NCT04226534

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
167mo left

Started Jan 2020

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

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2020Jan 2040

First Submitted

Initial submission to the registry

December 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

20 years

First QC Date

December 18, 2019

Last Update Submit

May 26, 2020

Conditions

Sports Physical Therapy

Outcome Measures

Primary Outcomes (1)

  • Ergospirometry

    oxygen consumption and carbon di-oxide production (ml/min/kg)

    Up to one hour

Secondary Outcomes (2)

  • blood samples

    Up to one hour

  • Rating of perceived effort

    Up to one hour

Study Arms (1)

Maximal effort test

OTHER

Physiological database

Other: Maximal effort test

Interventions

Maximal effort testOTHER

Performing a maximal effort test on the treadmill

Maximal effort test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Trained
  • No medication influencing heart rate or physical performance

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

RECRUITING

Study Officials

  • Luk Buyse, Msc. dr.

    Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luk Buyse, Msc. dr.

CONTACT

+32 2 629 22 22luk.buyse@vub.be

Jo Ghillebert, Msc.

CONTACT

+32 2 629 22 22jo.ghillebert@vub.be

Study Design

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

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 13, 2020

Study Start

January 1, 2020

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

January 1, 2040

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

BE(1)