Exercise Capacity in Patients With Fontan Procedure

NCT ID: NCT05063903

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-01-05

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Fontan Group

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

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

Intervention Type: OTHER

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

Control Group

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

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Haluk TEKERLEK

Principal Investigator/Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Goldberg DJ, Avitabile CM, McBride MG, Paridon SM. Exercise capacity in the Fontan circulation. Cardiol Young. 2013 Dec;23(6):824-30. doi: 10.1017/S1047951113001649.

Reference Type: BACKGROUND

PMID: 24401254 (View on PubMed)

Chen CA, Chen SY, Chiu HH, Wang JK, Chang CI, Chiu IS, Chen YS, Lu CW, Lin MT, Lue HC, Hua YC, Wu MH. Prognostic value of submaximal exercise data for cardiac morbidity in Fontan patients. Med Sci Sports Exerc. 2014 Jan;46(1):10-5. doi: 10.1249/MSS.0b013e31829f8326.

Reference Type: BACKGROUND

PMID: 23846156 (View on PubMed)

d'Udekem Y. Cardiorespiratory Fitness, Not the Severity of the Condition, Dictates Late Outcomes After Fontan Procedures. J Am Coll Cardiol. 2017 Jun 6;69(22):2745-2747. doi: 10.1016/j.jacc.2017.03.581. No abstract available.

Reference Type: BACKGROUND

PMID: 28571640 (View on PubMed)

Tekerlek H, Saglam M, Kucukdagli AC, Aykan HH, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Karagoz T. Assessment of exercise capacity using field walking tests in patients after the Fontan procedure: A case-control study. Heart Lung. 2023 Jul-Aug;60:66-73. doi: 10.1016/j.hrtlng.2023.02.022. Epub 2023 Mar 14.

Reference Type: DERIVED

PMID: 36924606 (View on PubMed)

Other Identifiers

exercisecapacityfontan

Identifier Type: -

Identifier Source: org_study_id