NCT06257342

Brief Summary

Physical abilities of teenagers with familial Mediterranean fever

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jul 2023Dec 2027

Study Start

First participant enrolled

July 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 13, 2024

Status Verified

June 1, 2023

Enrollment Period

4.2 years

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Familial Mediterranean Fever

Outcome Measures

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

    6 minutes

Interventions

6 minutes walkPROCEDURE

A 6 minutes walk test

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Teenagers with familian mediteranean fever

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Versailles

Le Chesnay, France

Location

MeSH Terms

Conditions

Familial Mediterranean Fever

Interventions

Walking

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 13, 2024

Study Start

July 30, 2023

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 13, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)