Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup (RyderHeart)

Evaluation of Heart Rate Variations of Golf Fans During the 2018 Edition of the Ryder Cup : the Ryder Heart Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate
• Intervention / Treatment: Device: ECG Holter SpiderFlash-t; Device: Actigraph GT3Xp

Detailed Description

In 1996, a Dutch research team highlighted, for the first time, a strong statistical relationship between the outcome of a football match and cardiovascular mortality in men over 45 years of age. An excess mortality was reported among football fans on June 22nd 1996, day of the elimination of the Dutch by the French team during the penalty shoot-out of the European Champions League. A more recent study by Ute Wilbert-Lampen et al., confirmed the relationship between football matches of the 2006 World Cup and the occurrence of cardiovascular events such as rhythm disorders and coronary syndromes among football fans. Two factors favoring increased cardiovascular risk appear to emerge from these different studies: high-level football matches (most often played at home) and strong support and passion for one's sports team. However, the physiopathological mechanisms involved have not been fully understood yet. In addition, very little data exists on sports other than football. The investigators research hypothesis is that cardiovascular events induced by the passion of a sports fan could not be unique to only one sport. The Ryder Cup, one of the biggest sporting events in the world, is the ideal event to collect consolidation elements for the investigators hypothesis.

The main phase of the Ryder Heart study will take place during the Ryder Cup from the 28th till the 30th of September 2018.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• France
  • Saint-Quentin-en-Yvelines, France, 78280
    • Golf National

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Golf fans attending at least one Ryder Cup match

Description

Inclusion Criteria:

• Man or a Woman golf fan ;
• At least 18 years old ;
• Either a healthy study volunteer or a study volunteer suffering from a heart disease ;
• With or without an implantable cardioverter-defibrillator ;
• Presence at the Golf National during at least one day of the Ryder Cup (September 28th and/or September 29th and/or September 30th, 2018);
• Presence and available for study inclusion :
• In the Ile de France zone on the eve of competition (September 27th, 2018);
• At Golf National at least two hours before matches' beginning at competition days ;
• In possession of official tickets issued by the organizers ;
• To accept to wear an ECG Holter for heart rate recording at inclusion (V0) and at least one competition day (from September 28th to September 30th, 2018).

Exclusion Criteria:

• Pregnant or lactating woman;
• Medical contraindication to ECG Holter ;
• Equipped with an implantable pacemaker ;
• Total dependence to stimulation of cardiac defibrillator;
• Suffering from a decompensated heart disease ;
• History of severe allergy to angioedema-type electrodes ;
• Body temperature under 36 celsius degree or equal or higher than 39 celsius degree at inclusion;
• Not opposed to the use of data collected via recording and electromagnetic measurements of heart rate (ECG) for research purposes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record and measure by Spider Flash-t of the increase in the heart rate peak	The measure of the increase in the heart rate peak (in beats per minute) of study subjects at the days and times of golf matches will be performed with Spider Flash-t. The algorithms built into SpiderFlash-t detect episodes palpitations, syncope, atrial fibrillation and atrial flutter in addition to all other arrhythmias such as bradycardia and tachycardia in patients symptomatic and asymptomatic. The integrated SpiderFlash-t software includes a dedicated and specific algorithm for detect atrial fibrillation. This atrial fibrillation algorithm is independent of the algorithm main arrhythmia detection, also incorporated into SpiderFlash-t. So comparing the data recorded at V0 (baseline) with the data recorded during the golf match, a minimum increase in the heart rate peak of at least 10% (at days and times of golf meetings) will be considered a significant variation.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average hourly variations of parameters related with heart rate	The exploratory nature of the Ryder Heart study does not allow adequate consideration of potential confounding factors that may affect heart rate. Thus, the variations of this heart rate can be described according to several characteristics: the intensity of the physical activity of the fans during the Ryder Cup using an Actigraph GT3Xp and the passion supporter for golf The data recorded by SpiderFlash-t will be analyzed by the analysis program of MicroPort. This program produces an automatic report of a classical and spectral analysis of the variability of the heart rate. The heart rate, its variability as well as the rhythmic events will thus be studied, with the description of the amplitudes, temporal, frequency and rhythmic parameters.	3 days
Fan's passion score for golf	The golf fan's degree of passion will be evaluated by a questionnaire including a series of items, inspired by studies by Vallerand et al. and Wann and Branscombe which help to classify the fans in three categories : little, moderately and very passionate.The scale includes 16 questions with answers choice going from 0 to 3. To whom will obtain a total score 0-16 = little passionate. To whom will obtain a total score 17-32 = moderately passionate. To whom will obtain a total score 33-48 = very passionate.	15 minutes
Record and measure fan physical activity by ActiGraph GT3Xp	The physical activity level of study participants will be quantified directly every day of competition, using a physical activity monitor / accelerometer type ActiGraph GT3Xp. This device will collect various information such as mouvements, gross acceleration, caloric flow, energy expenditure, active energy expenditure, the duration of physical activity and the number of steps of the supporter. The number of steps of the supporter is used to take into account a confounding factor (effect of the physical activity of the supporter on his heart rate) and estimate the main judgment criterion reliably.	3 days

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique
• Collaborators: Pfizer; Boston Pharmaceuticals; MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Fabrice DEMONIERE, MD, CHU deMartinique

Publications and helpful links

General Publications

• Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409. No abstract available.
• Vallerand RJ, Ntoumanis N, Philippe FL, Lavigne GL, Carbonneau N, Bonneville A, Lagace-Labonte C, Maliha G. On passion and sports fans: a look at football. J Sports Sci. 2008 Oct;26(12):1279-93. doi: 10.1080/02640410802123185.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18_RIPH3-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication.
• IPD Sharing Time Frame: After the main publication of the results, for not limited time.
• IPD Sharing Access Criteria: The conditions for the transfer of all or part of the database of the research are decided by the principal investigator / sponsor of the research and are the subject of a written contract.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No