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Osteoarthritis Running & Cartilage Assessment (ORCA)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Running volume increase
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, running, magnetic resonance imaging, MRI

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Motion Analysis and Biofeedback Laboratory, The University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Running volume increase

Arm Description

Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from Baseline to 12 weeks in weekly running distance
Participants will record their weekly running distance using an online diary.

Full Information

First Posted
March 25, 2020
Last Updated
May 16, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04325334
Brief Title
Osteoarthritis Running & Cartilage Assessment
Acronym
ORCA
Official Title
Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, knee, running, magnetic resonance imaging, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Running volume increase
Arm Type
Experimental
Arm Description
Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.
Intervention Type
Behavioral
Intervention Name(s)
Running volume increase
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
Description
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.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
Description
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
Description
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
Description
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
Description
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in foot strike pattern
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in step rate
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
Description
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.
Time Frame
Baseline to 12 weeks, averaged weekly
Title
Change from Baseline to 12 weeks in weekly running distance
Description
Participants will record their weekly running distance using an online diary.
Time Frame
Baseline to 12 weeks, averaged weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Krowchuk, BSc
Phone
604-822-7948
Email
natasha.krowchuk@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Hunt, PT, PhD
Phone
604-822-7948
Email
michael.hunt@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PT, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis and Biofeedback Laboratory, The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha M Krowchuk, BSc
Phone
604-822-7948
Email
natasha.krowchuk@ubc.ca
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PT, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Francois Esculier, PT, PhD
First Name & Middle Initial & Last Name & Degree
David R Wilson, DPhil
First Name & Middle Initial & Last Name & Degree
Alexander Rauscher, PhD
First Name & Middle Initial & Last Name & Degree
Jack Taunton, MD

12. IPD Sharing Statement

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Osteoarthritis Running & Cartilage Assessment

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