Sports Physical TherapyNCT04226534
A Psychophysiological Database of Maximal Effort Tests.
A study testing Maximal effort test in people with Sports Physical Therapy, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Maximal effort test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 1 Jan 2040
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Trained
- No medication influencing heart rate or physical performance
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Brussels, 1050
Luk Buyse, Msc. dr., +32 2 629 22 22, luk.buyse@vub.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Sports Physical Therapy
- Being tested
- Maximal effort test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal effort testOther
Performing a maximal effort test on the treadmill
| Study group | Role | What they receive |
|---|---|---|
| Maximal effort test | Other | Physiological database Receives: Other: Maximal effort test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ergospirometry
oxygen consumption and carbon di-oxide production (ml/min/kg)
Measured: Up to one hour
Secondary outcomes (2)
blood samples
Lactate concentration (mmol)
Measured: Up to one hour
Rating of perceived effort
Rating of Perceived exertion on a scale from six to twenty
Measured: Up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Ghillebert, Vrije Universiteit Brussel
- Investigators
- Luk Buyse, Msc. dr., Principal investigator, Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226534
- Sponsor's protocol ID
- VUB-BLITS
- Status last verified
- May 2020
- First submitted
- 18 Dec 2019
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructing a Psychophysiological Database Towards the Optimization of the Methodological Approach During, and Training Advice After Maximal Effort Tests.
- ClinicalTrials.gov ID
- NCT04226534
- Acronym / sponsor ID
- VUB-BLITS
- Conditions
- Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 13 Jan 2020 (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 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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maximal effort test | Other | Other: Maximal effort testPhysiological database |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Trained
- No medication influencing heart rate or physical performance
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Maximal effort testPerforming a maximal effort test on the treadmill | Other | Maximal effort test |
Primary outcome
Ergospirometry
Time frame: Up to one hour
oxygen consumption and carbon di-oxide production (ml/min/kg)
2 secondary outcomes
blood samples
Time frame: Up to one hour
Rating of perceived effort
Time frame: Up to one hour
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 28 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Luk Buyse, Msc. dr. principal investigator
Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal effort test in people with Sports Physical Therapy, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 3 inclusion and 4 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 28 May 2020. 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 Belgium. 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 Luk Buyse, Msc. dr. (+32 2 629 22 22, luk.buyse@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ergospirometry (time frame: Up to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2020.