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

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.

Study Overview

• Status: Completed
• Conditions: Heart Defects
• Intervention / Treatment: Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participants with Fontan circulation; 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; Other Names: Endothelial function measurements: Digital Thermal Monitoring (DTM) via Vendys (VENDYS-6000, Endothelix Inc., Houston, TX); Endothelial function measurements: Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical)
Other: Age and gender matched controlled; 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; Other Names: Endothelial function measurements: Digital Thermal Monitoring (DTM) via Vendys (VENDYS-6000, Endothelix Inc., Houston, TX); Endothelial function measurements: Endothelial Pulse Amplitude Test (Endo-PAT, Itamar Medical)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Jennifer Conway, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: congenital
• Other Study ID Numbers: Pro00060485