Comparing Stationary and Mobile Ergospirometry (QK5_2days)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Athletes
• Intervention / Treatment: Diagnostic test: Ergometric test

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Fabian Ammann, MSc; Phone Number: +41 41 939 66 24; Email: fabian.amman@paraplegie.ch

Study Locations

• Switzerland
  • Lucerne
    • Nottwil, Lucerne, Switzerland, 6207
      • Recruiting
      • Swiss Paraplegic Centre
      • Contact: Fabian Ammann, MSc; Phone Number: +41419396624; Email: fabian.ammann@paraplegie.ch
      • Contact: Anneke Hertig, PhD; Phone Number: +41419396603; Email: anneke.hertig@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy endurance trained male or female older than 18 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endurance Trained Athletes	Diagnostic test: Ergometric test; Ramp test followed by a step test, both with ergospirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 peak	Maximal oxygen consumption (VO2) peak values during the ramp test	during the last 30 seconds of the ramp test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2	oxygen consumption (VO2) values during step test in steady state	during the last 2 minutes of the step test
VCO2	carbon dioxide production (VCO2) values during step test in steady state	during the last 2 minutes of the step test
Ventilation	Ventilation during step test in steady state	during the last 2 minutes of the step test
breathing frequency	breathing frequency values during step test in steady state	during the last 2 minutes of the step test

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ergospirometry; endurance trained; Vo2peak
• Other Study ID Numbers: 2023-16; 2023-01505 (Registry Identifier: EKNZ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No