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

Not Applicable

Completed

• Conditions: Heart Defects

• Registration Number: NCT02938429
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Vascular health questionnaire	Once during routine clinical visit after informed consent/assent.

Trial Locations

Locations (1)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada