Osteoarthritis Running & Cartilage Assessment

NCT04325334 | Completed

• 1 other identifier: H19-01806
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; knee; running; magnetic resonance imaging; MRI

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (15)

• Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage

  Baseline, 12 weeks

• Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage

  Baseline, 12 weeks

• Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage

  Baseline, 12 weeks

• Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage

  Baseline, 12 weeks

• Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment

  Baseline, 12 weeks

Study Arms (1)

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.

Behavioral: Running volume increase

Interventions

Running volume increase BEHAVIORAL

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.

Running volume increase

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael A Hunt, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: December 1, 2019
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)