Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000017628
Ethics application status
Approved
Date submitted
28/10/2022
Date registered
10/01/2023
Date last updated
22/04/2024
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Education plus exercise versus advice for individuals who have ankle osteoarthritis: is a clinical trial feasible?
Scientific title
A combined program of education and exercise versus general advice for ankle osteoarthritis: A feasibility randomised controlled trial
Secondary ID [1] 308291 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EdEx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle osteoarthritis 328075 0
Condition category
Condition code
Musculoskeletal 325135 325135 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education and exercise:
The trial intervention will be delivered by a registered physiotherapist with experience delivering education and exercise interventions to patients with lower limb musculoskeletal conditions. The education and exercise intervention will be delivered in a group setting at a physiotherapy clinic with approximately four participants per group/class. There will be two education sessions which will discuss what osteoarthritis is; the diagnosis and symptoms of ankle osteoarthritis; recommendations from international guidelines for managing osteoarthritis; research evidence for the treatment of ankle osteoarthritis; Australian physical activity guidelines and tips; and information about the exercise and education intervention that participants will undertake. The education sessions will be guided by a PowerPoint presentation and accompanied by hard copy handouts, both of which have been designed for the intervention. The exercise program will include an aerobic exercise warm up (e.g., cycling on a stationary bike), and exercises to improve foot and ankle muscle strength (e.g., resisted ankle eversion and body weight resisted heel raises), compound lower limb strength and function (e.g., step ups and bridges), and balance (e.g., standing balance exercises). Exercise difficulty/load will be individually evaluated and progressed for each participant. Participants will attend the 2 education sessions and 12 exercise sessions twice weekly over 7 weeks. The 2 education sessions will occur in the first week of the intervention and the 12 exercise sessions will occur twice weekly for the next 6 weeks (e.g., weeks 2-7). Each session will be approximately 1 hour in length. Attendance and exercise completion will be recorded by the treating physiotherapist at each session. Participants will not be given home exercises during the 7-week program, but will be given a home exercise program after the final group exercise session. The home exercise program includes the exercises that participants performed in the group exercise program. Participants will be provided with a handout of the exercises and resistance bands. They will be asked to continue to perform the exercises twice a week (as they did during the group sessions).
Intervention code [1] 324745 0
Rehabilitation
Intervention code [2] 324746 0
Treatment: Other
Comparator / control treatment
General osteoarthritis advice:
The general osteoarthritis advice intervention will be provided by a registered physiotherapist and delivered at a physiotherapy clinic. Participants will attend one 1-hour group session where they will receive general information on osteoarthritis based on the online resources from Musculoskeletal Australia and Arthritis Australia’s Physical Activity Guidelines for individuals with Osteoarthritis. The session will be guided by a PowerPoint presentation and participants will be provided with the online resources identified above, and a small handout of tips for managing ankle osteoarthritis that has been designed for the intervention. From the Musculoskeletal Australia resource, general information about osteoarthritis and the role of exercise, weight management, medication and self-management in managing symptoms associated with osteoarthritis will be discussed. From Arthritis Australia’s Physical Activity Guidelines for individuals with Osteoarthritis, the session will include information about exercise recommendations.
In contrast, the education delivered to the exercise and education intervention group contains specific information on ankle osteoarthritis (e.g., anatomy, diagnosis, symptoms and evidence for management), recommendations from international guidelines for managing osteoarthritis (e.g., National Institute for Health and Care Excellence, American College of Rheumatology, and Royal Australian College of General Practitioners), Australian physical activity guidelines and tips, and information about the exercise and education intervention that participants will undertake.
There will be approximately four participants in per general osteoarthritis advice session. Attendance will be recorded by the physiotherapist delivering the session.
Control group
Active

Outcomes
Primary outcome [1] 332959 0
The primary outcome is to ascertain feasibility of conducting a full-scale randomised clinical trial. The following feasibility outcomes will be assessed as a composite primary outcome:
a) Participant interest in the study from the recruitment database (number of responses to advertisements);
b) Number (percentage) of eligible participants from interested participants from the recruitment database;
c) Recruitment rate from the recruitment database (average number of individuals who enrol in the study per week);
d) Participant adherence with allocated intervention (the number (percentage) of education and exercise sessions attended) from physiotherapy notes;
e) Physiotherapist fidelity delivering the intervention assessed by direct observation by a researcher not involved in the delivery of the intervention using the fidelity assessment from Davis et al 2018
f) Adverse events (number and type), such as a fall or injury, determined from physiotherapy notes and participant diaries;
g) Drop-out rate (the number (percentage) of participants who do not complete the intervention) from the recruitment database
Timepoint [1] 332959 0
Feasibility outcomes will be assessed at the conclusion of the study.
Primary outcome [2] 332960 0
To inform feasibility, credibility (how believable/logical the treatment is) will be evaluated using the Credibility/Expectancy Questionnaire.
Timepoint [2] 332960 0
The Credibility/Expectancy Questionnaire will be completed at baseline (pre-treatment commencement), 1 week and 8 weeks post-treatment commencement (e.g., after the first week of the treatment has been completed and after the full 7 weeks of the treatment has been completed).
Primary outcome [3] 333048 0
To inform feasibility, expectancy (expectations from treatment) will be evaluated using the Credibility/Expectancy Questionnaire.
Timepoint [3] 333048 0
The Credibility/Expectancy Questionnaire will be completed at baseline (pre-treatment commencement), 1 week and 8 weeks post-treatment commencement (e.g., after the first week of the treatment has been completed and after the full 7 weeks of the treatment has been completed).
Secondary outcome [1] 415333 0
Global Rating of Change will be measured by asking the participant to indicate the overall change in their ankle condition on a 7-point Likert scale (much better to much worse).
Timepoint [1] 415333 0
8 weeks and 3 months post-treatment commencement
Secondary outcome [2] 415334 0
Patient Acceptable Symptom State will assess overall acceptability of the condition from the perspective of the participant.
Timepoint [2] 415334 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [3] 415336 0
Severity of ankle pain (worst and average pain in the last week) will be evaluated using 11-point numerical rating scale.
Timepoint [3] 415336 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [4] 415338 0
Severity of ankle stiffness (worst and average stiffness in the last week) will be evaluated using 11-point numerical rating scale.
Timepoint [4] 415338 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [5] 415340 0
The Activities of Daily Living sub-scale of the Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported function.
Timepoint [5] 415340 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [6] 415341 0
The Foot and Ankle Outcome Score (FAOS) will measure ankle symptoms and functional limitations
Timepoint [6] 415341 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [7] 415342 0
The Patient Specific Functional Scale (PSFS) will measure self-reported function in relation to individual functional tasks that the participant has difficulty with. The participant will rate each nominated task on a numerical rating scale from 0 to 10.
Timepoint [7] 415342 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [8] 415343 0
Quality of life will be measured using the EQ-5D. This questionnaire measures quality of life in relation to five dimensions - mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Timepoint [8] 415343 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [9] 415344 0
Use of interventions outside of the study (e.g., medication use, physiotherapy) will be recorded in a participant diary.
Timepoint [9] 415344 0
Diary submitted weekly for 3 months post-treatment commencement
Secondary outcome [10] 415345 0
A timed 40m walk test will be used to measure ambulatory function. Time will be recorded using a stopwatch.
Timepoint [10] 415345 0
Baseline and 8 weeks post-treatment commencement
Secondary outcome [11] 415346 0
Timed stairs descent will be measured to evaluate physical function. Time will be recorded using a stopwatch.
Timepoint [11] 415346 0
Baseline and 8 weeks post-treatment commencement
Secondary outcome [12] 415347 0
Number of heel raises until fatigue will measure ankle/calf capacity.
Timepoint [12] 415347 0
Baseline and 8 weeks post-treatment commencement
Secondary outcome [13] 415604 0
Participant satisfaction with treatment will be assessed on a 5-point Likert scale (ranging from 'very satisfied' to 'very dissatisfied').
Timepoint [13] 415604 0
8 weeks and 3 months post-treatment commencement.
Secondary outcome [14] 415609 0
The Sports sub-scale of the Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported sport-related function.
Timepoint [14] 415609 0
Baseline, 8 weeks and 3 months post-treatment commencement
Secondary outcome [15] 416325 0
Ankle dorsiflexion range of motion will be measured using the knee to wall test.
Timepoint [15] 416325 0
Baseline and 8 weeks post-treatment commencement
Secondary outcome [16] 416689 0
Semi-structured interviews with a member of the research team will be conducted to understand participants' perspective of their allocated intervention.
Timepoint [16] 416689 0
3 months post-treatment commencement

Eligibility
Key inclusion criteria
a) Aged over 35 years
b) Ankle joint pain on most days for the last 3 months
c) Severity of pain in the last week greater than or equal to 3 out of 10 on an 11-point numerical rating scale (NRS) anchored with ‘no pain’ at 0 and ‘worst pain imaginable’ at 10
d) Modified Kellgren & Lawrence scale osteoarthritis grade greater than or equal to 2 at the subtalar and/or talocrural joints as determined by assessment of radiographs and defined as presence of osteophytes and/or joint space narrowing
e) Committed to undergo the allocated treatment and undertake all follow up outcome measurements
f) Able to understand verbal and written English
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Health problems or pain elsewhere that are more concerning than that at the ankle
b) Received exercise and/or education-based treatment for ankle osteoarthritis in the last 3 months
c) Previous ankle arthrodesis or total ankle replacement
d) Neurological, vestibular or systemic arthritic conditions
e) Receiving treatment for cancer
f) Inability to undertake radiographic evaluations (e.g. pregnancy) and/or participate in the treatment program

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 will be determined by an investigator independent to participant screening and data collection. To conceal randomization, consecutively numbered, sealed, opaque envelopes will be used and stored in a locked location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a random number generator with random blocks (blocks 2-6).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed descriptively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2023
Actual
20/02/2023
Date of last participant enrolment
Anticipated
Actual
7/09/2023
Date of last data collection
Anticipated
Actual
1/01/2024
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312542 0
Charities/Societies/Foundations
Name [1] 312542 0
Arthritis Foundation of Australia
Country [1] 312542 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, QLD
4072
Country
Australia
Secondary sponsor category [1] 314140 0
None
Name [1] 314140 0
Address [1] 314140 0
Country [1] 314140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311870 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 311870 0
Ethics committee country [1] 311870 0
Australia
Date submitted for ethics approval [1] 311870 0
Approval date [1] 311870 0
15/01/2019
Ethics approval number [1] 311870 0
2018/HE002196

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

Contacts
Principal investigator
Name 122666 0
A/Prof Michelle Smith
Address 122666 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 122666 0
Australia
Phone 122666 0
+61 7 3365 4660
Fax 122666 0
Email 122666 0
[email protected]
Contact person for public queries
Name 122667 0
Michelle Smith
Address 122667 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 122667 0
Australia
Phone 122667 0
+61 7 3365 4660
Fax 122667 0
Email 122667 0
[email protected]
Contact person for scientific queries
Name 122668 0
Michelle Smith
Address 122668 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 122668 0
Australia
Phone 122668 0
+61 7 3365 4660
Fax 122668 0
Email 122668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results.
When will data be available (start and end dates)?
Following publication, no end date determined.
Available to whom?
Access to this data will be determined on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access to the data will be subject to approval by Principal Investigator (email: [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22268Study protocolSmith MD, Vuvan V, Collins NJ, Hunter DJ, Costa N, Smith MMF, et al. Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis. J Foot Ankle Res. 2023;16(1):72.  



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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