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Exercise Capacity in Patients With Fontan Procedure

H

Hacettepe University

Status

Completed

Conditions

Single-ventricle
Fontan Procedure

Treatments

Other: Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition

Study type

Observational

Funder types

Other

Identifiers

NCT05063903
exercisecapacityfontan

Details and patient eligibility

About

In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly. Cardiopulmonary exercise test (CPET) was generally used to evaluate exercise capacity in children and adults with fontan circulation. The fact that CPET requires a clinically expert team and equipment and is more expensive does not always make it possible to perform routine cardiopulmonary exercise testing. In some cases, field tests evaluating submaximal and maximal exercise capacity may be more practical than cardiopulmonary exercise testing. Therefore, in this study, it is aimed to evaluate the exercise capacity of Fontan patients with 6-minute walking test and incremental shuttle walk test and to compare vital signs during the tests.

Enrollment

42 patients

Sex

All

Ages

8 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Fontan Group Inclusion Criteria

  • be between the ages of 8-50
  • Having undergone Fontan operation in our hospital or another center
  • 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 and to be followed in the Pediatric Cardiology Polyclinic of our hospital

Fontan Group Exclusion Criteria:

  • Inability to access the patient's medical data
  • 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

42 participants in 2 patient groups

Fontan Group
Description:
Fontan Group Inclusion Criteria be between the ages of 8-50 Having undergone Fontan operation in our hospital or another center 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 and to be followed in the Pediatric Cardiology Polyclinic of our hospital Fontan Group Exclusion Criteria: Inability to access the patient's medical data 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
Treatment:
Other: Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition
Control Group
Description:
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
Treatment:
Other: Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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