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NCT Number: NCT05063903

Exercise Capacity in Patients With Fontan Procedure

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.

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Key information

Conditions

Single-ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fontan Procedure Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Incremental shuttle walk test distance

    Time frame: 30-45 minutes

    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.

  2. 6 minute walk test distance

    Time frame: 15-20 minutes

    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.

  3. Right and left hand grip strength

    Time frame: 15-20 minutes

    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

  4. Maximum isometric muscle strength of the quadriceps femoris

    Time frame: 15-20 minutes

    The maximum isometric muscle strength of the Quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).

  5. Body fat ratio

    Time frame: 5-10 minutes

    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.

  6. Lean body weight

    Time frame: 5-10 minutes

    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.

  7. Fat weight

    Time frame: 5-10 minutes

    Fat weight will be evaluated by bioelectrical impedance analysis. Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2021
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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