NCT06075342

Brief Summary

The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level. Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography. Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

September 26, 2023

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • intracardiac hemodynamics in mmHg/mm using vector flow mapping

    intraventricular pressure gradient from left ventricular apex to base

    through study completion, an average of 1 year

  • myocardial strain in % using two-dimension tissue tracking

    left ventricular longitudinal strain

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • wall shear stress in pascal using vector flow mapping

    through study completion, an average of 1 year

Study Arms (4)

elite athlete

training year \> 10 years and weekly training time \> 20 hours

Behavioral: exercise

casual player

training year \< 10 years and weekly training time \< 20 hours

Behavioral: exercise

healthy control

healthy participants with irregular exercise habits

Behavioral: exercise

first responder

first responders with regular exercise training

Behavioral: exercise

Interventions

exerciseBEHAVIORAL

Exercise intervention according to the training program

Also known as: exercise training
casual playerelite athletefirst responderhealthy control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

athletes with training year \> 10 and WTT \> 20, athletes with training year \< 10 and WTT \< 20, healthy controls with irregular exercise habits

You may qualify if:

  • athletes and healthy control subjects without regular exercise habits;
  • no specific medical history or chronic illness.

You may not qualify if:

  • A previous history of arterial hypertension, diabetes mellitus, heart, kidney, hepatic, infectious, psychiatric, malignant, disorders, taking drugs that can influence ECG intervals, and electrolyte imbalance;
  • poor echocardiographic image quality and abnormal segmental ventricular wall movement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu Sport University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 10, 2023

Study Start

March 1, 2021

Primary Completion

July 30, 2023

Study Completion

July 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Locations