About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Running volume increase
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
T1rho relaxation time - medial tibia
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.
T1rho relaxation time - medial femur
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.
T1rho relaxation time - patella
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale
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.
Other outcomes
Numerical rating scale of pain
11-point numerical rating scale; 0 = no pain; 10 = worst pain imaginable
Knee joint contact force impulse during running
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.
Sponsors and contacts
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