Musculoskeletal InjuryROIPFNCT06538363
Running Online Injury Prevention Feasibility Study
A study testing Education and Generic Education in people with Musculoskeletal Injury, run by Simon Fraser University at 1 site in Canada.
Trial summary
The main purpose of this study is to test the feasibility of a larger scale interventional study. The investigators want to understand whether data can be reliably collected data various different streams while participants follow a standard 12-week half-marathon training program, and whether participants follow… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Education and Generic Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Jan 2025
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cis-gender female (someone who was born female and currently identifies as a woman) runners
- Over the age of 18
- Have not been injured in the last 3 months (For the purpose of this study, an injury is defined as "musculoskeletal (originating from the bones, muscles, joints) that has restricted the ability to run in any way (distance, speed, duration) for at least 7 days or for 3 consecutive training sessions")
- Have run on average 3 times/week for the last 6 months
- Own a GPS-enabled smart watch with an optical wrist heart rate sensor
- Fit shoe size between 6.5 and 8.5 US women's sizing
- Able to attend one of the in-person orientation sessions
- Able to understand written and spoken English
Who cannot join
- Any current pain with running
Trial locations and contacts
1 site in 1 country.
Patrick Mayerhofer, PhD contact
Canada1 site
Simon Fraser University
Burnaby, British Columbia, V5A 1S6
Chris Napier, PhD, 6047211310, cnapier@sfu.ca
About this study
The main purpose of this study is to test the feasibility of a larger scale interventional study. The investigators want to understand whether data can be reliably collected data various different streams while participants follow a standard 12-week half-marathon training program, and whether participants follow training recommendations.
Read the detailed description
Research procedures will include an online eligibility questionnaire, a demographic intake questionnaire, a weekly injury questionnaire, and an exit questionnaire (hosted on the SFU Survey Monkey platform). This study involves an initial in-person 1-hour orientation session. Multiple dates will be offered in order to accommodate participants. Participants will be randomly allocated to either the control or intervention group. All participants will be given a pair of running shoes (Hettas Sport Ltd.). Half of the participants in each group will also be outfitted with a pair of shoe-embedded sensors (Plantiga Technologies, Inc.). All participants will also be given access to a menstrual cycle tracking app (MyNormative). If participants have a Strava profile already, this will be linked to the study third-party data extraction API called "Strava API" to give the research team access to select workout data. If participants do not have a Strava profile, an anonymous profile will be created and linked to the API. Participants will be oriented on how to use the shoe-embedded sensors and MyNormative app. Following a one to two week familiarization period in which the participants can become comfortable with the protocol, participants will commence a 12-week half-marathon training program guided by a coach. The training program will consist of four runs per week, including two optional in-person group runs, and will culminate with a half-marathon race. Over the course of the training program, participants will be responsible for uploading the data from the shoe-embedded sensors after each run (for those that have them), tracking their menstrual cycle with the MyNormative app, and recording their runs with their GPS-enabled smartwatch which will automatically upload training data to Strava. Participants in the intervention group will be given individualized training recommendations based on their training data uploaded to Strava (e.g., "Training load is high, take a rest day tomorrow" or "Training load is appropriate, continue as planned"). Training load will be calculated from average distance, speed, step count, and heart rate. Participants in the control group will receive generic training recommendations (e.g., "Keep up the good work" or "Make sure to balance training with enough recovery time"). Communication with the participants will occur via text message on their personal cell phone. Following completion of the study, participants in the intervention group will be asked to complete an online questionnaire about why the participants did/did not follow the individualized training advice. Participants will be permitted to keep the running shoes but will be required to return the shoe-embedded sensors at study completion.
- Conditions
- Musculoskeletal Injury
- Being tested
- Education, Generic Education
- Keywords
- Running, Wearable sensors, Biomechanics, Training, Education, Female athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Personalized training advice
Generic EducationBehavioural
Generic training advice
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: Generic Education |
| Intervention | Experimental | Not described Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
- The number of participants enrolled versus the target number.
Measured: 4 weeks
Data Collection Compliance
- The percentage of participants who complete the online eligibility questionnaire, demographic intake questionnaire, weekly injury questionnaire, and exit questionnaire.
- The percentage of participants who reliably upload data from the shoe-embedded sensors after each run.
- The percentage of participants who consistently track their menstrual cycle with the MyNormative app.
- The percentage of participants who regularly record their runs with their GPS-enabled smartwatch and upload data to Strava.
Measured: 12 weeks
Attendance
- Attendance rate at the initial in-person orientation session and optional in-person group runs.
Measured: 16 weeks
Adherence to Training Recommendations
- Percentage of participants in the intervention group who follow the individualized training recommendations.
Measured: 12 weeks
Training Program Compliance
- Percentage of completed prescribed training runs per week during the 12-week half-marathon training program.
Measured: 12 weeks
Satisfaction and Usability
- Participant feedback on the ease of use and satisfaction with the shoe-embedded sensors, MyNormative app, and Strava integration. Measured during the exit questionnaire.
- Participant feedback on the clarity and usefulness of the training recommendations (both individualized and generic). Measured during the exit questionnaire.
Measured: 12 weeks
Barriers and Facilitators
- Reasons provided by participants in the intervention group for following or not following the individualized training advice, as captured in the exit questionnaire.
Measured: 12 weeks
Secondary outcomes (1)
Injury incidence
- Incidence and severity of running-related injuries reported weekly via the injury questionnaire. Injuries are defined according to the consensus definition of running injuries by Yamato et al ("musculoskeletal (originating from the bones, muscles, joints) that has restricted your ability to run in any way (distance, speed, duration) for at least 7 days or for 3 consecutive training sessions").
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
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 Musculoskeletal InjuryStudies 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
- Model description
- Control and Intervention group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Chris Napier, Simon Fraser University
- Investigators
- Chris Napier, PhD, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538363
- Sponsor's protocol ID
- SimonFraserU
- Acronym
- ROIPF
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamato TP, Saragiotto BT, Lopes AD. A consensus definition of running-related injury in recreational runners: a modified Delphi approach. J Orthop Sports Phys Ther. 2015 May;45(5):375-80. doi: 10.2519/jospt.2015.5741. Epub 2015 Mar 26.
PubMed 25808527
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Running Online Injury Prevention Feasibility Study
- ClinicalTrials.gov ID
- NCT06538363
- Acronym / sponsor ID
- ROIPF / SimonFraserU
- Conditions
- Musculoskeletal Injury
- Keywords
- Running, Wearable sensors, Biomechanics, Training, Education, Female athlete
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Aug 2024 (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.
The main purpose of this study is to test the feasibility of a larger scale interventional study. The investigators want to understand whether data can be reliably collected data various different streams while participants follow a standard 12-week half-marathon training program, and whether participants follow training recommendations.
Detailed description
Research procedures will include an online eligibility questionnaire, a demographic intake questionnaire, a weekly injury questionnaire, and an exit questionnaire (hosted on the SFU Survey Monkey platform). This study involves an initial in-person 1-hour orientation session. Multiple dates will be offered in order to accommodate participants. Participants will be randomly allocated to either the control or intervention group. All participants will be given a pair of running shoes (Hettas Sport Ltd.). Half of the participants in each group will also be outfitted with a pair of shoe-embedded sensors (Plantiga Technologies, Inc.). All participants will also be given access to a menstrual cycle tracking app (MyNormative). If participants have a Strava profile already, this will be linked to the study third-party data extraction API called "Strava API" to give the research team access to select workout data. If participants do not have a Strava profile, an anonymous profile will be created and linked to the API. Participants will be oriented on how to use the shoe-embedded sensors and MyNormative app. Following a one to two week familiarization period in which the participants can become comfortable with the protocol, participants will commence a 12-week half-marathon training program guided by a coach. The training program will consist of four runs per week, including two optional in-person group runs, and will culminate with a half-marathon race. Over the course of the training program, participants will be responsible for uploading the data from the shoe-embedded sensors after each run (for those that have them), tracking their menstrual cycle with the MyNormative app, and recording their runs with their GPS-enabled smartwatch which will automatically upload training data to Strava. Participants in the intervention group will be given individualized training recommendations based on their training data uploaded to Strava (e.g., "Training load is high, take a rest day tomorrow" or "Training load is appropriate, continue as planned"). Training load will be calculated from average distance, speed, step count, and heart rate. Participants in the control group will receive generic training recommendations (e.g., "Keep up the good work" or "Make sure to balance training with enough recovery time"). Communication with the participants will occur via text message on their personal cell phone. Following completion of the study, participants in the intervention group will be asked to complete an online questionnaire about why the participants did/did not follow the individualized training advice. Participants will be permitted to keep the running shoes but will be required to return the shoe-embedded sensors at study completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control and Intervention group
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Generic Education |
| Intervention | Experimental | Behavioral: Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cis-gender female (someone who was born female and currently identifies as a woman) runners
- Over the age of 18
- Have not been injured in the last 3 months (For the purpose of this study, an injury is defined as "musculoskeletal (originating from the bones, muscles, joints) that has restricted the ability to run in any way (distance, speed, duration) for at least 7 days or for 3 consecutive training sessions")
- Have run on average 3 times/week for the last 6 months
- Own a GPS-enabled smart watch with an optical wrist heart rate sensor
Key exclusion criteria (1 listed)
- Any current pain with running
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 |
|---|---|---|
| EducationPersonalized training advice | Behavioural | Intervention |
| Generic EducationGeneric training advice | Behavioural | Control |
Primary outcome
Recruitment Rate
Time frame: 4 weeks
- The number of participants enrolled versus the target number.
Data Collection Compliance
Time frame: 12 weeks
* The percentage of participants who complete the online eligibility questionnaire, demographic intake questionnaire, weekly injury questionnaire, and exit questionnaire. * The percentage of participants who reliably upload data from the shoe-embedded sensors after each run. * The percentage of participants who consistently track their menstrual cycle with the MyNormative app. * The percentage of participants who regularly record their runs with their GPS-enabled smartwatch and upload data to Strava.
Attendance
Time frame: 16 weeks
- Attendance rate at the initial in-person orientation session and optional in-person group runs.
Adherence to Training Recommendations
Time frame: 12 weeks
- Percentage of participants in the intervention group who follow the individualized training recommendations.
Training Program Compliance
Time frame: 12 weeks
- Percentage of completed prescribed training runs per week during the 12-week half-marathon training program.
Satisfaction and Usability
Time frame: 12 weeks
* Participant feedback on the ease of use and satisfaction with the shoe-embedded sensors, MyNormative app, and Strava integration. Measured during the exit questionnaire. * Participant feedback on the clarity and usefulness of the training recommendations (both individualized and generic). Measured during the exit questionnaire.
Barriers and Facilitators
Time frame: 12 weeks
- Reasons provided by participants in the intervention group for following or not following the individualized training advice, as captured in the exit questionnaire.
1 secondary outcome
Injury incidence
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 25808527Yamato TP, Saragiotto BT, Lopes AD. A consensus definition of running-related injury in recreational runners: a modified Delphi approach. J Orthop Sports Phys Ther. 2015 May;45(5):375-80. doi: 10.2519/jospt.2015.5741. Epub 2015 Mar 26.
- 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.
Patrick Mayerhofer, PhD contact
Chris Napier, PhD principal investigator
Simon Fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Generic Education in people with Musculoskeletal Injury, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Napier, PhD (6047211310, cnapier@sfu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 4 weeks). The study lists 7 primary outcomes in all. 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 NCT06538363, 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 5 Aug 2024.