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

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ClinicalTrials.gov Identifier: NCT03892239
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Luiz Carlos Hespanhol Junior, 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).


Condition or disease Intervention/treatment Phase
Running-related Injuries Behavioral: RunIn3 Prevention Program Behavioral: Feedback Based Surveillance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892239


Contacts
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Contact: Gabriela Oliveira, PT +5511959821986 gmartins9569@gmail.com
Contact: Pamela Marinelli, PT +5511981668819 pamelamarinelli@hotmail.com

Locations
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Brazil
Universidade Cidade de São Paulo (UNICID) Not yet recruiting
São Paulo, Brazil, 03071000
Contact: Luiz Hespanhol, PhD    +55 11 21781564    l.hespanhol@outlook.com   
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Caio S Vallio, PT Universidade Cidade de São Paulo (UNICID)
Study Chair: Luiz Hespanhol, PhD Universidade Cidade de São Paulo (UNICID)

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Responsible Party: Luiz Carlos Hespanhol Junior, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03892239     History of Changes
Other Study ID Numbers: UNICID 20
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries