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Trial registered on ANZCTR


Registration number
ACTRN12625000185460
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
17/02/2025
Date last updated
17/02/2025
Date data sharing statement initially provided
17/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
CASCADE-OA (Community bAsed phySical aCtivity AnD sElf management for OsteoArthritis)
Scientific title
CASCADE-OA: A randomised-controlled trial of the effect of community-based physical activity and self-management on physical activity levels in people with osteoarthritis
Secondary ID [1] 312013 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CASCADE-OA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 333623 0
Condition category
Condition code
Musculoskeletal 330310 330310 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 333074 333074 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the self-directed 12-week Walk with Ease Australia program. The Walk with Ease Australia program has been adapted from a 6-week self-directed walking program which was developed by the Thurston Arthritis Research Centre and the Institute on Aging of the University of North Carolina, for use in the USA. The program participants are encouraged to walk 3–5 times a week, with a weekly increase in duration. Each week, participants are prompted to read chapters from the Walk with Ease workbook to equip them with the tools and knowledge to achieve their walking goals, including: initial, midway, and end-point self-assessments, a guide to setting up a walking plan, a 5-step guide on what should be included in a walking session (warm-up, gentle stretching, walking, and speed up, cool down, and gentle stretching), the frequency, intensity, time (duration), and type of training (FITT) principles, and a walking diary (“Companion Workbook”). The Walk with Ease Australia program is a self-directed physical activity program and it is up to the participant to decide how much to walk based on their own goals. Once participants have completed consent, screening and eligibility processes they will be asked to complete the baseline questionnaire and receive “blinded” Fitbits (activity tracking monitors) to monitor their physical activity levels (primary outcome measure). The “blinded” Fitbits will be Fitbits that have all goal notifications and prompts to move turned off and step count will not be visible on their home screen. Access to step count through the Fitbit mobile app cannot be disabled so it is possible that participants will see their step count if they access the app. Following the 14-day data collection period, participants will be randomised and sent an electronic version of the 12-week self-directed Walk with Ease Australia book, followed by a physical copy by mail. Participants will also be invited to join a private CASCADE-OA Facebook group.
Intervention code [1] 328465 0
Lifestyle
Intervention code [2] 328466 0
Rehabilitation
Comparator / control treatment
During the intervention period, participants allocated to the Fitbit only group will receive the “blinded” Fitbit as described above. This is so that we can evaluate the true effect of the Walk with Ease Australia intervention, taking into account the interventional effect that the Fitbit will have on step count (primary outcome measure). Both groups will be able to access care as usual (i.e. continue to seek care as they usually would).
Control group
Active

Outcomes
Primary outcome [1] 338054 0
Physical activity levels at 12 weeks
Timepoint [1] 338054 0
6-, 12- (primary), 26- , 52 weeks post-commencement of intervention
Secondary outcome [1] 434316 0
Pain intensity of most painful hip or knee joint
Timepoint [1] 434316 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [2] 434317 0
Self-efficacy for managing OA pain
Timepoint [2] 434317 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [3] 444636 0
Physical function
Timepoint [3] 444636 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [4] 444637 0
Health-related quality of life
Timepoint [4] 444637 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [5] 444638 0
Absenteeism and presenteeism from work
Timepoint [5] 444638 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [6] 444639 0
Healthcare utilisation and medication use
Timepoint [6] 444639 0
Baseline, 6-, 12-, 26- and 52 weeks post-commencement of intervention
Secondary outcome [7] 444645 0
Acceptability of Walk with Ease Australia
Timepoint [7] 444645 0
12-weeks post- commencement intervention
Secondary outcome [8] 444646 0
Adoption of Walk with Ease Australia
Timepoint [8] 444646 0
Baseline, assessed at completion of study
Secondary outcome [9] 444647 0
Appropriateness of Walk with Ease Australia
Timepoint [9] 444647 0
12 weeks post-commencement of intervention
Secondary outcome [10] 444648 0
Feasibility of Walk with Ease Australia
Timepoint [10] 444648 0
12 weeks post-commencement of intervention
Secondary outcome [11] 444649 0
Fidelity to the Walk with Ease Australia intervention
Timepoint [11] 444649 0
12 weeks post-commencement of intervention
Secondary outcome [12] 444650 0
Sustainability of the Walk with Ease Australia
Timepoint [12] 444650 0
Participants allocated into the intervention group will be asked survey questions at 26- and 52-week post-commencement of intervention

Eligibility
Key inclusion criteria
Be aged 45 years or older,
Have activity-related hip or knee joint pain,
Is willing to participate in community walking
Have an average pain rating of 3 or more on the 11-point numerical rating scale (NRS, 0-10),
Be able to walk for at least 10 minutes at any pace/intensity (aided or unaided),
Have access to a GPS-tracking smartphone, and
Have internet access.
Be able to read and understand English.
Will be residing in Australia for the next 12 months
Potential participants must also be considered safe to participate in a walking trial using the Adult Pre-Screening Screening System (APSS),
and do not have joint-related stiffness or any morning stiffness that lasts beyond 30 minutes
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will not be eligible to participate if they do not meet the inclusion criteria above, have co-existing inflammatory arthritis including rheumatoid arthritis and gout, or are already meeting the minimum physical activity guideline requirements of 150 minutes of moderate physical activity or 75 minutes of vigorous activity per week.

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 concealed using the REDCap randomisation module, set up by an independent researcher. An independent statistician will generate the randomisation sequences.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (1:1) to the intervention or the control group through a computer-generated randomisation schedule using permuted blocks ratio and stratified by OA joint site, and biological 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
Primary and secondary outcome measures will be analysed using intention-to treat. Differences between groups at baseline will be assessed using independent samples t-tests. Normal distribution of data will be accounted for based on the central limit theorem that dictates that a difference of means will be normally distributed with a sample size greater than 30 (Kamis et al 2020). If required, logistic regression will be used to compare the number of participants in each group that met the minimum daily step count requirement (7500 steps).

Changes in steps count will be analysed using a linear mixed-effects model with treatment, month and their interaction (treatment ´ month) as covariates. The correlation within recruitment settings (based on state and whether they were recruited from the community or through the OACCP) and the repeated measures will be addressed using recruitment setting and participant identification as random intercepts. Month will be treated as random effect to allow different treatment effects among participants over time. Change in outcome measures within each group and difference of the changes between groups from baseline to follow-up will be calculated using linear combinations of the estimated coefficients adjusted for baseline outcome.

Secondary analysis for missing data will be performed using multiple imputation by chained equations. Baseline variables with complete data will be used for data imputation assuming missing at random.

Pre-specified stratified analyses will be performed to examine which subgroups may respond to treatment based on these variables: index joint site (hip/knee), biological sex and recruitment setting (community vs OACCP). Moderator analyses using generalized linear models will be performed to determine if any other variables (e.g. age, baseline physical activity levels) interacted with the effect of the intervention. Frequency data and proportion will be reported for implementation outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
24/10/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
414
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316363 0
Government body
Name [1] 316363 0
The National Health and Medical Research Council (NHMRC) under the Medical Research Future Fund (MRFF) Effective Treatments and Therapies scheme (Application ID: 2023131).
Country [1] 316363 0
Australia
Funding source category [2] 316364 0
Commercial sector/Industry
Name [2] 316364 0
The Ramsay Research and Teaching Fund.
Country [2] 316364 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319994 0
None
Name [1] 319994 0
Address [1] 319994 0
Country [1] 319994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315168 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315168 0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Ethics committee country [1] 315168 0
Australia
Date submitted for ethics approval [1] 315168 0
28/08/2024
Approval date [1] 315168 0
15/10/2024
Ethics approval number [1] 315168 0

Summary
Brief summary
Osteoarthritis (OA) is a common and debilitating condition affecting millions worldwide, with no known cure. Physical activity is beneficial for managing OA, but most patients fail to meet recommended activity levels. Walking is a safe, low-cost, accessible form of exercise suitable for OA patients. The Walk with Ease program, initially from the US, is a 12-week walking program designed to help OA patients manage pain and symptoms while staying active. It has proven to reduce pain, stiffness, and improve function in people with moderate to severe pain (greater than 4/10), also boosting physical activity levels in individuals with arthritis. This study will test whether Walk with Ease Australia has an effect on physical activity levels in Australians with OA through a two-arm, parallel, randomised controlled trial using a hybrid type 1 effectiveness-implementation design. The primary endpoint is assessed at 12 weeks. After screening and consenting, participants are randomized into either the Walk with Ease Australia plus Fitbit group or the Fitbit-only group. Surveys are completed at baseline (T0), six weeks (T1), 12-weeks (T2), and follow-ups at six and 12 months (T3 and T4). We expect that people assigned to the Walk with Ease Australia will have higher physical activity levels, compared to control at 12 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133886 0
Prof David Hunter
Address 133886 0
Kolling Institute University of Sydney 10 Westbourne Street St Leonards New South Wales 2064
Country 133886 0
Australia
Phone 133886 0
+61 294631887
Fax 133886 0
Email 133886 0
[email protected]
Contact person for public queries
Name 133887 0
Emily Si
Address 133887 0
Kolling Institute University of Sydney 10 Westbourne Street St Leonards New South Wales 2064
Country 133887 0
Australia
Phone 133887 0
+61 299264831
Fax 133887 0
Email 133887 0
[email protected]
Contact person for scientific queries
Name 133888 0
Sarah Kobayashi
Address 133888 0
Kolling Institute University of Sydney 10 Westbourne Street St Leonards New South Wales 2064
Country 133888 0
Australia
Phone 133888 0
+61438241868
Fax 133888 0
Email 133888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Initially, individual participant data underlying published results will be available (after de-identification). Prior to that other data may be available at the discretion of the CIs.
When will data be available (start and end dates)?
Immediately following publication or as agreed by the CIs, no end date has been determined.
Available to whom?
Initially, data will be available to researchers who provide a methodologically sound proposal. Data will become available through a public database once the major findings have been published.
Available for what types of analyses?
No restrictions
How or where can data be obtained?
Initially, access will be subject to approvals by the Principal Investigator, and may require a data access agreement. Data will eventually be submitted to a public database.
Principal Investigator: Prof David Hunter ([email protected])


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.