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OpenTrials
Completed

NCT Number: NCT02938429

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.

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Key information

Conditions

Heart Defects

Age range

24 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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)

Primary outcomes

  1. 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.

  2. 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

  1. Vascular health questionnaire

    Time frame: Once during routine clinical visit after informed consent/assent.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2016
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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