Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001568202
Ethics application status
Approved
Date submitted
14/09/2018
Date registered
19/09/2018
Date last updated
5/07/2021
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Unlocking the potential of a novel setting to promote physical activity among knee osteoarthritis (OA) patients – a parkrun feasibility study
Scientific title
Unlocking the potential of a novel setting to promote physical activity among knee osteoarthritis (OA) patients – a parkrun feasibility study
Secondary ID [1] 296068 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 309625 0
Condition category
Condition code
Musculoskeletal 308439 308439 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to participate in four consecutive Saturday parkruns, supervised by a member of our research staff. The project will take place in Southern Tasmania, utilising the weekly parkrun event on the Queens Domain.

parkrun is a 5 km volunteer led community run/walk event held weekly on Saturday mornings all around the world. Participants receive a barcode upon registration which is matched to a finishing position and run time. Each registered individual receives an email with their personal result and all runners’ results are published publicly on the parkrun website each week. Participants in parkrun consist of a broad demographic of people including walkers, joggers and runners and include a wide variety of ability levels from people starting their fitness journey to elite level. In this study, participants will be asked to walk in four (preferably consecutive) parkrun events, supervised by a member of our research staff. Participants will be able to end their participation in each event early if they are unable to complete the full 5 km.

An exercise physiotherapist with >3 years’ experience in supervising group exercise sessions will be present at all parkrun events and will ensure the exercise is performed safely. Physiotherapists are qualified to advise patients about recognising an “unsafe” symptom exacerbation – using an 11-point numeric rating scale (NRS-11) to score walking pain. If symptoms rise above unsafe levels, participants will be advised to rest and the intensity will be reduced appropriately.

Adherence will be monitored by attendance at each individual parkrun. If a participant does not attend one of the parkrun's they will be contacted to determine why they did not attend and if they are continuing with the study. If a participant chooses to withdraw from the study, some brief questions about why (detailed in our early withdrawal script) will be asked and recorded with participant permission. Our physiotherapist will be in attendance at each parkrun to encourage participants and ensure their participation in the event is safe.
Intervention code [1] 312401 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307405 0
Feasibility: Determined by participant adherence, attendance and/or study completion rates. Attendance will be recorded at each parkrun by research staff. Adherence will be measured by the number of parkrun's each participant attends and whether they are sequential. Study completion rates will be determined by the number of participants who complete all 4 parkrun's during the study.
Timepoint [1] 307405 0
Before, during and after each individual parkrun, and at the post-intervention interview approximately 1 week after the participant has completed their fourth parkrun.
Primary outcome [2] 307406 0
Acceptability of parkrun to knee osteoarthritis patients. Acceptability will be assessed by qualitative measurements of enjoyment using the Physical Activity Enjoyment Scale, reporting confidence in completing the upcoming parkrun on a visual scale of 1 through to 10, and levels of exertion using the Borg Perceived Exertion Scale.
Timepoint [2] 307406 0
Before and after each individual parkrun, and at the post-intervention interview approximately 1 week after the participant has completed their fourth parkrun.
Primary outcome [3] 307407 0
Safety: Measured by the number of adverse events recorded throughout the duration of the study.
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. Falls or injuries that occur during the intervention will be recorded by our physiotherapist. Knee pain will be recorded before and after each individual parkrun event using a 100mm visual analogue scale. Participants will be encouraged to contact the researchers should they have any concerns about injuries or pain and any adverse events that are reported in this way will be recorded.
Timepoint [3] 307407 0
Adverse events (AE) will be monitored throughout the study. AEs will be defined as any intervention-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. In the case of an AE, participants will be advised to rest and reduce activity. Research staff will be present at the parkrun events to support participants and assist should any safety issues arise.
Secondary outcome [1] 351864 0
Function and stiffness: Function and stiffness will be assessed using the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC).
Timepoint [1] 351864 0
WOMAC will be used at baseline and post-intervention interview approximately 1 week after the participant has completed their final parkrun.
Secondary outcome [2] 351865 0
Enjoyment: Physical activity enjoyment will be assessed using an adaptation of the Physical Activity Enjoyment Scale.
Timepoint [2] 351865 0
After each individual parkrun and at the post-intervention interview approximately 1 week after the participant has completed their fourth parkrun.
Secondary outcome [3] 351866 0
Exertion: Levels will be measured using the Borg rating of perceived exertion scale.
Timepoint [3] 351866 0
After each individual parkrun.

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) Are not currently meeting the physical activity guidelines of moderate to vigorous level activity for >150 min/week or walking >10,000 steps/day.
5) Have no difficulty in walking a city block (75-100 metres).
6) Be willing and available to participate in four consecutive parkrun events and undertake pre-involvement screening, post-parkrun interviews and the 6 month follow-up.
7) Are 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
1) Severe knee pain (on standing greater than 80mm/100mm on VAS);
2) Any condition or injury that precludes participation in exercise, including failing the Adult Pre-Exercise Screening Tool (Stage 1)
3) Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
7/11/2018
Actual
14/02/2019
Date of last participant enrolment
Anticipated
Actual
21/11/2019
Date of last data collection
Anticipated
Actual
20/01/2020
Sample size
Target
15
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 300664 0
Charities/Societies/Foundations
Name [1] 300664 0
Medibank Better Health Foundation
Country [1] 300664 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] 300204 0
None
Name [1] 300204 0
Address [1] 300204 0
Country [1] 300204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301443 0
Tasmania Health & Medical Human Research Ethics Committee [EC00337]
Ethics committee address [1] 301443 0
Ethics committee country [1] 301443 0
Australia
Date submitted for ethics approval [1] 301443 0
16/07/2018
Approval date [1] 301443 0
09/10/2018
Ethics approval number [1] 301443 0

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

Contacts
Principal investigator
Name 87018 0
Dr Dawn Aitken
Address 87018 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 87018 0
Australia
Phone 87018 0
+61 3 6226 7769
Fax 87018 0
Email 87018 0
[email protected]
Contact person for public queries
Name 87019 0
Dawn Aitken
Address 87019 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 87019 0
Australia
Phone 87019 0
+61 3 6226 7769
Fax 87019 0
Email 87019 0
[email protected]
Contact person for scientific queries
Name 87020 0
Dawn Aitken
Address 87020 0
Menzies Institute for Medical Research, University of Tasmania
17 Liverpool St (Private Bag 23)
Hobart, TAS
7000
Country 87020 0
Australia
Phone 87020 0
+61 3 6226 7769
Fax 87020 0
Email 87020 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
No additional documents have been identified.