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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06425939
Other study ID # PEP-2401
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2024
Est. completion date September 30, 2024

Study information

Verified date May 2024
Source PepsiCo Global R&D
Contact Corey Ungaro, PhD
Phone 815-382-3213
Email corey.ungaro1@pepsico.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Heart rate variability (HRV) is a measure of the variation in time between each heartbeat. It is an indirect and ubiquitous biomarker of performance readiness and recovery measured by most consumer-grade wearable fitness trackers. However, there is little documented on the relationship between HRV, training load, and performance measures in the Real-World. Whoop wrist-worn activity trackers have been validated against the gold-standard Electrocardiography (ECG) for HRV and HR measurements. Whoop leverages photoplethysmography (PPG) technology to continuously track (HR, HRV, respiratory rate, energy expenditure) and provides, daily, individual insights, trends, and coaching to improve strain, sleep, and recovery. Research has demonstrated that heart rate variability (HRV) guided training may be more optimal compared to predetermined training for aerobic exercise improvements. The purpose of this study is to assess the feasibility of providing personalized training recommendations based on HRV measured by a consumer-grade wearable (Whoop) in a real-world setting to better understand the HRV relationship with performance.


Description:

The purpose of this study is to determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates, which could lead to personalized training recommendations using HRV. The Investigators conducted a pilot study using Whoop devices to monitor 50 subjects for 3 months and observed that individuals had High Training Load (above their baseline) on Low HRV days (below their baseline) on over 200 days. The Investigators hypothesize seeing similar High Training Load on Low HRV days during this study and would like to understand that relationship with Performance Primary objective: To determine if Training Intensity (%HRmax in min.) during Low HRV periods acutely (below HRV baseline next day and consecutive days) and chronically (weeks below previous weeks HRV baseline) will have a negative relationship with Post-Test Performance Metrics as measured by Force Plates. Secondary Objective : Measure and determine if subjective journal entries (mood, anxiety, recovery, etc.) are related to HRV, RHR, Sleep Quantity, and Sleep Efficiency.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: 1. Actively participating in resistance training 2-4 times per week. 2. Age 21-50 years, male and female. 3. Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to visit(s). 4. Subject is willing to avoid alcohol consumption 24 hours prior to visit(s). 5. Subject is willing to provide consent. 6. Subject is able to continuously wear a wrist-worn device, including during sleep, except when submerged underwater (i.e., swimming, bathing). Exclusion Criteria: 1. Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project/study protocol, which might confound the interpretation of the project/study results or put the person at undue risk. 2. Those with a medical history that would interfere with the results of this study. 3. Under the care of a physician. 4. Skin sensitivities. 5. Sleep disorders. 6. Using prescription medications that would impact sleep. 7. If female, you are not pregnant, planning to get pregnant or currently breast feeding. 8. Smoker. 9. Not able to wear wrist-worn device continuously. 10. Lack of proficiency in English. 11. Lack of proficiency or access to the internet and email address. 12. Participation in another clinical trial within the past 30 days. 13. Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Force plate assessment
On Day 1, Day 45 and Day 90: 3x drop jumps, 2 min rest, 3x counter movement jumps, 2 min rest, 3x dynamic push-ups
Device:
Whoop wrist band
Whoop wrist worn activity tracker (not a medical device) collects continuous data via smartphone app. This is a marketed device. This is not a device study.

Locations

Country Name City State
United States PepsiCo R&D, Gatorade Sports Science Institute Chicago Illinois
United States PepsiCo R&D, Gatorade Sports Science Institute Frisco Texas

Sponsors (1)

Lead Sponsor Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Training Intensity % HRmax (in minutes) measured by force plates Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Primary Performance Reactive Strength Index in cm/s using force plates Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Primary Peak Power Output W/kg using force plates Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Primary Jump Height (cm) using force plates Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90)
Primary Dynamic Push Ups Peak Force (N)) using force plates Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Secondary Correlation of subjective measures to Heart Rate Variability (HRV) True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin Daily for 90 days
Secondary Correlation of subjective measures to resting heart rate (RHR) True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin Daily for 90 days
Secondary Correlation of subjective measures to sleep quantity True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin Daily for 90 days
Secondary Correlation of subjective measures to sleep efficiency True or False answers to Whoop app journal questions for mood, e.g., nervous, anxious, stability, motivation, energy, feeling sick or stressed, hydration, recovery, consumption of alcohol, caffeine, or melatonin Daily for 90 days
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