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Randomized Controlled Trial
. 2017 Jan 23;18(1):38.
doi: 10.1186/s13063-016-1773-7.

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

Qing Du  1 , Yasser Salem  2 , Hao Howe Liu  2 , Xuan Zhou  1 , Sun Chen  3 , Nan Chen  1 , Xiaoyan Yang  1 , Juping Liang  1 , Kun Sun  4
Affiliations
Randomized Controlled Trial

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

Qing Du et al. Trials. .

Abstract

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.

Keywords: Cardiac catheterization; Children; Congenital heart disease; Home-based exercise; Motor development.

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Figures

Fig. 1
Fig. 1
Flow diagram showing home-based exercise program for children with CHD following interventional cardiac catheterization
Fig. 2
Fig. 2
Time schedule of enrollment, assessments, and interventions
See this image and copyright information in PMC

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