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

Primary Purpose

Running-related Injuries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
RunIn3 Prevention Program
Feedback Based Surveillance
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Running-related Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • 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.

Sites / Locations

  • Universidade Cidade de São Paulo (UNICID)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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

Monitoring and suggestion of training progress.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2019
Last Updated
October 13, 2021
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03892239
Brief Title
The Effectiveness of a Running-related Injury Prevention Program in Runners
Official Title
The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Running-related Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Monitoring and suggestion of training progress.
Intervention Type
Behavioral
Intervention Name(s)
RunIn3 Prevention Program
Intervention Description
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
Intervention Name(s)
Feedback Based Surveillance
Intervention Description
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 Outcome Measure Information:
Title
Running-related injuries (RRI)
Description
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).
Time Frame
After 12 months from baseline
Secondary Outcome Measure Information:
Title
Behaviour
Description
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).
Time Frame
After 12 months from baseline
Title
Costs
Description
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.
Time Frame
After 12 months from baseline
Title
Incremental cost-effectiveness ratio (ICER)
Description
The incremental cost-effectiveness ratio (ICER) will be estimated taking total costs and the effects on running-related injuries (RRI).
Time Frame
After 12 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caio S Vallio, PT
Organizational Affiliation
Universidade Cidade de São Paulo (UNICID)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luiz Hespanhol, PhD
Organizational Affiliation
Universidade Cidade de São Paulo (UNICID)
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Cidade de São Paulo (UNICID)
City
São Paulo
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33553800
Citation
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.
Results Reference
derived

Learn more about this trial

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

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