High Intensity Interval Training in Youth With Congenital Heart Disease: A Prospective Clinical Trial of a Novel Telemedicine Video Game-Linked Exercise Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
研究概览
简要总结
Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life.
Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.
详细描述
Purpose: This project is a prospective clinical trial of a home-based high intensity interval training (HIIT) exercise program using a novel telemedicine-enabled and video game-linked customizable cycle ergometer (MedBIKE™) in the pediatric congenital heart disease (CHD) population.
Hypothesis: The home-based the MedBIKE™ HIIT program will significantly improve exercise capacity. The MedBIKE intervention will significantly improve time spent in MVPA and reduce sedentary time, improve HRQoL and self-efficacy towards PA, and improve endothelial function. Moreover, the investigators hypothesize that the improvements in exercise capacity, along with the improvements in the secondary outcomes will remain significantly improved up to one-year post- MedBIKE intervention, when compared to pre-intervention values.
Justification: Exercise intervention studies in the pediatric CHD population have been limited by small sample sizes and there is limited data pertaining to the sustained effects of exercise interventions on exercise capacity, physical activity, endothelial function, and quality of life. This study, using standardized and largely operator-independent measure, will be one of the largest exercise intervention clinical trials in the pediatric CHD population.
Primary Objective: Evaluate the impact of an eight-week, home-based HIIT MedBIKE™ program on exercise capacity in youth with repaired moderate-complex CHD.
Secondary Objectives: Evaluate the impact of the MedBIKE™ intervention on 1) PA; 2) HRQoL and self-efficacy towards PA; 3) endothelial function; and 4) sustained changes in the primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 10-18 years
- •Repaired moderate-complex congenital heart disease
排除标准
- •Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- •Home environment cannot accommodate the MedBIKE™ system (space limitations)
- •Previous involvement in a cardiac rehab or exercise intervention program
- •Primary cardiologist has exercise restricted the participant or counsels against participation
- •Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
- •Resting arterial saturation <85% or oxygen requirements
- •Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- •History of chest pain on exertion
- •Unrepaired/unpalliated CHD
- •Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))
- •New York Heart Association class II or worse symptoms
- •Active medical inter-current illness limiting ability to participate
- •Cognitive impairment limiting the communication needed for the HIIT program
- •Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
研究组 & 干预措施
MedBIKE HIIT
MedBIKE HIIT Exercise Program
干预措施: MedBIKE HIIT (Device)
结局指标
主要结局
Exercise capacity in the change in VO2peak (mL/kg/min) measured through CPET testing
时间窗: Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention
CPET (Exercise Stress Test and Spirometry) will be done to measure the VO2peak (mL/kg/min) output of participants. A comparison will be done pre- and post-MedBIKE intervention, as well as 6 and 12-months post, to determine the change in overall VO2peak of participants. We will also evaluate changes in VE/VCO2, peak power output (W), and HRmax (maximum heart rate).
次要结局
- Changes in Health-Related Quality of Life as measured using the TNO AZL Children's Quality of Life (TACQOL) questionnaire.(Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention)
- Changes in self efficacy towards physical activity measured on the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) scale.(Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention)
- Changes in endothelial function to determine arterial volume will be measured using an EndoPAT 2000 instrument.(Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention)
- Changes in physical activity, defined as time spent in moderate to vigorous physical activity (MVPA) and sedentary time, measured by wearing an accelerometer for 7-days prior and 7-days post MedBIKE intervention(Baseline, 1-week post-intervention, 6-months post-intervention, 12-months post-intervention)