Factors and Characteristics of Heart Rate Variability in Runners

• Sponsor: Huazhong University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04909788
• Collaborator: Shenzhen Second People's Hospital (Other)
• Enrollment: 520
• Location: 1
• Anticipated Duration (Months): 18.6
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate Variability; Sports Accident	Behavioral: a long-distance running (over 3 km)

Detailed Description

Heart rate variability is recognized as the indicator to measure the autonomic nerve activity. By monitoring the heart rate variability of runners during long-distance running, we could monitor the status of the runners' cardiovascular system and predict the exercise risk of runners during long-distance running.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 520 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Factors and Characteristics of Heart Rate Variability During Long Distance Running
• Actual Study Start Date: Jul 13, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthy adults with regular exercise Subjects will be asked to wear a small monitoring equipment before,during and after a long distance running (over 3 km).	Behavioral: a long-distance running (over 3 km); Complete a long distance running（over 3 km） within the specified time (30 minutes)

Outcome Measures

Primary Outcome Measures

1. change of heart rate variability [up to 1 year]

   Subjects will be asked to wear a small monitoring equipment before,during and after a long distance running (over 3 km)， and complete the corresponding amount of exercise within a specified time during the test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

People have below conditions could be included:

1. age is 18-60 years.

2. have normal ECG .

3. agree to participate in the study.

Exclusion Criteria:

People have below conditions will be excluded:

1. have known Congenital heart disease and rheumatic heart disease.

2. have known Hypertension and cerebrovascular disease.

3. have known Myocarditis and other heart diseases.

4. have known Coronary artery disease and severe arrhythmia.

5. have known Diabetes with high or low blood glucose.

6. have a cold within two weeks before the study.

7. have other diseases considered unsuitable for participants in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhou Qin	Wuhan	Hubei	China

Sponsors and Collaborators

• Huazhong University of Science and Technology
• Shenzhen Second People's Hospital

Investigators

• Principal Investigator: sheng wei, professor, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hua W, Zhang LF, Wu YF, Liu XQ, Guo DS, Zhou HL, Gou ZP, Zhao LC, Niu HX, Chen KP, Mai JZ, Chu LN, Zhang S. Incidence of sudden cardiac death in China: analysis of 4 regional populations. J Am Coll Cardiol. 2009 Sep 15;54(12):1110-8. doi: 10.1016/j.jacc.2009.06.016.
• Iskandar EG, Thompson PD. Exercise-related sudden death due to an unusual coronary artery anomaly. Med Sci Sports Exerc. 2004 Feb;36(2):180-2.

• Responsible Party: Sheng Wei, professor, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04909788
• Other Study ID Numbers: 2021-S039
• First Posted: Jun 2, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 9, 2022