- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06556212
Real-time Feedback in Swimming: Workout Compliance and Swimming Performance Outcomes Using Smart Swim Goggles
Study Overview
Status
Intervention / Treatment
Detailed Description
The following research questions guide the study design:
- Do recreational swimmers exhibit greater workout adherence when utilizing FORM goggles for real-time visual feedback in comparison to recreational swimmers who do not utilize such feedback?
- Will the utilization of real-time visual feedback lead to higher motivation levels for recreational swimmers in comparison to recreational swimmers who do not utilize such real-time feedback?
- Will there be a more pronounced performance enhancement among recreational swimmers who employ real-time visual feedback during a 12-week training period, as opposed to recreational swimmers who do not utilize such feedback?
The experiment will be conducted over 13 weeks. Week 1 and the final day of week 13 will be in-person. The remaining weeks/days will be completed by the participants on their own. The in-person days will be carried out in a designated 25-meter indoor swimming pool using 6 lanes with a total of 12 swimmers per session. Video footage will be captured on all in-person days as a reference for any discrepancies in the FORM goggles output, and as a more precise method of measuring the performance test. FORM goggles will be used by all participants.
Prior to Week 1, educational material and the Get Active Questionnaire will be provided to participants. The educational material will include information on standard swimming workout language, session rating of perceived exertion (sRPE), using the FORM goggles, and using the FORM Swim application on a cellular phone. The Get Active Questionnaire will need to be completed prior to commencing testing.
Week 1 sessions will be utilized for familiarization/testing purposes and for recording data for the heart rate validation component of the study. Within each session, all participants will be equipped with an external heart rate monitor (Polar Verity) and 4 will be equipped with an additional heart rate monitor (Garmin HRM-Swim). Two sessions will be designated for the participants to get accustomed to the FORM goggles (face fit, field of view, and user interface). These sessions will consist of standardized workouts between 1000m and 2000m. The remaining session will be used to complete a performance test as described in the paragraph below. Before the data collection commences the following will occur:
- Establishing the participants' understanding of the educational material distributed prior to week 1
- Retrieval of completed Get Active Questionnaires
- Briefing the participants on using the FORM goggles and FORM app by the research personnel
Week 1 will contain a baseline performance test. This performance test will determine the participants' critical swim speed (CSS) through two maximal efforts (400 m front crawl, followed by 50 m front crawl) with adequate rest between to produce "best-effort" swims. At the end of week 1, participants will be stratified and randomized into an intervention group ("feedback") and control group ("non-feedback") and reported using the CONSORT guidelines. "Feedback" will differ from "non-feedback" in that they will have the FORM goggles display on and receive real-time metrics and guided workouts throughout the remainder of the study. "non-feedback" will have the display turned on but will only have the workout timer visible during rest. Each group will be provided with the same twelve-week training program. Within each group there will be three training plan volumes (High, Medium, Low) that participants will be assigned to, ensuring appropriate training load prescription per participant. A swim coach will make the assignments using information from the participants' previous swimming experience, and the participants' baseline CSS. "Feedback" will have the convenience of guided workouts in the FORM goggles, while "non-feedback" will be required to use other methods of remembering their workouts (i.e., paper, standard training application, etc.).
Weeks 2-13 will consist of unsupervised sessions to assess the impact of motivation, compliance and workout adherence on CSS performance. The participants will complete three workouts per week on their own time at their local indoor pool.
Week 13 will conclude with a final CSS performance test on the final workout day.
Workout instructions will be provided via email and in-app to all participants at the beginning of each training week. A questionnaire will be delivered to each participant after each training session to record data such as their perceived effort of the training session, exercise motivation, and exercise enjoyment. An additional questionnaire will be provided every 4 weeks to assess participants' experience with the usability and legibility of the FORM goggles or other utilized workout instruction/performance feedback device.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6S 1V1
- St. George's Senior School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Can swim 400m front crawl (FR) continuously at a maximum effort
- Can swim a minimum of 3 times a week
- Can swim a minimum of 2000m in a session
- Are not currently injured and have had a minimum of 6 weeks recovery from a previous injury
- Are proficient in FR, backstroke (BK), breaststroke (BR)
- Prepared to dedicate 1-1.5 hours a session for 4 in-person sessions
- Are able to complete 3 workouts a week for 12 weeks on their own on separate days with at least one day in between workouts
- Live in British Columbia, Canada and live max 15km from nearest public pool
- Must be willing to minimize all other forms of physical training during the study period
Exclusion Criteria:
- Current competitive swimmer
- Currently training on a swim team or in a swim club
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback
This arm will have the smart swim goggles display on and receive real-time metrics and guided workouts via the goggles throughout the study training period.
|
Smart swim goggles (Form Athletica Inc.) with activity metrics (such as heart rate, swimming pace, and workout instructions) displayed in real-time during a swimming activity.
|
|
No Intervention: Non-feedback
This arm will have the smart swim goggles display turned on but will only have the workout timer visible during rest.
They will not receive real-time metrics or guided workouts via the goggles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance: Workout pool length count difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as the difference (count) between prescribed pool lengths and completed pool lengths per workout.
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Compliance: Interval rest time difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as the difference (seconds) between prescribed rest time and actual rest time per rest interval.
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Compliance: Interval stroke type difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as a "success" (1) or "failure" (0) to complete the prescribed stroke type per swim interval.
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Compliance: Interval effort difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as a "success" (1) or "failure" (0) to meet the prescribed effort (based on a participant-specific percentage of critical swim speed) per freestyle swim interval.
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Compliance: Workout effort difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as the difference (count) between prescribed workout effort and participant provided workout effort.
Workout effort is quantified using session rating of perceived exertion (sRPE) which is evaluated using the Borg Category-Ratio 10 scale.
The minimum value is 0 (indicating no exertion at all) and the maximum value is 10 (indicating maximal exertion).
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Motivation: Completed workout difference
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Measured as the difference (count) between prescribed workouts and completed workouts.
|
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Motivation: Questionnaire
Time Frame: From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
Evaluated after every workout (via an online questionnaire) on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree) for the following questions:
Higher scores indicate higher motivation levels. |
From Week 2 of the study to the end of Week 13 (Weeks 1 to 12 of the training program).
|
|
Performance: Adaptation (Critical swim speed)
Time Frame: From the start of Week 1 of the training program to the end of week 12 of the training program.
|
Performance is measured as the difference (metres/second) between the baseline critical swim speed, measured at the end of Week 1 of the study, and the post-training critical swim speed, measured at the end of Week 13 of the study (end of Week 12 of the training program).
|
From the start of Week 1 of the training program to the end of week 12 of the training program.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity: Heart rate sensor
Time Frame: Week 1 of the study
|
Is the smart swim goggles integrated photoplethysmography heart rate sensor valid and reliable when compared to an electrocardiogram sensor (Garmin HRM-Swim)? Validity will be measured as the difference (beats per minute) between heart rate values from the Garmin HRM-Swim monitor and heart rate values from the smart swim goggles from two separate workouts in Week 1 of the study. |
Week 1 of the study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David C Clarke, PhD, Simon Fraser University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 30001408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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