Osteoarthritis, KneeORCANCT04325334
Osteoarthritis Running & Cartilage Assessment
A study testing Running volume increase in people with Osteoarthritis, Knee, run by University of British Columbia at 1 site in Canada.
Trial summary
Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Running volume increase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL:
- aged greater than 40 years
- recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months
- comfortable running on a treadmill for 30 minutes.
- TFOA Group:
- exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)
Show all 10Show fewer
- report knee pain on most days of the previous 3 months (during running and activities of daily living).
- Control Group:
- free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)
- pain free in both knees for the 12 months prior to recruitment.
Who cannot join
- ALL:
- any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
- presence of an inflammatory arthritic condition
- presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running
- use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months
- any history of surgery in either knee
- standard contra-indications to magnetic resonance imaging (MRI).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Motion Analysis and Biofeedback Laboratory, The University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health
Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. There are no studies available to provide direct data to appropriately inform runners and clinicians whether running should be advocated for joint health. Our research study will address this gap.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Running volume increase
- Keywords
- osteoarthritis, knee, running, magnetic resonance imaging, MRI
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running volume increaseBehavioural
Participants will receive a 12-week running program to increase their running volume by approximately 10% per week on average, and in accordance with the "10% rule" advocated to minimize injury rates. For the purpose of this study, participants will run using their habitual technique - i.e. no specific instructions on 'how' to run will be provided; rather, they will simply be instructed on 'how much' to run.
| Study group | Role | What they receive |
|---|---|---|
| Running volume increase | Experimental | Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer. Receives: Behavioral: Running volume increase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Measured: Baseline, 12 weeks
Secondary outcomes (15)
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in foot strike pattern
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in step rate
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
Knee pain during and after running will be assessed for each training. The minimum value is "No Pain" and the maximum value is "Worst Pain Imaginable". Each week of training will be averaged.
Measured: Baseline to 12 weeks, averaged weekly
Change from Baseline to 12 weeks in weekly running distance
Participants will record their weekly running distance using an online diary.
Measured: Baseline to 12 weeks, averaged weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Dec 2019
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hunt, University of British Columbia
- Investigators
- Michael A Hunt, PT, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325334
- Sponsor's protocol ID
- H19-01806
- Acronym
- ORCA
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health
- ClinicalTrials.gov ID
- NCT04325334
- Acronym / sponsor ID
- ORCA / H19-01806
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, running, magnetic resonance imaging, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. There are no studies available to provide direct data to appropriately inform runners and clinicians whether running should be advocated for joint health. Our research study will address this gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Running volume increase | Experimental | Behavioral: Running volume increaseParticipants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged greater than 40 years
- recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months
- comfortable running on a treadmill for 30 minutes.
- exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)
- report knee pain on most days of the previous 3 months (during running and activities of daily living).
Key exclusion criteria (7 listed)
- any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
- presence of an inflammatory arthritic condition
- presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running
- use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months
- any history of surgery in either knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Running volume increaseParticipants will receive a 12-week running program to increase their running volume by approximately 10% per week on average, and in accordance with the "10% rule" advocated to minimize injury rates. For the purpose of this study, participants will run using their habitual technique - i.e. no specific instructions on 'how' to run will be provided; rather, they will simply be instructed on 'how much' to run. | Behavioural | Running volume increase |
Primary outcome
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
Time frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage
Time frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
Time frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
Time frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
15 secondary outcomes
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in foot strike pattern
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in step rate
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
Time frame: Baseline to 12 weeks, averaged weekly
Change from Baseline to 12 weeks in weekly running distance
Time frame: Baseline to 12 weeks, averaged weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Hunt, PT, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running volume increase in people with Osteoarthritis, Knee, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage (time frame: Baseline, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.