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Recruiting NCT07626593

The Extraordinary Endurance of the Human Species

No phase Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensive training.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 25 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Intensive training
    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 outcome measures

  • Transition from sedentary lifestyle to regular activity and completion of a 100 km ultra-trail [Time frame: up to 18 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07626593 · 25CH172 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗