Abstract
BackgroundDelayed motor development is reported in patients with congenital heart disease (CHD). Exercise is widely used to facilitate motor development and improve motor ability. Exercise for adolescents and adults with CHD has been extensively studied. However, the evidence of exercise for infants with CHD is sparse. This study aims to identify the effect of passive movement and active exercise on motor development within very young CHD infants with cardiac catheterization.Methods/DesignA prospective and randomized controlled trial will be conducted in very young CHD infants with cardiac catheterization. A total of 147 infants with CHD will be randomized by a 1:1:1 allocation ratio by computer to an exercise intervention group, a home-based intervention group and a control group. The exercise intervention group will receive passive movement and active exercise from experienced physiotherapists in pediatrics three times a week for 12 weeks. The home-based intervention group will receive passive movement and active exercise from their parents or caregivers at home three times a week for 12 weeks. The control group will receive follow up only. The follow-up duration is 20 months. The primary outcome measures are the motor quotient measured by the Peabody Developmental Motor Scales-II. The secondary outcome measures are the Ross score, ventricular function, bone quality, body length, weight, head circumference, upper arm circumference, and adverse events.DiscussionThis study has several important features, including the randomization process, the long follow-up duration, the control group, and the large sample size. The aim of this study is to determine whether 12-week passive movement and active exercise promotes motor development and produces other beneficial effects for very young CHD infants with cardiac catheterization. Therefore, this study will contribute new knowledge regarding the rehabilitation program in very young CHD infants with cardiac catheterization.Trial registrationCurrent Controlled Trials ChiCTR-IOR-15005909 (January 31, 2015).
Highlights
Delayed motor development is reported in patients with congenital heart disease (CHD)
The aim of this study is to determine whether 12-week passive movement and active exercise promotes motor development and produces other beneficial effects for very young CHD infants with cardiac catheterization
This paper describes the rationale, design and methodology of a randomized, controlled study being conducted in China
Summary
Delayed motor development is reported in patients with congenital heart disease (CHD). The evidence of exercise for infants with CHD is sparse. This study aims to identify the effect of passive movement and active exercise on motor development within very young CHD infants with cardiac catheterization. Congenital heart disease (CHD) is common in infants [1]. With the improvement of echocardiography and medical care, more patients with CHD were underwent cardiac catheterization than ever before. Lower exercise function [10, 11], dysfunction in speech and language [12], poor cognitive function [13, 14] and behavior difficulties [8] were reported in preschool and school-age patients with CHD. Infants with CHD require a large amount of physical activity to master movement control
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