Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status

April 3, 2025 updated by: ANA BELEN PEINADO LOZANO, Universidad Politecnica de Madrid

Prestación de Servicios científicos, evaluación y Control Del Rendimiento

The goal of this cross-over study is to evaluate the physiological response to exercise and body composition according to training status in participants with a wide spectrum of fitness states. The main questions it aims to answer are:

  • Which are the physiological differences across participants with different training status?
  • Which are the body composition differences across participants with different training status?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To satisfy the objective of the project, participants will perform an incremental test until volitional exhaustion. During this test, respiratory gases will be measured via a gas analyser as well as the cardiac response via an electrocardiogram. The same participants will have their body composition measured by dual X-ray densitometry (DXA).

Study Type

Interventional

Enrollment (Estimated)

1272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Comunity of Madrid
      • Madrid, Comunity of Madrid, Spain, 28040
        • Recruiting
        • Faculty of physical activity and sport sciences
        • Contact:
        • Contact:
          • Ana B Peinado Lozano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be in enough physical fitness to perform the incremental test to volitional exhaustion.

Exclusion Criteria:

  • Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incremental exercise test
Maximal incremental exercise test on a treadmill or a cycle ergometer until volitional exhaustion
Other: Exercise
Incremental exercise test until volitional exhaustion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training status
Time Frame: breath-by-breath during the whole test
Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2 and maximal oxygen uptake
breath-by-breath during the whole test
Body composition
Time Frame: one determination before the test
Fat mass (kg), fat free mass (kg), fat mass percentage, fat-free mass (FFM) percentage, weight (kg), and height (m). These variables are assesed by dual-energy X-ray absorptiometry (DXA).
one determination before the test
Bone mineral density
Time Frame: one determination before the test
Total, lumbar spine and femoral neck bone mineral density (g/cm^2). These variables are assesed by dual-energy X-ray absorptiometry (DXA).
one determination before the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Politecnica de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • PSC191100471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In accordance with the law 15/1999 on the protection of personal data, the personal data required are those necessary for scientific purposes, for possible studies that may be carried out. In none of these possible studies will your name appear and your identity will not be revealed to any person except to fulfil the purposes of the study, and in the event of a medical emergency or legal requirement. Any personally identifiable information will be retained and processed under secure conditions for the purpose of determining the results of possible studies. The results of these studies may be communicated to health authorities and the scientific community through conferences and/or publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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