- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07626593
The Extraordinary Endurance of the Human Species (0 TO 100)
June 2, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Léonard FEASSON, MD Phd
- Phone Number: +33 (0)4 77 82 83 00
- Email: leonard.feasson@chu-st-etienne.fr
Study Contact Backup
- Name: Céline LECLERCQ-TRAUTVETTER, CDP
- Phone Number: +33 04 77 82 94 27
- Email: Celine.LECLERCQ-TRAUTVETTER@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Etienne, France, 42055
- Recruiting
- CHU de Saint-Etienne
-
Sub-Investigator:
- David HUPIN, MD
-
Sub-Investigator:
- Clément FOSCHIA, MD
-
Sub-Investigator:
- Philippe BOIRON, MD
-
Sub-Investigator:
- Rémi VASSEUR, MD
-
Contact:
- Léonard FEASSON, MD Phd
- Phone Number: +33 (0)4 77 82 83 00
- Email: leonard.feasson@chu-st-etienne.fr
-
Sub-Investigator:
- Renan PLANCHER, MD
-
Sub-Investigator:
- Laurent GERGELE, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endurance training
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and tolerance of progressive endurance training
Time Frame: Weekly reporting during the 18-month intervention period
|
Rate of injuries or adverse events reported weekly, and dropout rate over the 18-month training period.
|
Weekly reporting during the 18-month intervention period
|
|
Feasibility and adherence to the endurance training program
Time Frame: up to 18 months
|
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.
|
up to 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2026
Primary Completion (Estimated)
September 28, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
June 2, 2026
First Posted (Actual)
June 4, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
June 2, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25CH172
- ANSM (Other Identifier: 2025-A01697-42)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
we are not decided for the moment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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