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

Heart Defects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938429
• Other study ID #: Pro00060485
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Defects

Intervention

Other:
• Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Vascular health questionnaire		Once during routine clinical visit after informed consent/assent.