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Active, not recruitingNCT06257342Sport & FMFUpdated Feb 13, 2024

Physical Abilities of Teenagers With Familial Mediterranean Fever

An observational study in Familial Mediterranean Fever, sponsored by Véronique Hentgen. Active, not recruiting at 1 site in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Véronique Hentgen · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
12 Years to 18 Years
Sex
All
01

Study summary

Physical abilities of teenagers with familial Mediterranean fever

Read the detailed description

Physical abilities of teenagers with familial Mediterranean fever by describing the maximum oxygen consumption (VO2max) estimated from a 6-minute walk test

02

Conditions studied

  • Familial Mediterranean Fever
03

In context

Familial Mediterranean Fever

61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.

This study's planned enrollment of 10 is below the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.

Browse Familial Mediterranean Fever studies →

Lead sponsor

This is the only study on the registry with Véronique Hentgen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Teenagers with familian mediteranean fever

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a clinical diagnosis of FMF according to the Tel-Hashomer criteria for whom a sports evaluation was offered during their bridging program
  • Age >12
  • Followed or having been followed in the pediatric department of the CH of Versailles
  • No opposition of the patient and his/her parent/legal guardian in case of a minor patient

Exclusion criteria

Exclusion Criteria:

Expressed refusal of the patient and his/her parent/legal guardian to participate in the study and/or to use genetic data for research purposes

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • Procedure6 minutes walk

    A 6 minutes walk test

06

What researchers measure

Primary outcomes

  1. the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test

    Describe the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test

    Time frame: 6 minutes

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Oct 2027, 50 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2024
First posted
Feb 13, 2024
StartActual
Jul 30, 2023
Primary completionEst.
Oct 15, 2027
CompletionEst.
Dec 31, 2027
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257342
Lead sponsor
Véronique Hentgen
Responsible party
Véronique Hentgen (Professor, Versailles Hospital) — Sponsor-investigator
First posted
Feb 13, 2024
Start date
Jul 30, 2023
Primary completion
Oct 15, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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