Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001533785
Ethics application status
Approved
Date submitted
28/11/2022
Date registered
12/12/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A self-directed digital exercise program for hip osteoarthritis (“My Hip Exercise”): a randomised controlled trial
Scientific title
Evaluating the effects of a self-directed, digital exercise program on hip pain and physical function in people with hip osteoarthritis: My Hip Exercise randomised controlled trial
Secondary ID [1] 308210 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 327960 0
Condition category
Condition code
Musculoskeletal 325025 325025 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this two-arm, parallel-design, superiority, pragmatic randomised controlled trial, participants randomised to the intervention group will receive access to a bespoke website, a 24-week exercise program, and an exercise adherence support mobile app. After randomisation, participants will be provided with details of how to access the website (the URL and their unique username and password).

The website has been constructed by the authors in conjunction with physiotherapy clinicians and consumers with hip osteoarthritis and developed in accordance with recommendations outlined by The Health on the Net Foundation’s Code of Conduct. It contains:
i) educational information about living with hip osteoarthritis, hip osteoarthritis treatment options, exercise as a treatment for hip osteoarthritis, and exercise recommendations, including links to scholarly references,
ii) a 24-week, self-directed, home-based exercise program predominately targeting lower limb muscle groups, including a downloadable/printable PDF of the exercise programs, and program logbook,
iii) information and guidance to assist participants to increase their general physical activity over the 24-week intervention period,
iv) a synthesis of resources from other sections within the website.

The strength exercise section consists of three, eight-week home exercise programs (Program 1, 2, and 3) with 5-6 lower limb strength exercises in each (ie. squats, bridges, step ups, standing hip abduction, etc). Participants are asked to complete 3x10 repetitions of each exercise and complete each program three times a week for eight weeks, for a total of 24 weeks. Each session should take approximately 30 minutes to complete (90 minutes per week). Programs 2 and 3 offer progressions of Program 1 exercises (adding ankle weights, resistance bands, single leg variations, etc). Each program includes a BORG scale, and participants are asked to work at a rate of perceived exertion of 5-6/10.

Both the intervention and control groups will be informed of the general physical activity guidelines (150-300 minutes of moderate intensity aerobic physical activity per week) in the education section of the website.

Videos are embedded throughout the website sections with educational content and information from those with lived experience of hip osteoarthritis. The website also contains instructions for downloading the exercise adherence support app.

Participants will be asked to log the number of completed exercise sessions in the app. Each week (or fortnight as they progress through the program), they will receive a notification prompting them to record their sessions and any obstacles they encountered. Users will then receive tailored messages to support their exercise adherence. Users also receive extra push notifications throughout the week to remind and support them to achieve their exercise target of three times per week.

Primary and secondary outcomes will be collected by web-based survey at baseline and 24 weeks post randomisation.
Intervention code [1] 324668 0
Rehabilitation
Intervention code [2] 324669 0
Behaviour
Comparator / control treatment
Those randomised to the control group will receive access to another bespoke website that only contains information from the education section of the intervention website.
Control group
Active

Outcomes
Primary outcome [1] 332841 0
Severity of hip pain while walking, scored on an 11-point, self-reported numeric rating scale for “average amount of pain felt over the last week in your study hip when you are walking” where 0=no pain and 10=worst pain possible
Timepoint [1] 332841 0
Baseline and 24-weeks post randomisation
Primary outcome [2] 332842 0
Physical function, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) self-reported subscale
Timepoint [2] 332842 0
Baseline and 24-weeks post randomisation
Secondary outcome [1] 414846 0
Pain subscale of Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [1] 414846 0
Baseline and 24-weeks post randomisation
Secondary outcome [2] 414847 0
Function, sports and recreational activities subscale of Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [2] 414847 0
Baseline and 24-weeks post randomisation
Secondary outcome [3] 414848 0
Hip-related quality-of-life subscale of Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [3] 414848 0
Baseline and 24-weeks post randomisation
Secondary outcome [4] 414849 0
Global rating of overall change in hip condition, scored using a 7-point global rating of change Likert scale
Timepoint [4] 414849 0
24-weeks post randomisation
Secondary outcome [5] 414850 0
Health-related quality of life, scored on Assessment of Quality of Life (AQoL-8D) Instrument
Timepoint [5] 414850 0
Baseline and 24-weeks post randomisation
Secondary outcome [6] 414851 0
Physical activity level, scored on Incidental and Planned Exercise Questionnaire version W (IPEQ-W)
Timepoint [6] 414851 0
Baseline and 24-weeks post randomisation
Secondary outcome [7] 414852 0
Global rating of change in physical activity, scored using a 7-point global rating of change Likert scale
Timepoint [7] 414852 0
24-weeks post randomisation
Secondary outcome [8] 414853 0
Fear of movement, scored using Brief Fear of Movement Scale for Osteoarthritis
Timepoint [8] 414853 0
Baseline and 24-weeks post randomisation
Secondary outcome [9] 414854 0
Pain self-efficacy, scored from the pain subscale of the Arthritis Self Efficacy Scale
Timepoint [9] 414854 0
Baseline and 24-weeks post randomisation
Secondary outcome [10] 414855 0
Self-efficacy for exercise, scored using the Self-Efficacy for Exercise Scale
Timepoint [10] 414855 0
Baseline and 24-weeks post randomisation
Secondary outcome [11] 414856 0
Self-reported use of oral pain medications for hip pain via study-specific survey
Timepoint [11] 414856 0
24-weeks post randomisation

Eligibility
Key inclusion criteria
i) Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (age 45 years and over, activity-related hip joint pain, hip joint morning stiffness less than or equal to 30 minutes or no hip joint morning stiffness);
ii) Report hip pain for at least 3 months;
iii) Report hip pain on most days in the past month;
iv) Report average hip pain during walking in past week as at least 4 out of 10 on an 11-point numeric rating scale (NRS);
v) Have a home Internet connection, a computer/tablet device that enables access to the Internet and a suitable phone to download an app; and
vi) Able to give informed consent and to participate fully in the interventions and assessment procedures.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Have undergone a hip joint replacement in the most painful hip;
ii) Planning to undergo a hip joint replacement in the next 6 months;
iii) Have participated in regular leg strengthening exercise over the past 6 weeks (one or more times per week for each week);
iv) Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis;
v) 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;
vi) 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;
vii) Have a health condition(s) listed on the Exercise and Sports Science Australia stage 1 pre-exercise screening questionnaire that might compromise exercise safety, and do not receive medical clearance from a general practitioner to participate in an unsupervised home exercise program; and/or
viii) 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)
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. The randomisation schedule will be concealed in a password protected computer database. A member of our research team will maintain and access the schedule and reveal allocation to the Trial Coordinator as each participant requires randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted random block 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
Pragmatic, 2-arm, parallel-design, superiority, assessor- and participant- blinded randomised controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: The sample size is based on detecting a difference in change between-groups that meets or exceeds a minimal clinically important difference (MCID) for the two primary outcomes of hip pain on walking (NRS) and physical function (WOMAC). We aim to detect the MCID on the clinical primary outcomes of 6 units in physical function on WOMAC, and 1.8 in improvement in hip pain on NRS. For these and other binary outcomes, groups will be compared using risk differences and risk ratios, calculated from logistic regression models and adjusted for the outcomes at baseline where available.
To achieve 80% power with a two-sided alpha of 0.05 split between the two primary outcomes, assuming a between-participant standard deviation of 2.5 for pain and 13 for function and a correlation between pre- and post-measurements of 0.25 for pain and 0.40 for function, and accounting for 15% loss to follow up, we require 91 participants per arm, for a total of 182 participants.

Statistical Analysis Plan: Analyses comparing the two groups will be performed by a statistician blinded to group details, using all available data from all randomised participants. Demographic and baseline characteristics of participants will be summarised as appropriate 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 risk differences and risk ratios, calculated from logistic regression models, adjusted for the outcome at baseline where available. Should the amount of missing data for either primary outcome be greater than 5%, multiple imputation will be conducted and imputed data will be used for the primary analysis.
A Statistical Analysis Plan will be written and published on our research centre’s website prior to commencement of data analysis while blind to group allocation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
8/03/2023
Date of last participant enrolment
Anticipated
20/09/2024
Actual
Date of last data collection
Anticipated
30/03/2025
Actual
Sample size
Target
182
Accrual to date
132
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312467 0
Government body
Name [1] 312467 0
National Health and Medical Research Council
Country [1] 312467 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry Street,
The University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 314050 0
None
Name [1] 314050 0
Address [1] 314050 0
Country [1] 314050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311812 0
The University of Melbourne Science, Technology, Engineering, Mathematics and Medicine 2 Human Research Ethics Committee
Ethics committee address [1] 311812 0
Ethics committee country [1] 311812 0
Australia
Date submitted for ethics approval [1] 311812 0
17/08/2022
Approval date [1] 311812 0
19/09/2022
Ethics approval number [1] 311812 0
2022-25064-32782-3

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

Contacts
Principal investigator
Name 122450 0
Prof Kim Bennell
Address 122450 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122450 0
Australia
Phone 122450 0
+61 3 8344 4135
Fax 122450 0
Email 122450 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 122451 0
Sarah Stratulate
Address 122451 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122451 0
Australia
Phone 122451 0
+61 3 9035 5702
Fax 122451 0
Email 122451 0
sarah.stratulate@unimelb.edu.au
Contact person for scientific queries
Name 122452 0
Kim Bennell
Address 122452 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122452 0
Australia
Phone 122452 0
+61 3 8344 4135
Fax 122452 0
Email 122452 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 of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Data can be obtained by contacting the principal investigator via email (Kim Bennell, k.bennell@unimelb.edu.au). Access is subject to approval by the principal investigator and the signing of an agreement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA self-directed digital exercise program for hip osteoarthritis ("My Hip Exercise"): protocol for a randomised controlled trial.2023https://dx.doi.org/10.1186/s12891-023-07009-1
N.B. These documents automatically identified may not have been verified by the study sponsor.