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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06194110
Other study ID # 2023-16
Secondary ID 2023-01505
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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