Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001043325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/06/2026
Date registered
Help: Date registered
25/08/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Running with Osteoarthritis: A physiotherapy-supported exercise, education and running program to increase physical activity for people with knee osteoarthritis
Scientific title
Running with Osteoarthritis: Feasibility and acceptability of a physiotherapy-supported exercise, education and running program to increase physical activity for people with knee osteoarthritis
Additional trial identifiers [1] 317719 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
knee osteoarthritis 342602 0
Condition category
Condition code
Physical Medicine / Rehabilitation 339261 339261 0 0
Other physical medicine / rehabilitation
Musculoskeletal 339262 339262 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Single arm intervention pilot cohort study

Under supervision of an experienced AHPRA registered and titled Sport and Exercise physiotherapist (Emma Draffin), participants will be instructed to complete a 12 week progressive running program, individualising the established ‘couch to 5km’ (C25K) program. C25K gradually increases time from walking to running aiming for a 5km distance at program end over 9 weeks. A Physiotherapists will individualise this program to run for 12 weeks and will not progress distance deemed to be unsafe (based on clinical assessment). This means potentially delaying running progressions to aid symptom management (e.g. running progression may take between 12 weeks, whilst participants will increase distance toward 5km, reaching this distance is not required). Physiotherapist-support will be provided with fortnightly (30min) sessions (at 2-, 4- ,6-, 8-, 10-weeks), in-person or via telehealth if preferred by participants. Intervention content provided will be pragmatic, guided by evidence, but may include:
• Education regarding the benefits and safety of running
• Delaying running progressions to aid symptom management (e.g. running progression may take between 12 weeks, whilst participants will increase distance toward 5km, reaching this distance is not required)
• Prescribing exercises for strength improvement (i.e., resistance training following established American College of Sports Medicine guidelines) of major lower-limb muscle groups to support running capacity.
• Gait retraining guided by video analysis
• Advice for osteoarthritis symptoms managment (e.g. pain relief)
• Manual therapy and adjunct treatments (e.g., massage and sports-taping) to manage symptoms


Symptoms (pain or discomfort caused by participation) will be regularly monitored by the treating physiotherapist at each fortnightly appointment. Where symptoms cannot be managed by the treating physiotherapist referral back to the research team will be made. Our research team comprises expert physiotherapists, and, where needed, a sports physician who can provide medical guidance to support patient safety.

Adherence:
Participation in a free community event (Parkrun, >500 locations in Australia) throughout the program will encourage adherence and ongoing participation in running following the intervention period.

Completion of prescribed running sessions will be recorded
Physiotherapy session attendance checklist will be recorded

Monitoring:
• Running data will be collected and recorded using a smartwatch (e.g., Garmin or apple watch) and/or ‘Strava™ app’ collected through study
• Attendance to physiotherapy sessions will be recorded and these sessions will also provide the opportunity for in-person review and assessment of any running-related symptoms or adverse events.
• Symptoms related to running will be monitored using the Numeric Pain Rating Scale (NPRS) assessing pain intensity in relation to the knee 12-24hrs after each run (online using REDCap software).
• An exercise diary will be completed at each of the 4-, 8-, 12-week timepoints to understand what physiotherapist-prescribed exercises were completed by participants. (online using REDCap software).
• Participants will also have the opportunity to contact the treating physiotherapist or research team at any time in relation to their pain or symptoms.
Intervention code [1] 334562 0
Treatment: Other
Intervention code [2] 334563 0
Rehabilitation
Intervention code [3] 334564 0
Lifestyle
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345959 0
Feasibility - composite measure
Timepoint [1] 345959 0
Upon conclusion of the study
Primary outcome [2] 345960 0
Acceptability - composite measure
Timepoint [2] 345960 0
12 weeks post-commencement of intervention
Secondary outcome [1] 463947 0
Pain
Timepoint [1] 463947 0
- 12-24hrs after each run. - 0,2,4,6,8,10,12,24 weeks post-commencement of intervention
Secondary outcome [2] 463948 0
Knee pain, symptoms and function composite measure
Timepoint [2] 463948 0
0,4,8,12,24 weeks post-commencement of intervention
Secondary outcome [3] 463949 0
Knee self-efficacy
Timepoint [3] 463949 0
0,12,24, weeks post-commencement of intervention
Secondary outcome [4] 463950 0
Physical activity levels
Timepoint [4] 463950 0
0,12,24 weeks post-commencement of intervention
Secondary outcome [5] 463951 0
Participant perception on running and knee joint health assessed as a composite outcome
Timepoint [5] 463951 0
0,12 weeks post-commencement of intervention
Secondary outcome [6] 463952 0
Running load - distance, time run, heart rate, pace in each session as a composite measure
Timepoint [6] 463952 0
0-12 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Eligibility criteria:
• Have not run for exercise in the past six months

• Satisfy either the National Institute for Health and Care Excellence (NICE) or the European Alliance of Associations for Rheumatology (EULAR) clinical criteria for knee osteoarthritis:

EULAR CRITERIA
o Are older than 40 years of age
o movement-related knee joint pain (e.g., pain with squatting or taking stairs)
o morning knee stiffness of less than 30 min,
o functional limitations due to knee (e.g., difficulty with exercise)
o AND in addition, have one or more examination findings:
- Crepitus (clicking and cracking knees related to movement of your knee)
- restricted range of knee motion (bending and straightening)
- bony enlargement

NICE CRITERIA
o Are older than 45 years of age
o movement-related knee joint pain (e.g., pain with squatting or taking stairs)
o morning knee stiffness of less than 30 min
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria
• Younger than 40 or older than 60 years.
• Self-reported inflammatory disease
• Inability to speak and understand the English language as this study does not have funding for translation or language support services
• Other known health issues preventing exercise participation (where this is unclear, the Adult Pre-Exercise Screening System (APSS) will be used to screen for risk.
Where any condition warrants the need for clearance of a medical professional potential participants will be offered the choice not to proceed or to self-refer to their treating doctor to be seen at their own expense to provide guidance on participation).

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2026
Actual
Date of last participant enrolment
Anticipated
22/02/2027
Actual
Date of last data collection
Anticipated
27/08/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322260 0
University
Name [1] 322260 0
La Trobe University
Country [1] 322260 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 325182 0
None
Name [1] 325182 0
Address [1] 325182 0
Country [1] 325182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320781 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 320781 0
Ethics committee country [1] 320781 0
Australia
Date submitted for ethics approval [1] 320781 0
31/07/2026
Approval date [1] 320781 0
11/08/2026
Ethics approval number [1] 320781 0

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

Contacts
Principal investigator
Name 151602 0
Dr Thomas West
Address 151602 0
La Trobe University, Plenty Road & Kingsbury Drive, Bundoora VIC 3086
Country 151602 0
Australia
Phone 151602 0
+61 3 9479 3840
Fax 151602 0
Email 151602 0
[email protected]
Contact person for public queries
Name 151603 0
Thomas West
Address 151603 0
La Trobe University, Plenty Road & Kingsbury Drive, Bundoora VIC 3086
Country 151603 0
Australia
Phone 151603 0
+61 3 9479 3840
Fax 151603 0
Email 151603 0
[email protected]
Contact person for scientific queries
Name 151604 0
Thomas West
Address 151604 0
La Trobe University, Plenty Road & Kingsbury Drive, Bundoora VIC 3086
Country 151604 0
Australia
Phone 151604 0
+61 3 9479 3840
Fax 151604 0
Email 151604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: no ethical approval for this at this stage



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.