Physical Activity Measured Through Accelerometers and Its Association With Endothelial Function in Young Patients With Fontan Physiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Physical activity measured by accelerometers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient hospitalized within the previous 2 weeks
- •Patient unable to ambulate independently
- •Underwent coarctation of the aorta repair using a subclavian flap.
研究组 & 干预措施
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.
干预措施: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days (Other)
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.
干预措施: Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days (Other)
结局指标
主要结局
Physical activity measured by accelerometers
时间窗: 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).
时间窗: Once consent/assent is obtained, endothelial function will be measured one time during a routine clinical visit.
次要结局
- Vascular health questionnaire(Once during routine clinical visit after informed consent/assent.)