Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000123640
Ethics application status
Approved
Date submitted
16/01/2023
Date registered
7/02/2023
Date last updated
14/07/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Benefits of education and exercise for knee osteoarthritis
Scientific title
Effects of self-directed versus supervised exercise program combined with digitally supported patient education for knee osteoarthritis: a mixed method feasibility study with a randomised controlled trial design
Secondary ID [1] 308732 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 328678 0
Condition category
Condition code
Musculoskeletal 325682 325682 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 325683 325683 0 0
Physiotherapy
Public Health 325684 325684 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a digitally supported patient education intervention, and will be supported to perform exercise-therapy.

Digitally supported patient education
A Physiotherapist will provide two online 60-minutes education sessions, facilitated on Zoom, to all participants prior to randomisation to exercise therapy delivery mode. During these sessions, participants will be provided a power point presentation covering education topics and content, with the opportunity to ask questions. They will be shown how to access specific pages and use resources of the ‘My Knee’ education and self-management toolkit (www.myknee.trekeducation.org ) related to each topic, and provided the opportunity to ask questions about how to use the resources if they are unsure. Particular emphasis and time will be spent on the self-directed exercise-therapy resources. In session 1, the topics ‘understanding osteoarthritis’, including information about osteoarthritis and its symptoms, and ‘understanding treatments’, including information about three lines of treatment will be covered. In session 2, further education about topics covered in session 1 will be provided, along with discussion of supports and processes to engage in exercise-therapy in a self-directed fashion. The two education sessions will be provided in the first two weeks (once a week) after the baseline assessment. The adherence to the education sessions will be monitored by the physiotherapist as one of the feasibility outcomes.

Exercise-therapy
Both self-directed and supervised (online or in-person) exercise groups will be encouraged to complete at least 12 60-minute exercise-therapy sessions (twice a week – over at least 6 weeks to complete the 12 sessions), and ideally complete an exercise program 3-4 times per week during the intervention period. The exercise-therapy program will be based on the neuromuscular exercise program [1] (www.nemex.trekeducation.org ). Each exercise-therapy session will consist of three parts: a warm-up (10 minutes of any cardiovascular exercise), a set of standardised but individualised exercises, and a cool down (walking and stretching). Exercises include sliders which are progressed to lunges, functional movements (step ups and chair stands), knee strength in sitting (flexion and extension), hip strength in standing (adduction and abduction), and trunk strength in supine with the aid of a gym ball (sit ups and pelvic lifts). Each exercise is progressed within and between levels with the goal of avoiding pain flares (<2/10 increase) during or following (return to day-to-day symptoms within 24 hours) exercise sessions, and participants finding the exercises at least moderately difficult based on the Borg rate of perceived exertion scale (ranging from 6 to 20) [2]. Guidance to facilitate these principles will be provided to all participants during the two online education sessions. Further details of the exercise program, including video instructions to support both groups in this study can be found at ‘My Knee’ toolkit. The program is designed to require minimal equipment (chair, step, resistance bands, light weights, gym ball), and able to be completed easily at home. All necessary equipment will be provided by the researchers to all participants enrolled in this trial.

The individualisation of the exercise-therapy program will occur through assessment of performance of exercises from the NEMEX program during the second education session. At that moment, a physiotherapist will provide recommendations on what level to start each NEMEX exercise component at to all participants - i.e. exercise difficulty will be individualised. Exercises will then be progressed or regressed based on guidance from the toolkit resources and/or physiotherapist providing supervision (if applicable).

Regardless of allocation, all participants will receive an electronic custom diary to monitor their adherence to exercise-therapy. Participants of both groups will be encouraged, during the entire study, to continue to use the ‘My Knee’ education and self-management toolkit to help answer questions they may have and reinforce strategies for active self-management.
Self-directed exercise group (n=16): Participants allocated to self-directed exercise group will be provided with an electronic version of a printable exercise guide and asked to perform the exercise-therapy sessions without supervision.

1. Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010;11:126. doi:10.1186/1471-2474-11-126
2. Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-58. doi:10.5271/sjweh.1815
Intervention code [1] 325198 0
Rehabilitation
Comparator / control treatment
Supervised Exercise Group (n=8): Participants allocated to the supervised exercise group will have access to either a physiotherapy clinic conveniently located near them or an online exercise program supervised by a physiotherapist. The exercise program consists of 12 60-minute supervised group-based sessions per week for at least 6 weeks (i.e., access to 12 supervised exercise therapy sessions).
Control group
Active

Outcomes
Primary outcome [1] 333536 0
Eligible participants rate will be determined by an audit of the study database, specifically observing number of eligible volunteers (minimum of 2 participants per week. Totalling 8 participants being eligible per month).
Timepoint [1] 333536 0
12 weeks post baseline data collection
Primary outcome [2] 333625 0
Recruitment rate will be determined by an audit of the study database, specifically observing a minimum recruitment rate of 5 out of 8 eligible participants recruit every four weeks.
Timepoint [2] 333625 0
12 weeks post baseline data collection
Primary outcome [3] 333626 0
Adherence to education sessions will be determined by the physiotherapist on a standardised recording sheet.
Timepoint [3] 333626 0
12 weeks post baseline data collection
Secondary outcome [1] 417786 0
Primary outcome

Adherence to exercise-therapy sessions will be determined by a minimum of at least 10 exercise therapy sessions, assessed via participant exercise diaries.
Timepoint [1] 417786 0
12 weeks post baseline data collection
Secondary outcome [2] 417787 0
Primary outcome

Drop-out rate will be determined by number of participants who withdraw from the study post enrolment (<20%) collect from our databse.
Timepoint [2] 417787 0
12 weeks post baseline data collection
Secondary outcome [3] 417788 0
Primary outcome

Adverse events such as occurrence of pain flares and musculoskeletal soreness will be determined by participant diaries.
Timepoint [3] 417788 0
12 weeks post baseline data collection
Secondary outcome [4] 417789 0
Primary outcome

Acceptability of study protocol will be determined by semi-structured interviews with participants.
Timepoint [4] 417789 0
12 weeks post baseline data collection
Secondary outcome [5] 417790 0
Primary outcome

Acceptability of the outcome measures will be determined through semi-structured interviews with participants.
Timepoint [5] 417790 0
12 weeks post baseline data collection
Secondary outcome [6] 417791 0
The Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12)1.

1. Gandek B, Roos EM, Franklin PD, Ware JE. A 12-item short form of the Knee injury and Osteoarthritis Outcome Score (KOOS-12): tests of reliability, validity and responsiveness. Osteoarthritis Cartilage. 2019;27(5):762-770. doi:10.1016/j.joca.2019.01.011
Timepoint [6] 417791 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [7] 417792 0
The Patient-Specific Functional Scale. This tool will evaluate patient’s physical function1.

1. Stratford P, Gill C, Westaway M, Binkley J. Assessing Disability and Change on Individual Patients: A Report of a Patient Specific Measure. Physiother Can. 1995;47(4):258-263. doi:10.3138/ptc.47.4.258
Timepoint [7] 417792 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [8] 417793 0
The European Quality of Life-5 Dimensions-5 Level Quality of Life Scale (EQ-5D-5L)1.

1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337-343. doi:10.3109/07853890109002087
Timepoint [8] 417793 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [9] 417794 0
The University of California, Los Angeles (UCLA) physical activity scale1.

1. Terwee CB, Bouwmeester W, van Elsland SL, de Vet HCW, Dekker J. Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Osteoarthritis Cartilage. 2011;19(6):620-633. doi:10.1016/j.joca.2011.01.002
Timepoint [9] 417794 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [10] 417795 0
Confidence about exercising with knee pain. To assess this outcome, participants will be asked to indicate on a 5-point Likert scale range from 1 (strongly agree) to 5 (strongly disagree) their belief for the following statement: “I am confident that exercise or physical activity will make my knee pain better”.
Timepoint [10] 417795 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [11] 417796 0
The Arthritis Self-Efficacy scale1.

1. Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32(1):37-44. doi:10.1002/anr.1780320107
Timepoint [11] 417796 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [12] 417797 0
The Keele STarT Musculoskeletal Tool. This tool will assess the average pain level in the last two weeks and the self-efficacy with osteoarthritis management1.

1. Dunn KM, Campbell P, Lewis M, et al. Refinement and validation of a tool for stratifying patients with musculoskeletal pain. Eur J Pain Lond Engl. 2021;25(10):2081-2093. doi:10.1002/ejp.1821
Timepoint [12] 417797 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [13] 417798 0
Outcome expectations for exercise. This outcome will be assessed through the Outcome Expectations for Exercise Scale1.

1. Resnick B, Zimmerman SI, Orwig D, Furstenberg AL, Magaziner J. Outcome expectations for exercise scale: utility and psychometrics. J Gerontol B Psychol Sci Soc Sci. 2000;55(6):S352-356. doi:10.1093/geronb/55.6.s352.
Timepoint [13] 417798 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [14] 417799 0
People’s beliefs about management treatment. To assess this outcome, participants will be asked to rate their beliefs related to: 1) the effectiveness of some treatments for knee osteoarthritis; 2) physical activity and exercise to prevent or slow the progression of knee osteoarthritis; 3) physical activity and exercise damage their joints; 4) physiotherapy-led exercise and education program can help people with knee osteoarthritis, regardless of how much pain they have; 5) the necessity of total knee joint replacement surgery in the future. Participants will rate their beliefs on a 5-point Likert scale (not effective at all, a little effective, moderately effective, very effective, I don’t know)1.

1. Wallis JA, Barton CJ, Ackerman IN, et al. A survey of patient and medical professional perspectives on implementing osteoarthritis management programs for hip and knee osteoarthritis. Musculoskeletal Care. Published online September 13, 2022. doi:10.1002/msc.1698
Timepoint [14] 417799 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [15] 417800 0
Determinants of exercise behaviour. To assess this outcome, we have developed a survey based on the Theorical Domains Framework (TDF)1, including the domains of knowledge, self-efficacy and outcome expectation. The participants will be asked to rate their beliefs on a 5-point Likert scale range from 1 (strongly disagree) to 5 (strongly agree).

1. Huijg JM, Gebhardt WA, Dusseldorp E, et al. Measuring determinants of implementation behavior: psychometric properties of a questionnaire based on the theoretical domains framework. Implement Sci IS. 2014;9:33. doi:10.1186/1748-5908-9-33
Timepoint [15] 417800 0
Baseline and 12 weeks post baseline data collection
Secondary outcome [16] 417801 0
Global Rating of Change Scale. This scale will evaluate the patient perceived recovery. Participants will rate their perceived recovery on a 7-point Likert scale (worse than ever, strongly worse, slightly worse, unchanged, slightly worse, strongly worse, completely recovered)1.

1. De Oliveira Silva D, Pazzinatto MF, Crossley KM, Azevedo FM, Barton CJ. Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study. J Med Internet Res. 2020;22(7):e18584. doi:10.2196/18584
Timepoint [16] 417801 0
12 weeks post baseline data collection
Secondary outcome [17] 417802 0
Treatment satisfaction. To assess this outcome, participants will rate their treatment satisfaction on a 5-point Likert scale (very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, very unsatisfied).
Timepoint [17] 417802 0
12 weeks post baseline data collection
Secondary outcome [18] 417803 0
Qualitative participant semi-structured interviews, guided by a topic guide, covering acceptance of the interventions, qualitative outcomes, and barriers and enablers to exercise therapy before, during and after completing the allocated trial intervention.
Timepoint [18] 417803 0
12 weeks follow-up post baseline data collection

Eligibility
Key inclusion criteria
Clinical diagnosis of knee osteoarthritis guided by the NICE guidelines1: i) age > 45 years; ii) Activity-related knee pain; iii) No morning knee joint stiffness or knee joint stiffness that lasts less than 30 minutes.

1. Conaghan PG, Dickson J, Grant RL, Guideline Development Group. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ. 2008;336(7642):502-503. doi:10.1136/bmj.39490.608009.AD
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any treatment for their knee pain in the previous 6-months;
• History of knee replacement, lower limb or back surgery in the past 12 months;
• Physical or cognitive impairment that would prevent participation in the exercise program;
• Presence of other joint problems with symptoms more pronounced than osteoarthritis, including recent trauma, tumour, inflammatory joint disease;
• People who are non-English speaking, self-identified as having low digital literacy (unable to use videoconferencing software)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be stratified by sex and will be performed by a person not involved in screening or data collection, using the website https://www.sealedenvelope.com/.

Participants will be randomised at a 2:1 ratio - i.e. 2 participants randomised to intervention for every 1 participant randomised to control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Quantitative
Primary feasibility outcomes will be reported descriptively. Estimates of i) standard deviation of the secondary clinical outcomes; and ii) effects size between- and within-group differences with 95% confidence intervals in secondary clinical outcomes, will be calculated. All participants who complete baseline and final assessment will be included in analysis, following CONSORT guidelines1.

Qualitative
Interviews will be transcribed verbatim by a third-party transcription service, ‘Transcription Australia’ (https://www.transcription.net.au/). Qualitative analysis of the interview data will commence with a close review of each transcript by one researcher (AE) to gain an overall picture of the data. Subsequently, data categories will be developed using inductive thematic analysis2, supported by NVivo software (QSR International Ptd Ltd, Melbourne, Australia). One researcher will conduct the initial analysis (AE), with support from a senior researcher (CB). A random sample of 50% of interviews will be coded independently by a second researcher (AE) to substantiate the initial analysis. Themes will be discussed between researchers (LS, AE, CB) until a consensus is reached.

1. Terwee CB, Bouwmeester W, van Elsland SL, de Vet HCW, Dekker J. Instruments to assess physical activity in patients with osteoarthritis of the hip or knee: a systematic review of measurement properties. Osteoarthritis Cartilage. 2011;19(6):620-633. doi:10.1016/j.joca.2011.01.002
2. Braun V, Clarke V. Using thermatic analysis in psychology. Qualitative Research in Psychology. 2006;3:77-101.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
6/03/2023
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
24
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39267 0
3056 - Brunswick
Recruitment postcode(s) [2] 39268 0
3068 - Clifton Hill
Recruitment postcode(s) [3] 39270 0
3082 - Mill Park
Recruitment postcode(s) [4] 39269 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 312956 0
University
Name [1] 312956 0
La Trobe University
Country [1] 312956 0
Australia
Primary sponsor type
Individual
Name
Christian Barton
Address
La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 314647 0
University
Name [1] 314647 0
La Trobe University
Address [1] 314647 0
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country [1] 314647 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312230 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 312230 0
La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 312230 0
Australia
Date submitted for ethics approval [1] 312230 0
14/11/2022
Approval date [1] 312230 0
03/02/2023
Ethics approval number [1] 312230 0

Summary
Brief summary
This pilot feasibility randomised controlled trial will recruit 24 people with knee osteoarthritis. Consenting participants will be randomised to either a self-directed exercise-therapy (n=16) or supervised exercise-therapy (n=8). Both groups will receive a digitally support patient education through the ‘My Knee’ tool kit.

The primary aim of this study is to determine the feasibility of conducting a fully powered randomised controlled trial to compare self-directed to supervised exercise-therapy for people with knee osteoarthritis.
Secondary aims include:
• To compare outcomes between groups, 12 weeks following treatment commencement, related to average pain, physical function, joint- and health-quality of life, exercise and physical activity participation, self-efficacy with exercise and osteoarthritis management, outcome expectations for exercise, people’s beliefs about management treatment, determinants of exercise behaviour, global rating of change and treatment satisfaction;
• To explore barriers and enablers to intervention effectiveness, potential intervention and study design improvements, and other factors that might influence the participant’s adherence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123918 0
A/Prof Christian Barton
Address 123918 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 123918 0
Australia
Phone 123918 0
+61 403012914
Fax 123918 0
Email 123918 0
c.barton@latrobe.edu.au
Contact person for public queries
Name 123919 0
A/Prof Dr Christian Barton
Address 123919 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 123919 0
Australia
Phone 123919 0
+61 403012914
Fax 123919 0
Email 123919 0
c.barton@latrobe.edu.au
Contact person for scientific queries
Name 123920 0
A/Prof Christian Barton
Address 123920 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 123920 0
Australia
Phone 123920 0
+61 403012914
Fax 123920 0
Email 123920 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


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
No additional documents have been identified.