Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Cardiac and skeletal function and metabolism
研究概览
简要总结
Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children.
Secondary Objectives:
- To determine if impairments do exist, are they related to exercise capacity.
- To determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism.
Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function are evident, influence exercise capacity, and can be improved with exercise training.
详细描述
This proposed research provides an interdisciplinary approach to understanding exercise intolerance by examining cardiac and musculoskeletal metabolism in a unique cohort of children with congenital heart disease. Study findings may more importantly lead to evidence-based exercise interventions that promote improvements in overall physical health, quality of life, and functional status for Fontan children. Furthermore, this pilot study will lead to the development of a novel research protocol which may be applied to larger Fontan and other congenital heart disease cohorts. This study will also provide preliminary data to develop and conduct a larger clinical research project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fontan Patients:
- •Patients who have had the Fontan cardiac procedure
- •10-16 years of age
- •Written Informed Consent
- •Healthy Controls:
- •10 - 16 years of age
- •Written Informed Consent
排除标准
- •Fontan Patients:
- •Contraindication to exercise
- •Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
- •Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
- •Patients with a known allergy to gadolinium.
- •Patients with a history of allergic disposition or have anaphylactic reactions
- •Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
- •Have Sickle Cell anemia
- •Known pregnancy, or breast feeding
- •Patient is uncooperative during a MRI without sedation or anesthesia
- •Healthy Controls:
- •Contraindication to exercise
- •Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
- •Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
- •Patient is uncooperative during a MRI without sedation or anesthesia
结局指标
主要结局
Cardiac and skeletal function and metabolism
时间窗: 1 day
Blood oxygen level dependent functional magnetic resonance imaging (BOLD fMRI), and 31P-MRS will allow for the precise measurement of cardiac and musculoskeletal function, circulatory perfusion and vascular reactivity, and aerobic and anaerobic metabolism, respectively. Cardiac function will be examined via MRI and exercise echocardiography.
次要结局
未报告次要终点
研究者
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children