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

NCT06964100 | Recruiting

• 1 other identifier: PEP-2502
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Rate Variability

Keywords

heart rate variability; HRV; real world; activity tracker; app engagement; app functionality; remote

Outcome Measures

Primary Outcomes (1)

• User engagement with Gatorade Sports Science Institute (GSSI) Labs app

  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 Outcomes (6)

• Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Heart rate variability (HRV)

  Week 1 baseline, Week 4 and Week 8

• Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Resting heart rate (RHR)

  Week 1 baseline, Week 4 and Week 8

• Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Quantity

  Week 1 baseline, Week 4 and Week 8

• Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Efficiency

  Week 1 baseline, Week 4 and Week 8

• Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Consistency

  Week 1 baseline, Week 4 and Week 8

Other Outcomes (3)

• Estimated VO2 Max

  At baseline

• Demographics

  At enrollment

• Activity details

  During study period from Baseline Week 1 to Week 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

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.
• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Remote study, no physical site. Managed by Gatorade Sports Science Institute. Do not contact investigators to enroll. Recruitment is handled by an independent agency.

Chicago, Illinois, 60607, United States

RECRUITING

Study Officials

• Corey Ungaro, do not contact to enroll, PhD

  PepsiCo R&D Life Sciences, Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corey Ungaro, do not contact to enroll, PhD

CONTACT

815-382-3213; corey.ungaro1@pepsico.com

Eric Freese, do not contact to enroll, PhD

CONTACT

eric.freese@pepsico.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 9, 2025
• Study Start: April 4, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)