Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance

NCT ID: NCT06425939

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Rate Variability Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single group

Healthy adults moderately trained in resistance exercises

Group Type OTHER

Force plate assessment

Intervention Type OTHER

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

Whoop wrist band

Intervention Type DEVICE

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corey Ungaro, PhD

Role: PRINCIPAL_INVESTIGATOR

PepsiCo, Inc. Sports Science

Locations

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PepsiCo R&D, Gatorade Sports Science Institute

Chicago, Illinois, United States

Site Status RECRUITING

PepsiCo R&D, Gatorade Sports Science Institute

Frisco, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Corey Ungaro, PhD

Role: CONTACT

815-382-3213

Eric Freese, PhD

Role: CONTACT

Facility Contacts

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Corey Ungaro, PhD

Role: primary

815-382-3213

Anthony Wolfe, M.S.

Role: primary

469-920-2862

Other Identifiers

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PEP-2401

Identifier Type: -

Identifier Source: org_study_id

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