Heart Rate VariabilityNCT06425939
Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance
A study testing Force plate assessment and Whoop wrist band in people with Heart Rate Variability and Exercise, run by PepsiCo Global R&D at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Exercise
- What is being tested?
- Force plate assessment and Whoop wrist band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2024to 11 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PepsiCo R&D, Gatorade Sports Science Institute
Chicago, Illinois, 60607
PepsiCo R&D, Gatorade Sports Science Institute
Frisco, Texas, 75034
About this study
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.
Read more
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.
Read the 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
- Heart Rate Variability, Exercise
- Being tested
- Force plate assessment, Whoop wrist band
- Keywords
- exercise performance, HRV, training load, Whoop, wrist worn tracker, exercise recovery
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Force plate assessmentOther
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 bandDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Other | Healthy adults moderately trained in resistance exercises Receives: Other: Force plate assessment; Device: Whoop wrist band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training Intensity
% HRmax (in minutes) measured by force plates
Measured: 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
Measured: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Peak Power Output
W/kg using force plates
Measured: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Jump Height
(cm) using force plates
Measured: Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90)
Dynamic Push Ups Peak Force
(N)) using force plates
Measured: 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)
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
Measured: Daily for 90 days
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
Measured: Daily for 90 days
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
Measured: Daily for 90 days
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
Measured: Daily for 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start8 May 2024
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corey Ungaro, PhD, Principal investigator, PepsiCo, Inc. Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425939
- Sponsor's protocol ID
- PEP-2401
- Status last verified
- Apr 2026
- First submitted
- 16 May 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance
- ClinicalTrials.gov ID
- NCT06425939
- Acronym / sponsor ID
- PEP-2401
- Conditions
- Heart Rate Variability, Exercise
- Keywords
- exercise performance, HRV, training load, Whoop, wrist worn tracker, exercise recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Other | Other: Force plate assessment, Device: Whoop wrist bandHealthy adults moderately trained in resistance exercises |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Force plate assessmentOn Day 1, Day 45 and Day 90: 3x drop jumps, 2 min rest, 3x counter movement jumps, 2 min rest, 3x dynamic push-ups | Other | Single group |
| Whoop wrist bandWhoop 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. | Device | Single group |
Primary outcome
Training Intensity
Time frame: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
% HRmax (in minutes) measured by force plates
Performance
Time frame: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
Reactive Strength Index in cm/s using force plates
Peak Power Output
Time frame: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
W/kg using force plates
Jump Height
Time frame: Change from baseline (Day1) to mid-study (Day 45) and end of study (Day 90)
(cm) using force plates
Dynamic Push Ups Peak Force
Time frame: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)
(N)) using force plates
4 secondary outcomes
Correlation of subjective measures to Heart Rate Variability (HRV)
Time frame: Daily for 90 days
Correlation of subjective measures to resting heart rate (RHR)
Time frame: Daily for 90 days
Correlation of subjective measures to sleep quantity
Time frame: Daily for 90 days
Correlation of subjective measures to sleep efficiency
Time frame: Daily for 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey Ungaro, PhD principal investigator
PepsiCo, Inc. Sports Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Force plate assessment and Whoop wrist band in people with Heart Rate Variability and Exercise, run by PepsiCo Global R&D at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training Intensity (time frame: Change from baseline (Day 1) to mid-study (Day 45) and end of study (Day 90)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.