Body CompositionNCT06246760
Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status
A study testing Exercise in people with Body Composition and Cardiovascular Health, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Cardiovascular Health, Ventilatory Physiology
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,272 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2000to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be in enough physical fitness to perform the incremental test to volitional exhaustion.
Who cannot join
- Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of physical activity and sport sciences
Madrid, Comunity of Madrid, 28040
Ana Belén Peinado Lozano, +34910677866, lab.exercise.physiology@gmail.com
Ana B Peinado Lozano
About this study
Official title: 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?
Read the 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).
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Incremental exercise test until volitional exhaustion
| Study group | Role | What they receive |
|---|---|---|
| Incremental exercise test | Experimental | Maximal incremental exercise test on a treadmill or a cycle ergometer until volitional exhaustion Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training status
Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2 and maximal oxygen uptake
Measured: 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).
Measured: 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).
Measured: one determination before the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2000
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA BELEN PEINADO LOZANO, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246760
- Sponsor's protocol ID
- PSC191100471
- Status last verified
- Apr 2025
- First submitted
- 30 Jan 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40528561Benitez-Munoz JA, Benito PJ, Cupeiro R, Alcocer-Ayuga M, Rojo-Tirado MA, Ramos-Campo DJ, Peinado AB. Differences in Ventilatory Function Based on Cardiorespiratory Fitness and Sex. Med Sci Sports Exerc. 2025 Oct 1;57(10):2269-2277. doi: 10.1249/MSS.0000000000003752. Epub 2025 May 6.
PubMed 40325607Benitez-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.
PubMed 39316126
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prestación de Servicios científicos, evaluación y Control Del Rendimiento
- ClinicalTrials.gov ID
- NCT06246760
- Acronym / sponsor ID
- PSC191100471
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,272 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 7 Feb 2024 (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.
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?
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incremental exercise test | Experimental | Other: ExerciseMaximal incremental exercise test on a treadmill or a cycle ergometer until volitional exhaustion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Be in enough physical fitness to perform the incremental test to volitional exhaustion.
Key exclusion criteria (1 listed)
- Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.
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 |
|---|---|---|
| ExerciseIncremental exercise test until volitional exhaustion | Other | Incremental exercise test |
Primary outcome
Training status
Time frame: breath-by-breath during the whole test
Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2 and maximal oxygen uptake
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 40528561Benitez-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.
- Derived from this study: PubMed 40325607Benitez-Munoz JA, Benito PJ, Cupeiro R, Alcocer-Ayuga M, Rojo-Tirado MA, Ramos-Campo DJ, Peinado AB. Differences in Ventilatory Function Based on Cardiorespiratory Fitness and Sex. Med Sci Sports Exerc. 2025 Oct 1;57(10):2269-2277. doi: 10.1249/MSS.0000000000003752. Epub 2025 May 6.
- Derived from this study: PubMed 39316126Benitez-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.
- Individual participant dataSharing planned: No. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Body Composition and Cardiovascular Health, run by Universidad Politecnica de Madrid at 1 site in Spain.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana B Peinado Lozano (910677866 ext. +34, lab.exercise.physiology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training status (time frame: breath-by-breath during the whole test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246760, which also lists 3 linked publications.
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 8 Apr 2025.