TY - JOUR
T1 - A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization
T2 - Study protocol for a randomized controlled trial
AU - Du, Qing
AU - Salem, Yasser
AU - Liu, Hao Howe
AU - Zhou, Xuan
AU - Chen, Sun
AU - Chen, Nan
AU - Yang, Xiaoyan
AU - Liang, Juping
AU - Sun, Kun
N1 - Funding Information:
This work was supported by the Xin Hua Hospital affiliated to the Shanghai Jiao Tong University School of Medicine and the Clinical Research Unit of Xin Hua Hospital. It was funded by the One Thousand Days project of Xin Hua Hospital affiliated to the Shanghai Jiao Tong University School of Medicine (15QT17), the key developing disciplines of Shanghai Municipal Commission of Health and Family Planning (2015ZB0406), and a project of the Shanghai Municipal Commission of Health and Family Planning (201640067).
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/1/23
Y1 - 2017/1/23
N2 - 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.
AB - 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.
KW - Cardiac catheterization
KW - Children
KW - Congenital heart disease
KW - Home-based exercise
KW - Motor development
UR - http://www.scopus.com/inward/record.url?scp=85010878183&partnerID=8YFLogxK
U2 - 10.1186/s13063-016-1773-7
DO - 10.1186/s13063-016-1773-7
M3 - Article
C2 - 28115007
AN - SCOPUS:85010878183
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 38
ER -