The GORUN Study: Gradual Onset of RUNning and Knee Joint Health in Novice Runners (GORUN)

April 7, 2026 updated by: Michael Hunt, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Motion Analysis and Biofeedback Laboratory, The University of British Columbia
        • Contact:
        • Principal Investigator:
          • Michael A Hunt, PT, PhD
        • Sub-Investigator:
          • Jean-Francois Esculier, PT, PhD
        • Sub-Investigator:
          • Alexander Rauscher, PhD
        • Sub-Investigator:
          • Jacqueline Whittaker, PT, PhD
        • Sub-Investigator:
          • Jesse Charlton, PhD
        • Sub-Investigator:
          • Justin Losciale, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria (all):

  • 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

Inclusion criteria (knee osteoarthritis (OA) group):

  • have definitive knee OA as diagnosed using x-rays
  • report having experienced frequent knee pain over the past 3 months

Inclusion criteria (Control group):

  • have no evidence of knee OA based on x-rays
  • have had pain-free knees for at least the past 3 months

Exclusion Criteria (all):

  • 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

Additionally, exclusion criteria based on MRI safety:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy control
Pain-free Individuals without radiographic evidence of knee osteoarthritis who will receive the running program intervention
Behavioral: Running volume increase
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.
Active Comparator: Knee osteoarthritis group
Individuals with knee pain and radiographic evidence of knee osteoarthritis who will receive the running program intervention
Behavioral: Running volume increase
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
T2 relaxation time - medial tibia
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T1rho relaxation time - medial tibia
Time Frame: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to assess the interaction between water and macromolecules. T1rho relaxation time (measured in milliseconds) measures how fast water protons spin-locked to macromolecules leave this locked state. 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
T1rho relaxation time - medial femur
Time Frame: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to assess the interaction between water and macromolecules. T1rho relaxation time (measured in milliseconds) measures how fast water protons spin-locked to macromolecules leave this locked state. 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
T1rho relaxation time - patella
Time Frame: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to assess the interaction between water and macromolecules. T1rho relaxation time (measured in milliseconds) measures how fast water protons spin-locked to macromolecules leave this locked state. 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
Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale
Time Frame: Baseline and 6 months
There are 9 questions in this subscale, with each question scored on a 5-point Likert scale ranging from "None" to "Extreme". The total sum of this subscale is calculated and divided by the maximum score to generate a score out of 100. Subscale totals range from 0 to 100, with higher scores indicating less pain.
Baseline and 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) - function in daily living subscale
Time Frame: Baseline and 6 months
There are 17 questions in this subscale, with each question scored on a 5-point Likert scale ranging from "None" to "Extreme". The total sum of this subscale is calculated and divided by the maximum score to generate a score out of 100. Subscale totals range from 0 to 100, with higher scores indicating less pain.
Baseline and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numerical rating scale of pain
Time Frame: Baseline and 6 months
11-point numerical rating scale; 0 = no pain; 10 = worst pain imaginable
Baseline and 6 months
Knee joint contact force impulse during running
Time Frame: Baseline and 6 months
3D motion capture technology will be used to measure joint motion trajectories and external forces applied to the lower limb during running. Musculoskeletal modelling techniques will be used to calculate the contact force within the tibiofemoral joint.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Hunt, PT, PhD, The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H26-00511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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