Understanding how heart rate variability affects endurance performance
Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Endurance Performance
This study is testing how heart rate variability affects running performance in people doing cardio training over 8 weeks while using a mobile app to track their progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06964100 on ClinicalTrials.gov |
What this trial studies
This study explores the relationship between heart rate variability (HRV), training load, and endurance performance using data collected from wearable devices and a mobile app. Participants will engage in cardiovascular training and perform self-administered 5K runs over an 8-week period while wearing activity trackers to monitor their physiological responses. The primary goal is to assess user engagement with the Gatorade Sports Science Institute Labs App and evaluate the feasibility of conducting real-world research. Additionally, the study aims to determine if training intensity during low HRV periods negatively impacts running performance, potentially leading to personalized training recommendations.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-65 who are actively participating in cardiovascular training and can run a 5K distance.
Not a fit: Patients with conditions that may interfere with their ability to comply with the study protocol or provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing training regimens based on individual heart rate variability, enhancing endurance performance.
How similar studies have performed: While the use of wearable devices for monitoring HRV is common, this specific approach to linking HRV with training load and performance in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- 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, United States (Recruiting)
Study contacts
- Principal investigator: Corey Ungaro, do not contact to enroll, PhD — PepsiCo R&D Life Sciences, Sports Science
- Study coordinator: Corey Ungaro, do not contact to enroll, PhD
- Email: corey.ungaro1@pepsico.com
- Phone: 815-382-3213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.