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Clinical Trials/NCT02938429
NCT02938429
Completed
Not Applicable

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

University of Alberta1 site in 1 country25 target enrollmentOctober 2016
ConditionsHeart Defects

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Defects
Sponsor
University of Alberta
Enrollment
25
Locations
1
Primary Endpoint
Physical activity measured by accelerometers
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
August 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children with Fontan physiology between the ages 24 months to 18 years at the Stollery Children's Hospital
  • Informed written consent obtained prior to enrolment
  • At least 6 months post Fontan procedure

Exclusion Criteria

  • Patient hospitalized within the previous 2 weeks
  • Patient unable to ambulate independently
  • Underwent coarctation of the aorta repair using a subclavian flap.

Outcomes

Primary Outcomes

Physical activity measured by accelerometers

Time Frame: 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).

Time Frame: Once consent/assent is obtained, endothelial function will be measured one time during a routine clinical visit.

Secondary Outcomes

  • Vascular health questionnaire(Once during routine clinical visit after informed consent/assent.)

Study Sites (1)

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