Running-related InjuriesNCT03892239
The Effectiveness of a Running-related Injury Prevention Program in Runners
A study testing RunIn3 Prevention Program and Feedback Based Surveillance in people with Running-related Injuries, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Running-related Injuries
- What is being tested?
- RunIn3 Prevention Program and Feedback Based Surveillance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2019to 8 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial
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).
- Conditions
- Running-related Injuries
- Being tested
- RunIn3 Prevention Program, Feedback Based Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RunIn3 Prevention ProgramBehavioural
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.
Feedback Based SurveillanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Monitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge. Receives: Behavioral: RunIn3 Prevention Program |
| Control | Active comparator | Monitoring and suggestion of training progress. Receives: Behavioral: Feedback Based Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 12 months from baseline
Secondary outcomes (3)
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).
Measured: After 12 months from baseline
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.
Measured: After 12 months from baseline
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).
Measured: After 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Running-related InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Hespanhol Junior, Universidade Cidade de Sao Paulo
- Investigators
- Caio S Vallio, PT, Principal investigator, Universidade Cidade de São Paulo (UNICID)Luiz Hespanhol, PhD, Study chair, Universidade Cidade de São Paulo (UNICID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892239
- Sponsor's protocol ID
- UNICID 20
- Status last verified
- Oct 2021
- First submitted
- 5 Feb 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33553800
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Running-related Injury Prevention Program in Brazilian Runners: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03892239
- Acronym / sponsor ID
- UNICID 20
- Conditions
- Running-related Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: RunIn3 Prevention ProgramMonitoring and suggestion of training progress. Behaviour change strategy based on increasing knowledge. |
| Control | Active comparator | Behavioral: Feedback Based SurveillanceMonitoring and suggestion of training progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RunIn3 Prevention ProgramThe 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. | Behavioural | Intervention |
| Feedback Based SurveillanceThe 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. | Behavioural | Control |
Primary outcome
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).
3 secondary outcomes
Behaviour
Time frame: After 12 months from baseline
Costs
Time frame: After 12 months from baseline
Incremental cost-effectiveness ratio (ICER)
Time frame: After 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 33553800Barros 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caio S Vallio, PT principal investigator
Universidade Cidade de São Paulo (UNICID)
Luiz Hespanhol, PhD study chair
Universidade Cidade de São Paulo (UNICID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RunIn3 Prevention Program and Feedback Based Surveillance in people with Running-related Injuries, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Running-related injuries (RRI) (time frame: After 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.