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

NCT ID: NCT03892239

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-08

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).

Detailed Description

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Conditions

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Running-related Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge.

Group Type EXPERIMENTAL

RunIn3 Prevention Program

Intervention Type 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.

Control

Monitoring and suggestion of training progress.

Group Type ACTIVE_COMPARATOR

Feedback Based Surveillance

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luiz Carlos Hespanhol Junior

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caio S Vallio, PT

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo (UNICID)

Luiz Hespanhol, PhD

Role: STUDY_CHAIR

Universidade Cidade de São Paulo (UNICID)

Locations

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Universidade Cidade de São Paulo (UNICID)

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Barros PM, Vallio CS, Oliveira GM, Miyamoto GC, Hespanhol L. Cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3): Protocol of a randomized controlled trial. Contemp Clin Trials Commun. 2021 Jan 20;21:100726. doi: 10.1016/j.conctc.2021.100726. eCollection 2021 Mar.

Reference Type DERIVED
PMID: 33553800 (View on PubMed)

Other Identifiers

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UNICID 20

Identifier Type: -

Identifier Source: org_study_id