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

October 13, 2021 updated by: Luiz Carlos Hespanhol Junior, Universidade Cidade de Sao Paulo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 03071000
        • Universidade Cidade de São Paulo (UNICID)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge.
Behavioral: RunIn3 Prevention Program

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.
Active Comparator: Control
Monitoring and suggestion of training progress.
Behavioral: Feedback Based Surveillance
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
After 12 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
After 12 months from baseline
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.
After 12 months from baseline
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).
After 12 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Cidade de Sao Paulo

Investigators

  • Principal Investigator: Caio S Vallio, PT, Universidade Cidade de São Paulo (UNICID)
  • Study Chair: Luiz Hespanhol, PhD, Universidade Cidade de São Paulo (UNICID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

January 8, 2021

Study Completion (Actual)

January 8, 2021

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNICID 20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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