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

NCT02938429 | Completed

• 1 other identifier: Pro00060485
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects

Keywords

congenital

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Vascular health questionnaire

  Once during routine clinical visit after informed consent/assent.

Study Arms (2)

Participants with Fontan circulation

OTHER

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

Age and gender matched controlled

OTHER

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

Interventions

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

Also known as: 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)

Age and gender matched controlled; Participants with Fontan circulation

Eligibility Criteria

• Age: 24 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

• Jennifer Conway, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CA (1)