Clinical trial NCT05063903: Exercise Capacity in Patients With Fontan Procedure
Official title: Assessment of Exercise Capacity in Single-ventricle Patients Undergoing Fontan Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-ventricle
Fontan Procedure
Keywords: Exercise capacity
Six minute walk test
Incremental shuttle walk test
Fontan procedure
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The number of individuals to be included in the study was determined as 27 According to the power analysis at α=0.05 and β=0.20 (for 80% power). In this study, the medical information and medical records of the patients (patient files, computer records, etc.) will be examined and recorded. Patients aged 8-50 years who underwent the fonton procedure and were followed by Hacettepe University, Department of Pediatric Cardiology will be included in the study. The eligible patients will be referred to Faculty of Physical Therapy and Rehabilitation after the routine evaluations are completed. Control cases planned to be included in the study to be compared with the results of Fontan patients will be created by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. In addition, control cases will be invited to work through an online advertisement.

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.


Eligibility 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

Primary outcomes:
measure: Incremental shuttle walk test distance
timeFrame: 30-45 minutes
measure: 6 minute walk test distance
timeFrame: 15-20 minutes
measure: Right and left hand grip strength
timeFrame: 15-20 minutes
measure: Maximum isometric muscle strength of the quadriceps femoris
timeFrame: 15-20 minutes
measure: Body fat ratio
timeFrame: 5-10 minutes
measure: Lean body weight
timeFrame: 5-10 minutes
measure: Fat weight
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
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.
citation: 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.
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. No abstract available.