title: A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  http://www.chictr.org.cn/ on: ChiCTR-IOR-16007762 . Registered on 13 January 2016.
authors.affiliation: Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Du
authors.affiliation: Department of Physical Therapy, University of North Texas Health Science Center, Fort Worth, TX, USA.
authors.forename: Yasser
authors.initials: Y
authors.lastname: Salem
authors.affiliation: Department of Physical Therapy, University of North Texas Health Science Center, Fort Worth, TX, USA.
authors.forename: Hao Howe
authors.initials: HH
authors.lastname: Liu
authors.affiliation: Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Xuan
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Department of Pediatric Cardiology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Sun
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
authors.affiliation: Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Yang
authors.affiliation: Department of Rehabilitation Medicine, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
authors.forename: Juping
authors.initials: J
authors.lastname: Liang
authors.affiliation: Department of Pediatric Cardiology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China. sunkunxh@126.com.
authors.forename: Kun
authors.initials: K
authors.lastname: Sun
mesh_terms: D000367:Age Factors; D006328:Cardiac Catheterization / Q000009:adverse effects; D017028:Caregivers / Q000523:psychology; D002657:Child Development; D002675:Child, Preschool; D002681:China; D002985:Clinical Protocols; D017281:Cost of Illness; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods*; D017079:Exercise Tolerance; D005260:Female; D006304:Health Status; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D018575:Home Care Services, Hospital-Based; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009043:Motor Activity; D010290:Parents / Q000523:psychology; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
keywords: Cardiac catheterization; Children; Congenital heart disease; Home-based exercise; Motor development