NCT05063903

Exercise Capacity in Patients With Fontan Procedure

Assessment of Exercise Capacity in Single-ventricle Patients Undergoing Fontan Procedure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 8 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Single-ventricle
• Fontan Procedure

Interventions

Type	Name	Description
OTHER	Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition	Demographic and clinical characteristics Age and complaints, post-operative follow-up, other problems, medications, ECHO and ECG findings, laboratory tests (complete blood count, liver and kidney function tests, brain natriuretic peptide (BNP) level) Hand grip strength Right and left hand grip strength the highest of the three measurements Lower extremity muscle strength Maximum isometric muscle strength of the quadriceps femoris Body composition Body fat ratio, lean body weight and fat weight by bioelectrical impedance analysis 6 minute walk test The six minute walk test distance recorded in meters Incremental shuttle walk test The lap number, the number of laps of the last level they can reach, and the walking/running distances recorded in meters

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2021-10-01
• Last updated: 2022-01-20

Locations

1 site across 1 country: Turkey (Türkiye)