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

Not Applicable

Completed

• Conditions: Heart Defects
• Interventions: Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Fontan circulation	Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days	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.
Age and gender matched controlled	Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days	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.

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