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Clinical Trials/NCT06425939
NCT06425939
Completed
Not Applicable

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

PepsiCo Global R&D3 sites in 1 country49 target enrollmentMay 8, 2024

Overview

Phase
Not Applicable
Intervention
Force plate assessment
Conditions
Heart Rate Variability
Sponsor
PepsiCo Global R&D
Enrollment
49
Locations
3
Primary Endpoint
Jump Height
Status
Completed
Last Updated
11 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2024
End Date
October 11, 2024
Last Updated
11 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

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.
  • 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.
  • Not able to wear wrist-worn device continuously.
  • Lack of proficiency in English.
  • Lack of proficiency or access to the internet and email address.

Arms & Interventions

Single group

Healthy adults moderately trained in resistance exercises

Intervention: Force plate assessment

Single group

Healthy adults moderately trained in resistance exercises

Intervention: Whoop wrist band

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

  • Correlation of subjective measures to sleep quantity(Daily for 90 days)
  • Correlation of subjective measures to sleep efficiency(Daily for 90 days)
  • 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)

Study Sites (3)

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