Physical Abilities of Teenagers With Familial Mediterrane... | NCT06257342

Studies
Physical Abilities of Teenagers With Familial Mediterranean Fever

NCT06257342

Sponsor

Véronique Hentgen

Status

Active, not recruiting

Last Update Posted

Feb 13, 2024Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Familial Mediterranean Fever

Interventions

6 minutes walk

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2023Actual

Primary Completion Date

Oct 15, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Physical abilities of teenagers with familial Mediterranean fever

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
6 minutes walk	Procedure	A 6 minutes walk test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Teenagers with familian mediteranean fever

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010505	Familial Mediterranean Fever

Ancestor Terms

ID	Term
D056660	Hereditary Autoinflammatory Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided