Cardiopulmonary Exercise TestNCT05770453
Double Anaerobic Threshold in Athletes
An observational study of Cardiopulmonary Exercise Test and Anaerobic Threshold, run by Centro Cardiologico Monzino at 3 sites in Italy.
Trial summary
During an incremental cardiopulmonary exercise test (CPET) performed with a ramp protocol, it is very important to determine the anaerobic threshold, defined as the point at which the metabolism switches from being predominantly aerobic to also being anaerobic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Exercise Test, Anaerobic Threshold, Athlete
- How many people
- 100 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Mar 2022to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male and female athletes who performed a cardiopulmonary test at our laboratories from 2007 to the present (retrospectively recruited) and prospectively recruited will be enrolled
Who may be able to join
- no major present or past illnesses, no ongoing treatment
- At least 2 training sessions per week.
Who cannot join
- Current illnesses and treatments for any physical condition that could potentially alter performance
- Subjects who have performed a submaximal test (RER < 1.05)
- CPET during which the AT determination is poorly assessable, i.e. due to changes in respiration.
- obese subjects (BMI >30)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence
Pietro Amedeo Modesti, Prof
- Not yet recruiting
University of Foggia
Foggia
Michele Correale, MD
- Recruiting
Centro Cardiologico Monzino
Milan, 20138
Piergiuseppe Agostoni, Prof, +39 0258002010, piergiuseppe.agostoni@cardiologicomonzino.it
About this study
Official title: Evaluation of the Presence of a Double Anaerobic Threshold in a Population of Athletes
During an incremental cardiopulmonary exercise test (CPET) performed with a ramp protocol, it is very important to determine the anaerobic threshold, defined as the point at which the metabolism switches from being predominantly aerobic to also being anaerobic. The anaerobic threshold can be determined invasively, by identifying the increase in blood lactates with an arterial sampling, or, more commonly, non-invasively by three methods: the V-slope method, the ventilatory equivalents method and by using end-expiratory oxygen and carbon dioxide pressure (PETO2 and PETCO2 respectively). Normally, the anaerobic threshold is determined by the first method and the other two are used to confirm the value. The finding of different anaerobic threshold values using these three methods has been reported anecdotally in the past, while a prevalence of 11% in a healthy population has recently been described. Regular training, particularly that aimed at endurance sports, is able to shift the anaerobic threshold to higher exercise intensities. At present, the physiological reasons for the presence of a double threshold are unclear.
The aim of the study is to identify the anaerobic threshold by means of the V-slope method and by means of the ventilatory equivalents method in athletes who have performed an incremental ramp CPET at the laboratories of the investigating centres, to assess in how many athletes a double threshold is present and to try to interpret the physiological/ pathophysiological significance of this finding.
In this retrospective and prospective observational study, healthy male and female athletes who have had a cardiopulmonary test at our laboratories from 2007 to the present (retrospectively recruited) and prospectively recruited until the calculated sample size is reached will be enrolled.
- Conditions
- Cardiopulmonary Exercise Test, Anaerobic Threshold, Athlete
What is being measured
The primary outcome is the main question the study is designed to answer.
Athletes groups
Identification of two groups of athletes (those with identified double anaerobic threshold and those without)
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Secondary outcomes (9)
Groups differences in age
Assess whether there are differences in age (years) between the two groups of subjects.
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in sport practised
Assess whether the two groups of subjects differ in term of the sport practised (information collected during patient interview)
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in exercise performance
Assess whether the two groups of subjects differ in term of exercise performance (peak power (Watts) reached during CPET)
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VO2
Assess whether there are differences in the oxygen intake VO2 (cardiopulmonary exercise test) between the two groups
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VE/VCO2 slope
Assess whether there are differences in minute ventilation/carbon dioxide production relationship VE/VCO2 slope (cardiopulmonary exercise test) between the two groups
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VE
Assess whether there are differences in minute ventilation VE (cardiopulmonary exercise test) between the two groups
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VO2 at the two thresholds
Highlight the differences in oxygen intake VO2 (cardiopulmonary exercise test), in the subjects with double anaerobic threshold, at the two thresholds.
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VE/VCO2 at the two thresholds
Highlight the differences in minute ventilation/carbon dioxide production relationship VE/VCO2 slope (cardiopulmonary exercise test), in the subjects with double anaerobic threshold, at the two thresholds.
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VE at the two thresholds
Highlight the differences in minute ventilation VE (cardiopulmonary exercise test), in the subjects with double anaerobic threshold, at the two thresholds.
Measured: immediately after the incremental cardiopulmonary exercise test evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary Exercise TestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, University of Foggia
- Responsible party
- Sponsor
- Investigators
- Piergiuseppe Agostoni, Prof., Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770453
- Sponsor's protocol ID
- CCM 1719
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Presence of a Double Anaerobic Threshold in a Population of Athletes
- ClinicalTrials.gov ID
- NCT05770453
- Acronym / sponsor ID
- CCM 1719
- Conditions
- Cardiopulmonary Exercise Test, Anaerobic Threshold, Athlete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Careggi, University of Foggia
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Mar 2023 (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.
During an incremental cardiopulmonary exercise test (CPET) performed with a ramp protocol, it is very important to determine the anaerobic threshold, defined as the point at which the metabolism switches from being predominantly aerobic to also being anaerobic. The anaerobic threshold can be determined invasively, by identifying the increase in blood lactates with an arterial sampling, or, more commonly, non-invasively by three methods: the V-slope method, the ventilatory equivalents method and by using end-expiratory oxygen and carbon dioxide pressure (PETO2 and PETCO2 respectively). Normally, the anaerobic threshold is determined by the first method and the other two are used to confirm the value. The finding of different anaerobic threshold values using these three methods has been reported anecdotally in the past, while a prevalence of 11% in a healthy population has recently been described. Regular training, particularly that aimed at endurance sports, is able to shift the anaerobic threshold to higher exercise intensities. At present, the physiological reasons for the presence of a double threshold are unclear.
The aim of the study is to identify the anaerobic threshold by means of the V-slope method and by means of the ventilatory equivalents method in athletes who have performed an incremental ramp CPET at the laboratories of the investigating centres, to assess in how many athletes a double threshold is present and to try to interpret the physiological/ pathophysiological significance of this finding.
In this retrospective and prospective observational study, healthy male and female athletes who have had a cardiopulmonary test at our laboratories from 2007 to the present (retrospectively recruited) and prospectively recruited until the calculated sample size is reached will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male and female athletes who performed a cardiopulmonary test at our laboratories from 2007 to the present (retrospectively recruited) and prospectively recruited will be enrolled
Key inclusion criteria (2 listed)
- no major present or past illnesses, no ongoing treatment
- At least 2 training sessions per week.
Key exclusion criteria (4 listed)
- Current illnesses and treatments for any physical condition that could potentially alter performance
- Subjects who have performed a submaximal test (RER < 1.05)
- CPET during which the AT determination is poorly assessable, i.e. due to changes in respiration.
- obese subjects (BMI >30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Athletes groups
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Identification of two groups of athletes (those with identified double anaerobic threshold and those without)
9 secondary outcomes
Groups differences in age
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in sport practised
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in exercise performance
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VO2
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VE/VCO2 slope
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Groups differences in VE
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VO2 at the two thresholds
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VE/VCO2 at the two thresholds
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Differences in VE at the two thresholds
Time frame: immediately after the incremental cardiopulmonary exercise test evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Piergiuseppe Agostoni, Prof. principal investigator
Centro Cardiologico Monzino
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Exercise Test and Anaerobic Threshold, run by Centro Cardiologico Monzino at 3 sites in Italy.
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 2 inclusion and 4 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 Piergiuseppe Agostoni, Prof (+39 0258002772, piergiuseppe.agostoni@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Athletes groups (time frame: immediately after the incremental cardiopulmonary exercise test evaluation). 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 15 Mar 2023.