NCT06194110

Brief Summary

The goal of this randomized crossover trial is to compare the results of a stationary and a mobile ergospirometry system in 20 healthy endurance trained participants. The main question it aims to answer is to investigate the differences in VO2-measurements between the mobile K5 and the stationary Quark ergospirometry system. Participants will do a maximal ramp test followed by a sub maximal step test with 6 stages on two different days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

December 27, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

December 1, 2023

Last Update Submit

December 24, 2024

Conditions

Athletes

Keywords

endurance trainedergospirometryVo2peak

Outcome Measures

Primary Outcomes (1)

  • VO2 peak

    Maximal oxygen consumption (VO2) peak values during the ramp test

    during the last 30 seconds of the ramp test

Secondary Outcomes (4)

  • VO2

    during the last 2 minutes of the step test

  • VCO2

    during the last 2 minutes of the step test

  • Ventilation

    during the last 2 minutes of the step test

  • breathing frequency

    during the last 2 minutes of the step test

Study Arms (1)

Endurance Trained Athletes

Diagnostic Test: Ergometric test

Interventions

Ergometric testDIAGNOSTIC_TEST

Ramp test followed by a step test, both with ergospirometry

Endurance Trained Athletes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy endurance trained male or female older than 18 years

You may qualify if:

  • endurance trained (minimum two times endurance training per week)
  • healthy as assessed by the physical-activity-readiness-questionnaire (PAR-Q)
  • adequately informed and consent confirmed per signature

You may not qualify if:

  • Pregnancy based on anamnesis
  • acute illness, injury, infection, etc., which would impact the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2023

First Posted

January 8, 2024

Study Start

September 30, 2023

Primary Completion

February 29, 2024

Study Completion

July 30, 2024

Last Updated

December 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)