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

Not Applicable

Completed

• Conditions: Running-related Injuries
• Interventions: Behavioral: Feedback Based Surveillance; Behavioral: RunIn3 Prevention Program

• Registration Number: NCT03892239
• Lead Sponsor: Universidade Cidade de Sao Paulo

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-04-01
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Feedback Based Surveillance	Monitoring and suggestion of training progress.
Intervention	RunIn3 Prevention Program	Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge.

Primary Outcome Measures

Name	Time	Method
Running-related injuries (RRI)	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 Outcome Measures

Name	Time	Method
Costs	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.
Incremental cost-effectiveness ratio (ICER)	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).
Behaviour	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).

Trial Locations

Locations (1)

Universidade Cidade de São Paulo (UNICID); 🇧🇷 São Paulo, Brazil