NCT04909788

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

May 26, 2021

Last Update Submit

August 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Interventions

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

Healthy adults with regular exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults with regular exercise

You may qualify if:

  • People have below conditions could be included:
  • age is 18-60 years.
  • have normal ECG .
  • agree to participate in the study.

You may not qualify if:

  • People have below conditions will be excluded:
  • have known Congenital heart disease and rheumatic heart disease.
  • have known Hypertension and cerebrovascular disease.
  • have known Myocarditis and other heart diseases.
  • have known Coronary artery disease and severe arrhythmia.
  • have known Diabetes with high or low blood glucose.
  • have a cold within two weeks before the study.
  • have other diseases considered unsuitable for participants in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhou Qin

Wuhan, Hubei, China

RECRUITING

Related 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. No abstract available.

    PMID: 19744622BACKGROUND
  • 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. doi: 10.1249/01.MSS.0000113685.89906.04.

    PMID: 14767237BACKGROUND

Study Officials

  • sheng wei, professor

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sheng wei, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 2, 2021

Study Start

July 13, 2021

Primary Completion

November 30, 2022

Study Completion

January 31, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations