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Exercise Capacity in Patients With Fontan Procedure

NCT05063903 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2022-01-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2022-01-05
Completion
2022-01-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063903 on ClinicalTrials.gov