Muscle; Fatigue, HeartFACEFINCT02126891
FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study
A study testing Tests in people with Muscle; Fatigue, Heart, run by Rennes University Hospital at 1 site in France.
Trial summary
To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects: Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training; Young recruits in military school of officers in ground… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle; Fatigue, Heart
- What is being tested?
- Tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men between 18 and 35 years old;
- Giving their writing informed consent;
- And affiliated to the French social security.
Who cannot join
- To be a smoker.
- To present any known pathology that forbids the realisation of any test, or that can alter the measurements: cardiovascular risk factors treated or not (diabetes, dyslipidaemia, arterial hypertension, obesity), cardiac arrhythmia, coronary disease, heart failure, cardiac pacemaker or defibrillator, valvular disease after surgery or not, kidneys failure with dialyse or not, kidney pulmonary cardiac or liver transplantation, chronic bronchopneumopathy, asthma, etc.
- To take any medication that could alter autonomic nervous system or cardiovascular adaptation to maximal exercise (anti-arrhythmia, anti-hypertensive, anti-inflammatory,…).
- Drinking exciting drinks (coffee or tee for example) in the 12h before the tests.
- To be under legal protection (trusteeship, guardianship) or to be deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:
- Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
- Young recruits in military school of officers in ground forces of the French army during an intensive.
- Conditions
- Muscle; Fatigue, Heart
- Being tested
- Tests
- Keywords
- Cardiac functions, Endurance training, Senior athletes
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestsProcedure or surgery
Individual parameters of echocardiography and heart rate variability
| Study group | Role | What they receive |
|---|---|---|
| Canoeists | Experimental | 13 canoeists from a training center of the French canoeing team Receives: Procedure: Tests |
| Military | Experimental | 10 young recruits in military school of officers in ground forces of the French army Receives: Procedure: Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of classical echocardiographic parameters to attest systolic and diastolic functions
Speckle tracking will also be used to get strain parameters of the left ventricle. Measure will by recording daily before, during, and after a period of intensive training, in order to attest possible cardiovascular effects of such periods.
Echocardiographic data will be recorded at rest and during a submaximal exercise.
Measured: day 8 (canoeists) / day 5 (military)
Secondary outcomes (1)
Measure of classical heart rate variability parameters
Measure will by recording daily before, during, and after a period of intensive training, in order to attest possible cardiovascular effects of such periods.
Measure will be recorded during 5 min resting and 5 min standing.
Measured: day 8 (canoeists) / day 5 (military)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle; Fatigue, HeartStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François FC Carré, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126891
- Sponsor's protocol ID
- 2013-A01524-41
- Acronym
- FACEFI
- Status last verified
- Apr 2014
- First submitted
- 28 Apr 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study
- ClinicalTrials.gov ID
- NCT02126891
- Acronym / sponsor ID
- FACEFI / 2013-A01524-41
- Conditions
- Muscle; Fatigue, Heart
- Keywords
- Cardiac functions, Endurance training, Senior athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- 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.
To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:
- Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
- Young recruits in military school of officers in ground forces of the French army during an intensive.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canoeists | Experimental | Procedure: Tests13 canoeists from a training center of the French canoeing team |
| Military | Experimental | Procedure: Tests10 young recruits in military school of officers in ground forces of the French army |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men between 18 and 35 years old;
- Giving their writing informed consent;
- And affiliated to the French social security.
Key exclusion criteria (5 listed)
- To be a smoker.
- To present any known pathology that forbids the realisation of any test, or that can alter the measurements: cardiovascular risk factors treated or not (diabetes, dyslipidaemia, arterial hypertension, obesity), cardiac arrhythmia, coronary disease, heart failure, cardiac pacemaker or defibrillator, valvular disease after surgery or not, kidneys failure with dialyse or not, kidney pulmonary cardiac or liver transplantation, chronic bronchopneumopathy, asthma, etc.
- To take any medication that could alter autonomic nervous system or cardiovascular adaptation to maximal exercise (anti-arrhythmia, anti-hypertensive, anti-inflammatory,…).
- Drinking exciting drinks (coffee or tee for example) in the 12h before the tests.
- To be under legal protection (trusteeship, guardianship) or to be deprived of liberty.
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 |
|---|---|---|
| TestsIndividual parameters of echocardiography and heart rate variability | Procedure or surgery | Canoeists, Military |
Primary outcome
Measure of classical echocardiographic parameters to attest systolic and diastolic functions
Time frame: day 8 (canoeists) / day 5 (military)
Speckle tracking will also be used to get strain parameters of the left ventricle. Measure will by recording daily before, during, and after a period of intensive training, in order to attest possible cardiovascular effects of such periods. Echocardiographic data will be recorded at rest and during a submaximal exercise.
1 secondary outcome
Measure of classical heart rate variability parameters
Time frame: day 8 (canoeists) / day 5 (military)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
François FC Carré principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tests in people with Muscle; Fatigue, Heart, run by Rennes University Hospital at 1 site in France.
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 3 inclusion and 5 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 26 Jan 2015. 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 France. 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 François FC Carré (33-2-9928-3750, francois.carre@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of classical echocardiographic parameters to attest systolic and diastolic functions (time frame: day 8 (canoeists) / day 5 (military)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015.