Viewing Study NCT06425939



Ignite Creation Date: 2024-06-16 @ 11:47 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06425939
Status: RECRUITING
Last Update Posted: 2024-05-29
First Post: 2024-05-16

Brief Title: Exploring the Relationship Between Heart Rate Variability HRV Training Load and Exercise Performance
Sponsor: PepsiCo Global RD
Organization: PepsiCo Global RD

Study Overview

Official Title: Exploring the Relationship Between Heart Rate Variability HRV Training Load and Exercise Performance
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None