Top

Trials

Published in:

Open Access 01-12-2024 | Telemedicine | Study protocol

The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT

Authors: Gina Wood, Anna Scheer, Jelena Saundankar, Derek Tran, Rachael Cordina, Andrew Maiorana

Published in: Trials | Issue 1/2024

Abstract

Background

Accumulated evidence suggests that exercise training exerts beneficial effects on people with congenital heart conditions. These findings are predominantly derived from small, single-centre exercise trials conducted in outpatient rehabilitation facilities. In recent years, the delivery of exercise interventions remotely has increased through digital communications technology (telerehabilitation). However, very little research to date has been conducted into the efficacy of telerehabilitation in people with a congenital heart condition.

Aims

To evaluate the effects of a telehealth-delivered exercise intervention in people with a history of a surgical biventricular repair due to a congenital heart condition.

Methods

One hundred eligible adolescent (≥ 16 years) and adult participants living with a complex biventricular congenital heart condition will be recruited from four Australian sites and randomised to either (1) a 16-week telehealth-delivered combined (aerobic and resistance) exercise training programme of moderate-to-vigorous intensity or (2) usual care (control group), in a 1:1 allocation, with an 8-month follow-up.

Outcomes of interest

The primary outcome will be the change in aerobic capacity expressed as peak oxygen uptake (VO_2peak). Secondary outcomes will include changes in vascular function, muscle oxygenation, metabolic profile, body composition and musculoskeletal fitness, neurohormonal activation, neurocognitive function, physical activity levels, dietary and nutritional status, and quality of life. Outcomes will be assessed at baseline, 16 weeks, and 12 months (to determine longer-term maintenance potential).

Discussion

If found to be efficacious, telerehabilitation may be an alternative option for delivering exercise, improving health outcomes, and increasing accessibility to exercise programmes. Efficacy data is required to quantify the clinical significance of this delivery mode of exercise.

Trial registration

ACTRN12622000050752

Trial registration date: 17 January 2022

Trial registration URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382635&showOriginal=true&isReview=true

Trial registry name: Australian and New Zealand Clinical Trials Registry

Available only for authorised users

Mylotte D, Pilote L, Ionescu-Ittu R, et al. Specialized adult congenital heart disease care: the impact of policy on mortality. Circulation. 2014;129(18):1804–12.CrossRefPubMed

Smith SC, Jackson R, Pearson TA, et al. Principles for national and regional guidelines on cardiovascular disease prevention. Circulation. 2004;109(25):3112–21. https://doi.org/10.1161/01.CIR.0000133427.35111.67.CrossRefPubMed

Naci H, Ioannidis JPA. Comparative effectiveness of exercise and drug interventions on mortality outcomes: meta-epidemiological study. Br J Sports Med. 2015;49(21):1414. https://doi.org/10.1136/bjsports-2015-f5577rep.CrossRefPubMed

Pinto NM, Marino BS, Wernovsky G, et al. Obesity is a common comorbidity in children with congenital and acquired heart disease. Pediatrics. 2007;120(5):e1157–64.CrossRefPubMed

Diller G-P, Dimopoulos K, Okonko D, et al. Exercise intolerance in adult congenital heart disease. Circulation. 2005;112(6):828–35. https://doi.org/10.1161/circulationaha.104.529800.CrossRefPubMed

Giardini A, Hager A, Lammers AE, et al. Ventilatory efficiency and aerobic capacity predict event-free survival in adults with atrial repair for complete transposition of the great arteries. J Am Coll Cardiol. 2009;53(17):1548–55. https://doi.org/10.1016/j.jacc.2009.02.005.CrossRefPubMed

Swank AM, Horton J, Fleg JL, et al. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012;5(5):579–85.CrossRefPubMedPubMedCentral

Shekhar S, Agrawal A, Pampori A, et al. Mortality in adult congenital heart disease: analysis of outcomes and risk stratification. J Cardiothorac Vasc Anesth. 2022;36(8b):3379–88. https://doi.org/10.1053/j.jvca.2022.03.010. ISSN 1053-0770.CrossRefPubMed

Diller G-P, Kempny A, Alonso-Gonzalez R, et al. Survival prospects and circumstances of death in contemporary adult congenital heart disease patients under follow-up at a large tertiary centre. Circulation. 2015;132:2118–25. https://doi.org/10.1161/CIRCULATIONAHA.115.017202.CrossRefPubMed

10.

Zomer AC, Vaartjes I, Uiterwaal CSPM, et al. Circumstances of death in adult congenital heart disease. Int J Cardiol. 2012;154(2):168–72. https://doi.org/10.1016/j.ijcard.2010.09.015. [published Online First: 2010/10/11].CrossRefPubMed

11.

Swan L, Hillis WS. Exercise prescription in adults with congenital heart disease: a long way to go. Heart. 2000;83(6):685–7. https://doi.org/10.1136/heart.83.6.685.CrossRefPubMedPubMedCentral

12.

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. https://doi.org/10.1097/01.hjr.0000176510.84165.eb. [published Online First: 2005/10/08].CrossRefPubMed

13.

Sandberg C, Thilén U, Wadell K, et al. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015;22(2):1523–30. https://doi.org/10.1177/2047487314543076. [published Online First: 2013 Oct 9].CrossRefPubMed

14.

Gratz A, Hess J, Hager A. Self-estimated physical functioning poorly predicts actual exercise capacity in adolescents and adults with congenital heart disease. Eur Heart J. 2008;30(4):497–504. https://doi.org/10.1093/eurheartj/ehn531.CrossRefPubMed

15.

Sandberg C, Johansson K, Christersson C, et al. Sarcopenia is common in adults with complex congenital heart disease. Int J Cardiol. 2019;296:57–62. https://doi.org/10.1016/j.ijcard.2019.06.011.CrossRefPubMed

16.

Kröönström LA, Johansson L, Zetterström A-K, et al. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014;170(3):358–63. https://doi.org/10.1016/j.ijcard.2013.11.014.CrossRefPubMed

17.

Bassareo PP, Saba L, Solla P, et al. Factors influencing adaptation and performance at physical exercise in complex congenital heart diseases after surgical repair. Biomed Res Int. 2014;2014:862372–472. https://doi.org/10.1155/2014/862372. [published Online First: 2014/04/15].CrossRefPubMedPubMedCentral

18.

Dimopoulos K, Diller G-P, Piepoli MF, et al. Exercise intolerance in adults with congenital heart disease. Cardiol Clin. 2006;24(4):641–60. https://doi.org/10.1016/j.ccl.2006.08.002.CrossRefPubMed

19.

Verrall CE, Yang JYM, Chen J, et al. Neurocognitive dysfunction and smaller brain volumes in adolescents and adults with a fontan circulation. Circulation. 2021;143(9):878–91. https://doi.org/10.1161/circulationaha.120.048202. [published Online First: 2020/11/25].CrossRefPubMed

20.

Perrotta ML, Saha P, Zawadski R, et al. Adults with mild-to-moderate congenital heart disease demonstrate measurable neurocognitive deficits. Am Heart Assoc. 2020;9:e015379. https://doi.org/10.1161/JAHA.119.CrossRef

21.

Cohen S, Earing MG. Neurocognitive impairment and its long-term impact on adults with congenital heart disease. Prog Cardiovasc Dis. 2018;61(3):287–93. https://doi.org/10.1016/j.pcad.2018.08.002.CrossRefPubMed

22.

Ilardi D, Ono KE, McCartney R, Book W, Stringer AY. Neurocognitive functioning in adults with congenital heart disease. Congenit Heart Dis. 2017;12(2):166–73. https://doi.org/10.1111/chd.12434. Epub 2016 Dec 13. PMID: 27957813.CrossRefPubMed

23.

Li X, Chen N, Zhou X, et al. Exercise training in adults with congenital heart disease: a systematic review and meta-analysis. J Cardiopulm Rehabil Prev. 2019;39(5):299–307. https://doi.org/10.097/hcr.0000000000000420.CrossRefPubMed

24.

Tran D, Maiorana A, Ayer J, et al. Recommendations for exercise in adolescents and adults with congenital heart disease. Prog Cardiovasc Dis. 2020;63(3):350–66. https://doi.org/10.1016/j.pcad.2020.03.002.CrossRefPubMed

25.

Chaix M-A, Marcotte F, Dore A, et al. Risks and benefits of exercise training in adults with congenital heart disease. Can J Cardiol. 2016;32(4):459–66. https://doi.org/10.1016/j.cjca.2015.12.007.CrossRefPubMed

26.

Ubeda Tikkanen A, Opotowsky AR, Bhatt AB, et al. Physical activity is associated with improved aerobic exercise capacity over time in adults with congenital heart disease. Int J Cardiol. 2013;168(5):4685–91. https://doi.org/10.1016/j.ijcard.2013.07.177.CrossRef

27.

Cordina RL, O’Meagher S, Karmali A, et al. Resistance training improves cardiac output, exercise capacity and tolerance to positive airway pressure in Fontan physiology. Int J Cardiol. 2013;168(2):780–8. https://doi.org/10.1016/j.ijcard.2012.10.012. [published Online First: 2012/11/17].CrossRefPubMed

28.

Sheng P, Feinberg JL, Bostrom JA, et al. Adherence and exercise capacity improvements of patients with adult congenital heart disease participating in cardiac rehabilitation. J Am Heart Assoc. 2022;11:e023896. https://doi.org/10.1161/JAHA.121.023896.CrossRefPubMedPubMedCentral

29.

Ntelios D, Giannakoulas G, Dimopoulos K. Strength training in congenital heart disease: a way to boost respiratory function? Eur J Prev Cardiol. 2019;26(5):489–91. https://doi.org/10.1177/2047487318812505.CrossRefPubMed

30.

Sandberg C, Engström KG, Dellborg M, et al. The level of physical exercise is associated with self-reported health status (EQ-5D) in adults with congenital heart disease. Eur J Prev Cardiol. 2015;22(2):240–8. https://doi.org/10.1177/2047487313508665. [published Online First: 2013/10/11].CrossRefPubMed

31.

Thomas R, Beatty A, Beckie T, et al. Home-based cardiac rehabilitation. J Am Coll Cardiol. 2019;74(1):133–53. https://doi.org/10.1016/j.jacc.2019.03.008.CrossRefPubMedPubMedCentral

32.

Maddison R, Rawstorn JC, Stewart RAH, et al. Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial. Heart. 2019;105:122–9.CrossRefPubMed

33.

Brouwers RWM, van der Poort EKJ, Kemps HMC, et al. Cost-effectiveness of cardiac telerehabilitation with relapse prevention for the treatment of patients with coronary artery disease in the Netherlands. JAMA Netw Open. 2021;4(12):e2136652–752. https://doi.org/10.1001/jamanetworkopen.2021.3665230.CrossRefPubMedPubMedCentral

34.

Grustam AS, Severens JL, De Massari D, et al. Cost-effectiveness analysis in telehealth: a comparison between home telemonitoring, nurse telephone support, and usual care in chronic heart failure management. Value in Health. 2018;21(7):772–82. https://doi.org/10.1016/j.jval.2017.11.011.CrossRefPubMed

35.

Snoswell CL, Taylor ML, Comans TA, et al. Determining if telehealth can reduce health system costs: scoping review. J Med Internet Res. 2020;22(10):e17298. https://doi.org/10.2196/17298. [published Online First: 19.10.2020].CrossRefPubMedPubMedCentral

36.

Hwang R, Morris NR, Mandrusiak A, et al. Cost-utility analysis of home-based telerehabilitation compared with centre-based rehabilitation in patients with heart failure. Heart Lung Circ. 2019;28(12):1795–803.CrossRefPubMed

37.

Williams CA, Wadey C, Pieles G, et al. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020;10(10):Cd013400. https://doi.org/10.1002/14651858.CD013400.CrossRefPubMed

38.

Longmuir PE, Brothers JA, Ferranti SD, et al. Promotion of physical activity for children and adults with congenital heart disease. Circulation. 2013;127(21):2147–59. https://doi.org/10.1161/CIR.0b013e318293688f.CrossRefPubMed

39.

Xu C, Su X, Ma S, et al. Effects of exercise training in postoperative patients with congenital heart disease: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2020;9(5):e013516. https://doi.org/10.1161/JAHA.119.013516.CrossRefPubMedPubMedCentral

40.

Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 2019;139(14):e637–97. https://doi.org/10.1161/CIR.0000000000000602.CrossRefPubMed

41.

Cordina R, O’Meagher S, Karmali A, et al. Resistance training improves cardiac output, exercise capacity and tolerance to positive airway pressure in Fontan physiology. Int J Cardiol. 2013;168:780. https://doi.org/doi.org/10.1016/j.ijcard.2012.10.012.CrossRefPubMed

42.

Elliott P, Hawthorne G. Imputing missing repeated measures data: how should we proceed? AUST N Z J Psych. 2005;39(7):575–82. https://doi.org/10.1080/j.1440-1614.2005.01629.x.CrossRef

43.

Brooks R, Boye KS, Slaap B. EQ-5D: a plea for accurate nomenclature. J Patient-Rep Outcomes. 2020;4(1):52. https://doi.org/10.1186/s41687-020-00222-9.CrossRefPubMedPubMedCentral

44.

Resnick B, Jenkins LS. Testing the reliability and validity of the self-efficacy for exercise scale. Nurs Res. 2000;49(3):154–9.CrossRefPubMed

Title: The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT
Authors: Gina Wood
Anna Scheer
Jelena Saundankar
Derek Tran
Rachael Cordina
Andrew Maiorana
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Telemedicine
Congenital Heart Anomaly
Congenital Heart Anomaly
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-08019-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT

Abstract

Background

Aims

Methods

Outcomes of interest

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Aims

Methods

Outcomes of interest

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders—a double-blind, randomized, placebo-controlled proof-of-concept study

Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder—a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT

Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III)

Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians

Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial