- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246760
Assessment of Training Status
January 30, 2024 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 Locations
-
-
Comunity Of Madrid
-
Madrid, Comunity Of Madrid, Spain, 28040
- Recruiting
- Faculty of Physical Activity and Sport Sciences
-
Contact:
- Ana Belén Peinado Lozano
- Phone Number: +34910677866
- Email: lab.exercise.physiology@gmail.com
-
Principal Investigator:
- Ana Belén 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
|
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
|
Fat percentage
Time Frame: one determination before the test
|
fat percentage of an individual
|
one determination before the test
|
Fat free mass
Time Frame: one determination before the test
|
fat percentage of an individual
|
one determination before the test
|
Bone mineral density
Time Frame: one determination before the test
|
Bone mineral density of an individual
|
one determination before the test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 7, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
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
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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