Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup

NCT03723954 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2018-10-30

No results posted yet for this study

Summary

Ryder Heart is an exploratory study of the heart rate variations of golf fans during the 2018 edition of the Ryder Cup. The main objective is to evaluate the impact of stress and strong emotions on heart rate variations and the occurrence of rhythmic anomalies in golf fans during this high-level golf competition. Such data are actually poorly described in medical and scientific literature.

Conditions

  • Heart Rate

Interventions

DEVICE

ECG Holter SpiderFlash-t

Record at visit V0 (day without match) and the competition days (Visit V1, V2 et V3) during the matches the heart rate of the golf fans. SpiderFlash-t™ from MicroPort is a long-lasting event recorder set in walking position by the investigator the day of the record and it is activated by detecting rhythm anomalies. This recorder is a Class IIA medical device (according to European Economic Community Directive 93/42). It benefits from European Economic marking.

DEVICE

Actigraph GT3Xp

Record the study participant's physical activity while we record his heart rate. The GT3Xp based activity monitors provide objective measurements of human activity and are used in many research and clinical applications. It includes a micro-electro-mechanical system (MEMS) based accelerometer and an ambient light sensor. It benefits from CE marking and FDA agreement (Class II medical device).

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    collaborator INDUSTRY
  • Boston Pharmaceuticals

    collaborator INDUSTRY
  • Pfizer

    collaborator INDUSTRY
  • University Hospital Center of Martinique

    lead OTHER

Principal Investigators

  • Fabrice DEMONIERE, MD · CHU deMartinique

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723954 on ClinicalTrials.gov