Healthy Volunteers0 TO 100NCT07626593
The Extraordinary Endurance of the Human Species
A study testing Intensive training in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
We hypothesize, based on field and scientific data, that setting a very ambitious goal such as completing a mountain ultra-marathon could motivate sedentary and inactive individuals not only to begin training but also to follow a progressive yet extremely ambitious program that has not yet been studied… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Intensive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Affiliation to social security.
- Informed consent signed.
- Male or female, aged 25-50.
- Sedentary (>6h/day sitting) and inactive (no regular training), assessed by GPAQ questionnaire.
Who cannot join
- Chronic joint or cardiac diseases.
- Neurological disorders.
- Legal protection status.
- Moderate to severe depression (BDI-13 > 7) or use of antidepressants/anxiolytics.
- Use of banned substances.
- Excessive alcohol or caffeine consumption.
- Pregnancy.
- Inability to understand or consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Céline LECLERCQ-TRAUTVETTER, CDP contact
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Léonard FEASSON, MD Phd, (0)4 77 82 83 00 ext. +33, leonard.feasson@chu-st-etienne.fr
David HUPIN, MD
About this study
We hypothesize, based on field and scientific data, that setting a very ambitious goal such as completing a mountain ultra-marathon could motivate sedentary and inactive individuals not only to begin training but also to follow a progressive yet extremely ambitious program that has not yet been studied comprehensively. Indeed, the effects of intense and prolonged endurance training (18 months) on the health and performance of completely sedentary individuals have never been investigated exhaustively.
- Conditions
- Healthy Volunteers
- Being tested
- Intensive training
- Keywords
- Ultra-endurance, Sedentary, Healthy volunteers
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive trainingBehavioural
participants will follow individualized coaching: starting at 5-6 hours per week and progressing to 7-10 hours (rarely 15 hours) per week before mountain ultra marathon
| Study group | Role | What they receive |
|---|---|---|
| Endurance training | Experimental | From March 1, 2026 to August 2027, participants will follow individualized coaching: starting at 5-6 hours per week and progressing to 7-10 hours (rarely 15 hours) per week before mountain ultra marathon Receives: Behavioral: Intensive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition from sedentary lifestyle to regular activity and completion of a 100 km ultra-trail
Percentage of participants who (i) become sufficiently active to be ready to start the Courmayeur-Champex-Chamonix (CCC) 100 km ultra-trail of the Ultra Trail du Mont-Blanc, and (ii) complete the 100 km CCC race.
Measured: up to 18 months
Secondary outcomes (2)
Safety and tolerance of progressive endurance training
Rate of injuries or adverse events reported weekly, and dropout rate over the 18-month training period.
Measured: Weekly reporting during the 18-month intervention period
Feasibility and adherence to the endurance training program
Proportion of scheduled training sessions completed by participants and the percentage of participants finishing the 100 km CCC ultra-trail among those who started the race.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start3 Feb 2026
- Primary completion28 Sep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626593
- Sponsor's protocol ID
- 25CH172
- Other IDs
- ANSM
- Acronym
- 0 TO 100
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we are not decided for the moment
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extraordinary Endurance of the Human Species
- ClinicalTrials.gov ID
- NCT07626593
- Acronym / sponsor ID
- 0 TO 100 / 25CH172
- Conditions
- Healthy Volunteers
- Keywords
- Ultra-endurance, Sedentary, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
We hypothesize, based on field and scientific data, that setting a very ambitious goal such as completing a mountain ultra-marathon could motivate sedentary and inactive individuals not only to begin training but also to follow a progressive yet extremely ambitious program that has not yet been studied comprehensively. Indeed, the effects of intense and prolonged endurance training (18 months) on the health and performance of completely sedentary individuals have never been investigated exhaustively.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endurance training | Experimental | Behavioral: Intensive trainingFrom March 1, 2026 to August 2027, participants will follow individualized coaching: starting at 5-6 hours per week and progressing to 7-10 hours (rarely 15 hours) per week before mountain ultra marathon |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Affiliation to social security.
- Informed consent signed.
- Male or female, aged 25-50.
- Sedentary (>6h/day sitting) and inactive (no regular training), assessed by GPAQ questionnaire.
Key exclusion criteria (8 listed)
- Chronic joint or cardiac diseases.
- Neurological disorders.
- Legal protection status.
- Moderate to severe depression (BDI-13 > 7) or use of antidepressants/anxiolytics.
- Use of banned substances.
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 |
|---|---|---|
| Intensive trainingparticipants will follow individualized coaching: starting at 5-6 hours per week and progressing to 7-10 hours (rarely 15 hours) per week before mountain ultra marathon | Behavioural | Endurance training |
Primary outcome
Transition from sedentary lifestyle to regular activity and completion of a 100 km ultra-trail
Time frame: up to 18 months
Percentage of participants who (i) become sufficiently active to be ready to start the Courmayeur-Champex-Chamonix (CCC) 100 km ultra-trail of the Ultra Trail du Mont-Blanc, and (ii) complete the 100 km CCC race.
2 secondary outcomes
Safety and tolerance of progressive endurance training
Time frame: Weekly reporting during the 18-month intervention period
Feasibility and adherence to the endurance training program
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided. we are not decided for the moment
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Screening Protocol
Pain
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.
Céline LECLERCQ-TRAUTVETTER, CDP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive training in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonard FEASSON, MD Phd ((0)4 77 82 83 00 ext. +33, leonard.feasson@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition from sedentary lifestyle to regular activity and completion of a 100 km ultra-trail (time frame: up to 18 months). 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 4 Jun 2026.