NCT07626593

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
17mo left

Started Feb 2026

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Nov 2027

Study Start

First participant enrolled

February 3, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

February 26, 2026

Last Update Submit

June 2, 2026

Conditions

Healthy Volunteers

Keywords

Ultra-enduranceSedentaryHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 18 months

Secondary Outcomes (2)

  • Safety and tolerance of progressive endurance training

    Weekly reporting during the 18-month intervention period

  • Feasibility and adherence to the endurance training program

    up to 18 months

Study Arms (1)

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

Behavioral: Intensive training

Interventions

Intensive trainingBEHAVIORAL

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

Endurance training

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Leonard FEASSON, MD Phd

CONTACT

(0)4 77 82 83 00leonard.feasson@chu-st-etienne.fr

Céline LECLERCQ-TRAUTVETTER, CDP

CONTACT

04 77 82 94 27Celine.LECLERCQ-TRAUTVETTER@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

June 4, 2026

Study Start

February 3, 2026

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

FR(1)