Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

Hacettepe University

Status: Enrolling

Conditions: Congenital Heart Disease; Fontan Procedure

Treatments: Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Cardiopulmonary exercise test

Study type: Observational

Funder types: Other

Identifiers

NCT05684562

fontanpulmonarydeterminants

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 8 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

78 participants in 2 patient groups

Fontan group

Description:

Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test

Treatment:

Other: Cardiopulmonary exercise test

Other: Respiratory muscle strength test

Other: Pulmonary function test

Control Group

Description:

Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test

Treatment:

Other: Cardiopulmonary exercise test

Other: Respiratory muscle strength test

Other: Pulmonary function test