Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000780651
Ethics application status
Approved
Date submitted
30/06/2023
Date registered
18/07/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a self-directed online Tai Chi program in people with knee osteoarthritis: randomised controlled trial (The RETREAT Trial)
Scientific title
Effects of a self-diRected onlinE Tai Chi pRogram for people with knEe osteoArthriTis: Randomised controlled trial (The RETREAT Trial)
Secondary ID [1] 309873 0
Nil known
Universal Trial Number (UTN)
U1111-1294-0687
Trial acronym
The RETREAT Study
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 330493 0
Condition category
Condition code
Musculoskeletal 327341 327341 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 327342 327342 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will have access to a bespoke website (“MyJoint Tai Chi”). The "MyJoint Tai Chi" website is designed specifically for this study. It contains i) educational information about osteoarthritis and exercise management and Tai Chi; ii) a self-directed 12-week progressive Tai Chi program; and iii) information about an app (“My Exercise Messages”) to support their adherence to the Tai Chi program.

The educational materials on the website will be provided in online written format as well as online videos (each lasting no more than 5 minutes). The online videos contain interviews of people with osteoarthritis and osteoarthritis experts. The website recommends that participants read the educational material and watch the videos. The self-directed Tai Chi program on the website is guided by an instructor delivering the program in a series of 12 pre-recorded videos (one per week). Each video (40-45 mins) includes a warm-up consisting of an introduction by the instructor, standing meditation, breathing exercises, and Qigong. The central portion of each video utilises a modified 10-form Yang style Tai Chi which involves slow and controlled movements. Modifications to the movements were made to ensure suitability for people with lower limb osteoarthritis and little prior Tai Chi experience. Each video ends with a cool-down consisting of breathing practices and relaxation exercises. The 12-week program starts with simple Tai Chi movements with new movements progressively added throughout the program. Participants will be able to undertake the program in their home using their own device at a time of their choosing. They will be asked to complete the Tai Chi program 3 times per week for 12 weeks. Google analytics will be used to track website activity of the individuals using the site. The website recommends that participants also use a free app (“My Exercise Messages”) that is downloadable from the App Store (Apple devices) and Google Play Store (Android devices) to help them adhere to the Tai Chi program. The app allows participants to input the number of Tai Chi sessions they undertake each week and provides them with tailored behaviour change messages.
Intervention code [1] 326417 0
Treatment: Other
Intervention code [2] 326418 0
Rehabilitation
Comparator / control treatment
Participants in the control group will have access to a different bespoke website that contains the same educational information about osteoarthritis and exercise management but does not contain information about Tai Chi nor contain an exercise program. The online content can be accessed as many times as the participant wishes. The educational information on this website is designed specifically for this study.
Control group
Active

Outcomes
Primary outcome [1] 335213 0
Self-reported overall knee pain during walking in the past week on an 11-point numeric rating scale
Timepoint [1] 335213 0
Baseline, 12 weeks after randomisation (primary time-point)
Primary outcome [2] 335214 0
The physical function sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (extracted from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire)
Timepoint [2] 335214 0
Baseline, 12 weeks after randomisation (primary time-point)
Secondary outcome [1] 423512 0
Pain subscale of the Knee Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 423512 0
Baseline, 12 weeks after randomisation
Secondary outcome [2] 423513 0
Sport and Recreation Function subscale of the Knee Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 423513 0
Baseline, 12 weeks after randomisation
Secondary outcome [3] 423514 0
Knee-related Quality of Life subscale of the Knee Osteoarthritis Outcome Score (KOOS)
Timepoint [3] 423514 0
Baseline, 12 weeks after randomisation
Secondary outcome [4] 423515 0
Physical component score of the Short Form 12 (SF-12)
Timepoint [4] 423515 0
Baseline, 12 weeks after randomisation
Secondary outcome [5] 423516 0
Mental component Score of the Short Form 12 (SF-12)
Timepoint [5] 423516 0
Baseline, 12 weeks after randomisation
Secondary outcome [6] 423517 0
Brief Fear of Movement Scale for Osteoarthritis
Timepoint [6] 423517 0
Baseline, 12 weeks after randomisation
Secondary outcome [7] 423518 0
Global rating of overall change in knee condition on a 5-point Likert scale from “markedly improved” to “markedly worsened” when compared to baseline
Timepoint [7] 423518 0
12 weeks after randomisation
Secondary outcome [8] 423519 0
Activities-Specific Balance Confidence (ABC-6) Scale
Timepoint [8] 423519 0
Baseline, 12 weeks after randomisation
Secondary outcome [9] 423520 0
Self-Efficacy Pain subscale of the Arthritis Self Efficacy Scale
Timepoint [9] 423520 0
Baseline, 12 weeks after randomisation
Secondary outcome [10] 423521 0
International Positive and Negative Affect Schedule - Short form (IPANAS-SF)
Timepoint [10] 423521 0
Baseline, 12 weeks after randomisation
Secondary outcome [11] 423522 0
Sleep quality - a single modified sleep quality question taken from the Pittsburgh Sleep Quality of Index (PSQI)
Timepoint [11] 423522 0
Baseline, 12 weeks after randomisation
Secondary outcome [12] 423523 0
Self-reported use of oral pain medications for knee pain using study-specific questionnaire
Timepoint [12] 423523 0
12 weeks after randomisation

Eligibility
Key inclusion criteria
i) National Institute for Health and Care Excellence clinical criteria for knee
osteoarthritis:
a. aged 45 years and over;
b. activity-related knee joint pain;
c. no morning knee stiffness or morning knee stiffness 30 minutes or less;
ii) live in Australia;
iii) report knee pain for 3 months or more;
iv) report knee pain on most days in the past month;
v) report overall average knee pain in the past week during walking equal to or greater than 4 on 11-point numerical rating scale (NRS: 0 = no pain, 10 = worst pain possible);
vi) have a home internet connection and a computer/tablet device that enables access to the internet
vii) have a suitable smartphone to download an app
viii) able to give informed consent.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) inability to speak or read English;
ii) recent knee surgery (past 6 months);
iii) on waiting list for/planning knee surgery in next 3 months;
iv) previous knee joint replacement on affected side;
v) participated in regular (one or more times per week) exercise (home-based leg strengthening exercises, swimming/water exercises, cycling or attending a gym or group exercise classes such as Tai Chi, Yoga, Pilates) over the past 3 months;
vi) unable to walk unaided (without use of a frame or walking stick);
vii) self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
viii) history of fall (past 12 months) and no general practitioner (GP) clearance to participate;
ix) house-bound due to immobility and no GP clearance to participate;
x) have a health condition(s) listed on the Exercise and Sports Science Australia stage 1 pre-exercise screening questionnaire that might compromise exercise safety and do not receive medical clearance from a GP to participate;
xi) unable to commit to study requirements; and/or
xii) currently taking part in another OA study.

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 randomization schedule will be prepared by the biostatistician. The schedule will be stored on a password-protected website (REDCap) maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures. Group allocation will be revealed by this same researcher after baseline primary/secondary outcomes have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur according to a 1: 1 allocation. The randomisation schedule will be prepared by the biostatistician, and will be prepared using permuted blocks of varying sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pragmatic superiority, 2 group, parallel-design randomised controlled trial (RCT)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
The sample size is based on detecting a difference in change between-groups that meets or exceeds a specified minimal clinically important difference (MCID) for the two primary outcomes of knee pain on walking and WOMAC physical function. The MCIDs we are using are 1.8 units for NRS knee pain (Bellamy N et al., 1992) and 6 non-normalised units for WOMAC physical function (Angst et al., 2001). To achieve 80% power and a two-sided 5% significance level split equally across the two primary outcomes, assuming equal between-participant standard deviations of 2.5 for pain and 13 for function for both groups and a correlation between pre- and post measurements of 0.25 for pain and 0.4 for function (Bennell et al., 2022), and accounting for 15% loss to follow up, we require 89 participants per arm, for a total of 178 participants. We will consider the intervention to be effective if at least one of the two primary outcomes shows a significant between-group difference.

Statistical Analysis Plan:
A priori statistical analysis plan will be completed and published on our Centre’s website prior to statistical analyses. Analyses comparing the two groups will be performed by the statistician blind to group details using all available data from all randomised participants according to the intention-to-treat principle. Should the amount of missing data for either primary outcome be greater than 5%, multiple imputation will be conducted, and the method reported. The primary analysis will then use multiply imputed datasets, with a sensitivity analysis using complete case datasets. Demographic and baseline characteristics of participants will be summarised as appropriate and will be inspected to assess baseline comparability of treatment groups. For continuous outcomes, mean differences in change will be compared between groups using linear regression models adjusted for baseline levels of these outcomes. Model assumptions will be assessed using standard diagnostic plots. Binary outcomes will be compared between arms using log-binomial regression, adjusting for the outcome at baseline if available, with results reported as risk ratios and risk differences. Should the log-binomial regression models fail to converge, logistic regression models adjusting for the outcome at baseline will be fitted, with results reported as risk ratios and risk differences.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
9/08/2023
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
178
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314056 0
Government body
Name [1] 314056 0
National Health and Medical Research Council (NHMRC)
Country [1] 314056 0
Australia
Funding source category [2] 314175 0
Government body
Name [2] 314175 0
Department of Education - Australian Government Research Training Program (RTP) Scholarship
Country [2] 314175 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, 1-100 Grattan Street, Melbourne, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 316092 0
None
Name [1] 316092 0
Address [1] 316092 0
Country [1] 316092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313193 0
University of Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 313193 0
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Ethics committee country [1] 313193 0
Australia
Date submitted for ethics approval [1] 313193 0
07/04/2023
Approval date [1] 313193 0
23/05/2023
Ethics approval number [1] 313193 0
HREC review reference (2023-26838-40794-4)

Summary
Brief summary
The trial aims to determine the effectiveness of a self-directed 12-week online Tai Chi program plus online educational information supported by the “My Exercise Messages” app on the primary outcomes of knee pain during walking and physical function at 12 weeks when compared to an online educational information control for people with knee OA.

Following baseline assessment, participants (people with knee osteoarthritis who meet eligibility criteria) will be randomly allocated to one of two groups i) intervention - 12-week self-directed online Tai Chi program “MyJoint Tai Chi program” plus online educational information and an exercise adherence support app (“My Exercise Messages” app), or ii) control - online educational information alone. The intervention group will have access to a self-directed online 12-week Tai Chi program guided by an instructor delivering the program in a pre-recorded video format. The study hypothesis is that the Tai Chi intervention plus online educational information group supported by “My Exercise Messages” app will have greater benefits in improving pain and function compared to the online educational information group for people with knee osteoarthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127302 0
Prof Kim Bennell
Address 127302 0
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 127302 0
Australia
Phone 127302 0
+61 3 8344 4135
Fax 127302 0
Email 127302 0
[email protected]
Contact person for public queries
Name 127303 0
Ms Shiyi (Julia) Zhu
Address 127303 0
Level 6, Alan Gilbert Building, 161 Barry Street

The University of Melbourne, Victoria 3010 Australia
Country 127303 0
Australia
Phone 127303 0
+61 3 834 49531
Fax 127303 0
Email 127303 0
[email protected]
Contact person for scientific queries
Name 127304 0
Prof Kim Bennell
Address 127304 0
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 127304 0
Australia
Phone 127304 0
+61 3 8344 4135
Fax 127304 0
Email 127304 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19563Informed consent form  [email protected]



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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