NCT03892239

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

February 5, 2019

Last Update Submit

October 13, 2021

Conditions

Running-related Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Behaviour

    After 12 months from baseline

  • Costs

    After 12 months from baseline

  • Incremental cost-effectiveness ratio (ICER)

    After 12 months from baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: RunIn3 Prevention Program

Control

ACTIVE COMPARATOR

Monitoring and suggestion of training progress.

Behavioral: Feedback Based Surveillance

Interventions

RunIn3 Prevention ProgramBEHAVIORAL

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
Feedback Based SurveillanceBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Universidade Cidade de São Paulo (UNICID)

São Paulo, 03071000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 33553800DERIVED

Study Officials

  • Caio S Vallio, PT

    Universidade Cidade de São Paulo (UNICID)

    PRINCIPAL INVESTIGATOR

  • Luiz Hespanhol, PhD

    Universidade Cidade de São Paulo (UNICID)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

March 27, 2019

Study Start

April 1, 2019

Primary Completion

January 8, 2021

Study Completion

January 8, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)