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

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ClinicalTrials.gov Identifier: NCT02938429
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Conway, 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.

Condition or disease Intervention/treatment Phase
Heart Defects Other: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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)




Primary Outcome Measures :
  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 Outcome Measures :
  1. Vascular health questionnaire [ Time Frame: Once during routine clinical visit after informed consent/assent. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938429


Contacts
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Contact: Jennifer Conway, MD 7804073355 conway@ualberta.ca

Locations
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Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Jennifer Conway, MD    780-407-3355    Jennifer.Conway2@albertahealthservices.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jennifer Conway, MD University of Alberta

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Responsible Party: Jennifer Conway, Assistant Professor/Cardiology, University of Alberta
ClinicalTrials.gov Identifier: NCT02938429     History of Changes
Other Study ID Numbers: Pro00060485
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Keywords provided by Jennifer Conway, University of Alberta:
congenital