Evaluation of Free-living Physical Activity and the Assessment Tools Used to Support Pharmacological Therapy Titration and Exercise Prescription in Children and Adolescents Diagnosed With Inherited Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Correlation of maximum heart rate during clinical exercise tolerance test and daily physical activity
研究概览
简要总结
The goal of this observational study is to evaluate exercise testing and daily physical activity in children and adolescents who are diagnosed with an inherited arrhythmia.
The main question it aims to answer is: Does maximum heart rate during controlled exercise tolerance testing accurately reflect maximum heart rate and peak exercise levels during free living daily physical activity in children and adolescents diagnosed with an inherited arrhythmia?
Participants will:
- Complete routine exercise tolerance testing
- Record daily physical activity and exercise over two weeks, while wearing an activity and heart rate monitor and digit diary.
- Complete a physical activity questionnaire at the end of two weeks.
详细描述
Exercise tolerance testing (ETT) using an exercise treadmill is a tool used to assess children's physical response to stress, which is thought to accurately reflect normal physiology during normal daily activities and can be used to:
- Evaluate heart rhythm and symptoms occurring during exercise.
- Evaluate children with a family history of sudden death and inherited heart conditions.
- Assess the response of medications prescribed to control heart rhythm.
The maximum heart rate achieved during ETT is used to estimate the effect of daily medications and to guide exercise prescription.
Originally designed to assess adult heart disease patients, ETTs were not intended for use in children. To accommodate the needs of children, shorter ETT protocols have been developed which increase the speed and/or incline of the treadmill quickly.
Despite this, many children rarely complete the full ETT protocol as they grow tired or develop other symptoms, which leads to them stopping exercise early, resulting in variable lengths of testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Affected cohort
- •Male and female children
- •Aged 6-16 years
- •Diagnosed with long QT syndrome or catecholaminergic polymorphic ventricular tachycardia
- •Treated with beta-blocker and/or sodium channel blockade
- •Able to complete a treadmill ETT
- •Healthy cohort
- •Male and female children
- •Aged 6-16 years
- •Siblings of affected children (gene negative)
- •Undergoing IAS screening
- •Able to complete a treadmill ETT
排除标准
- •Children aged less than 6 years
- •Adults, 17 years of age and above
- •Unable to run on an exercise treadmill due to physical limitations.
- •Individuals unable to speak or understand English, due to no translation service available.
- •Pregnancy
研究组 & 干预措施
Affected
Children diagnosed with Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
干预措施: Exercise tolerance test (Diagnostic Test)
Affected
Children diagnosed with Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia
干预措施: Physical activity & heart rate monitoring (Other)
Unaffected
Healthy children (siblings of affected or those undergoing screening)
干预措施: Exercise tolerance test (Diagnostic Test)
Unaffected
Healthy children (siblings of affected or those undergoing screening)
干预措施: Physical activity & heart rate monitoring (Other)
结局指标
主要结局
Correlation of maximum heart rate during clinical exercise tolerance test and daily physical activity
时间窗: Baseline assessment (week one of study assessments)
Assess the correlation between maximum heart rate (HRmax) obtained during controlled exercise tolerance test (ETT) and wearable heart rate devices during daily free-living (FL) physical activity (PA) and exercise.
Physical activity questionnaire
时间窗: End of two-week physical activity monitoring (week two of study assessments)
Investigate actual versus reported PA children engage in using a questionnaire to record accuracy of child/parent recall of the type and intensity of PA.
次要结局
- Heart rate assessment during exercise tolerance testing(Baseline assessment (week one of study assessment))
- Comparison of exercise tolerance testing protocols(Immediately after the intervention)
研究者
Renwick Catherine
Consultant Nurse / HEE/NIHR Doctoral Clinical and Practitioner Academic Fellow
Royal Brompton & Harefield NHS Foundation Trust