Heart Rate Variability Recording With Elite HRV Application and Polar V800
Comparation of Heart Rate Variability Recording With Elite HRV Application and Polar V800 for the Analysis in Healthy Adults
1 other identifier
observational
58
1 country
1
Brief Summary
The Elite HRV is a reliable HRV analysis tool and could be a valid option to replace the Polar V800. The objective of study is Comparing the HRV index recorded with the mobile app Elite HRV and with the multisport watch Polar V800. Individuals will submit to two RR interval recordings with a Polar H7 strap that sent the data either to the Polar V800 heart rate monitor or to the Elite HRV app. The volunteers will supine position and breathing spontaneously, and the RR intervals will collect during 25 minutes. Subsequently, without warning the subject, the strap will connect to a nother device, and the second 25minute evaluation was made. The order in which the devices will use is randomized and the HRV indexes will generated via Kubios HRV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 4, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedDecember 5, 2022
December 1, 2022
2.4 years
November 4, 2022
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
similarity of indices of heart rate variability between two devices
assessment of heart rate variability indices from both devices
1 day
Study Arms (2)
group EliteHRV
the group (Elite) that started the assessment with the EliteHRV mobile application
group Polar
the (Polar) group that started the evaluation with the Polar V800 watch
Interventions
Collection and Analysis of Heart Rate Variability
Eligibility Criteria
To determine the sample size, a sample size calculation was performed, assuming the following parameters: alpha of 5%, beta of 20% (power = 80%) and difference between groups of 10% regarding the scores on the scale. With these data, 30 subjects were calculated in each study arm.
You may qualify if:
- Individuals over 18 years of age
- Apparently healthy
You may not qualify if:
- Diagnoses of previously installed heart disease
- Continuous medication use that can alter HRV
- Use of any substance that could influence the autonomic nervous system, such as caffeinated drinks and foods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paulist School of Medicine
São Paulo, São Paulo, 04024-002, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Talita D da Silva
Researcher
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2022
First Posted
December 5, 2022
Study Start
April 13, 2020
Primary Completion
September 15, 2022
Study Completion
February 15, 2023
Last Updated
December 5, 2022
Record last verified: 2022-12