NCT05770453

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 21, 2023

Last Update Submit

March 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Athletes groups

    Identification of two groups of athletes (those with identified double anaerobic threshold and those without)

    immediately after the incremental cardiopulmonary exercise test evaluation

Secondary Outcomes (9)

  • Groups differences in age

    immediately after the incremental cardiopulmonary exercise test evaluation

  • Groups differences in sport practised

    immediately after the incremental cardiopulmonary exercise test evaluation

  • Groups differences in exercise performance

    immediately after the incremental cardiopulmonary exercise test evaluation

  • Groups differences in VO2

    immediately after the incremental cardiopulmonary exercise test evaluation

  • Groups differences in VE/VCO2 slope

    immediately after the incremental cardiopulmonary exercise test evaluation

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • no major present or past illnesses, no ongoing treatment
  • At least 2 training sessions per week.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

RECRUITING

University of Foggia

Foggia, Italy

NOT YET RECRUITING

Centro Cardiologico Monzino

Milan, 20138, Italy

RECRUITING

Study Officials

  • Piergiuseppe Agostoni, Prof.

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 15, 2023

Study Start

March 15, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-02

Locations