一项针对先天性心脏病患儿介入性心导管术后的家庭锻炼计划：一项随机对照试验的研究方案
A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial.
作者信息
Du Qing, Salem Yasser, Liu Hao Howe, Zhou Xuan, Chen Sun, Chen Nan, Yang Xiaoyan, Liang Juping, Sun Kun
机构信息
Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
Department of Physical Therapy, University of North Texas Health Science Center, Fort Worth, TX, USA.
出版信息
Trials. 2017 Jan 23;18(1):38. doi: 10.1186/s13063-016-1773-7.
BACKGROUND
Cardiac catheterization has opened an innovative treatment field for cardiac disease; this treatment is becoming the most popular approach for pediatric congenital heart disease (CHD) and has led to a significant growth in the number of children with cardiac catheterization. Unfortunately, based on evidence, it has been demonstrated that the majority of children with CHD are at an increased risk of "non-cardiac" problems. Effective exercise therapy could improve their functional status significantly. As studies identifying the efficacy of exercise therapy are rare in this field, the aims of this study are to (1) identify the efficacy of a home-based exercise program to improve the motor function of children with CHD with cardiac catheterization, (2) reduce parental anxiety and parenting burden, and (3) improve the quality of life for parents whose children are diagnosed with CHD with cardiac catheterization through the program.
METHODS/DESIGN: A total of 300 children who will perform a cardiac catheterization will be randomly assigned to two groups: a home-based intervention group and a control group. The home-based intervention group will carry out a home-based exercise program, and the control group will receive only home-based exercise education. Assessments will be undertaken before catheterization and at 1, 3, and 6 months after catheterization. Motor ability quotients will be assessed as the primary outcomes. The modified Ross score, cardiac function, speed of sound at the tibia, functional independence of the children, anxiety, quality of life, and caregiver burden of their parents or the main caregivers will be the secondary outcome measurements.
DISCUSSION
The proposed prospective randomized controlled trial will evaluate the efficiency of a home-based exercise program for children with CHD with cardiac catheterization. We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families.
TRIAL REGISTRATION
http://www.chictr.org.cn/ on: ChiCTR-IOR-16007762 . Registered on 13 January 2016.
背景
心导管检查为心脏病开辟了一个创新的治疗领域；这种治疗正成为小儿先天性心脏病（CHD）最常用的方法，并导致接受心导管检查的儿童数量显著增加。不幸的是，有证据表明，大多数患有CHD的儿童面临“非心脏”问题的风险增加。有效的运动疗法可以显著改善他们的功能状态。由于在该领域确定运动疗法疗效的研究很少，本研究的目的是：（1）确定家庭运动计划对改善接受心导管检查的CHD儿童运动功能的疗效；（2）减轻父母的焦虑和育儿负担；（3）通过该计划提高其孩子被诊断为接受心导管检查的CHD的父母的生活质量。
方法/设计：总共300名将要进行心导管检查的儿童将被随机分为两组：家庭干预组和对照组。家庭干预组将开展家庭运动计划，对照组仅接受家庭运动教育。在导管插入术前以及导管插入术后1、3和6个月进行评估。运动能力商数将作为主要结果进行评估。改良罗斯评分、心功能、胫骨声速、儿童功能独立性、焦虑、生活质量以及其父母或主要照顾者的照顾者负担将作为次要结果测量指标。
讨论
拟议的前瞻性随机对照试验将评估家庭运动计划对接受心导管检查的CHD儿童的有效性。我们预计家庭运动计划可能对患有CHD的儿童及其家庭是一种有价值且有效的干预措施。
试验注册
http://www.chictr.org.cn/ ，注册号：ChiCTR-IOR-16007762 。于2016年1月13日注册。
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