Physical Activity Measured Through Accelerometers and Its Association With Endothelial Function in Young Patients With Fontan Physiology

Study Overview
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Brief Summary
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This study will be a cross sectional assessment of physical activity as measured through accelerometers and its association with endothelial function of children with Fontan circulation and healthy age and gender matched controls who are followed at the University of Alberta - Stollery Children's hospital.

Conditions
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Heart Defects

Intervention / Treatment
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* Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with Fontan physiology between the ages 24 months to 18 years at the Stollery Children's Hospital Informed written consent obtained prior to enrolment At least 6 months post Fontan procedure Exclusion Criteria: Patient hospitalized within the previous 2 weeks Patient unable to ambulate independently Underwent coarctation of the aorta repair using a subclavian flap.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with Fontan circulation<br>Physical activity measurements: Participants will wear Actigraph GT3X+ accelerometers for 7 consecutive days and complete a physical activity log. Data from the accelerometers and physical activity log will be cross referenced. Endothelial function measurements: Participants undergo Digital Thermal Monitoring (DTM) via Vendys (VENDYS-6000, Endothelix Inc., Houston, TX). Since DTM is not currently a validated tool and its use has not been published in a paediatric population, we will employ a second assessment of endothelial function, the Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical). Participants will complete a questionnaire to access factors that can affect endothelial function. | Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days<br> <br> * Other names: Endothelial function measurements: Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical);|
| Other: Age and gender matched controlled<br>Physical activity measurements: Participants will wear Actigraph GT3X+ accelerometers for 7 consecutive days and complete a physical activity log. Data from the accelerometers and physical activity log will be cross referenced. Endothelial function measurements: Participants undergo Digital Thermal Monitoring (DTM) via Vendys (VENDYS-6000, Endothelix Inc., Houston, TX). Since DTM is not currently a validated tool and its use has not been published in a paediatric population, we will employ a second assessment of endothelial function, the Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical). Participants will complete a questionnaire to access factors that can affect endothelial function. | Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days<br> <br> * Other names: Endothelial function measurements: Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity measured by accelerometers |  | Once consent/assent is obtained, participants will be asked to wear an Actigraph GT3X+ accelerometers for seven consecutive days, during waking hours. | 
| Endothelial function measured by Digital Thermal Monitoring (DTM) via the automated, operator-independent protocol (VENDYS-6000, Endothelix Inc., Houston, TX) and the Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical). |  | Once consent/assent is obtained, endothelial function will be measured one time during a routine clinical visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular health questionnaire |  | Once during routine clinical visit after informed consent/assent. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital