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

NCT06425939 | Completed

• 1 other identifier: PEP-2401
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Rate Variability; Exercise

Keywords

exercise performance; HRV; training load; Whoop; wrist worn tracker; exercise recovery

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• Peak Power Output

  W/kg using force plates

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

• Jump Height

  (cm) using force plates

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

• 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 Outcomes (4)

• Correlation of subjective measures to Heart Rate Variability (HRV)

  Daily for 90 days

• Correlation of subjective measures to resting heart rate (RHR)

  Daily for 90 days

• Correlation of subjective measures to sleep quantity

  Daily for 90 days

• Correlation of subjective measures to sleep efficiency

  Daily for 90 days

Study Arms (1)

Single group

OTHER

Healthy adults moderately trained in resistance exercises

Other: Force plate assessment; Device: Whoop wrist band

Interventions

Force plate assessment 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

Single group

Whoop wrist band 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.

Single group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Actively participating in resistance training 2-4 times per week.
• Age 21-50 years, male and female.
• Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to visit(s).
• Subject is willing to avoid alcohol consumption 24 hours prior to visit(s).
• Subject is willing to provide consent.
• Subject is able to continuously wear a wrist-worn device, including during sleep, except when submerged underwater (i.e., swimming, bathing).

You may not qualify if:

• 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.
• Those with a medical history that would interfere with the results of this study.
• Under the care of a physician.
• Skin sensitivities.
• Sleep disorders.
• Using prescription medications that would impact sleep.
• If female, you are not pregnant, planning to get pregnant or currently breast feeding.
• Smoker.
• Not able to wear wrist-worn device continuously.
• Lack of proficiency in English.
• Lack of proficiency or access to the internet and email address.
• Participation in another clinical trial within the past 30 days.
• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (2)

PepsiCo R&D, Gatorade Sports Science Institute

Chicago, Illinois, 60607, United States

Location

PepsiCo R&D, Gatorade Sports Science Institute

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Corey Ungaro, PhD

  PepsiCo, Inc. Sports Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: May 8, 2024
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)