Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-55
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Not have cardiovascular, neurological, and/or genetic musculoskeletal disease
Trial population
Patients aged 8-55 years who underwent the Fontan procedure and followed up by Department of Pediatric Cardiology will be included in the study. In the evaluation of patients in terms of suitability for the study, a detailed history, medical and family history, and a physical examination focused on all systems. The eligible patients will be referred to the Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics and laboratory tests are completed. For patients aged 8-17 years, the parental informed consent form for the research study and the child consent form for the research study will be carefully explained and included in the study after the parents and patients have read, understood, and accepted. For patients aged 18 years and older, the informed consent form for the research study will be carefully explained and will be included in the study after the patients have read, understood, and accepted.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Cardiopulmonary exercise test
Other interventionCPET, the gold standard, will be used in the assessment of cardiorespiratory fitness. The cardiopulmonary exercise test system (Cosmed Quark CPET, Rome, Italy) is a safe method in which the patient can be monitored via ECG during the execution of the individual on a treadmill, and simultaneously lactate measurement, maximal O2 consumption, and CO2 production are evaluated. The Bruce protocol is the most commonly used method for KPET applied with a treadmill. However, since the Bruce protocol prefers high workload preferences, the Modified Bruce/half Bruce protocol with intermediate increments will be used. In addition, dyspnea, leg fatigue, and general fatigue at rest, during the test, and during the recovery phases after the test will be recorded with a sphygmomanometer using the Modified Borg Scale.
Pulmonary function test
Other interventionPulmonary function testing will be performed with a spirometer (Cosmed Quark CPET, Rome, Italy) connected to the CPET system using standard procedures. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC, peak expiratory volume measured at 25% and 75% of forced expiratory time (FEF 25-75%), and peak expiratory volume (PEF) parameters will be saved.
Respiratory muscle strength test
Other interventionIntraoral maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be used as indicators of respiratory muscle strength. A portable intraoral pressure gauge (MicroRPM, Micromedical, Kent, UK) and nose clip will be used during MIP and MEP assessments. MIP and MEP measurements will be obtained using standard procedures. 3 measurements will be made where the difference between each measurement is not more than 10% and the maximum value of MIP and MEP will be recorded.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Fontan group3 interventions
Group B: Control Group3 interventions
Trial outcomes
Primary outcomes
1
Maximal oxygen consumption
Time frame
30-45 minutes2
Forced vital capacity (FVC)
Time frame
15-20 minutes3
Forced expiratory volume in 1 second (FEV1)
Time frame
15-20 minutes4
FEV1/FVC
Time frame
15-20 minutesSponsors and contacts
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Source ClinicalTrials.gov