Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

Recruiting

• Conditions: Fontan Procedure; Congenital Heart Disease
• Interventions: Other: Cardiopulmonary exercise test; Other: Pulmonary function test; Other: Respiratory muscle strength test

• Registration Number: NCT05684562
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-13
• Study Start: 2023-12-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-25
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fontan group	Cardiopulmonary exercise test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Control Group	Pulmonary function test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Control Group	Respiratory muscle strength test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Fontan group	Pulmonary function test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Control Group	Cardiopulmonary exercise test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Fontan group	Respiratory muscle strength test	Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test

Primary Outcome Measures

Name	Time	Method
Ratio of minute ventilation to carbon dioxide production (VE/VCO2)	30-45 minutes
Oxygen uptake efficiency slope (OUES)	30-45 minutes
Maximal inspiratory pressure	15-20 minutes
Ratio curve of minute ventilation to carbon dioxide production (VE/VCO2) slope	30-45 minutes
FEV1/FVC	15-20 minutes
Maximal oxygen consumption	30-45 minutes
Forced vital capacity (FVC)	15-20 minutes
Forced expiratory volume in 1 second (FEV1)	15-20 minutes
Maximal expiratory pressure	15-20 minutes
Minute ventilation (VE)	30-45 minutes
End tidal carbon dioxide pressure (PetCO2)	30-45 minutes
End tidal oxygen pressure (PetO2)	30-45 minutes

Trial Locations

Locations (1)

Hacettepe Unıversity; 🇹🇷 Ankara, Turkey