- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06780514
Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Debo
- Phone Number: 093329813
- Email: bauke.debo@uzgent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Recruiting
- Ghent University Hospital
-
Contact:
- Bauke Debo
- Phone Number: 093329813
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Turner syndrome girls aged 8-18 years old
Exclusion Criteria:
- Severe mental impairement making it impossible to perform an exercise test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2 max
Time Frame: Whitin a week after the CPET
|
VO2 max is the maximum volume (V) of oxygen (O2) your body can process during exercise
|
Whitin a week after the CPET
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bloodpressure
Time Frame: Whitin a week after the CPET
|
Whitin a week after the CPET
|
|
Heart rate
Time Frame: Whitin a week after the CPET
|
Whitin a week after the CPET
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Cardiovascular Diseases
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Genetic Diseases, Inborn
- Gonadal Disorders
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Defects, Congenital
- Disorders of Sex Development
- Urogenital Abnormalities
- Sex Chromosome Disorders
- Chromosome Disorders
- Sex Chromosome Disorders of Sex Development
- Turner Syndrome
- Gonadal Dysgenesis
Other Study ID Numbers
- ONZ-2023-0632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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