ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

U1111-1214-8770

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis

Chronic Knee Pain

Condition category

Condition code

Musculoskeletal

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]

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]

Average overall knee pain severity in past week using a Numeric Rating Scale (NRS)

Timepoint [1]

Baseline and 24 weeks after intervention commencement (primary time-point)

Primary outcome [2]

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.

Timepoint [2]

Baseline and 24 weeks after intervention commencement (primary time-point)

Secondary outcome [1]

Pain sub scale of the Knee Osteoarthritis Outcome Score

Timepoint [1]

Baseline and 24 weeks after intervention commencement

Secondary outcome [2]

Function in Sport and Recreation sub scale of the Knee Osteoarthritis Outcome Score

Timepoint [2]

Baseline and 24 weeks after intervention commencement

Secondary outcome [3]

Knee related Quality of Life sub scale of the Knee Osteoarthritis Outcome Score

Timepoint [3]

Baseline and 24 weeks after intervention commencement

Secondary outcome [4]

Participant perceived global rating of change scale (GRC) (7-point Likert where 1=much worse, 7=much better)

Timepoint [4]

24 weeks after intervention commencement (primary time-point)

Secondary outcome [5]

Assessment of Quality of Life (AQoL)

Timepoint [5]

Baseline and 24 weeks after intervention commencement

Secondary outcome [6]

Physical Activity scale for the Elderly (PASE)

Timepoint [6]

Baseline and 24 weeks after intervention commencement

Secondary outcome [7]

Self-efficacy pain sub-scale of the Arthritis self-efficacy scale

Timepoint [7]

Baseline and 24 weeks after intervention commencement

Secondary outcome [8]

Self-efficacy For Exercise (SEE) Scale

Timepoint [8]

Baseline and 24 weeks after intervention commencement

Secondary outcome [9]

Overall Satisfaction on a 7 point Likert scale

Timepoint [9]

24 weeks after intervention commencement

Secondary outcome [10]

Self-efficacy function sub-scale of the Arthritis self-efficacy scale

Timepoint [10]

Baseline and 24 weeks after intervention commencement

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?

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

Date of first participant enrolment

Anticipated

24/07/2018

Actual

25/07/2018

Date of last participant enrolment

Anticipated

7/10/2019

Actual

9/08/2019

Date of last data collection

Anticipated

7/04/2020

Actual

3/02/2020

Sample size

Target

206

Accrual to date

Final

206

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Research Training Program (RTP) Scholarship.

Address [1]

GPO Box 9880
Department of Education and Training,
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council (NHMRC)

Address [2]

L 1 16 MARCUS CLARKE Street, Canberra Australian Capital Territory 2601

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee (HREC). Psychology, Health and Applied Sciences (PHAS).

Ethics committee address [1]

The University of Melbourne
Address	1-100 Grattan Street, Parkville, Victoria, 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/01/2018

Approval date [1]

09/03/2018

Ethics approval number [1]

1851085

Summary

Brief summary

Knee osteoarthritis (KOA) is a leading contributor to burden of disease in Australia. Pain and impaired function are characteristic symptoms leading to physical disability, inactivity and reduced quality of life all of which further perpetuate functional decline.
Guidance to facilitate self-management is key in the treatment of KOA with physical activity and exercise advocated by all clinical guidelines as the cornerstone of conservative management irrespective of disease severity.  Unfortunately, many people suffering with KOA are not receiving the advice or behaviour change support required to incorporate regular exercise and physical activity into their daily routines. A combination of factors may be responsible including financial, geographical, and personal barriers. To overcome these barriers innovative, novel and cost-effective approaches to exercise education, prescription and exercise behaviour change are needed to increase exercise uptake and reduce physical inactivity in the KOA population and ultimately reduce both the individual and societal burden of OA in Australia. 
Electronically delivered physical activity and exercise interventions may be one solutions. Several OA specific internet resources already exist within Australia. These resources provide only general exercise and physical activity advice to people with KOA, with minimal evidence supporting their positive effect on clinical outcomes. It can be speculated that the effectiveness of such resources may be enhanced by the addition of higher quality, detailed and specific physical activity and exercise instruction and guidance.
This trial will, therefore, investigate whether the addition of “My Knee Exercise” (an Internet delivered 24-week exercise program with mobile phone text message exercise adherence support) to Internet delivered exercise education enhances clinical outcomes at 24-weeks in people with KOA.
Participants will be randomly assigned to one of two groups;
i)	My Knee Education (control condition): participants will be provided access to “My Knee Education”, a website containing information about KOA and exercise benefits plus general exercise and physical activity recommendations, similar to those provided in current Australian OA consumers resources.
ii)	My Knee Exercise (intervention): participants will be provided access to “My Knee Exercise”, a website containing the same information provided to the control condition in addition to a 24-week Internet delivered exercise program, supported by mobile phone text message exercise adherence support and detailed physical activity guidance.

Data collection will be self-reported questionnaires relating to knee pain, physical function, global rating of change, health-related quality of life, physical activity levels, self-efficacy and satisfaction, collected at baseline and 24-weeks after commencement of the intervention.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kim Louise Bennell

Address

University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010

Country

Australia

Phone

+61 3 8344 4135

Fax

k.bennell@unimelb.edu.au

Contact person for public queries

Name

Rachel Kate Nelligan

Address

The University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010

Country

Australia

Phone

+61 3 8344 9411

Fax

rachel.nelligan@unimelb.edu.au

Contact person for scientific queries

Name

Kim Louise Bennell

Address

The University of Melbourne
L7, 161 Barry Street, Parkville, Victoria, 3010

Country

Australia

Phone

+61 3 8344 4135

Fax

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.

When will data be available (start and end dates)?

12-04-2021 to 12-04-2036 (a period of 15 years from publication)

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.

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.

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.

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
1889	Informed consent form		375219-(Uploaded-16-04-2019-14-10-02)-Study-related document.docx
1890	Ethical approval		375219-(Uploaded-16-04-2019-14-11-26)-Study-related document.pdf
22258	Data dictionary	The Data Dictionary will be supplied with the de-i... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effectiveness of internet-delivered education and home exercise supported by behaviour change SMS on pain and function for people with knee osteoarthritis: A randomised controlled trial protocol.	2019	https://dx.doi.org/10.1186/s12891-019-2714-x
Embase	Moderators of the effect of a self-directed digitally delivered exercise program for people with knee osteoarthritis: Exploratory analysis of a randomized controlled trial.	2021	https://dx.doi.org/10.2196/30768

N.B. These documents automatically identified may not have been verified by the study sponsor.

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