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Completed

NCT Number: NCT03892239

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

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).

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Key information

Conditions

Running-related Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Cidade de São Paulo (UNICID)

São Paulo, 03071000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

RunIn3 Prevention Program

Behavioral

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.

Feedback Based Surveillance

Behavioral

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.

Primary outcomes

  1. Running-related injuries (RRI)

    Time frame: After 12 months from baseline

    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).

Secondary outcomes

  1. Behaviour

    Time frame: After 12 months from baseline

    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).

  2. Costs

    Time frame: After 12 months from baseline

    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.

  3. Incremental cost-effectiveness ratio (ICER)

    Time frame: After 12 months from baseline

    The incremental cost-effectiveness ratio (ICER) will be estimated taking total costs and the effects on running-related injuries (RRI).

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2019
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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