The Garmin-RUNSAFE Running Health Study on the aetiology of running-related injuries: rationale and design of an 18-month prospective cohort study including runners worldwide.

introductionRunning injuries affect millions of persons every year and have become a substantial public health issue owing to the popularity of running. To ensure adherence to running, it is important to prevent injuries and to have an in-depth understanding of the aetiology of running injuries. The main purpose of the present paper was to describe the design of a future prospective cohort study exploring if a dose-response relationship exists between changes in training load and running injury occurrence, and how this association is modified by other variables. METHODS AND ANALYSIS: In this protocol, the design of an 18-month observational prospective cohort study is described that will include a minimum of 20 000 consenting runners who upload their running data to Garmin Connect and volunteer to be a part of the study. The primary outcome is running-related injuries categorised into the following states: (1) no injury; (2) a problem; and (3) injury. The primary exposure is change in training load (eg, running distance and the cumulative training load based on the number of strides, ground contact time, vertical oscillation and body weight). The change in training load is a time-dependent exposure in the sense that progression or regression can change many times during follow-up. Effect-measure modifiers include, but is not limited to, other types of sports activity, activity of daily living and demographics, and are assessed through questionnaires and/or by Garmin devices. ETHICS AND DISSEMINATION: The study design, procedures and informed consent have been evaluated by the Ethics Committee of the Central Denmark Region (Request number: 227/2016 - Record number: 1-10-72-189-16).