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RE-ENERGIZE FONTAN - RandomizEd Exercise INtERvention desiGned to MaximIZE Fitness in Pediatric FONTAN patients

重新激活 FONTAN - 随机运动干预旨在最大限度地提高儿童 FONTAN 患者的健康状况

基本信息

批准号：
9893292
负责人：
Daniel Bernstein
金额：
$ 75.27万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-10 至 2021-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9893292
关键词：
19 year old Accelerometer Adherence Admission activity Adolescent Adolescent and Young Adult Adolescent obesity Adult Aerobic Age Angiotensin Receptor Angiotensin-Converting Enzyme Inhibitors Arginine Biological Markers Brain natriuretic peptide Cardiac Cardiopulmonary Cessation of life Chemicals Child Child Health Childhood Chronic Common Ventricle Creatine Data Disease Progression Dual-Energy X-Ray Absorptiometry Echocardiography Effectiveness Endothelium Equipment and supply inventories Exercise Exercise stress test Goals Health Heart Heart Transplantation Heart failure Intervention Leg Magnetic Resonance Imaging Measures Mission Modality Modeling Morbidity - disease rate Movement Muscle Mitochondria Muscle function Nitrates Nitric Oxide Nitric Oxide Pathway Nitrites Obesity Outcome Patients Physical Capacity Physical Function Physical activity Physiologic pulse Plasma Population Quality of life Questionnaires Randomized Randomized Clinical Trials Randomized Controlled Trials Reproducibility Research Resistance Risk Scanning Schools Site Supervision Testing Thinness Translations Transplant Recipients Transportation Treatment Failure United States National Institutes of Health VO2max Work Youth adherence rate arm cardiorespiratory fitness clinical application congenital heart disorder design endothelial dysfunction evidence base exercise capacity exercise intervention exercise prescription fitness heart function improved improved outcome indexing mortality multidisciplinary muscle form muscle strength neonatal period novel novel strategies novel therapeutic intervention palliation physical conditioning prevent primary outcome reduced muscle mass success symposium therapy design treatment as usual

项目摘要

PROJECT SUMMARY Survival of children with single ventricles (“half a heart”) beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With >1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. We propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. Adherence is a major limitation in pediatric exercise interventions delivered on-site, with adherence rates as low as 10%, due to distance from site, transportation difficulties, and missed school or work days. To overcome these challenges, we will utilize live-video conferencing to deliver the supervised exercise sessions. In our pilot exercise interventions, this approach resulted in excellent adherence (>85%) and improved exercise capacity and endothelial function. This proposal is designed to determine if the intervention improves: (Aim 1) cardiac and physical capacity (primary outcome: VO2 max), (Aim 2) muscle mass strength and function; and (Aim 3) endothelial function in pediatric Fontan patients. Our multidisciplinary team of experts will assess the effectiveness of a live-video-supervised exercise intervention, rigorously designed to maximize adherence and improve key and novel measures of health in pediatric Fontan patients associated with poor long-term outcomes. The use of exercise as a non-pharmacologic treatment modality in pediatric Fontan patients represents a paradigm shift, where standard therapies have failed. Our ultimate goal is the translation of this model to clinical application as an ”exercise prescription” to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality, in alignment with the NIH’s mission to develop evidence-based data for new approaches to improve outcomes in youth with chronic conditions.

项目总结