greater than 5%, multiple imputation will be conducted and the method reported.

Recruitment
Recruitment status
Completed
Updated from
Recruiting  
Reason: recruitment completed
Updated on 20/03/2020 7:34:35 AM
Updated from
Not yet recruiting  
Reason: Recruitment commenced
Updated on 14/08/2018 1:49:27 PM
Date of first participant enrolment
Anticipated
Actual
Updated from
16/07/2018 
Reason: Recruitment delay.
Updated on 23/07/2018 9:00:12 AM
Updated from
 
Reason: Recruitment commenced
Updated on 14/08/2018 1:49:27 PM
Date of last participant enrolment
Anticipated
Actual
Updated from
 
Reason: recruitment completed
Updated on 20/03/2020 7:34:35 AM
Date of last data collection
Anticipated
Actual
Updated from
 
Reason: study completed
Updated on 20/03/2020 7:34:35 AM
Sample size
Target
Accrual to date
Final
Updated from
18 
Reason: Recruitment complete
Updated on 20/03/2020 7:34:35 AM
Updated from
 
Reason: recruitment commenced
Updated on 14/08/2018 1:49:27 PM
Updated from
 
Reason: study completed
Updated on 20/03/2020 7:34:35 AM
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299623 0
Government body
Name [1] 299623 0
Australian Government Research Training Program (RTP) Scholarship.
Country [1] 299623 0
Australia
Funding source category [2] 299642 0
Government body
Name [2] 299642 0
National Health and Medical Research Council (NHMRC)
Country [2] 299642 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
Address 1-100 Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 298968 0
None
Name [1] 298968 0
Address [1] 298968 0
Country [1] 298968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300522 0
University of Melbourne Human Research Ethics Committee (HREC). Psychology, Health and Applied Sciences (PHAS).
Ethics committee address [1] 300522 0
Ethics committee country [1] 300522 0
Australia
Date submitted for ethics approval [1] 300522 0
23/01/2018
Approval date [1] 300522 0
09/03/2018
Ethics approval number [1] 300522 0
1851085

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

Contacts
Principal investigator
Name 83934 0
Prof Kim Louise Bennell
Address 83934 0
University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010
Country 83934 0
Australia
Phone 83934 0
+61 3 8344 4135
Fax 83934 0
Email 83934 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 83935 0
Rachel Kate Nelligan
Address 83935 0
The University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010
Country 83935 0
Australia
Phone 83935 0
+61 3 8344 9411
Fax 83935 0
Email 83935 0
rachel.nelligan@unimelb.edu.au
Updated from
rachel.nelligan@unimleb.edu.au  

Updated on 24/09/2018 9:57:15 AM
Contact person for scientific queries
Name 83936 0
Kim Louise Bennell
Address 83936 0
The University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010
Country 83936 0
Australia
Phone 83936 0
+61 3 8344 4135
Fax 83936 0
Email 83936 0
k.bennell@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data presented in the results paper (JAMA Intern Med. 2021;181(6):776-785) available in XLSX format.
Updated from
All of the individual participant data collected during the trial, after de-identification  

Updated on 22/04/2024 9:56:26 AM
When will data be available (start and end dates)?
12-04-2021 to 12-04-2036 (a period of 15 years from publication)
Updated from
Immediately following publication, no end date  

Updated on 22/04/2024 9:56:26 AM
Available to whom?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Updated from
Case-by-case basis at the discretion of Primary Sponsor  

Updated on 22/04/2024 9:56:26 AM
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
Updated from
For IPD meta-analyses  

Updated on 22/04/2024 9:56:26 AM
How or where can data be obtained?
By emailing the Principal Investigator at rachel.nelligan@unimelb.edu.au. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.
Updated from
Access subject to approvals by Principal Investigator  

Updated on 22/04/2024 9:56:26 AM


What supporting documents are/will be available?

Supporting Document [1] (Reference No. 1889)
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TypeCitationLinkEmailOther detailsAttachment
Informed consent form    375219-(Uploaded-16-04-2019-14-10-02)-Study-related document.docx


Supporting Document [2] (Reference No. 1890)
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TypeCitationLinkEmailOther detailsAttachment
Ethical approval    375219-(Uploaded-16-04-2019-14-11-26)-Study-related document.pdf


Supporting Document [3] (Reference No. 22258)
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TypeCitationLinkEmailOther detailsAttachment
Data dictionary   The Data Dictionary will be supplied with the de-identified data. 


Results publications and other study-related documents

No Study Results Provided