ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

EdEx

Linked study record

Health condition

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

Ankle osteoarthritis

Condition category

Condition code

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

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]

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]

Feasibility outcomes will be assessed at the conclusion of the study.

Primary outcome [2]

To inform feasibility, credibility (how believable/logical the treatment is) will be evaluated using the Credibility/Expectancy Questionnaire.

Timepoint [2]

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]

To inform feasibility, expectancy (expectations from treatment) will be evaluated using the Credibility/Expectancy Questionnaire.

Timepoint [3]

Secondary outcome [1]

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]

8 weeks and 3 months post-treatment commencement

Secondary outcome [2]

Patient Acceptable Symptom State will assess overall acceptability of the condition from the perspective of the participant.

Timepoint [2]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [3]

Severity of ankle pain (worst and average pain in the last week) will be evaluated using 11-point numerical rating scale.

Timepoint [3]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [4]

Severity of ankle stiffness (worst and average stiffness in the last week) will be evaluated using 11-point numerical rating scale.

Timepoint [4]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [5]

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]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [6]

The Foot and Ankle Outcome Score (FAOS) will measure ankle symptoms and functional limitations

Timepoint [6]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [7]

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]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [8]

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]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [9]

Use of interventions outside of the study (e.g., medication use, physiotherapy) will be recorded in a participant diary.

Timepoint [9]

Diary submitted weekly for 3 months post-treatment commencement

Secondary outcome [10]

A timed 40m walk test will be used to measure ambulatory function. Time will be recorded using a stopwatch.

Timepoint [10]

Baseline and 8 weeks post-treatment commencement

Secondary outcome [11]

Timed stairs descent will be measured to evaluate physical function. Time will be recorded using a stopwatch.

Timepoint [11]

Baseline and 8 weeks post-treatment commencement

Secondary outcome [12]

Number of heel raises until fatigue will measure ankle/calf capacity.

Timepoint [12]

Baseline and 8 weeks post-treatment commencement

Secondary outcome [13]

Participant satisfaction with treatment will be assessed on a 5-point Likert scale (ranging from 'very satisfied' to 'very dissatisfied').

Timepoint [13]

8 weeks and 3 months post-treatment commencement.

Secondary outcome [14]

The Sports sub-scale of the Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported sport-related function.

Timepoint [14]

Baseline, 8 weeks and 3 months post-treatment commencement

Secondary outcome [15]

Ankle dorsiflexion range of motion will be measured using the knee to wall test.

Timepoint [15]

Baseline and 8 weeks post-treatment commencement

Secondary outcome [16]

Semi-structured interviews with a member of the research team will be conducted to understand participants' perspective of their allocated intervention.

Timepoint [16]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Arthritis Foundation of Australia

Address [1]

PO Box 550
Broadway, NSW
2007

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

St Lucia, QLD
4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

The University of Queensland
St Lucia, QLD
4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/01/2019

Ethics approval number [1]

2018/HE002196

Summary

Brief summary

Ankle osteoarthritis is a debilitating condition that affects individuals of working age and is characterised by high levels of pain and disability. However, very little is known about how to manage ankle osteoarthritis. While education and exercise interventions have been shown to be successful in the management of hip and knee osteoarthritis, such an intervention has not been investigated in ankle osteoarthritis. The proposed study will establish the feasibility and credibility of a combined education and exercise intervention for ankle osteoarthritis. Secondary outcomes will explore whether education and exercise can improve pain, stiffness, function, and quality of life in this population. This study will determine the feasibility of conducting a full-scale randomised clinical trial investigating education and exercise in people with ankle osteoarthritis and inform the selection of outcome measures. It is an essential first step in determining the effectiveness of an education and exercise intervention for individuals with ankle osteoarthritis. Study findings have the capacity to change the way ankle osteoarthritis is managed and inform the development of clinical practice guidelines to help clinicians make evidence-based decisions when managing people with ankle osteoarthritis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Michelle Smith

Address

School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072

Country

Australia

Phone

+61 7 3365 4660

Fax

m.smith5@uq.edu.au

Contact person for public queries

Name

Michelle Smith

Address

School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072

Country

Australia

Phone

+61 7 3365 4660

Fax

m.smith5@uq.edu.au

Contact person for scientific queries

Name

Michelle Smith

Address

School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072

Country

Australia

Phone

+61 7 3365 4660

Fax

m.smith5@uq.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?

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: m.smith5@uq.edu.au).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22268	Study protocol	Smith 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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