- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05063903
Exercise Capacity in Patients With Fontan Procedure
Assessment of Exercise Capacity in Single-ventricle Patients Undergoing Fontan Procedure
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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 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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental shuttle walk test distance
Time Frame: 30-45 minutes
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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.
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30-45 minutes
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6 minute walk test distance
Time Frame: 15-20 minutes
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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.
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15-20 minutes
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Right and left hand grip strength
Time Frame: 15-20 minutes
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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
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15-20 minutes
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Maximum isometric muscle strength of the quadriceps femoris
Time Frame: 15-20 minutes
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The maximum isometric muscle strength of the Quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).
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15-20 minutes
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Body fat ratio
Time Frame: 5-10 minutes
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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.
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5-10 minutes
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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.
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5-10 minutes
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Fat weight
Time Frame: 5-10 minutes
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Fat weight will be evaluated by bioelectrical impedance analysis.
Tanita Body Fat Analyzer (model TBF 300, Tokyo, Japan) will be used during the analysis.
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5-10 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- exercisecapacityfontan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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