Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001097235
Ethics application status
Approved
Date submitted
21/06/2018
Date registered
2/07/2018
Date last updated
2/07/2020
Date data sharing statement initially provided
2/07/2020
Date results information initially provided
2/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
WALK - A pilot randomised controlled trial evaluating community walking for knee osteoarthritis
Scientific title
WALK - A pilot randomised controlled trial evaluating the feasibility of community walking for knee osteoarthritis
Secondary ID [1] 294695 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 307556 0
Condition category
Condition code
Musculoskeletal 306634 306634 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group (community walking plus usual care) will be asked to train 3 days per week for 6 months. They will walk 2 days/week in a supervised group session and 1 day/week unsupervised at home. Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients. Trained physiotherapists/exercise physiologists will lead a group of up to 10 participants. The structure of our walking program is based on a walking protocol published by Ettinger et al in JAMA 1997. Each session (group based or home based) will last 1 hour and consist of:
• 10 min warm up consisting of slow walking and arm circles, trunk rotation, shoulder and chest stretches, and side stretch.
• 40 min group walking where participants are encouraged to walk at 50–70% of their heart rate reserve. This frequency and intensity is currently recommended for Australian adults and for adults with knee OA.
• 10 min cool down. The cool-down will consist of slow walking and 3 flexibility exercises: a shoulder stretch, hamstring stretch, and lower back stretch.

Using the validated Rating of Perceived Exertion Scale (RPE), physiotherapists/exercise physiologists will instruct and motivate participants to walk at a moderate intensity, defined as intensity to raise heart rate to a point where you sweat and are working somewhat hard (13-15 RPE - equivalent to 50-70% of heart rate reserve). The walking classes will occur at locations around Hobart that offer a loop track or an out and back course, to allow participants to walk at their own intensity. Also, at the start of the intervention each physiotherapist/exercise physiologist will have a volunteer from our research team with them to help familiarise participants with the intervention and the courses.

Strategies to maintain adherence: We have researchers on the team who are trained in behavioural methods to enhance adoption and maintenance of exercise (both from a research and clinical perspective). Our program will provide social support, positive reinforcement, goal setting, rewards for attendance, frequent contact, recognition in study update newsletters, and participants will receive a Fitbit in recognition of their commitment, time and effort. The participants will report all training sessions in training diaries. The physiotherapists/exercise physiologists and an unblinded research officer specifically employed to implement the intervention will monitor compliance. Together they will identify any participants who need additional reminders and/or counselling. If a participant misses a group-based session, they will receive a phone call to discuss their study goals and barriers to participation. All physiotherapists/exercise physiologists employed to work on the project will be required to complete a ‘train-the-trainers’ 1/2-day workshop to ensure the program is consistently administered and compliance is consistently monitored.

Participants in this group will also receive the same care provided to the usual care group (see below for details).
Intervention code [1] 300987 0
Lifestyle
Comparator / control treatment
Participants randomised to the control group (usual care group) will receive usual standard care from their medical practitioner. They will also receive basic generic information/resources including:
• Standardised management advice in the form of a booklet (provided by Arthritis Australia);
• Information about community services available for patients with knee OA;
• Information about Arthritis Australia’s website ‘MyJointPain’ which offers management options for those suffering from OA; and
• Generic project newsletters that contain project updates to help minimise attrition over the 6 month study.
Control group
Active

Outcomes
Primary outcome [1] 305627 0
Design: Any required changes to the study protocol (determined as the 'required changes needed' during the study and documented on a tracked changes version of the study protocol by study staff)
Timepoint [1] 305627 0
During screening and every week of intervention from baseline to 6 months.
Primary outcome [2] 306455 0
Recruitment and Screening: Time and number of people screened to enrol 48 participants.
Timepoint [2] 306455 0
Time from recruitment commencement to when 48 participants are enrolled.
Primary outcome [3] 306456 0
Balance of characteristics in each group including age, sex, BMI, and knee pain levels self-reported by VAS.
Timepoint [3] 306456 0
At 6 months from commencement of intervention.
Secondary outcome [1] 345969 0
Pain, function and stiffness: Knee pain will be assessed using a 100mm visual analogue scale (VAS). Pain will also be assessed using the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Function and stiffness will be assessed using the WOMAC.






Timepoint [1] 345969 0
3 and 6 months from commencement of intervention
Secondary outcome [2] 348411 0
MRI detected bone marrow lesions (BMLs): An MRI scan of the ‘study’ knee will be performed at screening and 6 months. BMLs are the ideal OA structural outcome to examine short-term structure modification. They will be assessed quantitatively in the tibia, femur and patella.
Timepoint [2] 348411 0
6 month change from screening.
Secondary outcome [3] 348412 0
MRI-detected knee structures other than bone marrow lesions: Cartilage defects will be assessed at the medial tibial, medial femoral, lateral tibial, lateral femoral and patella sites.
Timepoint [3] 348412 0
6 months change from screening
Secondary outcome [4] 348413 0
Leg strength: We will assess leg muscle strength (involving both legs simultaneously) by dynamometry (TTM Muscular Meter, Tokyo, Japan).
Timepoint [4] 348413 0
3 and 6 months from commencement of intervention
Secondary outcome [5] 348414 0
OARSI performance measures: We will assess the participants’ physical function at baseline, month 3 and 6 using the OARSI recommended set of performance. These tests will be performed and scored as outlined in the manual of OARSI recommended set of performance-based measures of physical function. This performance-based test includes:
- 30s Chair Stand Test: This is a test of sit-to-stand activity but it also evaluates an individual’s lower body strength and dynamic balance. The test assesses the number of chair stand repetitions that can be performed by an individual in a 30 second period. Equipment includes a chair and stopwatch.
- 40m Fast-paced Walk Test: This is a test of short distance walking activity. It is a direct measure of an individual’s ability to walk quickly over short distances and to change direction during walking. Equipment includes a 40m walking space.
- 6-minute walk test: This is a test of aerobic capacity and long distance walking activity. The test also evaluates endurance and dynamic balance when changing directions during walking. The test assesses the maximal distance covered in a 6-minute period. Equipment: walking space.
- Timed up and Go test: This is a test of ‘transition’ during ambulatory activity. The test incorporates multiple activities including sit-to-stand activity, ability to walk short distances, change direction during walking and to transition between these activities. The test assesses the time, in seconds, that it takes an individual to rise from a chair, walk 3 metres, turn, walk back to the chair and then sit down. Equipment required chair, stopwatch.
- Stair Climb Test: This is a test of ascending and descending stair activity but it also measure an individual’s lower body strength and balance. The test assesses the time, in seconds, that it takes an individual to ascend a flight of stairs. Nine stairs with 20cm (8 inch) step height and handrail is recommended. Equipment required includes nine stairs and a stopwatch.
Timepoint [5] 348414 0
3 and 6 months from commencement of intervention
Secondary outcome [6] 348418 0
Depression as assessed by the PHQ-9.
Timepoint [6] 348418 0
3 and 6 months from commencement of intervention
Secondary outcome [7] 348421 0
Quality of Life (QoL) and utility: Health related quality of life and utility will be assessed using the Assessment of Quality of Life (AQoL-8D) and the EQ-5D-5L.
Timepoint [7] 348421 0
3 and 6 months from commencement of intervention
Secondary outcome [8] 348422 0
Participants’ satisfaction with intervention (assessed using a self-reported questionnaire designed specifically for this study),
Timepoint [8] 348422 0
3 and 6 months from commencement of intervention
Secondary outcome [9] 348423 0
OMERACT-OARSI responder criteria: A simplified set of responder criteria focused on pain, function and patient global assessment developed by OMERACT (Outcome measures in Rheumatology)-OARSI will be assessed.
Timepoint [9] 348423 0
3 and 6 months from commencement of intervention
Secondary outcome [10] 348424 0
This is a primary outcome. Adverse events (AEs): Adverse events will be monitored throughout the study. Physiotherapists/exercise physiologists and the unblinded research assistant will monitor AEs during their weekly contact with participants. Any reported AE will be recorded with an adverse events form.. AEs will be defined as any treatment-related problem that lasts for >2 days and/or caused the patient to seek other treatment. Potential AEs from this study include increased knee pain or pain at other sites, temporary muscle stiffness, falls or other injuries related to the exercise. There is a very rare chance of an exercise induced heart attack or case sudden death.
Timepoint [10] 348424 0
Weekly throughout the trial and 3 and 6 months (from commencement of intervention)
Secondary outcome [11] 348602 0
This is a primary outcome: Adherence: Assessed as number of times walked per week, number of supervised sessions attended, and number of non-supervised (home) sessions completed. Non-supervised sessions will be assessed by a participant exercise diary.

Timepoint [11] 348602 0
Every week throughout the trial and at 6 months from commencement of intervention.
Secondary outcome [12] 348605 0
This is a primary outcome.

Retention: Number of participants that withdrew by group.
Timepoint [12] 348605 0
At 6 months from commencement of intervention.
Secondary outcome [13] 348608 0
Meniscal extrusion will be assessed as the proportion of the menisci affected by a partial or full extrusion (yes/no) at the anterior, middle, and posterior horns (medially/laterally).
Timepoint [13] 348608 0
6 month change from screening

Eligibility
Key inclusion criteria
1) Males and females aged 45 or over;
2) Have clinically diagnosed knee OA (according to the American College of Rheumatology criteria);
3) Have had symptomatic knee OA for at least 6 months with a pain visual analogue scale (VAS) score of at least 40mm/100mm over the last 7 days;
4) Have a bone marrow lesion (BML) present on MRI (prevalence 88% at screening in our recent clinical trial).
5) Have no difficulty in walking a city block (75-100 metres).
6) Be willing to participate in a walking program for 6 months, and can attend on days/times of the week that scheduled walking classes are running.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Severe knee pain (on standing greater than 80mm/100mm on VAS);
2) Participation in any form of exercise at a moderate/vigorous level for >150 min/week or walking >10,000 steps/day – will be assessed for 7 consecutive days during screening using Actigraph accelerometers (meta-analysis data demonstrates that few knee OA sufferers meet these levels of activity (13% and 19% respectively));
3) Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance; see below for the procedure for this);
4) Other forms of arthritis in which disease is active and concomitant medication is used (e.g., rheumatoid arthritis);
5) Participants who have undergone significant trauma to the ‘study’ knee in the previous 12 months (injury, arthroscopy or open surgery);
6) Receiving intra-articular therapy (e.g. corticosteroids, hyaluronic acid) in the study knee in the last 6 months;
7) Anticipated need for knee or hip surgery within the next 6 months;
8) Contra-indication to MRI (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for scanner);
9) Plan to commence exercise or another new treatment for knee OA in the next 6 months.
10) Use of a gait aid.
11) Inability to give informed consent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/10/2018
Actual
5/12/2018
Date of last participant enrolment
Anticipated
Actual
24/06/2019
Date of last data collection
Anticipated
Actual
16/12/2019
Sample size
Target
48
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 299301 0
Charities/Societies/Foundations
Name [1] 299301 0
Arthritis Australia
Country [1] 299301 0
Australia
Funding source category [2] 299872 0
University
Name [2] 299872 0
University of Tasmania Better Health Theme Research Grant
Country [2] 299872 0
Australia
Primary sponsor type
University
Name
Menzies Institute for Medical Research, University of Tasmania
Address
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country
Australia
Secondary sponsor category [1] 299223 0
None
Name [1] 299223 0
Address [1] 299223 0
Country [1] 299223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300212 0
Tasmania Health & Medical Human Research Ethics Committee [EC00337]
Ethics committee address [1] 300212 0
Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 300212 0
Australia
Date submitted for ethics approval [1] 300212 0
23/01/2018
Approval date [1] 300212 0
20/04/2018
Ethics approval number [1] 300212 0
H0017108

Summary
Brief summary
A common but likely erroneous belief is that using exercise as a treatment for knee osteoarthritis will cause damage to an already worn joint. We propose to perform the first RCT to examine the effect walking has on knee structure, objectively assessed using MRI. Participants will be randomised to either community walking plus usual care or usual care alone for 6 months. Participants randomised to walking will walk 3 days/week for one hour (2 days/week supervised group sessions and 1 day/week unsupervised). Group sessions will be tailored to individual fitness levels and led by a physiotherapist or exercise physiologist with experience in prescribing exercise for OA patients.

The aim of this study is to generate pilot data for a proposed larger study (which aims to enrol a total of 186 participants, funding applications currently under consideration) to demonstrate feasibility of the study design, recruitment, screening, adherence, safety and retention. This pilot study will enrol 48 participants (24 randomised to walking plus usual care and 24 to usual care). It will be conducted in line with the recent CONSORT statement for pilot and feasibility trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82930 0
Dr Dawn Aitken
Address 82930 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 82930 0
Australia
Phone 82930 0
+61 3 6226 7769
Fax 82930 0
Email 82930 0
Dawn.Aitken@utas.edu.au
Contact person for public queries
Name 82931 0
Dr Dawn Aitken
Address 82931 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 82931 0
Australia
Phone 82931 0
+61 3 6226 7769
Fax 82931 0
Email 82931 0
Dawn.Aitken@utas.edu.au
Contact person for scientific queries
Name 82932 0
Dr Dawn Aitken
Address 82932 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 82932 0
Australia
Phone 82932 0
+61 3 6226 7769
Fax 82932 0
Email 82932 0
Dawn.Aitken@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual participant data collected during the trial can be shared on reasonable request subject to a data sharing agreement.
When will data be available (start and end dates)?
Data can be shared immediately following the first publication of this study with no end date.
Available to whom?
The data is available to all researchers who provide a methodologically sound proposal, subject to a data sharing agreement.
Available for what types of analyses?
The data can be available for any purpose.
How or where can data be obtained?
Access to the data is subject to approvals by the Principal Investigator (dawn.aitken@utas.edu.au) along with approval from the other co-investigators.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8384 0
Study protocol
Citation [1] 8384 0
Link [1] 8384 0
Email [1] 8384 0
dawn.aitken@utas.edu.au
Other [1] 8384 0
Attachment [1] 8384 0
Type [2] 8385 0
Statistical analysis plan
Citation [2] 8385 0
Link [2] 8385 0
Email [2] 8385 0
dawn.aitken@utas.edu.au
Other [2] 8385 0
Attachment [2] 8385 0
Type [3] 8386 0
Informed consent form
Citation [3] 8386 0
Link [3] 8386 0
Email [3] 8386 0
dawn.aitken@utas.edu.au
Other [3] 8386 0
Attachment [3] 8386 0
Type [4] 8387 0
Ethical approval
Citation [4] 8387 0
Link [4] 8387 0
Email [4] 8387 0
dawn.aitken@utas.edu.au
Other [4] 8387 0
Attachment [4] 8387 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary