Cardiorespiratory ResponsesNCT03946215
Cardiorespiratory Responses to Treadmill Running at Different Slopes
A study testing Each participant will perform: in people with Cardiorespiratory Responses and Well-trained Athletes, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Responses, Well-trained Athletes
- What is being tested?
- Each participant will perform:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 17 Dec 2018
- Phase
- Interventional
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be a well-trained runner with a VO2max > à 55 ml/kg/min
- nonsmoker or stopped smoking for 5 years
- BMI < 25
- affiliation to the social health insurance scheme
- signing an informed consent form.
Who cannot join
- impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...);
- subject under the protection of justice
- subject under guardianship or curatorship
- contraindication to the practice of physical and sport activities
- lower limbs musculotendinous or articular problems
- respiratory, cardiovascular or metabolic pathology
- drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes
The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.
- Conditions
- Cardiorespiratory Responses, Well-trained Athletes
- Being tested
- Each participant will perform:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Each participant will perform:Other
Part 1: Maximal incremental tests will require running at fixed slopes (+15%, 0% -15%) for stages (2min duration) of increasing velocities (0.5, 1 and 1.5 km/h) Part two: submaximal running tests will require running at constant velocity (80% VO2max uphill; 80%VO2max downhill and downhill at similar velocity as uphill)
| Study group | Role | What they receive |
|---|---|---|
| well-trained athletes | Experimental | A cardiorespiratory stress test Receives: Other: Each participant will perform: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen
The peak oxygen uptake will be collected during downhill, flat and uphill running
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Sep 2018
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory ResponsesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946215
- Sponsor's protocol ID
- 7038
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lemire M, Hureau TJ, Remetter R, Geny B, Kouassi BYL, Lonsdorfer E, Isner-Horobeti ME, Favret F, Dufour SP. Trail Runners Cannot Reach V O2max during a Maximal Incremental Downhill Test. Med Sci Sports Exerc. 2020 May;52(5):1135-1143. doi: 10.1249/MSS.0000000000002240.
PubMed 31815832
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes
- ClinicalTrials.gov ID
- NCT03946215
- Acronym / sponsor ID
- 7038
- Conditions
- Cardiorespiratory Responses, Well-trained Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 10 May 2019 (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 purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| well-trained athletes | Experimental | Other: Each participant will perform:A cardiorespiratory stress test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- to be a well-trained runner with a VO2max > à 55 ml/kg/min
- nonsmoker or stopped smoking for 5 years
- BMI < 25
- affiliation to the social health insurance scheme
- signing an informed consent form.
Key exclusion criteria (7 listed)
- impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, ...);
- subject under the protection of justice
- subject under guardianship or curatorship
- contraindication to the practice of physical and sport activities
- lower limbs musculotendinous or articular problems
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 |
|---|---|---|
| Each participant will perform:Part 1: Maximal incremental tests will require running at fixed slopes (+15%, 0% -15%) for stages (2min duration) of increasing velocities (0.5, 1 and 1.5 km/h) Part two: submaximal running tests will require running at constant velocity (80% VO2max uphill; 80%VO2max downhill and downhill at similar velocity as uphill) | Other | well-trained athletes |
Primary outcome
Peak oxygen
Time frame: 15 minutes
The peak oxygen uptake will be collected during downhill, flat and uphill running
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 1 Oct 2025.
- Background: PubMed 31815832Lemire M, Hureau TJ, Remetter R, Geny B, Kouassi BYL, Lonsdorfer E, Isner-Horobeti ME, Favret F, Dufour SP. Trail Runners Cannot Reach V O2max during a Maximal Incremental Downhill Test. Med Sci Sports Exerc. 2020 May;52(5):1135-1143. doi: 10.1249/MSS.0000000000002240.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Each participant will perform: in people with Cardiorespiratory Responses and Well-trained Athletes, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 7 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 1 Oct 2025. 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 France. 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?
Peak oxygen (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946215, which also lists 1 linked publication.
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 1 Oct 2025.