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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04909788
Other study ID # 2021-S039
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2021
Est. completion date January 31, 2023

Study information

Verified date August 2022
Source Huazhong University of Science and Technology
Contact sheng wei, professor
Phone 18571729969
Email shengwei@hust.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date January 31, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
a long-distance running (over 3 km)
Complete a long distance running(over 3 km) within the specified time (30 minutes)

Locations

Country Name City State
China Zhou Qin Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Huazhong University of Science and Technology Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary change of heart rate variability 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 up to 1 year
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