Running Online Injury Prevention Feasibility Study

NCT06538363 | Not Yet Recruiting

• 1 other identifier: SimonFraserU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 training recommendations.

Conditions

Musculoskeletal Injury

Keywords

Running; Wearable sensors; Biomechanics; Training; Education; Female athlete

Outcome Measures

Primary Outcomes (7)

• Recruitment Rate

  \- The number of participants enrolled versus the target number.

  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.

  12 weeks

• Attendance

  \- Attendance rate at the initial in-person orientation session and optional in-person group runs.

  16 weeks

• Adherence to Training Recommendations

  \- Percentage of participants in the intervention group who follow the individualized training recommendations.

  12 weeks

• Training Program Compliance

  \- Percentage of completed prescribed training runs per week during the 12-week half-marathon training program.

  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.

  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.

  12 weeks

Secondary Outcomes (1)

• Injury incidence

  12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Behavioral: Generic Education

Intervention

EXPERIMENTAL

Behavioral: Education

Interventions

Education BEHAVIORAL

Personalized training advice

Intervention

Generic Education BEHAVIORAL

Generic training advice

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any current pain with running

Sponsors & Collaborators

• Simon Fraser University: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25808527 BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Chris Napier, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Napier, PhD

CONTACT

6047211310; cnapier@sfu.ca

Patrick Mayerhofer, PhD

CONTACT

patrick_mayerhofer@sfu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control and Intervention group

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)