Osteoarthritis Running & Cartilage Assessment

NCT ID: NCT04325334

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2024-10-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Running volume increase

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Michael Hunt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Hunt, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H19-01806

Identifier Type: -

Identifier Source: org_study_id