Comparing Stationary and Mobile Ergospirometry

Athletes Clinical Trial

— QK5_2days  

Official title:

Comparing the Results of a Stationary and a Mobile Ergospirometry System - A Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194110
• Other study ID #: 2023-16
• Secondary ID: 2023-01505
• Status: Recruiting
• Start date: September 30, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2023
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Fabian Ammann, MSc
• Phone: +41 41 939 66 24
• Email: fabian.amman[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

20 endurance trained men and/or women will be recruited. A screening will be done before starting with the test protocol on the treadmill to ensure the suitability of the participants. The test protocol includes two parts. The first part is a maximal ramp test (+0.6km/h each minute until exhaustion). The second part includes a step test with 6 sub maximal stages - each lasting 5 minutes - at 50%, 55%, 60%, 70%, 75% and 80% of the maximal velocity achieved in the first part. There will be a short break between the ramp and the step test. The stationary and the mobile system are tested on 2 separate days with a break of 1-3 days in between. On the second day, procedure will be exactly the same for the participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Athletes

Intervention

Diagnostic Test:
• Ergometric test
Ramp test followed by a step test, both with ergospirometry

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 peak	Maximal oxygen consumption (VO2) peak values during the ramp test	during the last 30 seconds of the ramp test
Secondary	VO2	oxygen consumption (VO2) values during step test in steady state	during the last 2 minutes of the step test
Secondary	VCO2	carbon dioxide production (VCO2) values during step test in steady state	during the last 2 minutes of the step test
Secondary	Ventilation	Ventilation during step test in steady state	during the last 2 minutes of the step test
Secondary	breathing frequency	breathing frequency values during step test in steady state	during the last 2 minutes of the step test