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

April 30, 2025 updated by: PepsiCo Global R&D
The ability of smart phones, aided by wearable devices (e.g. smart watches), to collect a variety of data, including physical activity, heart rate, and other exercise metrics, may provide a unique opportunity to understand real-world variability. The primary objective of this study is to test user engagement, app functionality, and feasibility of the newly developed Gatorade Sports Science Institute (GSSI) Labs App to conduct Real-World research studies. The secondary purpose of this study is to determine if Training Intensity (%Heart Rate maximum) in minutes during low heart rate variability (HRV) periods (below HRV baseline consecutive days) will have a negative relationship with post-study 5K (5 kilometer) running times as measured by their activity tracker, which could lead to personalized training recommendations using HRV. This study is conducted remotely, there are no in-person visits.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Heart rate variability (HRV) is an indirect biomarker of an individual's performance readiness and recovery. HRV is a ubiquitous biomarker 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. Using activity trackers to monitor multiple physiological and subjective measures of health and wellness, subjects will perform self-administered 5 kilometer (5K) timed runs on Week 1, Week 4, and Week 8. Users will be instructed to run their 5K (3.1 miles) on the same outdoor course, indoor track, or treadmill to provide consistency in their performance assessments, with the understanding that there will be some limitations in creating a consistent performance assessment environment (i.e.; weather).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Remote study, no physical site. Managed by Gatorade Sports Science Institute. Do not contact investigators to enroll. Recruitment is handled by an independent agency.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers ages 8-65, actively participating in cardiovascular training (3-5 days/week), able to run a 5K (3.1 miles) distance at a self-selected location, three times over 8 weeks, wear an activity tracker and willing to use the study smartphone app.

Description

Inclusion Criteria:

Actively participating in cardiovascular training (3-5 days/week).

Able to run a 5K (3.1 miles) distance at a self-selected location, three times over 8 weeks.

Age 18-65 years.

Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to timed 5K assessment.

Subject is willing to avoid alcohol consumption 24 hours prior to 5K assessment.

Subject is willing to provide consent.

Subject is able to continuously wear their activity tracker, including during sleep, except when submerged underwater (i.e., swimming, bathing).

Subjects must have compatible wearable device (Android, Apple Health, Dexcom, Fitbit, Garmin, Health Connect, Oura, Polar, Whoop, and Withings).

Exclusion Criteria:

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.

Those that have ≥1 risk factor for cardiovascular disease according to the American College of Sports Medicine.

Age: Men ≥ 45 yrs; Women ≥ 55 yrs.

Family History: Heart attack, "bypass surgery", or sudden death before the age of 55 yrs for father/brother, or before 65 yrs for mother/sister.

Cigarette Smoking: Current smoker, or have quit < 6 months, or exposed to environmental smoke.

Sedentary lifestyle: Not participating in moderate (sweating) physical activity at least 3 days/week for 3-months.

Obesity: Body mass index ≥ 30 kg/m2 or waist girth 102 cm (40 inches) for men and 88 cm (35 inches) for women.

Hypertension: Systolic Blood Pressure ≥ 140 mmHg and/or Diastolic ≥90 mmHg, or taking medication.

Dyslipidemia: LDL ≥130 mg/dl, or HDL < 40 mg/dl, or taking medication. Or triglycerides (TG) > 200 > mg/dl.

Pre-diabetes: Impaired fasting glucose (IFG) ≥ 100 mg/dl or oral glucose tolerance test (OGTT) ≥ 140 or ≤ 199 mg/dl confirmed by two different measurements.

Under the care of a physician.

Sleep disorders.

Using prescription medications that would impact sleep.

If female, you are not pregnant, planning to get pregnant or currently breast feeding.

Not able to wear activity tracker 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User engagement with Gatorade Sports Science Institute (GSSI) Labs app
Time Frame: From activating app through study Week 8
Percent (%) who complete enrollment, informed consent form (ICF), demographics, sync biometrics, complete journal entries, 5 kilometer (5K) performance assessment, and complete study
From activating app through study Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Heart rate variability (HRV)
Time Frame: Week 1 baseline, Week 4 and Week 8
Fluctuation in the amount of time between heartbeats in milliseconds (ms)
Week 1 baseline, Week 4 and Week 8
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Resting heart rate (RHR)
Time Frame: Week 1 baseline, Week 4 and Week 8
Heart rate at rest in beats per minute (bpm)
Week 1 baseline, Week 4 and Week 8
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Quantity
Time Frame: Week 1 baseline, Week 4 and Week 8
Sleep at night in minutes
Week 1 baseline, Week 4 and Week 8
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Efficiency
Time Frame: Week 1 baseline, Week 4 and Week 8
Percentage (%) of time spent asleep while in bed, calculated by dividing total sleep time by time in bed in hours
Week 1 baseline, Week 4 and Week 8
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Consistency
Time Frame: Week 1 baseline, Week 4 and Week 8
Percent (%) of consistency in sleep-wake schedule
Week 1 baseline, Week 4 and Week 8
Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Training Zones Percent (%) maximum heart rate (HRmax) in minutes
Time Frame: Week 1 baseline, Week 4 and Week 8
Heart rate training zones from Zone 1 (Very Light/Recovery): 50-60 percent (%) of maximum heart rate (HR) to Zone 5 (Very Hard/Maximum): 90-100% of max HR, in minutes (min)
Week 1 baseline, Week 4 and Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated VO2 Max
Time Frame: At baseline
Maximal oxygen consumption (VO2 max) = 15.3 x (HRmax/HRrest)
At baseline
Demographics
Time Frame: At enrollment
Age, Gender, Race
At enrollment
Activity details
Time Frame: During study period from Baseline Week 1 to Week 8
Journal entries (Felt nervous or anxious, Have any alcoholic drinks, Have caffeine, Feel emotionally and mentally stable, Feel energized, Hydrated sufficiently, Take melatonin, Feel motivated, Felt recovered, Feeling sick or ill, and Feel stress).
During study period from Baseline Week 1 to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Corey Ungaro, do not contact to enroll, PhD, PepsiCo R&D Life Sciences, Sports Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP-2502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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