Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
Key facts
- Who runs it
- Hacettepe University
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 78 people, planned
- Started
- 26 Dec 2023
- Expected to end
- 30 Apr 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Cardiopulmonary exercise test
- Pulmonary function test
- Respiratory muscle strength test
- Record updated
- 16 September 2026
Who can take part
- Age
- 8 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Other criteria
- Fontan Group Inclusion Criteria:
- Be between 8-55 years old
- Having undergone a Fontan operation
- Clinical stability of the patients (preserved ventricular function)
- No change in ongoing drug therapy that adversely affects clinical stability
- At least 1 year after the operation; Fontan Group Exclusion Criteria:
- Neurological and/or genetic musculoskeletal disease
- Having orthopedic and cognitive problems that prevent testing
- The patient's and/or family's unwillingness to participate in the study; Control Group Inclusion Criteria:
- Not have cardiovascular, neurological, and/or genetic musculoskeletal disease
- Not having orthopedic and cognitive problems that prevent testing
- The patient's and/or family's willingness to participate in the study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 55 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc. evaluations are made during the routine controls of the patients. Within the scope of this study, no attempt will be made on the patients, no additional tests will be performed, or treatment changes will not be made in the patients because they are included in this study. After these records, KPET will be performed by a specialist doctor and physiotherapist for the patients who are directed to the Faculty of Physical Therapy and Rehabilitation Cardiopulmonary Rehabilitation Unit. Pulmonary function tests and respiratory muscle strength measurements will be performed on patients who have adequate rest after CPET.
The 2 groups in the trial
- Fontan group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Treatment: Cardiopulmonary exercise test, Pulmonary function test, and Respiratory muscle strength test
- Control Group
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Treatment: Cardiopulmonary exercise test, Pulmonary function test, and Respiratory muscle strength test
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
- Fit questions
- Built from NCT05684562, who can take part
- Record updated
- 16 September 2026