Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Qing Du, Yasser Salem, Hao (Howe) Liu, Xuan Zhou, Sun Chen, Nan Chen, Xiaoyan Yang, Juping Liang, Kun Sun

Published in: Trials | Issue 1/2017

Login to get access

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

Appendix
Available only for authorised users
Literature
1.
Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890–900.CrossRefPubMed
2.
Nelle M, Raio L, Pavlovic M, Carrel T, Surbek D, Meyer-Wittkopf M. Prenatal diagnosis and treatment planning of congenital heart defects-possibilities and limits. World J Pediatr. 2009;5(1):18–22.CrossRefPubMed
3.
Sun K. Advances in pediatric interventional catheterizationn. J Clin Pediatr. 2008;26(5):365–70.
4.
Congenital Heart Disease Committee, Chinese Pediatric Physicians Association, Chinese Medical Doctor Association; Subspecialty Group of Cardiology, the Society of Pediatrics, Chinese Medical Association; Editorial Board, Chinese Journal of Pediatrics. Expert consensus for the interventional treatment of pediatric congenital heart disease. Zhonghua Er Ke Za Zhi. 2015;53(1):17–24.
5.
Mahle WT, Spray TL, Wernovsky G, Gaynor JW, Clark 3rd BJ. Survival after reconstructive surgery for hypoplastic left heart syndrome: a 15-year experience from a single institution. Circulation. 2000;102(19 Suppl 3):III136–41.PubMed
6.
Jacobs JP, Quintessenza JA, Burke RP, Bleiweis MS, Byrne BJ, Ceithaml EL, et al. Analysis of regional congenital cardiac surgical outcomes in Florida using the Society of Thoracic Surgeons Congenital Heart Surgery Database. Cardiol Young. 2009;19(4):360–9.CrossRefPubMed
7.
Green A. Outcomes of congenital heart disease: a review. Pediatr Nurs. 2004;30(4):280–4.PubMed
8.
Knowles RL, Bull C, Wren C, Wade A, Goldstein H, Dezateux C, et al. Modelling survival and mortality risk to 15 years of age for a national cohort of children with serious congenital heart defects diagnosed in infancy. PLoS One. 2014;9(8):e106806.CrossRefPubMedPubMedCentral
9.
Owen M, Shevell M, Donofrio M, Majnemer A, McCarter R, Vezina G, et al. Brain volume and neurobehavior in newborns with complex congenital heart defects. J Pediatr. 2014;164(5):1121–7. e1.CrossRefPubMed
10.
Li Y, Yin S, Fang J, Hua Y, Wang C, Mu D, et al. Adverse neurological performance with critical congenital heart diseases mainly from prenatal injury not cardiac surgery: current evidence based on a meta-analysis of functional magnetic resonance imaging. Ultrasound Obstet Gynecol. 2015;45(6):639–48.CrossRefPubMed
11.
Bjarnason-Wehrens B, Dordel S, Schickendantz S, Krumm C, Bott D, Sreeram N, et al. Motor development in children with congenital cardiac diseases compared to their healthy peers. Cardiol Young. 2007;17:487–98.CrossRefPubMed
12.
Snookes SH, Gunn JK, Eldridge BJ, Donath SM, Hunt RW, Galea MP, et al. A systematic review of motor and cognitive outcomes after early surgery for congenital heart disease. Pediatrics. 2010;125(4):818–27.CrossRef
13.
Yang XY, Sun K, Du Q, Chen S, Zhou X, Bai K, et al. Development of motor cognition and language in children with congenital heart disease. Chin J Appl Clin Pediatr. 2015;30(1):26–9.
14.
Holm I, Fredriksen PM, Fosdahl MA, Olstad M, Vøllestad N. Impaired motor competence in school-aged children with complex congenital heart disease. Arch Pediatr Adolesc Med. 2007;161(10):945–50.CrossRefPubMed
15.
Longmuir PE, McCrindle BW. Physical activity restrictions for children after the Fontan operation: disagreement between parent, cardiologist, and medical record reports. Am Heart J. 2009;157(5):853–9.CrossRefPubMed
16.
Reybrouck T, Mertens L. Physical performance and physical activity in grown-up congenital heart disease. Eur J Cardiovasc Prev Rehabil. 2005;12(5):498–502.CrossRefPubMed
17.
Cohen MS. Clinical practice: the effect of obesity in children with congenital heart disease. Eur J Pediatr. 2012;171(8):1145–50.CrossRefPubMed
18.
Mellion K, Uzark K, Cassedy A, Drotar D, Wernovsky G, Newburger JW, et al. Health-related quality of life outcomes in children and adolescents with congenital heart disease. J Pediatr. 2014;164(4):781–8.CrossRefPubMed
19.
Carey LK, Nicholson BC, Fox RA. Maternal factors related to parenting young children with congenital heart disease. J Pediatr Nurs. 2002;17(3):174–83.CrossRefPubMed
20.
Niebauer J. Cardiac Rehabilitation Manual. Dayi Hu, translator. Beijing: Peking University Medical Press; 2012.
21.
Müller J, Pringsheim M, Engelhardt A, Meixner J, Halle M, Oberhoffer R, et al. Motor training of sixty minutes once per week improves motor ability in children with congenital heart disease and retarded motor development: a pilot study. Cardiol Young. 2013;23(5):717–21.CrossRefPubMed
22.
Smith BK, Bleiweis MS, Neel CR. Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. Phys Ther. 2013;93(2):229–36.CrossRefPubMed
23.
Felcar JM, Guitti JC, Marson AC, Cardoso JR. Preoperative physiotherapy in prevention of pulmonary complications in pediatric cardiac surgery. Rev Bras Cir Cardiovasc. 2008;23(3):383–8.CrossRefPubMed
24.
Cirovic D, Nikolic D, Petronice I. Early rehabilitation of children in different age groups after correction of non-cyanotic congenital heart defects. Turk J Phys Med Rehab. 2014;60(Supp.1):S25–9.CrossRef
25.
Stieber NA, Gilmour S, Morra A, Rainbow J, Robitaille S, Van Arsdell G, et al. Feasibility of improving the motor development of toddlers with congenital heart defects using a home-based intervention. Pediatr Cardiol. 2012;33(4):521–32.CrossRefPubMed
26.
Liu Q. Clinical care with the interventional therapy in children with congenital heart disease. Chin Community Doctors. 2015;31(4):142–3. 145.
27.
Folio MK, Fewell R. Peabody Developmental Motor Scale: Motor Activities Program. 2nd ed. Austin: PRO-ED Inc.; 2000.
28.
Folio MK, Fewell R. Peabody Developmental Motor Scale: examiner’s manual. 2nd ed. Austin: PRO-ED Inc.; 2000.
29.
Ross RD. The Ross classification for heart failure in children after 25 years: a review and an age-stratified revision. Pediatr Cardiol. 2012;33(5):1295–300.CrossRefPubMed
30.
Yu X, Zhang J, Yan C, et al. Relationships between serum 25-hydroxyvitamin D and quantitative ultrasound bone mineral density in 0-6 year old children. Bone. 2013;53(1):306–10.CrossRefPubMed
31.
Uniform Data System for Medical Rehabilitation. WeeFIM system Clinical Guide, version 5.01. Buffalo: University of Buffalo; 1998.
32.
Wong V, Wong S, Chan K, Wong W. Functional Independence Measure (WeeFIM) for Chinese children: Hong Kong Cohort. Pediatrics. 2002;109(2):E36.CrossRefPubMed
33.
34.
Li L, Wang HM, Shen Y. Development and psychometric tests of a Chinese version of the SF-36 Health Survey Scales. Chin J Prev Med. 2002;36(2):109–13.
35.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649–55.CrossRefPubMed
Metadata
Title
A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial
Authors
Qing Du
Yasser Salem
Hao (Howe) Liu
Xuan Zhou
Sun Chen
Nan Chen
Xiaoyan Yang
Juping Liang
Kun Sun
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1773-7

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Study protocol

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial

Research

Subversion of allocation concealment in a randomised controlled trial: a historical case study

Update

A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update

Update

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis

Study protocol

The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial