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Not yet recruiting NCT07528885

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

No phase Interventional Osteoarthritis (OA) of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Running volume increase.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • T2 relaxation time - medial tibia [Time frame: Baseline and 6 months]
  • T2 relaxation time - medial femur [Time frame: Baseline and 6 months]
  • T2 relaxation time - patella [Time frame: Baseline and 6 months]
Secondary outcome measures (5)
  • T1rho relaxation time - medial tibia [Time frame: Baseline and 6 months]
  • T1rho relaxation time - medial femur [Time frame: Baseline and 6 months]
  • T1rho relaxation time - patella [Time frame: Baseline and 6 months]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale [Time frame: Baseline and 6 months]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) - function in daily living subscale [Time frame: Baseline and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Canada · 1 center
  • Motion Analysis and Biofeedback Laboratory, The University of British Columbia — Vancouver

Identifiers

NCT: NCT07528885 · H26-00511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗