Cardiopulmonary Exercise Testing in Girls (8-18y) with Tu... | NCT06780514

Studies
Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.

NCT06780514

Sponsor

University Hospital, Ghent

Status

Recruiting

Last Update Posted

Jan 17, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Turner Syndrome

Interventions

Cardiopulmonary exercise test

Countries

Belgium

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

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2024Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

Jan 13, 2025

First Submission Date that Met QC Criteria

Jan 13, 2025

First Posted Date

Jan 17, 2025Actual

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

Jan 13, 2025

Last Update Posted Date

Jan 17, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to have a beter insight in the exercise tolerance in girls with Turner Syndrome aged 8-18 years . The main question it aims to answer is:

Is there a difference in VO2 max comparing Turner syndrome girls with standard values? How do cardiovascular parameters change during exercise (heart rate, bloodpressure, ...)

Participants will perform a cyclo-ergometry in a standardised way.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiopulmonary exercise test	Diagnostic Test	To our knowledge, this is the first study to perform CPET's in Turner Girls aged <18 years		CPET cyclo-ergometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VO2 max	VO2 max is the maximum volume (V) of oxygen (O2) your body can process during exercise	Whitin a week after the CPET

Secondary Outcomes

Measure	Description	Time Frame
Bloodpressure		Whitin a week after the CPET
Heart rate		Whitin a week after the CPET

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Turner syndrome girls aged 8-18 years old

Exclusion Criteria:

Severe mental impairement making it impossible to perform an exercise test

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Debo	Contact	093329813		bauke.debo@uzgent.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital	Recruiting	Ghent		9000	Belgium

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
D014424	Turner Syndrome

Ancestor Terms

ID	Term
D006059	Gonadal Dysgenesis
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005080	Exercise Test

Ancestor Terms

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided