Running Online Injury Prevention Feasibility Study

NCT ID: NCT06538363

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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

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Musculoskeletal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control and Intervention group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will be blinded to their group

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Generic Education

Intervention Type BEHAVIORAL

Generic training advice

Intervention

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Personalized training advice

Interventions

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Education

Personalized training advice

Intervention Type BEHAVIORAL

Generic Education

Generic training advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Any current pain with running
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

Simon Fraser University

OTHER

Sponsor Role lead

Responsible Party

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Chris Napier

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris Napier, PhD

Role: PRINCIPAL_INVESTIGATOR

Simon Fraser University

Locations

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Simon Fraser University

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Chris Napier, PhD

Role: CONTACT

6047211310

Patrick Mayerhofer, PhD

Role: CONTACT

Facility Contacts

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Chris Napier, PhD

Role: primary

6047211310

References

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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.

Reference Type BACKGROUND
PMID: 25808527 (View on PubMed)

Other Identifiers

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SimonFraserU

Identifier Type: -

Identifier Source: org_study_id

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