NCT07528885

Brief Summary

Knee osteoarthritis (OA) is a debilitating disease affecting millions worldwide. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. Running is a common exercise that is accessible and evokes a number of positive physical and psychological benefits. However, the appropriateness of recreational running in the presence of knee OA is unclear. A growing literature base appears to suggest that running may not be deleterious to the health - especially at the knee joint - of people with knee OA. Our recent research has focused on examining a number of health outcomes relevant to knee OA in older individuals with knee OA, but has been limited to experienced runners. This study will address that limitation by focusing on how novice (new) runners respond to a new running program.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
55mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2030

First Submitted

Initial submission to the registry

March 28, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

March 28, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

runningexercise

Outcome Measures

Primary Outcomes (3)

  • T2 relaxation time - medial tibia

    Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.

    Baseline and 6 months

  • T2 relaxation time - medial femur

    Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.

    Baseline and 6 months

  • T2 relaxation time - patella

    Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.

    Baseline and 6 months

Secondary Outcomes (5)

  • T1rho relaxation time - medial tibia

    Baseline and 6 months

  • T1rho relaxation time - medial femur

    Baseline and 6 months

  • T1rho relaxation time - patella

    Baseline and 6 months

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale

    Baseline and 6 months

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) - function in daily living subscale

    Baseline and 6 months

Other Outcomes (2)

  • Numerical rating scale of pain

    Baseline and 6 months

  • Knee joint contact force impulse during running

    Baseline and 6 months

Study Arms (2)

Healthy control

ACTIVE COMPARATOR

Pain-free Individuals without radiographic evidence of knee osteoarthritis who will receive the running program intervention

Behavioral: Running volume increase

Knee osteoarthritis group

ACTIVE COMPARATOR

Individuals with knee pain and radiographic evidence of knee osteoarthritis who will receive the running program intervention

Behavioral: Running volume increase

Interventions

Participants will receive a 6-month running program focusing on gradual increases in weekly running volume (no more than 5% per week, on average). For the purpose of this study, there will be no specific instructions on 'how' to run; rather, participants will simply be instructed on 'how much' to run.

Healthy controlKnee osteoarthritis group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have been running consistently for no more than six months at time of enrolment, with a cumulative weekly volume of less than 5 kilometres OR have yet to take up recreational running consistently
  • are comfortable running and walking on a treadmill for at least 30 minutes
  • have definitive knee OA as diagnosed using x-rays
  • report having experienced frequent knee pain over the past 3 months
  • have no evidence of knee OA based on x-rays
  • have had pain-free knees for at least the past 3 months

You may not qualify if:

  • have an inflammatory arthritic condition (e.g. gout or rheumatoid arthritis)
  • have a presence of any health condition (other than OA in the knee OA group) affecting normal movement or that precludes engaging in moderate to high impact activities such as running
  • cannot safely fit into the MRI scanner
  • presence of metallic implants (including pace makers, brain aneurysm clips, stents, cochlear implants, artificial heart valves, and prostheses)
  • recent surgery or tattoos within the past 6 weeks
  • current or possible pregnancy
  • electrical stimulator for nerves or bones
  • infusion pumps
  • shrapnel or other metallic fragments
  • non-removable metallic jewellry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Michael Hunt, PT, PhD

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Krowchuk, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 14, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations