The Effectiveness of a Running-related Injury Prevention Program in Runners

Study Overview
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Brief Summary
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Running is effective in increasing levels of physical activity and promotes a number of beneficial health effects. However, running can lead to running- related injuries (RRI). In theory, such injuries can be avoided with the implementation of prevention programs. But in practice, there is a paucity of prevention programs that are effective in reducing the risk of RRIs. In a previous study, the investigators developed an RRI prevention program using the Intervention Mapping framework. The RRI prevention program was named RunIn3. The present study will evaluate the effectiveness of the RunIn3 RRI prevention program. Objective: To investigate the effectiveness of an RRI prevention program (i.e., RunIn3). There will be recruited 530 runners of the state of São Paulo aged 18 years or older. After inclusion, participants will be randomly assigned and allocated in two groups: (1) intervention group, which will be the target of the implementation of the RunIn3 prevention program; and (2) control group, which will receive a minimal intervention (i.e., feedback based on surveillance).

Official Title
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The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial

Conditions
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Running-related Injuries

Intervention / Treatment
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* Behavioral: RunIn3 Prevention Program
* Behavioral: Feedback Based Surveillance


Participation Criteria
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Eligibility Criteria
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Running experience of at least three months; Residents of the state of São Paulo; No running-related injury (RRI) at baseline; No history of RRI in the past three months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge. | Behavioral: RunIn3 Prevention Program<br>* The intervention will be delivered online. Every two weeks we will send a link to participants that will direct them to an online questionnaire. The online questionnaire will collect information on complaints and symptoms related to running, and the volume, intensity and frequency of running practice within the 2-week period. If the participant reports any symptom and if she/he accepts a suggestion regarding running training, an algorithm embedded in the online system will automatically suggest a training volume for the next two weeks based on the distance and/or duration reported by the participant. Through a website we will make available informative texts, videos and infographics in order to increase the participant's knowledge regarding topics such as: musculoskeletal symptoms; foot strike patterns; training workload; running shoes; warming-up/cooling-down, stretching; and concomitant strength training.<br>|
| Active Comparator: Control<br>Monitoring and suggestion of training progress. | Behavioral: Feedback Based Surveillance<br>* The intervention will be delivered online. Every two weeks we will send a link to participants that will direct them to an online questionnaire. The online questionnaire will collect information on complaints and symptoms related to running, and the volume, intensity and frequency of running practice within the 2-week period. If the participant reports any symptom and if she/he accepts a suggestion regarding running training, an algorithm embedded in the online system will automatically suggest a training volume for the next two weeks based on the distance and/or duration reported by the participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Running-related injuries (RRI) | Symptoms and complaints related to running will be measured and monitored by the Brazilian-Portuguese version of the Oslo Sports Trauma Research Center (OSTRC) Questionnaire on Health Problems (OSTRC-Br). | After 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour | The preventive behaviours towards running-related injuries (RRI) adopted or modified will be collected using an online questionnaire that will be composed of questions with 7-point Likert scales (-3 to +3). | After 12 months from baseline | 
| Costs | The cost data will be collected through a questionnaire composed of open-ended and multiple choice questions regarding direct costs (medical and non-medical costs) and indirect costs (work absenteeism) regarding participants' health related to running practice. | After 12 months from baseline | 
| Incremental cost-effectiveness ratio (ICER) | The incremental cost-effectiveness ratio (ICER) will be estimated taking total costs and the effects on running-related injuries (RRI). | After 12 months from baseline |