Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention

项目摘要/摘要 随着先天性心脏病(CHD)幸存者进入成年期，他们患后天性心脏病的风险更大 心血管并发症(如高血压和冠心病)。这些合并症是 容易受到生活方式变化的影响，比如增加体力活动，但青春期和青春期是 当身体活动率开始下降时。冠心病体力活动生活干预(CHD-PAL) 以过渡年龄的冠心病幸存者为目标，使用一种引人入胜的面对面视频会议形式，这一理论- 了解并根据每个参与者的独特生理和活动需求量身定做。CHD-PAL 视频会议讨论计划行为理论(TPB；即，态度， 主观规范和对从事行为的感知控制)，并实施自我监控和目标- 布景技巧。CHD-PAL可行性/初步疗效试验表明，CHD-PAL对 Ayas和CHD-PAL相比，增加了花在中等到剧烈体力活动(MVPA)上的时间 对于体力活动水平较低的AYA的对照组。然而，需要进行更大规模的试验。 确定CHD-PAL对MVPA的影响、可能的机制(即TPB的要素)和健康 患有冠心病的AYA患者的预后。目前这项研究的主要目标是确定 144例15~25岁中、复杂型冠心病患者MVPA变化的CHD-PAL研究 将随机分为2组：CHD-PAL或注意控制组(Control)。CHD-PAL由为期20周的 视频会议-实施体力活动干预(9、20到30分钟的会议；Fitbit®到自我 监督和设定目标)与干预者(“教练”)。对照参与者将收到相同的号码和 与教练联系的频率，使用相同的模式讨论使用Fitbit而不涉及 TPB假设的机制，或被指示进行自我监督或设定目标。主要的研究结果是 由加速度计测量的MVPA的变化。TPB假设的机制的变化将是 评估为次要结果和心肺功能的变化(即最大摄氧量和最大吸氧量) 探索过了。我们的具体目标是(1)确定CHD-PAL对MVPA变化的影响，并研究 影响持久性，(2)探索TPB机制的变化及其与MVPA变化的相关性，以及(3) 探讨CHD-PAL对心肺功能变化的影响。目前的研究是一项 在对长期健康影响和成本进行多点评估之前，反复进行CHD-PAL的精炼过程 AYAS合并冠心病的临床干预效果。归根结底，这项研究具有 改善过渡年龄冠心病幸存者心血管预后的潜力--一个未被充分研究的增长 有需要的人口，以及其他有心肺风险的儿科慢性疾病。

PROJECT SUMMARY/ABSTRACT As congenital heart disease (CHD) survivors enter adulthood, they have a greater risk for developing acquired cardiovascular complications (e.g., hypertension and coronary artery disease). These comorbidities are amenable to lifestyle changes, such as increasing physical activity, yet adolescence and young adulthood are when physical activity rates begin declining. The CHD Physical Activity Lifestyle intervention (CHD-PAL) targets transition-age CHD survivors, using an engaging face-to-face videoconferencing format that this theory- informed and tailored to the unique physiology and activity needs of each participant. The CHD-PAL videoconferencing sessions address elements of the Theory of Planned Behavior (TPB; i.e., attitudes, subjective norms, and perceived control for engaging in a behavior) and implements self-monitoring and goal- setting techniques. The CHD-PAL feasibility/preliminary efficacy trials indicated that CHD-PAL is feasible for AYAs and that CHD-PAL increases time spent in moderate-to-vigorous physical activity (MVPA) as compared to the control group for AYAs who engage in lower levels of physical activity. However, a larger trial is needed to determine the impact of CHD-PAL on MVPA, purported mechanisms (i.e., elements of TPB), and health outcomes among AYAs with CHD. The primary objective of the current study is to determine the impact of CHD-PAL on change in MVPA among 144 AYAs (ages 15-25) with moderate and complex forms of CHD who will be randomized to 1 of 2 arms: CHD-PAL or attention control (Control). CHD-PAL consists of a 20-week videoconferencing-administered physical activity intervention (9, 20- to 30-minute sessions; Fitbit® to self- monitor and set goals) with an interventionist (“coach”). Control participants will receive the same number and frequency of contacts with a coach using the same modality to discuss using the Fitbit without addressing the TPB hypothesized mechanisms or being directed to self-monitor or set goals. The primary study outcome is change in MVPA as measured by an accelerometer. Change in the TPB hypothesized mechanisms will be assessed as secondary outcomes and change in cardiorespiratory fitness (i.e., peak VO2 and METs) will be explored. Our specific aims are to (1) determine the impact of CHD-PAL on change in MVPA and examine effect durability, (2) explore change in the TPB mechanisms and their relevance to change MVPA, and (3) explore the impact of CHD-PAL on change in cardiorespiratory fitness. The current study is the next step in an iterative process to refine CHD-PAL before multisite assessment of longer-term health implications and cost effectiveness of the intervention for AYAs with CHD in a clinical setting. Ultimately, this research has the potential to improve cardiovascular outcomes for transition-aged CHD survivors, an understudied growing population in need, as well as other pediatric chronic conditions with cardiopulmonary risk.