- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528885
The GORUN Study: Gradual Onset of RUNning and Knee Joint Health in Novice Runners (GORUN)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natasha Krowchuk, BSc
- Phone Number: 604-822-7948
- Email: natasha.krowchuk@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- Motion Analysis and Biofeedback Laboratory, The University of British Columbia
-
Contact:
- Natasha Krowchuk, BSc
- Phone Number: 604-822-7948
- Email: natasha.krowchuk@ubc.ca
-
Principal Investigator:
- Michael A Hunt, PT, PhD
-
Sub-Investigator:
- Jean-Francois Esculier, PT, PhD
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Sub-Investigator:
- Alexander Rauscher, PhD
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Sub-Investigator:
- Jacqueline Whittaker, PT, PhD
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Sub-Investigator:
- Jesse Charlton, PhD
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Sub-Investigator:
- Justin Losciale, PT, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Healthy control
Pain-free Individuals without radiographic evidence of knee osteoarthritis who will receive the running program intervention
|
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
|
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
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
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
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
Sponsor
Investigators
- Principal Investigator: Michael Hunt, PT, PhD, The University of British Columbia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H26-00511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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