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Trial registered on ANZCTR


Registration number
ACTRN12619000235101
Ethics application status
Approved
Date submitted
4/02/2019
Date registered
18/02/2019
Date last updated
17/01/2023
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise-therapy and education for knee osteoarthritis: comparison of telerehabilitation with face-to-face delivery
Scientific title
Telerehabilitation compared to face-to-face exercise-therapy and education for knee osteoarthritis: A non-inferiority randomised controlled trial
Secondary ID [1] 297282 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 311364 0
Condition category
Condition code
Musculoskeletal 310002 310002 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This RCT aligns with the SPIRIT (Chan et al, 2013; Calvert et al, 2018), and Australian Good Clinical Practice guidelines. Participants with knee OA will be recruited via the Musculoskeletal Australia help line (https://www.msk.org.au/) (project partner) or other social media channels. Eligibility will be determined via telephone and online screening.

110 eligible participants will be randomised on a 1:1 basis (computer random number generator) to either a face-to-face (Active control group; delivered at one of more than 35 sites in Victoria) or telerehabilitation (Intervention group; delivered remotely from La Trobe University) GLA:DTM Australia exercise-therapy and education program.

The telerehabilitation intervention will be delivered via the eHAB® telerehabilitation platform (NeoRehab, Brisbane, Australia), a clinically validated system that allows clinicians to provide services to their patients via real time video-conferencing into the home.

GLA:DTM (Good Life with Arthritis from Denmark) Australia is an 8-week exercise-therapy and education program for people with OA, supported by evidence and clinical guidelines.

Prior to study enrolment, screening and baseline assessment, including all outcome measures will occur at La Trobe University, Bundoora. Follow up assessment will involve repeat of the same outcomes measures three months following enrolment, completed again at La Trobe University, Bundoora.

The program
Education: Two education sessions (60-90 minutes) will focus on the latest research on OA and explain the neuromuscular exercises involved in GLA:D™ Australia. These education sessions are held at different times to the exercise-therapy sessions and typically occur prior to commencing the exercise-therapy program. However, in some instances they may occur once the exercise therapy-program has commenced (but still within the first 4 weeks), depending on time availability of the patient and actual education sessions. Education session occur on different days, typically 1 week apart. They can occur on the same day, or separate day to an exercise session dependingon time availability.

Exercise-therapy: Participants attend group neuromuscular exercise therapy sessions (60 minutes) twice a week for six weeks. The exercise program is standardised but individualised and progressive. Exercises (standing up from sitting, stepping onto a step, lunging, moving leg against a resistance band, etc.) are designed to be moderately hard and ensure they do not flare any pain after the exercise session, although some pain is allowed during the session. The level of training and progression is guided by the patient's neuromuscular function (control) and pain responses during and after sessions.
Further details about the program can be found here: http://nemex.trekeducation.org/

To minimise participant burden, study physiotherapists will be located at clinics across greater Melbourne. Eligibility will require participants to live within a 10km radius of a clinical site offering GLA:D Australia.

Treating physiotherapists in both arms of the trial will undergo a GLA:DTM Australia Training (16-hour training session) provided by the research team. Further implementation support is provided via treatment manuals and online suppliments that have been designed by the researchers with input from experienced clinicians.

To ensure fidelity of the face-to-face GLA:DTM Australia program, a clinical RA familiar with the program (but not a provider for this study) will conduct four direct observations at each physiotherapy clinic providing GLA:DTM Australia to participants over the course of the study – evaluating treatment fidelity and clinical processes based on a priori criteria developed by Davis et al. who have implemented the GLA:D® program in Canada.

Our initiatives to optimise standardisation include examples of exercise videos, frequently asked questions, and being available to address queries promptly via phone/e-mail. The treating physiotherapists will record per protocol treatment and any co-interventions in a log book.

REFERENCES
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ : British Medical Journal. 2013;346.

Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. Jama. 2018;319(5):483-94
Intervention code [1] 313536 0
Rehabilitation
Intervention code [2] 313677 0
Treatment: Other
Comparator / control treatment
The same education and exercise-therapy intervention will be delivered to both groups
1. Active control group = Face to face delivery
2. Intervention group = Telerehabilitation delivery
Control group
Active

Outcomes
Primary outcome [1] 318912 0
Knee-related burden, assessed with the KOOS4, which is the average score of 4 of the 5 Knee injury and Osteoarthritis Outcome Score (KOOS) subscales covering pain, symptoms, difficulty in sports and recreational activities and quality of life.
Timepoint [1] 318912 0
Baseline (prior to first intervention session) will be compared to 3 months (13 weeks) (following last intervention session). Timepoints for primary outcome will also include 1 year, 2 years and 5 years,
Secondary outcome [1] 366396 0
- patient satisfaction with treatment, assessed on a 5 point Likert scale (0=very unsatisfied, to 5=very satisfied)
Timepoint [1] 366396 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [2] 366397 0
30 second chair stand test which is an example of a proxy measure of strength in the lower extremities. The number of chair stands a participant can do in 30 seconds is recorded
Timepoint [2] 366397 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years.
Secondary outcome [3] 366398 0
40 metre fast paced walk test which is a described as a short distance walking activity test. The participant is asked to walk at a fast pace and is timed over 4 x10m (total 40m).
Timepoint [3] 366398 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [4] 366399 0
Arthritis self-efficacy scale

Lorig K, Chastain RL, Ung E, Shoor S, & Holman HR: Development and evaluation of a scale to
measure self-efficacy in people with arthritis. Arthritis and Rheumatism, 32, 1, 1989, pp. 37-44 (original
scales)
Timepoint [4] 366399 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years.
Secondary outcome [5] 366400 0
Pain visual analogue scale (100mm - worst in previous 4 weeks
Timepoint [5] 366400 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [6] 366401 0
Physical activity - UCLA
Timepoint [6] 366401 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [7] 366403 0
The Keele STarT MSK tool
This is a newly developed 10 item tool designed to stratify risk of poor prognosis for people with musculoskeletal pain including osteoarthritis
More details here: https://www.keele.ac.uk/sbst/researchers/furtherresearch/
Timepoint [7] 366403 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [8] 366404 0
Surgical beliefs - "Do you have so much trouble and pain from your knee that you want to have surgery?"

The proportion who change from "yes" to"no" in response to this question will be measured
Timepoint [8] 366404 0
3 months post baseline assessment (enrolment) and longer term timepoints at 1 year, 2 years and 5 years,
Secondary outcome [9] 397908 0
The EQ-5D, which is a standardised, non-disease-specific instrument for describing and valuing health states. Contains five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. (Ref: Group E. EuroQol--a new facility for the measurement of health-related quality of life. Health policy (Amsterdam, Netherlands). 1990;16(3):199-208).
Timepoint [9] 397908 0
Baseline, 3 months, 1 year, 2 years and 5 years
Secondary outcome [10] 397909 0
the Global rating of change scale (GROC). The GROC scale for this trial will include seven descriptors for perceived change: completely recovered, strongly recovered, slightly recovered, unchanged, slightly worse, strongly worse and worse than ever. The reliability of the GROC is high with intraclass correlation coefficient (ICC) greater than 0.90.(REF:Kamper SJ, Ostelo RW, Knol DL, Maher CG, De Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. Journal of clinical epidemiology. 2010;63(7):760-6. e1)
Timepoint [10] 397909 0
Baseline, 3 months, 1 year, 2 years and 5 years

Eligibility
Key inclusion criteria
- NICE guidelines for primary clinical diagnosis of knee OA (Conaghan et al, 2008)
o is 45 or over AND
o has activity-related joint pain AND
o has either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes.

- Sufficient English language proficiency to participate in the intervention and complete the study baseline and follow up measures

- Live within a 10km radius of a clinical site offering GLA:D Australia

REFERENCES
Conaghan PG, Dickson J, Grant RL. Guidelines: care and management of osteoarthritis in adults: summary of NICE guidance. BMJ: British Medical Journal. 2008;336(7642):502
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previously attended the GLA:DTM Australia program
• Physiotherapy treatment in the previous six months
• History of joint replacement in the affected knee/s
• Impairment that would impact on ability to participate in the GLA:DTM Australia intervention
• Non-English speaking

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 randomisation schedule will be generated and maintained centrally by Latrobe University via central computer randomisation (to either Group A (intervention) or Group B (control), and will be revealed via telephone by the project coordinator, to the treating physiotherapist following baseline assessment. Participants will be informed that they will be randomised to one of two treatments but will not be informed of the other treatment nor our hypotheses. As patients may be recruited at staggered time points, the computer randomisation will be set up so that there is a random sequence of "A" or "B" that will result in 55 "A" and 55 "B" by the end point of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in ratio 1:1
Stratified for sex
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Both intention-to-treat and as-treated analyses as recommended in the extension of the Consolidated Standards of Reporting Trials (CONSORT) guideline for noninferiority trials will be performed. Data will be tested for compliance with the assumptions of parametric statistics (normality, skewing, kurtosis, etc). If failing to meet these assumptions, data transformation will be attempted to achieve compliance. Nonparametric equivalents will be employed if parametric assumptions are not met. Covariance will be determined and incorporated into analyses as appropriate. First, the treatment effect of each intervention will be evaluated by comparing the pre-to-post intervention measures. Our primary analysis of noninferiority will be implied if the lower limit of a 1-sided 95% confidence interval of the difference between the telerehabilitation and control group is within the pre-stated MCII values.

Economic Evaluation
Given that a noninferiority research hypothesis is proposed, the planned economic evaluation will be a cost-minimization analysis. Direct costs to the health system and total direct costs (including non–health care costs and out of pocket costs) will be considered in this evaluation.

An incremental cost-utility analysis (CUA) will be undertaken if a difference in clinical outcomes between groups is determined. The EQ-5D scores will be used to generate quality-adjusted life year scores for the purpose of the CUA. Multivariate sensitivity analyses will be conducted to confirm stability of results and adjust for uncertainty in clinical and economic data. The time horizon for this economic evaluation will be the 3-month follow-up during which each participant is involved in the study.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Safety concerns
Other reasons/comments
Other reasons
COVID-19 restrictions on in-person group-based care provided as part of trial intervention
Date of first participant enrolment
Anticipated
25/02/2019
Actual
5/04/2019
Date of last participant enrolment
Anticipated
7/02/2022
Actual
12/03/2020
Date of last data collection
Anticipated
12/03/2027
Actual
Sample size
Target
110
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301841 0
University
Name [1] 301841 0
La Trobe
Country [1] 301841 0
Australia
Primary sponsor type
Individual
Name
Dr Christian Barton
Address
La Trobe Sport and Exercise Medicine Research Centre
Health Science 3 Building
Plenty Road, Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 301592 0
None
Name [1] 301592 0
Address [1] 301592 0
Country [1] 301592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302542 0
Human Ethics Committee, La Trobe University
Ethics committee address [1] 302542 0
Ethics committee country [1] 302542 0
Australia
Date submitted for ethics approval [1] 302542 0
Approval date [1] 302542 0
19/12/2018
Ethics approval number [1] 302542 0
HEC18500

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

Contacts
Principal investigator
Name 90582 0
Dr Christian Barton
Address 90582 0
La Trobe Sport and Exercise Medicine Research Centre
Health Science 3 Building
Plenty Road, Bundoor, VIC 3083
Country 90582 0
Australia
Phone 90582 0
+61 403 012 914
Fax 90582 0
Email 90582 0
c.barton@latrobe.edu.au
Contact person for public queries
Name 90583 0
Christian Barton
Address 90583 0
La Trobe Sport and Exercise Medicine Research Centre
Health Science 3 Building
Plenty Road, Bundoor, VIC 3083
Country 90583 0
Australia
Phone 90583 0
+61 403 012 914
Fax 90583 0
Email 90583 0
c.barton@latrobe.edu.au
Contact person for scientific queries
Name 90584 0
Christian Barton
Address 90584 0
La Trobe Sport and Exercise Medicine Research Centre
Health Science 3 Building
Plenty Road, Bundoor, VIC 3083
Country 90584 0
Australia
Phone 90584 0
+61 403 012 914
Fax 90584 0
Email 90584 0
c.barton@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics has not been obtained for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1279Study protocol    Currently being written for submission



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPlacebo gait retraining for use in knee osteoarthritis clinical trials does not change surrogate knee load measures: A randomized pilot study2022https://doi.org/10.1016/j.jsams.2022.09.080
N.B. These documents automatically identified may not have been verified by the study sponsor.