Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000012976
Ethics application status
Approved
Date submitted
19/11/2019
Date registered
13/01/2020
Date last updated
13/10/2020
Date data sharing statement initially provided
13/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing effects of an online exercise plus education program to online education only in people with knee osteoarthritis: randomised controlled trial: The COPE Trial
Scientific title
Effects of a self-directed online yoga program on pain and function in people with knee osteoarthritis: randomised controlled trial
Secondary ID [1] 299561 0
Nil known
Universal Trial Number (UTN)
U1111-1242-0936
Trial acronym
The COPE Study
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 314822 0
knee osteoarthritis 314823 0
Condition category
Condition code
Musculoskeletal 313164 313164 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 313957 313957 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in both the intervention and controls groups will have access to online educational content for osteoarthritis management in the form of reading material. The online content will be based on current best-practice research and resources that we have previously used for our other studies. Topics covered include: understanding osteoarthritis; osteoarthritis treatment options; exercise and physical activity; weight loss; understanding and managing pain; sleep; links to additional resources. The website can be accessed as many times as the participant wishes.

The intervention group will also have access to a self directed online 12-week progressive yoga program guided by an instructor delivering the program in a pre-recorded video format. Videos of the yoga program will run approximately 30-40 minutes each and will look like a class session with an instructor and a small group of people performing as people with knee osteoarthritis. Classes will be beginner to intermediate in level/intensity and will progress throughout the 12 weeks. Participants will be encouraged to monitor their intensity by focusing on the ability to breathe in a slow, controlled manner - a common approach in yoga classes. Each class will have several modifications and progressions demonstrated so that participants may choose options that match their abilities as they progress.

The intervention will include such things as "chair pose" (yogic squats), "warrior poses" (yogic lunges), "cat/cow pose" (yogic spine mobilization), and "downward dog pose". Breathing techniques will include things such as working to sync movements to breath cycles, and meditation techniques centred around monitoring of the breath.

Participants will be able to undertake the program in their home at a time of their choosing. They will be asked to complete the yoga program 3 times per week (approx. 30-40 minutes per session) for the 12 weeks and encouraged to continue with this during the subsequent follow up period. They will watch a new video each week for a total of 12 videos performed a minimum of 3 times each.

Adherence will be monitored via self-reported study log books and study questionnaires, and also via website analytics.
Intervention code [1] 315814 0
Treatment: Other
Intervention code [2] 316409 0
Rehabilitation
Comparator / control treatment
Participants in both the intervention and controls groups will have access to online educational content for osteoarthritis management. The online content will be based on current best-practice research and resources that we have previously used for our other studies. Topics covered include: understanding osteoarthritis; osteoarthritis treatment options; exercise and physical activity; weight loss; understanding and managing pain; sleep; links to additional resources. The website can be accessed as many times as the participant wishes.
Control group
Active

Outcomes
Primary outcome [1] 321736 0
Self-reported average walking pain in the past week on an 11-point numeric rating scale
Timepoint [1] 321736 0
Baseline, 12 weeks after baseline (primary endpoint), 24 weeks after baseline
Primary outcome [2] 321737 0
Physical function sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [2] 321737 0
Baseline, 12 weeks after baseline (primary endpoint), 24 weeks after baseline
Secondary outcome [1] 376052 0
Self-reported overall average knee pain in the last week on an 11-point numeric rating scale
Timepoint [1] 376052 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [2] 376053 0
Pain Sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [2] 376053 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [3] 376054 0
Stiffness Sub-scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [3] 376054 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [4] 376087 0
Anxiety Sub-scale of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [4] 376087 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [5] 376088 0
Depression Sub-scale of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [5] 376088 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [6] 376089 0
Stress Sub-scale of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [6] 376089 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [7] 376090 0
Global Change Overall on a 7-point global rating of change Likert scale from “much worse” to “much better” when compared to baseline.
Timepoint [7] 376090 0
12 weeks after baseline, 24 weeks after baseline
Secondary outcome [8] 376091 0
Quality of life (AQoL-6D)
Timepoint [8] 376091 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [9] 376092 0
Self-Efficacy Pain Scale of the Arthritis Self Efficacy Scale
Timepoint [9] 376092 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [10] 376093 0
Self-Efficacy Other Symptoms Scale of the Arthritis Self Efficacy Scale
Timepoint [10] 376093 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [11] 376094 0
Brief Fear of Movement Scale for Osteoarthritis
Timepoint [11] 376094 0
Baseline, 12 weeks after baseline, 24 weeks after baseline
Secondary outcome [12] 376095 0
Activities-Specific Balance Confidence (ABC) Scale
Timepoint [12] 376095 0
Baseline, 12 weeks after baseline, 24 weeks after baseline

Eligibility
Key inclusion criteria
I. Meet the National Institute for Health and Care Excellence clinical criteria for diagnosing knee osteoarthritis:
i. age >/=45;
ii. activity-related knee joint pain;
iii. morning knee stiffness < /= 30 minutes
II. report knee pain on most days of the past month;
III. experienced knee pain for 3 months or more;
IV. report a minimum average pain score of 4 on an 11-point numeric rating scale (NRS) when walking over the previous week (NRS 0=no pain, 10=worst pain possible)
V. self-reported difficulty with walking and/or climbing stairs
VI. access to the internet
VII. written clearance from a general practitioner to participate in exercise will be required for anyone who:
i. reports a fall in the past 12 months;
ii. is house-bound due to immobility
iii. fails the Exercise and Sports Science Australia stage 1 pre-exercise screening
questions
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 English
II. knee surgery/joint injection in past 6 months, currently scheduled appointment with orthopaedic surgeon, or planned surgery in the next 6 months;
III. previous knee replacement on affected side
IV. systemic/inflammatory arthritic conditions;
V. undertaking regular (at least weekly) exercise (i.e. independently completing home-based leg strengthening exercises or attending gym or group exercise classes at least weekly) for the past 3 months;
VI. unable to commit to study requirements;
VII. unable to walk unaided (without use of a frame or walking stick)

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 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)
The randomisation schedule will be prepared by the biostatistician, and will be prepared using permuted blocks of sizes 6 to 12.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
For an effect size of 0.4 for the primary outcomes of pain and self-reported function (appropriate effect size for exercise interventions in knee osteoarthritis 1, 2) with a correlation between baseline to final assessment of 0.3 (based on our previous studies) and using an ANCOVA adjusted for baseline scores, we need 90 participants per treatment arm to achieve 80% power and using a significance level of 0.05. Allowing for 15% attrition, we will recruit 106 people per arm (212 in total).

A biostatistician will analyse blinded data. Main comparative analyses between groups will be performed using intention-to-treat. Multiple imputation will be used to account for missing data if required. For the primary hypotheses, differences in mean change in pain and physical function (baseline minus follow-up) will be compared between groups using linear regression models adjusted for baseline value of the primary outcome. The program will be considered effective if either or both primary outcomes show benefits. Similar analyses will be conducted for continuous secondary outcomes. Improvement based on global change will be compared across groups using risk differences, calculated from fitted logistic regression models. A sensitivity analysis will estimate treatment effects assuming full adherence to intervention (yoga sessions conducted 3x per week for 12 weeks), using an instrumental variables approach. Moderation of the treatment effect by selected moderators will be assessed by including interaction terms between each moderator and the treatment in the models. Standard diagnostic plots will be used to check model assumptions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/03/2020
Actual
1/05/2020
Date of last participant enrolment
Anticipated
31/10/2021
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
212
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304047 0
Government body
Name [1] 304047 0
National Health and Medical Research Council (NHMRC)
Country [1] 304047 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
1-100 Grattan Street, Melbourne, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 304239 0
None
Name [1] 304239 0
Address [1] 304239 0
Country [1] 304239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304538 0
University of Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 304538 0
Ethics committee country [1] 304538 0
Australia
Date submitted for ethics approval [1] 304538 0
18/02/2019
Approval date [1] 304538 0
12/03/2019
Ethics approval number [1] 304538 0
1852823

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

Contacts
Principal investigator
Name 97310 0
Prof Kim L Bennell
Address 97310 0
L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010
Country 97310 0
Australia
Phone 97310 0
+61 3 8344 4135
Fax 97310 0
Email 97310 0
[email protected]
Contact person for public queries
Name 97311 0
Alex Kimp
Address 97311 0
L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010
Country 97311 0
Australia
Phone 97311 0
+61 3 8344 3109
Fax 97311 0
Email 97311 0
[email protected]
Contact person for scientific queries
Name 97312 0
Kim L Bennell
Address 97312 0
L7 161 Barry Street, The University of Melbourne, Victoria, Australia, 3010
Country 97312 0
Australia
Phone 97312 0
+61 3 8344 8455
Fax 97312 0
Email 97312 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?

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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis A Randomized Clinical Trial.2022https://dx.doi.org/10.7326/M22-1761
N.B. These documents automatically identified may not have been verified by the study sponsor.