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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• T2 relaxation time - medial tibia [Срок оценки: Baseline and 6 months]
• T2 relaxation time - medial femur [Срок оценки: Baseline and 6 months]
• T2 relaxation time - patella [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (5)

• T1rho relaxation time - medial tibia [Срок оценки: Baseline and 6 months]
• T1rho relaxation time - medial femur [Срок оценки: Baseline and 6 months]
• T1rho relaxation time - patella [Срок оценки: Baseline and 6 months]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale [Срок оценки: Baseline and 6 months]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) - function in daily living subscale [Срок оценки: Baseline and 6 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 1 центр

• Motion Analysis and Biofeedback Laboratory, The University of British Columbia — Vancouver

Идентификаторы

NCT: NCT07528885 · H26-00511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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