AthletesQK5_2daysNCT06194110
Comparing Stationary and Mobile Ergospirometry
An observational study of Athletes, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Ergometric test
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Sep 2023to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy endurance trained male or female older than 18 years
Who may be able to join
- 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
Who cannot join
- Pregnancy based on anamnesis
- acute illness, injury, infection, etc., which would impact the measurements
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletes
- Being tested
- Ergometric test
- Keywords
- endurance trained, ergospirometry, Vo2peak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergometric testDiagnostic test
Ramp test followed by a step test, both with ergospirometry
| Study group | Role | What they receive |
|---|---|---|
| Endurance Trained Athletes | Not described Receives: Diagnostic Test: Ergometric test |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Maximal oxygen consumption (VO2) peak values during the ramp test
Measured: during the last 30 seconds of the ramp test
Secondary outcomes (4)
VO2
oxygen consumption (VO2) values during step test in steady state
Measured: during the last 2 minutes of the step test
VCO2
carbon dioxide production (VCO2) values during step test in steady state
Measured: during the last 2 minutes of the step test
Ventilation
Ventilation during step test in steady state
Measured: during the last 2 minutes of the step test
breathing frequency
breathing frequency values during step test in steady state
Measured: during the last 2 minutes of the step test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start30 Sep 2023
- Primary completion29 Feb 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194110
- Sponsor's protocol ID
- 2023-16
- Other IDs
- 2023-01505, 2023
- Acronym
- QK5_2days
- Status last verified
- Aug 2024
- First submitted
- 1 Dec 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Results of a Stationary and a Mobile Ergospirometry System - a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06194110
- Acronym / sponsor ID
- QK5_2days / 2023-16
- Conditions
- Athletes
- Keywords
- endurance trained, ergospirometry, Vo2peak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endurance Trained Athletes | – | Diagnostic Test: Ergometric test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy endurance trained male or female older than 18 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy based on anamnesis
- acute illness, injury, infection, etc., which would impact the measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergometric testRamp test followed by a step test, both with ergospirometry | Diagnostic test | Endurance Trained Athletes |
Primary outcome
VO2 peak
Time frame: during the last 30 seconds of the ramp test
Maximal oxygen consumption (VO2) peak values during the ramp test
4 secondary outcomes
VO2
Time frame: during the last 2 minutes of the step test
VCO2
Time frame: during the last 2 minutes of the step test
Ventilation
Time frame: during the last 2 minutes of the step test
breathing frequency
Time frame: during the last 2 minutes of the step test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 peak (time frame: during the last 30 seconds of the ramp test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.