Running Online Injury Prevention Feasibility Study (ROIPF)

August 1, 2024 updated by: Chris Napier, Simon Fraser University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chris Napier, PhD
  • Phone Number: 6047211310
  • Email: cnapier@sfu.ca

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A 1S6
        • Simon Fraser University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Education
Personalized training advice
Active Comparator: Control
Behavioral: Generic Education
Generic training advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: 4 weeks
- The number of participants enrolled versus the target number.
4 weeks
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.
12 weeks
Attendance
Time Frame: 16 weeks
- Attendance rate at the initial in-person orientation session and optional in-person group runs.
16 weeks
Adherence to Training Recommendations
Time Frame: 12 weeks
- Percentage of participants in the intervention group who follow the individualized training recommendations.
12 weeks
Training Program Compliance
Time Frame: 12 weeks
- Percentage of completed prescribed training runs per week during the 12-week half-marathon training program.
12 weeks
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury incidence
Time Frame: 12 weeks
- 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").
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Collaborators

Natural Sciences and Engineering Research Council, Canada

Investigators

  • Principal Investigator: Chris Napier, PhD, Simon Fraser University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SimonFraserU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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