- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325334
Osteoarthritis Running & Cartilage Assessment (ORCA)
November 27, 2023 updated by: Michael Hunt, University of British Columbia
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Natasha Krowchuk, BSc
- Phone Number: 604-822-7948
- Email: natasha.krowchuk@ubc.ca
Study Contact Backup
- Name: Michael A Hunt, PT, PhD
- Phone Number: 604-822-7948
- Email: michael.hunt@ubc.ca
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- Recruiting
- Motion Analysis and Biofeedback Laboratory, The University of British Columbia
-
Contact:
- Natasha M Krowchuk, BSc
- Phone Number: 604-822-7948
- Email: natasha.krowchuk@ubc.ca
-
Principal Investigator:
- Michael A Hunt, PT, PhD
-
Sub-Investigator:
- Jean-Francois Esculier, PT, PhD
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Sub-Investigator:
- David R Wilson, DPhil
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Sub-Investigator:
- Alexander Rauscher, PhD
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Sub-Investigator:
- Jack Taunton, MD
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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)
- 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.
Exclusion Criteria:
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Running volume increase
Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
Time Frame: Baseline, 12 weeks
|
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
Time Frame: Baseline, 12 weeks
|
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
Time Frame: Baseline, 12 weeks
|
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
Time Frame: Baseline, 12 weeks
|
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in foot strike pattern
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in step rate
Time Frame: Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
Time Frame: Baseline to 12 weeks, averaged weekly
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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.
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Baseline to 12 weeks, averaged weekly
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Change from Baseline to 12 weeks in weekly running distance
Time Frame: Baseline to 12 weeks, averaged weekly
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Participants will record their weekly running distance using an online diary.
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Baseline to 12 weeks, averaged weekly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael A Hunt, PT, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19-01806
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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