Heart Rate VariabilityNCT04909788
Factors and Characteristics of Heart Rate Variability in Runners
An observational study of Heart Rate Variability and Sports Accident, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Sports Accident
- What is being tested?
- a long-distance running (over 3 km)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults with regular exercise
Who may be able to join
- People have below conditions could be included:
- age is 18-60 years.
- have normal ECG .
- agree to participate in the study.
Who cannot join
- 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.
Show all 9Show fewer
- have a cold within two weeks before the study.
- have other diseases considered unsuitable for participants in this study.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhou Qin
Wuhan, Hubei
Zhou Qin, 15248078650, 1506507293@qq.com
About this study
Official title: Factors and Characteristics of Heart Rate Variability During Long Distance Running
The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running.
Read the 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.
- Conditions
- Heart Rate Variability, Sports Accident
- Being tested
- a long-distance running (over 3 km)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a long-distance running (over 3 km)Behavioural
Complete a long distance running（over 3 km） within the specified time (30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: a long-distance running (over 3 km) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start13 Jul 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Responsible party
- Principal investigator, Sheng Wei, Huazhong University of Science and Technology
- Investigators
- sheng wei, professor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909788
- Sponsor's protocol ID
- 2021-S039
- Status last verified
- Aug 2022
- First submitted
- 26 May 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. No abstract available.
PubMed 19744622Iskandar 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.
PubMed 14767237
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors and Characteristics of Heart Rate Variability During Long Distance Running
- ClinicalTrials.gov ID
- NCT04909788
- Acronym / sponsor ID
- 2021-S039
- Conditions
- Heart Rate Variability, Sports Accident
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults with regular exercise | – | Behavioral: a long-distance running (over 3 km)Subjects will be asked to wear a small monitoring equipment before,during and after a long distance running (over 3 km). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults with regular exercise
Key inclusion criteria (4 listed)
- age is 18-60 years.
- have normal ECG .
- agree to participate in the study.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a long-distance running (over 3 km)Complete a long distance running（over 3 km） within the specified time (30 minutes) | Behavioural | Healthy adults with regular exercise |
Primary outcome
change of heart rate variability
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 19744622Hua 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.
- Background: PubMed 14767237Iskandar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sheng wei, professor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Variability and Sports Accident, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sheng wei, professor (18571729969, shengwei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of heart rate variability (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.