- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04226534
A Psychophysiological Database of Maximal Effort Tests.
May 26, 2020 updated by: Jo Ghillebert, Vrije Universiteit Brussel
Constructing a Psychophysiological Database Towards the Optimization of the Methodological Approach During, and Training Advice After Maximal Effort Tests.
The aim of this study is first to construct a database containing psychophysiological data from athletes performing a maximal effort test.
Second, the investigators want to use the data to optimize the methodological approach during, and trainings advice after maximal effort tests.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The lab (and research group) of Human Physiology and Sports Physiotherapy of the Vrije Universiteit Brussel performs exercise tests in both trained and untrained populations.
The aim of the maximal effort test is to evaluate endurance capacity and provide recommendations to monitor training load.
Until now, this is done by objective parameters such as heart rate, speed, time, power, etcetera.
Researchers already presented a method to quantify training intensity distribution in elite endurance athletes based on the rating of perceived exertion.
However, during pilot testing and everyday experience, these cut-off values are not always applicable to each individual athlete, nor are they the same for different sports.
Therefore, the investigators want to investigate the possible relation between the exercise intensity, and objective and subjective parameters.
Thereafter, the investigators want to provide recommendations to a new way of methodological approach during, and trainings advice after maximal effort tests.
Study Type
Interventional
Enrollment (Anticipated)
100
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
- Name: Luk Buyse, Msc. dr.
- Phone Number: +32 2 629 22 22
- Email: luk.buyse@vub.be
Study Contact Backup
- Name: Jo Ghillebert, Msc.
- Phone Number: +32 2 629 22 22
- Email: jo.ghillebert@vub.be
Study Locations
-
-
-
Brussel, Belgium, 1050
- Recruiting
- Vrije Universiteit Brussel
-
Contact:
- Luk Buyse, Msc. dr.
- Phone Number: +32 2 629 22 22
- Email: luk.buyse@vub.be
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- Trained
- No medication influencing heart rate or physical performance
Exclusion Criteria:
- Disease
- injury
- medication influencing (maximal) heart rate or exercise performance
Decision made after sports medical evaluation, comprising personal and family history, physical examination and resting electrocardiogram (ECG).
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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Maximal effort test
Physiological database
|
Performing a maximal effort test on the treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ergospirometry
Time Frame: Up to one hour
|
oxygen consumption and carbon di-oxide production (ml/min/kg)
|
Up to one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood samples
Time Frame: Up to one hour
|
Lactate concentration (mmol)
|
Up to one hour
|
|
Rating of perceived effort
Time Frame: Up to one hour
|
Rating of Perceived exertion on a scale from six to twenty
|
Up to one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luk Buyse, Msc. dr., Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy
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, 2020
Primary Completion (Anticipated)
January 1, 2040
Study Completion (Anticipated)
January 1, 2040
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
January 8, 2020
First Posted (Actual)
January 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 28, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- VUB-BLITS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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