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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list