Osteoarthritis Running & Cartilage Assessment

Osteoarthritis, Knee Clinical Trial

— ORCA  

Official title:

Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325334
• Other study ID #: H19-01806
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of British Columbia
• Contact: Natasha Krowchuk, BSc
• Phone: 604-822-7948
• Email: natasha.krowchuk[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Running volume increase
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.

Locations

Country	Name	City	State
Canada	Motion Analysis and Biofeedback Laboratory, The University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Secondary	Change from Baseline to 12 weeks in T1? relaxation time of the medial femoral cartilage	T1? provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.	Baseline, 12 weeks
Secondary	Change from Baseline to 12 weeks in T1? relaxation time of the medial tibial cartilage	T1? provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.	Baseline, 12 weeks
Secondary	Change from Baseline to 12 weeks in T1? relaxation time of the lateral femoral cartilage	T1? provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.	Baseline, 12 weeks
Secondary	Change from Baseline to 12 weeks in T1? relaxation time of the lateral tibial cartilage	T1? provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	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.	Baseline to 12 weeks, averaged weekly
Secondary	Change from Baseline to 12 weeks in weekly running distance	Participants will record their weekly running distance using an online diary.	Baseline to 12 weeks, averaged weekly