Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000066886
Ethics application status
Approved
Date submitted
26/10/2020
Date registered
27/01/2021
Date last updated
27/01/2021
Date data sharing statement initially provided
27/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised comparative effectiveness trial of YOGa and strengthening exercise for knee osteoArthritis (YOGA Trial)
Scientific title
A randomised comparative effectiveness trial of yoga and strengthening exercise for knee osteoarthritis.
Secondary ID [1] 302016 0
Nil known
Universal Trial Number (UTN)
U1111-1260-1404
Trial acronym
YOGA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 318578 0
Condition category
Condition code
Musculoskeletal 316590 316590 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 316591 316591 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
63 eligible participants will be randomly allocated to a 24-week yoga program with three 1-hour sessions per week (two 1 hour group-based sessions and one 1 hour home-based session) for the first 12 weeks and then three 1-hour per week home-based yoga sessions for the remaining 12 weeks. The group-based yoga sessions will be led by yoga teachers and participants will be instructed to continue their 1-hour yoga program at home (1 day per week for the first 12 weeks and 3days/week for another 12 weeks. The participants will be given a detailed information sheet on their yoga sessions which they were doing in the group-based sessions. We will give them a recorded video of the individual sessions for reference. Self-reported adherence to the intervention and comparator program from baseline to 12 and 12 to 24 weeks will be assessed using an online logbook (includes checklist).
Yoga sessions will include low to moderate intensity asanas such as, Low intensity: Breathing practices, mental practices, warm-up and stretches
Moderate intensity: Sun salutations, standing, balancing, and stabilizing poses.
We will use a modified Borg Scale questionnaire to describe the intensity of the yoga. We will ask the participants to work at 5-7 on the modified Borg Scale, which would be deemed as a moderate-intensity yoga.
Intervention code [1] 318307 0
Treatment: Other
Comparator / control treatment
63 eligible participants will be randomly allocated to a 24-week strengthening exercise program each with three 1-hour sessions per week (two 1 hour group-based sessions and one 1 hour home-based session) for the first 12 weeks and then three 1-hour per week home-based exercise sessions for the remaining 12 weeks. The group-based strengthening exercise sessions will be led by exercise teachers and participants will be instructed to continue their strengthening exercise at home for another 12 weeks. The participants will be given a detailed information sheet on their exercise sessions to continue in the home-based sessions. They will also be provided with a video of the individual sessions for reference. Self-reported adherence to the intervention and comparator program from baseline to 12 and 12 to 24 weeks will be assessed using an online logbook (includes checklist). Strengthening exercise session will include moderate-intensity exercises such as Forwards/backwards exercise, Sideways exercise, Hip muscle strengthening, Knee muscle strengthening, Step-ups, Hamstring strengthening, Calf strengthening, Seated Knee Extension.
We will use a modified Borg Scale questionnaire to describe the intensity of the exercise. We will ask the participants to work at 5-7 on the modified Borg Scale, which would be deemed as a moderate-intensity exercise.
Control group
Active

Outcomes
Primary outcome [1] 324722 0
Change in knee pain (assessed by 100mm VAS) over 12 weeks.
Timepoint [1] 324722 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, and ending at week 12) in knee pain (assessed using a 100mm visual analogue scale (VAS)) from baseline over 12 weeks (primary endpoint).
Secondary outcome [1] 385562 0
Change in VAS knee pain over 12 weeks in patients with painDETECT>12 at baseline
Timepoint [1] 385562 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, and ending at week 12) in patients with painDETECT>12 at baseline.
Secondary outcome [2] 385563 0
Change in VAS knee pain over 24 weeks.
Timepoint [2] 385563 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in knee pain from baseline.
Secondary outcome [3] 385564 0
Change in the WOMAC knee pain over 12 weeks.
Timepoint [3] 385564 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, and ending at week 12) in WOMAC knee pain from baseline.
Secondary outcome [4] 385565 0
Change in physical function as assessed by the 30s Chair Stand Test over 12 weeks.
Timepoint [4] 385565 0
Mixed model accounting for the overall change (slope of the 30s Chair Stand Test graph from baseline to weeks 12) in physical function as assessed by the 30s Chair Stand Test from baseline.
Secondary outcome [5] 385566 0
OMERACT-OARSI responders (meeting responder criteria) at week 12.
Timepoint [5] 385566 0
Week 12
Secondary outcome [6] 385567 0
Change in urinary CTX-II biomarker using the urine sample, change in serum Cartilage oligomeric matrix protein (COMP) and serum hyaluronan (HA) biomarker using the serum sample, and change in hs-CRP, IL-6, and TNF-a systemic inflammatory markers using serum sample over 12, and over 24 weeks.
Timepoint [6] 385567 0
Baseline and weeks 12, and 24.
Secondary outcome [7] 385568 0
Change in Patient Health Questionnaire (PHQ-9) scales over 12, and over 24 weeks
Timepoint [7] 385568 0
Baseline and weeks 12, and 24.
Secondary outcome [8] 385569 0
Change in patient global satisfaction score over 12, and over 24 weeks
Timepoint [8] 385569 0
Baseline and weeks 4, 8, 12, 16, 20, and 24.
Secondary outcome [9] 385570 0
Change in painDETECT scores over 12 weeks
Timepoint [9] 385570 0
Baseline and weeks 12.
Secondary outcome [10] 385571 0
Change in leg muscle strength (quadriceps) over 12 weeks assessed using Back dynamometer.
Timepoint [10] 385571 0
Mixed model accounting for the overall change (slope of the leg muscle strength graph from baseline to weeks 12) in leg muscle strength (quadriceps) from baseline.
Secondary outcome [11] 385572 0
Change in gait speed from baseline to week 12 and baseline to 24 weeks using the GAITRite system.
Timepoint [11] 385572 0
Baseline and weeks 12, and 24.
Secondary outcome [12] 385573 0
Change in concomitant medications (assessed using self-reported medication history questionnaire) from baseline to 12 and baseline to 24 weeks and associated costs.
Timepoint [12] 385573 0
From baseline to week 12 and week 24.
Secondary outcome [13] 385574 0
Self-reported adherence to the intervention and comparator program from baseline to 12 and baseline to 24 weeks assessed using online logbook and defined as the percentage of prescribed session undertaken.
Timepoint [13] 385574 0
From baseline to week 12 and week 24.
Secondary outcome [14] 385575 0
Change in QoL assessed by AQoL-8D from baseline to week 12.
Timepoint [14] 385575 0
From baseline to week 12.
Secondary outcome [15] 385576 0
Change in health resource utilisation (assessed using a self-reported questionnaire) at 12 and 24 weeks.
Timepoint [15] 385576 0
From baseline to week 12 and week 24.
Secondary outcome [16] 389649 0
Change in the WOMAC knee pain over 24 weeks,
Timepoint [16] 389649 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in WOMAC knee pain from baseline.
Secondary outcome [17] 389650 0
Change in WOMAC stiffness over 12 weeks.
Timepoint [17] 389650 0
Mixed model accounting for the overall change (slope of the WOMAC stiffness graph from baseline through weeks 4, 8, and ending at week 12) in WOMAC stiffness from baseline.
Secondary outcome [18] 389651 0
Change in WOMAC stiffness over 24 weeks.
Timepoint [18] 389651 0
Mixed model accounting for the overall change (slope of the WOMAC stiffness graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in WOMAC stiffness from baseline.
Secondary outcome [19] 389652 0
Change in WOMAC knee function over 12 weeks.
Timepoint [19] 389652 0
Mixed model accounting for the overall change (slope of the WOMAC knee function graph from baseline through weeks 4, 8, and ending at week 12) in WOMAC knee function from baseline.
Secondary outcome [20] 389653 0
Change in WOMAC knee function over 24 weeks.
Timepoint [20] 389653 0
Mixed model accounting for the overall change (slope of the WOMAC knee function graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in WOMAC knee function from baseline.
Secondary outcome [21] 389654 0
Change in physical function as assessed by the 30s Chair Stand Test over 24 weeks.
Timepoint [21] 389654 0
Mixed model accounting for the overall change (slope of the 30s Chair Stand Test graph from baseline through weeks 12, and ending at week 24) in physical function as assessed by the 30s Chair Stand Test from baseline.
Secondary outcome [22] 389655 0
Change in physical function as assessed by 40m Fast Walk Test over 12 weeks.
Timepoint [22] 389655 0
Mixed model accounting for the overall change (slope of the 40m Fast Walk Test graph from baseline to weeks 12) in physical function as assessed by 40m Fast Walk Test from baseline.
Secondary outcome [23] 389656 0
Change in physical function as assessed by 40m Fast Walk Test over 24 weeks.
Timepoint [23] 389656 0
Mixed model accounting for the overall change (slope of the 40m Fast Walk Test graph from baseline through weeks 12, and ending at week 24) in physical function as assessed by 40m Fast Walk Test from baseline.
Secondary outcome [24] 389657 0
Change in physical function as assessed by Stair Climb Test over 12 weeks
Timepoint [24] 389657 0
Mixed model accounting for the overall change (slope of the Stair Climb Test over 12 graph from baseline to weeks 12) in physical function as assessed by Stair Climb Test from baseline.
Secondary outcome [25] 389658 0
Change in the physical function as assessed by Stair Climb Test over 24 weeks
Timepoint [25] 389658 0
Mixed model accounting for the overall change (slope of the Stair Climb Test graph from baseline through weeks 12, and ending at week 24) in physical function as assessed by Stair Climb Test from baseline.
Secondary outcome [26] 389664 0
Change in leg muscle strength (quadriceps) over 24 weeks assessed using Back dynamometer
Timepoint [26] 389664 0
Mixed model accounting for the overall change (slope of the leg muscle strength graph from baseline through weeks 12, and ending at week 24) in leg muscle strength (quadriceps) from baseline.
Secondary outcome [27] 389691 0
Change in painDETECT scores over 24 weeks
Timepoint [27] 389691 0
Baseline and weeks 24.
Secondary outcome [28] 389692 0
Change in the WOMAC knee pain over 12 weeks in people with painDETECT >12
Timepoint [28] 389692 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, and ending at week 12) in WOMAC knee pain from baseline.
Secondary outcome [29] 389693 0
Change in the WOMAC knee pain over 24 weeks in people with painDETECT >12
Timepoint [29] 389693 0
Mixed model accounting for the overall change (slope of the knee pain graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in WOMAC knee pain from baseline.
Secondary outcome [30] 389694 0
Change in the WOMAC function over 12 weeks in people with painDETECT >12
Timepoint [30] 389694 0
Mixed model accounting for the overall change (slope of the WOMAC knee function graph from baseline through weeks 4, 8, and ending at week 12) in WOMAC knee function from baseline.
Secondary outcome [31] 389695 0
Change in the WOMAC function over 24 weeks in people with painDETECT >12
Timepoint [31] 389695 0
Mixed model accounting for the overall change (slope of the WOMAC knee function graph from baseline through weeks 4, 8, 12, 16, 20, and ending at week 24) in WOMAC knee function from baseline.
Secondary outcome [32] 389696 0
Change in QoL assessed by AQoL-8D from baseline to week 12 in people with painDETECT >12
Timepoint [32] 389696 0
From baseline to week 12.
Secondary outcome [33] 389697 0
Change in QoL assessed by AQoL-8D from baseline to 24 weeks in people with painDETECT >12
Timepoint [33] 389697 0
From baseline to week 24.
Secondary outcome [34] 389698 0
Change in QoL assessed by EQ-5D-5L from baseline to week 12 in people with painDETECT >12
Timepoint [34] 389698 0
From baseline to week 12.
Secondary outcome [35] 389699 0
Change in QoL assessed by EQ-5D-5L from baseline to week 24 in people with painDETECT >12
Timepoint [35] 389699 0
From baseline to week 24.
Secondary outcome [36] 389700 0
Change in QoL assessed by AQoL-8D from baseline to 24 weeks.
Timepoint [36] 389700 0
From baseline to week 24.
Secondary outcome [37] 389701 0
Change in QoL assessed by EQ-5D-5L from baseline to week 12.
Timepoint [37] 389701 0
From baseline to week 12.
Secondary outcome [38] 389702 0
Change in QoL assessed by EQ-5D-5L from baseline to week 24.
Timepoint [38] 389702 0
From baseline to week 24.
Secondary outcome [39] 389703 0
OMERACT-OARSI responders (meeting responder criteria) at 24 weeks
Timepoint [39] 389703 0
Week 24

Eligibility
Key inclusion criteria
1. Aged >/=40 years
2. Knee pain on most days for at least six months
3. VAS knee pain intensity of >/=40 mm in the last month.
4. Meet American College of Rheumatology (ACR) clinical criteria for the diagnosis of knee OA
5. Be willing to participate in a group yoga program or group strengthening exercise program three times per week for 12-weeks and can attend on the days/times of the week that scheduled classes are running.

A painDETECT score of more than 12 will be used to identify neuropathic pain.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients currently or in the past three months engaged in strengthening exercise or yoga program
2. Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout).
3. A significant knee injury that required treatment within the last six months.
4. Arthroscopy or open surgery in the index knee in the last six months or planned in the next 6-8 months.
5. Injections of corticosteroids (last three months) or hyaluronic acid (last six months) in the index knee.
6. Pregnancy or breastfeeding.
7. Currently participating in any other drug/device/exercise clinical trial related to OA.
8. Presence of any serious medical illness or condition that may preclude a 24-week follow up.
9. Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance).
10. Unable to walk without a gait aid.
11. Inability to provide informed consent in English.
12. Plan to start an exercise or another new treatment for knee OA in the next six months.
13. Planned absences (e.g. trips away) of >2 weeks maximum during the 12-week period.

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)
For this single-blinded study, allocation concealment will be done using central randomisation by computer. The investigators and assessors will be blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of participants in a 1:1 ratio to either a 24-week yoga program or strengthening exercise program will be based on computer-generated random numbers prepared by a statistician with no involvement in the trial. Code-break for the full randomisation schedule will be maintained by the administering institute.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The comparisons of pain and other continuous scores will be made using a repeated–measures mixed model with terms of treatment, time, and corresponding baseline values as covariates. The effect of treatment will be evaluated by the intervention by time interaction, and then proceed to the main effects model with only group and time. We will also assess the effects of potential confounders or interaction with treatment by covariates, including age, sex, BMI, disease severity, comorbidities, health status, and use of pain medications. A 2-sided P-value less than 0.05 will be considered to indicate the statistical significance, and the results will be shown as the between-group differences with 95% confidence intervals (95% CIs) of the differences.
We will explore the role of clustering effects in the trial by performing a sensitivity analysis examining the implications of clustering by the instructor by adding an instructor random effect to the mixed-effects model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 306436 0
Charities/Societies/Foundations
Name [1] 306436 0
This trial is funded by the Rebecca L Cooper Medical Research Foundation
Country [1] 306436 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
17 Liverpool Street
Hobart, TAS, 7000
Country
Australia
Secondary sponsor category [1] 306953 0
None
Name [1] 306953 0
Address [1] 306953 0
Country [1] 306953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306645 0
Tasmanian Health & Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 306645 0
Ethics committee country [1] 306645 0
Australia
Date submitted for ethics approval [1] 306645 0
03/08/2020
Approval date [1] 306645 0
13/11/2020
Ethics approval number [1] 306645 0
21869

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

Contacts
Principal investigator
Name 104534 0
Dr Benny Antony
Address 104534 0
Menzies Institute for Medical Research
Private Bag 23
Hobart, TAS, 7000
Country 104534 0
Australia
Phone 104534 0
+61 362264255
Fax 104534 0
Email 104534 0
[email protected]
Contact person for public queries
Name 104535 0
Ambrish Singh
Address 104535 0
Menzies Institute for Medical Research
17 Liverpool Street
Hobart, TAS, 7000
Country 104535 0
Australia
Phone 104535 0
+61 469701341
Fax 104535 0
Email 104535 0
[email protected]
Contact person for scientific queries
Name 104536 0
Benny Antony
Address 104536 0
Menzies Institute for Medical Research
Private Bag 23
Hobart, TAS, 7000
Country 104536 0
Australia
Phone 104536 0
+61 362264255
Fax 104536 0
Email 104536 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
We will decide on the IPD sharing agreement as soon as we publish the paper from the trial


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.