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Recruiting

NCT Number: NCT07626593

The Extraordinary Endurance of the Human Species

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.

Recruiting

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Key information

Conditions

Healthy Volunteers Behavior Sedentary Behavior

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Clément FOSCHIA, MD

SUB_INVESTIGATOR

David HUPIN, MD

SUB_INVESTIGATOR

Laurent GERGELE, MD

SUB_INVESTIGATOR

Léonard FEASSON, MD Phd

CONTACT

[email protected]

(0)4 77 82 83 00 ext. +33

Philippe BOIRON, MD

SUB_INVESTIGATOR

Renan PLANCHER, MD

SUB_INVESTIGATOR

Rémi VASSEUR, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive Training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline LECLERCQ-TRAUTVETTER, CDP

CONTACT

[email protected]

04 77 82 94 27 ext. +33

Leonard FEASSON, MD Phd

CONTACT

[email protected]

(0)4 77 82 83 00 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: 0 TO 100

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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