NCT06246760

Brief Summary

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?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,272

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2000Jan 2030

Study Start

First participant enrolled

January 1, 2000

Completed
24.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

30 years

First QC Date

January 30, 2024

Last Update Submit

April 3, 2025

Conditions

Body CompositionCardiovascular HealthVentilatory Physiology

Outcome Measures

Primary Outcomes (3)

  • Training status

    Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2 and maximal oxygen uptake

    breath-by-breath during the whole test

  • Body composition

    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

    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

Study Arms (1)

Incremental exercise test

EXPERIMENTAL

Maximal incremental exercise test on a treadmill or a cycle ergometer until volitional exhaustion

Other: Exercise

Interventions

ExerciseOTHER

Incremental exercise test until volitional exhaustion

Incremental exercise test

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical activity and sport sciences

Madrid, Comunity of Madrid, 28040, Spain

RECRUITING

Related Publications (2)

  • Benitez-Munoz JA, Alcocer-Ayuga M, Cupeiro R, Guisado-Cuadrado I, Rojo-Tirado MA, Alfaro-Magallanes VM, Romero-Parra N, Aparecida-Castro E, Ramos-Campo DJ, Armero-Sotillo A, Peinado AB, Benito PJ. Ventilatory Thresholds Differences According to Aerobic Fitness Level in 1450 Males and 241 Females on Cycle-Ergometer: A Cross-Sectional Study. Eur J Sport Sci. 2025 Jul;25(7):e12323. doi: 10.1002/ejsc.12323.

    PMID: 40528561DERIVED

  • Benitez-Munoz JA, Benito PJ, Guisado-Cuadrado I, Cupeiro R, Peinado AB. Differences in the ventilatory thresholds in treadmill according to training status in 971 males and 301 females: a cross-sectional study. Eur J Appl Physiol. 2025 Feb;125(2):499-510. doi: 10.1007/s00421-024-05622-z. Epub 2024 Sep 24.

    PMID: 39316126DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ana B Peinado Lozano

CONTACT

910677866lab.exercise.physiology@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

January 1, 2000

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)