Exercise Capacity in Patients With Fontan Procedure

Single-ventricle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063903
• Other study ID #: exercisecapacityfontan
• Status: Completed
• Start date: September 20, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fontan Procedure
• Single-ventricle
• Univentricular Heart

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental shuttle walk test distance	For the incremental shuttle walk test, it will be adjusted to a total of 10 meters with 2 cones placed at a distance of 9.0 meters from each other and a rotational margin of 0.5 meters. In this system, the patient will be asked to walk in a round-trip way by adapting to the increasing speed and the sound coming from outside. Walking/running distances of the patients in meters will be recorded.	30-45 minutes
Primary	6 minute walk test distance	The standard test protocol will be applied in a continuous 30 meter corridor. The patient wearing comfortable clothes and shoes will be given standard instructions and verbal guidance during the test. The distance the patient walked during the test will be recorded in meters.	15-20 minutes
Primary	Right and left hand grip strength	Right and left hand grip strength will be measured using a hand grip strength hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL, USA). Measurements shall be made using standard procedures, right and left sides, with the arms at the side of the trunk, the elbow in a 90 degree flexion position, and the forearm and wrist in a neutral position. The highest of the three measurements will be considered as hand grip strength	15-20 minutes
Primary	Maximum isometric muscle strength of the quadriceps femoris	The maximum isometric muscle strength of the Quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).	15-20 minutes
Primary	Body fat ratio	Body fat ratio will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.	5-10 minutes
Primary	Lean body weight	Lean body weight will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.	5-10 minutes
Primary	Fat weight	Fat weight will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.	5-10 minutes