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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05684562
Other study ID # fontanpulmonarydeterminants
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 26, 2023
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Hacettepe University
Contact Haluk Tekerlek
Phone +905355915009
Email haluktekerlek@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date December 30, 2024
Est. primary completion date December 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 55 Years
Eligibility 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

Study Design


Intervention

Other:
Cardiopulmonary exercise test
CPET, 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
Pulmonary 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
Intraoral 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.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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