Condition category
Circulatory System
Date applied
05/12/2017
Date assigned
23/03/2018
Last edited
23/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
During the transitions from rest to exercise, oxygen uptake is limited by muscle oxygen delivery, which directly depends of the response of the cardiorespiratory system (heart and lungs) at the start of the exercise. Endurance training is known for allowing a faster cardiac (heart) adaptation. However, data about cardiac adaptation during the transition from rest to exercise are limited to heart rate, stroke volume and cardiac output. Today, new advances in echocardiography based on speckle tracking can be used to measure regional left ventricular (LV) strains and twist. The aim of this study is to assess regional LV strains and twist of endurance trained cyclists compared to sedentary adults at the onset of dynamic exercise.

Who can participate?
Young male cyclists and healthy volunteers aged 18-35

What does the study involve?
The participants perform five similar constant work-load exercises on an exercise bicycle (target heart rate: 130 bpm), in order to measure myocardial (heart muscle) strains with speckle-tracking echocardiography (a type of ultrasound scan). Heart function is assessed every 15 seconds during the first minute and then every 30 seconds up until 240 seconds.

What are the possible benefits and risks of participating?
Participants may benefit from a clinical examination performed by a cardiologist. Exercises are performed at submaximal intensities (corresponding to 130 bpm). Therefore, there are no risks for participants.

Where is the study run from?
University of Avignon (France)

When is the study starting and how long is it expected to run for?
January 2015 to December 2017

Who is funding the study?
University of Avignon (France)

Who is the main contact?
1. Dr Stephane Nottin
stephane.nottin@univ-avignon.fr
2. Dr Omar Izem
omizem@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stéphane Nottin

ORCID ID

Contact details

74 rue Louis Pasteur
Avignon
84000
France
+33 (0)490162931
stephane.nottin@univ-avignon.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KINETICS01

Study information

Scientific title

Kinetics of left ventricular function and regional mechanics at the onset of exercise in sedentary and endurance-trained subjects

Acronym

Study hypothesis

The trialists hypothesized that the fast increase of stroke volume at the onset of exercise would result mainly from a rapid improvement in diastolic function implying an important contribution of LV untwist. They hypothesized that these mechanisms adapted better in endurance-trained subjects.

Ethics approval

University of Avignon ethics committee

Study design

Observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cardiac evaluations at rest and during effort in healthy young controls and endurance-trained cyclists

Intervention

This study was a pilot study to check the feasibility of fast evaluation of echocardiography every 15 seconds during exercise. Young male cyclists (18 – 25 years) and age-matched sedentary controls performed five similar constant work-load exercises on a cyclo-ergometer (target heart rate: 130 bpm), in order to follow kinetics of diastolic and systolic myocardial strains by speckle-tracking echocardiography with high temporal resolution. Cardiac function was assessed every 15 seconds during the first minute and then every 30 seconds up until 240 seconds.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Left ventricular strains and twist/untwist kinetics during the transitions from rest to exercise, measured non-invasively using 2D-strain echocardiography. Each subject of the study was evaluated one time only (i.e. transversal design)

Secondary outcome measures

Global systolic and diastolic functions, measured non-invasively using Doppler echocardiography. Each subject of the study was evaluated one time only (i.e. transversal design)

Overall trial start date

01/01/2015

Overall trial end date

20/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cyclists training at least 10 hours per week for at least 8 years or sedentary young men reporting regular training habits
2. 18-35 years old
3. Non-smokers
4. No history of diabetes, hypertension or cardiovascular disease
5. Normal clinical examination
6. In sinus rhythm
7. Screening echocardiography showing normal left and right heart morphology and function and the absence of valvular disease

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

25 subjects in each group

Participant exclusion criteria

1. Smokers
2. History of diabetes, hypertension or cardiovascular disease
3. Abnormal sinus rhythm
4. Screening echocardiography shows abnormal left and right heart morphology and function and or valvular disease

Recruitment start date

01/09/2015

Recruitment end date

20/12/2016

Locations

Countries of recruitment

France

Trial participating centre

University of Avignon
84000

Sponsor information

Organisation

University of Avignon

Sponsor details

74 rue Louis Pasteur
Avignon
84000
France
+33 (0)490162931
stephane.nottin@univ-avignon.fr

Sponsor type

University/education

Website

http://www.univ-avignon.fr

Funders

Funder type

University/education

Funder name

University of Avignon

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists plan two publications in high-impact peer reviewed journals. The first one will be sent soon to the Journal of Physiology (London) and the second will be sent to Medicine & Science in Sports & Exercise.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/02/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes