Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000418572p
Ethics application status
Submitted, not yet approved
Date submitted
19/03/2024
Date registered
5/04/2024
Date last updated
5/04/2024
Date data sharing statement initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The PEEKO study - Patient education to enhance exercise outcomes in people with knee osteoarthritis: a randomised controlled trial
Scientific title
Patient e-learning to enhance exercise outcomes in people with knee osteoarthritis: a
randomised controlled trial
Secondary ID [1] 311259 0
None
Universal Trial Number (UTN)
Trial acronym
PEEKO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 332481 0
Condition category
Condition code
Musculoskeletal 329173 329173 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Verbal OA information + strengthening exercise PLUS patient e-learning course (Experimental intervention)

Participants in this group will receive two consultations of 30 minutes each, one-on-one with a physiotherapist over Zoom videoconferencing software over 6 weeks. Appointments will be in approximately week 1 and the second in week 6. The purpose of the consults will be for the physiotherapist to provide verbal OA information and to prescribe a home-based strengthening exercise program. In addition, participants in this group will be given access to the free e-learning course, Taking Control of your Knee and Hip Osteoarthritis, available on the online education platform FutureLearn.

Participants will be provided an information booklet for reference about how to prepare for the first consultation and a booklet of strength exercises, as well as 4 coloured therabands (red, green, blue, and black) for performing strengthening exercises at home.

The physiotherapist will provide verbal information about OA and its recommended management and address any related participant questions. The verbal information provided will be scripted. The physiotherapist will answer participant questions based on their clinical knowledge.

The physiotherapists will prescribe 4 strengthening exercises to be performed at home three times/week, including two quadriceps exercises (from 17 options including weightbearing such as squats and non-weightbearing exercises such as seated knee extensions), one hip (from a list of `13 options such as crab walking or bridges) and one calf (from a list of 4 options including claf raises), selected as most suitable for the participant from a range of options for each. These exercises are described in the booklet sent out to participants. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training. During the second physiotherapy consultation, participants will also be advised how to independently progress their exercise program, and encouraged to continue with their strengthening exercises (three times per week) until the 24-week re-assessment.

In addition, participants in this group will be provided access to the eLearning course that provides more in-depth information about OA and recommended self-management approaches. The physiotherapist will encourage participants to trial any of the management approaches recommended within the e-learning course that they may be interested in pursuing. The information is presented in four modules using written text, videos, infographics, downloadable resources (including physical activity/exercise logbook and action plan templates) and learning activities. In total, the time required to complete all four modules and learning activities is approximately four hours (one hour per module).

The four modules are: (1) Learning about osteoarthritis; (2) Physical activity and exercise for osteoarthritis; (3) Body weight and osteoarthritis; (4) Additional management strategies and conclusion. Each module includes a range of learning activities (e.g. non-moderated discussion boards to promote learner interaction, poll questions enabling learner comparison, quizzes aligned with learning objectives, action plan templates to facilitate turning learnings into action).

Physiotherapists will record attendance at each session to monitor adherence. Participants will also answer survey questions about how often they completed the exercises at 24-weeks. Participants will be asked whether they completed each of the 4 online course modules at 8-weeks, and about subsequent use of the online resource at 24-weeks.
Intervention code [1] 328196 0
Rehabilitation
Intervention code [2] 328305 0
Treatment: Other
Comparator / control treatment
Verbal OA information + strengthening exercise (Control intervention)

Participants in this group will receive two consultations of 30 minutes each, one-on-one with a physiotherapist over Zoom videoconferencing software over 6 weeks. Appointments will be in approximately week 1 and the second in week 6. The purpose of the consults will be for the physiotherapist to provide verbal OA information and to prescribe a home-based strengthening exercise program.

Participants will be provided an information booklet for reference about how to prepare for the first consultation and a booklet of strength exercises, as well as 4 coloured therabands (red, green, blue, and black) for performing strengthening exercises at home.

The physiotherapist will provide verbal information about OA and its recommended management and address any related participant questions. The verbal information provided will be scripted. The physiotherapist will answer participant questions based on their clinical knowledge.

The physiotherapists will prescribe 4 strengthening exercises to be performed at home three times/week, including two quadriceps exercises (from 17 options including weightbearing such as squats and non-weightbearing exercises such as seated knee extensions), one hip (from a list of `13 options such as crab walking or bridges) and one calf (from a list of 4 options including claf raises), selected as most suitable for the participant from a range of options for each. These exercises are described in the booklet sent out to participants. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training. During the second physiotherapy consultation, participants will also be advised how to independently progress their exercise program, and encouraged to continue with their strengthening exercises (three times per week) until the 24-week re-assessment.

Physiotherapists will record attendance at each session to monitor adherence. Participants will also answer survey questions about how often they completed the exercises at 24-weeks.
Control group
Active

Outcomes
Primary outcome [1] 337674 0
Self-reported severity of knee pain during walking over the past week
Timepoint [1] 337674 0
Baseline & 24 weeks after randomisation
Primary outcome [2] 337675 0
Self-reported physical function
Timepoint [2] 337675 0
Baseline & 24 weeks after randomisation
Secondary outcome [1] 432807 0
Function with sport/recreational activities
Timepoint [1] 432807 0
Baseline & 24 weeks after randomisation
Secondary outcome [2] 432808 0
Knee-related quality of life
Timepoint [2] 432808 0
Baseline & 24 weeks after randomisation
Secondary outcome [3] 432809 0
Pain self-efficacy
Timepoint [3] 432809 0
Baseline & 24 weeks after randomisation
Secondary outcome [4] 432810 0
Exercise self efficacy
Timepoint [4] 432810 0
Baseline & 24 weeks after randomisation
Secondary outcome [5] 432881 0
Fear of movement
Timepoint [5] 432881 0
Baseline & 24 weeks after randomisation
Secondary outcome [6] 432882 0
Physical activity level
Timepoint [6] 432882 0
Baseline & 24 weeks after randomisation
Secondary outcome [7] 432883 0
Knowledge of osteoarthritis
Timepoint [7] 432883 0
Baseline & 24 weeks after randomisation
Secondary outcome [8] 432884 0
Illness perception of osteoarthritis
Timepoint [8] 432884 0
Baseline & 24 weeks after randomisation
Secondary outcome [9] 432885 0
Belief in the inevitability of needing knee joint replacement surgery
Timepoint [9] 432885 0
Baseline & 24 weeks after randomisation
Secondary outcome [10] 432886 0
Global rating of change in the knee overall
Timepoint [10] 432886 0
24 weeks after randomisation
Secondary outcome [11] 432889 0
Satisfaction with treatment
Timepoint [11] 432889 0
24 weeks after randomisation
Secondary outcome [12] 432890 0
Exercise adherence
Timepoint [12] 432890 0
24 weeks after randomisation
Secondary outcome [13] 432891 0
Exercise adherence
Timepoint [13] 432891 0
24 weeks after randomisation
Secondary outcome [14] 432892 0
Uptake of additional physical activity
Timepoint [14] 432892 0
24 weeks after randomisation
Secondary outcome [15] 432893 0
Weight loss efforts
Timepoint [15] 432893 0
24 weeks after randomisation
Secondary outcome [16] 432894 0
Oral pain medication usage
Timepoint [16] 432894 0
Baseline & 24 weeks after randomisation

Eligibility
Key inclusion criteria
i. live in Australia;
ii. aged 45 years or over;
iii. have an unreplaced/native knee joint with:
a. activity-related pain at the joint;
b. joint morning stiffness that lasts less than 30 mins or no morning stiffness at the joint;
c. history of pain for 3 months or more at the joint; and
d. joint pain on most days of the past month;
iv. report overall average knee pain in the past week during walking 4 or more on 11-point numerical rating scale (NRS; 0 = no pain, 10 = worst pain possible);
v. willing to participate in video consultations for physiotherapy appointments;
vi. have access to a computer with internet connection and an email address; and
vii. able to give informed consent and willing to commit to all study evaluation 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) scheduled for or planning lower limb joint surgery in the next 9 months;
ii) previous arthroplasty on the most painful knee;
iii) recent knee injection on the most painful knee (past 6 months);
iv) recent knee surgery on either knee (past 6 months);
v) consulting/ed physiotherapy or doing regular strengthening (at least once per week) exercise for knee (past 6 months);
vi) self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
vii) any neurological or other condition affecting lower limbs;
viii) any unstable/uncontrolled cardiovascular condition;
ix) completed an online educational course about OA that involved at least 2 hours of learning in total in the past 12 months; and/or
x) unable to easily read and understand 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) stratified by physiotherapist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimations:
There are two primary outcomes: WOMAC physical function and NRS pain scale. A total sample size of 136 (68 per arm) is required to detect a minimally clinically important difference of 6 WOMAC units between the two treatment arms with 80% power and an alpha of 0.025 (alpha of 0.05 split between the two primary outcomes), assuming a correlation of 0.35 between baseline and 24 weeks follow-up, a standard deviation (SD) of 11 WOMAC units and 15% loss to follow-up.
This sample size is more than sufficient to detect a minimally clinically important difference of 1.8 NRS units in the NRS pain scale[4] with >98% power and 15% loss to follow-up, assuming a SD of 2.3 NRS units and correlation of 0.35 between baseline and 24 weeks follow-up.

Statistical Analysis Plan:
The statistical analysis plan will be written and published while the biostatisticians are blinded to group allocation, and the main analyses will be performed while the biostatisticians are blinded to group names. The analysis will include all participants according to their randomised allocation (intention-to-treat). Multiple imputation will be used as the primary analysis to account for missing data if more than 5% of one or both primary outcomes are missing at 24 weeks. For each primary and continuous secondary outcome, mean between-group differences at 24 weeks will be estimated from multiple linear regression models. The proportion of participants in each group that show an improvement that reaches or exceeds the minimum clinically important difference in NRS pain (=1.8 units) and WOMAC function (=6 units) will be calculated. For this and each binary outcome, groups will be compared using risk ratios and risk differences estimated from logistic regression models. For the ordinal outcome, weight loss efforts, a proportional odds model will be fitted similarly. All models will include adjustment for baseline values, where relevant, and the stratifying variable of physiotherapist.

To assess whether the treatment effect differs for different subgroups (pre-specified moderators), exploratory analyses will be undertaken to add interaction terms between treatment arm and each potential moderator in the models for the primary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315515 0
Government body
Name [1] 315515 0
National Health and Medical Research Council (NHMRC) Investigator Grant
Country [1] 315515 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 317599 0
None
Name [1] 317599 0
Address [1] 317599 0
Country [1] 317599 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314418 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314418 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 314418 0
Australia
Date submitted for ethics approval [1] 314418 0
09/02/2024
Approval date [1] 314418 0
Ethics approval number [1] 314418 0

Summary
Brief summary
Participants in both groups will receive quality care by a physiotherapist based on the best current research evidence. This care involves two telehealth consultations, approximately 5 weeks apart, with a physiotherapist via Zoom software. During these sessions, participants will receive an individualised strengthening exercise program for the knee comprising 4 leg exercises. In addition to the exercise program, participants will be randomly assigned to recieve either of two different ways a physiotherapist provided information about osteoarthritis and its management, i) information provided verbally or ii) information provided verbally and supported by an online resource. We hypothesize that the use of the online resource will enhance pain and/or physical function outcomes at 24-weeks in comparison to information provided verbally only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131506 0
Dr Rachel Nelligan
Address 131506 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy Level 7, Alan Gilbert Building The University of Melbourne, Victoria 3010 Australia
Country 131506 0
Australia
Phone 131506 0
+61 3 8344 5892
Fax 131506 0
Email 131506 0
rachel.nelligan@unimelb.edu.au
Contact person for public queries
Name 131507 0
Ben Metcalf
Address 131507 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy Level 7, Alan Gilbert Building The University of Melbourne, Victoria 3010 Australia
Country 131507 0
Australia
Phone 131507 0
+61 3 83448127
Fax 131507 0
Email 131507 0
b.metcalf@unimelb.edu.au
Contact person for scientific queries
Name 131508 0
Rachel Nelligan
Address 131508 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy Level 7, Alan Gilbert Building The University of Melbourne, Victoria 3010 Australia
Country 131508 0
Australia
Phone 131508 0
+61 3 8344 5892
Fax 131508 0
Email 131508 0
rachel.nelligan@unimelb.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.