## Protocol Section
### Identification Module
**NCT ID:** NCT06425939

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

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

#### Organization Study ID Info
**ID:** PEP-2401
#### Organization
**Class:** INDUSTRY
**Full Name:** PepsiCo Global R&D
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** PepsiCo Global R&D

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Heart Rate Variability

- Exercise

**Keywords:**

- exercise performance

- HRV

- training load

- Whoop

- wrist worn tracker

- exercise recovery

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Healthy adults moderately trained in resistance exercises

**Intervention Names:**

- Other: Force plate assessment

- Device: Whoop wrist band

**Label:** Single group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single group

**Description:** 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

**Name:** Force plate assessment

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Single group

**Description:** 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.

**Name:** Whoop wrist band

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** % HRmax (in minutes) measured by force plates

**Measure:** Training Intensity

**Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)

**Description:** Reactive Strength Index in cm/s using force plates

**Measure:** Performance

**Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)

**Description:** W/kg using force plates

**Measure:** Peak Power Output

**Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)

**Description:** (cm) using force plates

**Measure:** Jump Height

**Time Frame:** Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90)

**Description:** (N)) using force plates

**Measure:** Dynamic Push Ups Peak Force

**Time Frame:** Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)

#### Secondary Outcomes

**Description:** 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

**Measure:** Correlation of subjective measures to Heart Rate Variability (HRV)

**Time Frame:** Daily for 90 days

**Description:** 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

**Measure:** Correlation of subjective measures to resting heart rate (RHR)

**Time Frame:** Daily for 90 days

**Description:** 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

**Measure:** Correlation of subjective measures to sleep quantity

**Time Frame:** Daily for 90 days

**Description:** 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

**Measure:** Correlation of subjective measures to sleep efficiency

**Time Frame:** Daily for 90 days

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** corey.ungaro1@pepsico.com

**Name:** Corey Ungaro, PhD

**Phone:** 815-382-3213

**Role:** CONTACT

**Contact 2:**

**Email:** eric.freese@pepsico.com

**Name:** Eric Freese, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** corey.ungaro1@pepsico.com

- **Name:** Corey Ungaro, PhD

- **Phone:** 815-382-3213

- **Role:** CONTACT

**Country:** United States

**Facility:** PepsiCo R&D, Gatorade Sports Science Institute

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60607

**Location 2:**

**City:** Frisco

**Contacts:**

***Contact 1:***

- **Email:** Anthony.Wolfe@pepsico.com

- **Name:** Anthony Wolfe, M.S.

- **Phone:** 469-920-2862

- **Role:** CONTACT

**Country:** United States

**Facility:** PepsiCo R&D, Gatorade Sports Science Institute

**State:** Texas

**Status:** RECRUITING

**Zip:** 75034

#### Overall Officials

**Official 1:**

**Affiliation:** PepsiCo, Inc. Sports Science

**Name:** Corey Ungaro, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
