Heart Defects
Conditions
Keywords
congenital
Brief summary
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.
Interventions
OTHERPhysical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days
Sponsors
University of Alberta
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Children with Fontan physiology between the ages 24 months to 18 years at the Stollery Children's Hospital 2. Informed written consent obtained prior to enrolment 3. At least 6 months post Fontan procedure
Exclusion criteria
1. Patient hospitalized within the previous 2 weeks 2. Patient unable to ambulate independently 3. Underwent coarctation of the aorta repair using a subclavian flap.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Vascular health questionnaire | Once during routine clinical visit after informed consent/assent. |
Countries
Canada
Outcome results
None listed