Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538363
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Running Online Injury Prevention Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Running Online Injury Prevention Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROIPF
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
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 eg 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 eg 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 diddid 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None