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Meta-Analysis
. 2020 Oct 28;10(10):CD013400.
doi: 10.1002/14651858.CD013400.pub2.

Physical activity interventions for people with congenital heart disease

Affiliations
Meta-Analysis

Physical activity interventions for people with congenital heart disease

Craig A Williams et al. Cochrane Database Syst Rev. .

Abstract

Background: Congenital heart disease (ConHD) affects approximately 1% of all live births. People with ConHD are living longer due to improved medical intervention and are at risk of developing non-communicable diseases. Cardiorespiratory fitness (CRF) is reduced in people with ConHD, who deteriorate faster compared to healthy people. CRF is known to be prognostic of future mortality and morbidity: it is therefore important to assess the evidence base on physical activity interventions in this population to inform decision making.

Objectives: To assess the effectiveness and safety of all types of physical activity interventions versus standard care in individuals with congenital heart disease.

Search methods: We undertook a systematic search on 23 September 2019 of the following databases: CENTRAL, MEDLINE, Embase, CINAHL, AMED, BIOSIS Citation Index, Web of Science Core Collection, LILACS and DARE. We also searched ClinicalTrials.gov and we reviewed the reference lists of relevant systematic reviews.

Selection criteria: We included randomised controlled trials (RCT) that compared any type of physical activity intervention against a 'no physical activity' (usual care) control. We included all individuals with a diagnosis of congenital heart disease, regardless of age or previous medical interventions. DATA COLLECTION AND ANALYSIS: Two review authors (CAW and CW) independently screened all the identified references for inclusion. We retrieved and read all full papers; and we contacted study authors if we needed any further information. The same two independent reviewers who extracted the data then processed the included papers, assessed their risk of bias using RoB 2 and assessed the certainty of the evidence using the GRADE approach. The primary outcomes were: maximal cardiorespiratory fitness (CRF) assessed by peak oxygen consumption; health-related quality of life (HRQoL) determined by a validated questionnaire; and device-worn 'objective' measures of physical activity.

Main results: We included 15 RCTs with 924 participants in the review. The median intervention length/follow-up length was 12 weeks (12 to 26 interquartile range (IQR)). There were five RCTs of children and adolescents (n = 500) and 10 adult RCTs (n = 424). We identified three types of intervention: physical activity promotion; exercise training; and inspiratory muscle training. We assessed the risk of bias of results for CRF as either being of some concern (n = 12) or at a high risk of bias (n = 2), due to a failure to blind intervention staff. One study did not report this outcome. Using the GRADE method, we assessed the certainty of evidence as moderate to very low across measured outcomes. When we pooled all types of interventions (physical activity promotion, exercise training and inspiratory muscle training), compared to a 'no exercise' control CRF may slightly increase, with a mean difference (MD) of 1.89 mL/kg-1/min-1 (95% CI -0.22 to 3.99; n = 732; moderate-certainty evidence). The evidence is very uncertain about the effect of physical activity and exercise interventions on HRQoL. There was a standardised mean difference (SMD) of 0.76 (95% CI -0.13 to 1.65; n = 163; very low certainty evidence) in HRQoL. However, we could pool only three studies in a meta-analysis, due to different ways of reporting. Only one study out of eight showed a positive effect on HRQoL. There may be a small improvement in mean daily physical activity (PA) (SMD 0.38, 95% CI -0.15 to 0.92; n = 328; low-certainty evidence), which equates to approximately an additional 10 minutes of physical activity daily (95% CI -2.50 to 22.20). Physical activity and exercise interventions likely result in an increase in submaximal cardiorespiratory fitness (MD 2.05, 95% CI 0.05 to 4.05; n = 179; moderate-certainty evidence). Physical activity and exercise interventions likely increase muscular strength (MD 17.13, 95% CI 3.45 to 30.81; n = 18; moderate-certainty evidence). Eleven studies (n = 501) reported on the outcome of adverse events (73% of total studies). Of the 11 studies, six studies reported zero adverse events. Five studies reported a total of 11 adverse events; 36% of adverse events were cardiac related (n = 4); there were, however, no serious adverse events related to the interventions or reported fatalities (moderate-certainty evidence). No studies reported hospital admissions.

Authors' conclusions: This review summarises the latest evidence on CRF, HRQoL and PA. Although there were only small improvements in CRF and PA, and small to no improvements in HRQoL, there were no reported serious adverse events related to the interventions. Although these data are promising, there is currently insufficient evidence to definitively determine the impact of physical activity interventions in ConHD. Further high-quality randomised controlled trials are therefore needed, utilising a longer duration of follow-up.

Trial registration: ClinicalTrials.gov NCT02283255 NCT02658266 NCT04135859 NCT04208893 NCT04264650.

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Conflict of interest statement

CAW has received funding from Heart Research UK and Canon Medical Systems Ltd to complete research into the heart health of young people. The author had full control of the design of the study, methods used, outcome parameters, analysis of the data and production of any manuscripts. Neither of these organisations have a financial interest in this review. CW has a funded PhD scholarship from the University of Exeter and Canon Medical. Canon Medical Systems Ltd does not have a financial interest in this review. GEP is lead researcher in a contractual research partnership between the University of Bristol and Canon Medical Systems UK Ltd. Canon Medical Systems Ltd does not have a financial interest in this review. GS is Medical Director of Sports Cardiology UK. Research grant from Heart research UK to evaluate an exercise prescription programme in congenital heart patients. Fee for lecturing at scientific meetings and financial support for educational arrhythmia meeting in February 2019 from Medtronic Actelion. None of the organisations named have a financial interest in this review. LL has no known conflicts of interest. RST has no known conflicts of interest.

Figures

1
1
Study flow diagram
2
2
Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease. Outcome: Maximal cardiorespiratory fitness (V̇O2 mL.kg‐1.min‐1 at maximal exercise).
3
3
Exercise training versus no activity (usual care) in people with congenital heart disease. Outcome: Health related quality of life.
4
4
Physical activity promotion and exercise training interventions versus no activity (usual care) in people with congenital heart disease. Outcome: Physical activity (device‐worn).
5
5
Exercise training interventions versus no activity (usual care) in people with congenital heart disease. . Outcome: Sub‐maximal cardiorespiratory fitness (V̇O2 mL.kg‐1.min‐1 at the gas exchange threshold).
6
6
Exercise training interventions versus no activity (usual care) in people with congenital heart disease. Outcome: Muscular strength.
7
7
Meta‐regression analyses investigating the effect of the 'overall risk of bias' and the 'length of intervention'. Outcome: Maximal cardiorespiratory fitness (see Table 5).
8
8
Funnel plot investigating publication bias. Outcome: Maximal cardiorespiratory fitness (Egger 1997 test, P=0.268).
1.1
1.1. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 1: Maximal cardiorespiratory fitness
1.2
1.2. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 2: Health‐related quality of life
1.3
1.3. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 3: Physical activity (device‐worn)
1.4
1.4. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 4: Submaximal cardiorespiratory fitness (gas exchange threshold)
1.5
1.5. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 5: Muscular strength
1.6
1.6. Analysis
Comparison 1: Physical activity promotion, exercise training and inspiratory muscle training interventions versus no activity (usual care) in people with congenital heart disease, Outcome 6: Maximal cardiorespiratory fitness (type of ConHD subgroup analysis)

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NCT01463800 {published data only}
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NCT01671566 {published data only}
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NCT01822769 {published data only}
    1. NCT01822769. Cardiopulmonary rehabilitation for adolescents and adults with congenital heart disease. clinicaltrials.gov/show/nct01822769 (first posted 2 April 2013).
NCT02632253 {published data only}
    1. NCT02632253. Effects of high-intensity interval training on exercise capacity in patients with grown-up congenital heart disease. clinicaltrials.gov/show/nct02632253 (first posted 16 December 2015).
NCT02643810 {published data only}
    1. NCT02643810. Exercise training in adults with corrected Tetralogy of Fallot. clinicaltrials.gov/show/nct02643810 (first posted 31 December 2015).
NCT02980393 {published data only}
    1. NCT02980393. Smart Heart Trial: structured lifestyle intervention for overweight and obese youth with operated heart defects. clinicaltrials.gov/show/nct02980393 (first posted 2 December 2016).
NCT03297918 {published data only}
    1. NCT03297918. Impact of a structural phonation training on respiratory muscle function in patients with structural heart disease. clinicaltrials.gov/show/nct03297918 (first posted 29 September 2017).
Nehyba 2009 {published data only}
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NTR2527 {published data only}
    1. NTR2527. High intensity interval training after cardiac resynchronization therapy. www.who.int/trialsearch/Trial2.aspx?TrialID=NTR2527 (date of registration 25 September 2010).
NTR3041 {published data only}
    1. NTR3041. Effects of high intensity interval training on cardiac function at rest and during exercise. www.who.int/trialsearch/Trial2.aspx?TrialID=NTR3041 (date of registration 19 August 2011).
Rhodes 2006 {published data only}
    1. Rhodes J, Curran TJ, Camil L, Rabideau N, Fulton DR, Gauthier NS, et al. Sustained effects of cardiac rehabilitation in children with serious congenital heart disease. Pediatrics 2006;118(3):e586-93. - PubMed
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References to studies awaiting assessment

Ali 2018 {published data only}
    1. Ali LA, Pingitore A, Piaggi P, Brucini F, Passera M, Marotta M, et al. Respiratory training late after Fontan intervention: impact on cardiorespiratory performance. Pediatric Cardiology 2018;39(4):695-704. [DOI: 10.1007/s00246-018-1808-9] - DOI - PubMed
Callaghan 2017 {published data only}
    1. Callaghan S, Morrison ML, McCusker C, McKeown P, Casey F. A structured intervention programme can improve the biophysical wellbeing in children with congenital heart disease. Cardiology in the Young 2017;27(4):S228-9. [DOI: ]
Morrison 2015 {published data only}
    1. Morrison BN, DeSouza AM, Voss C, Potts JE, Sandor GG, Harris KC. The use of individualized exercise prescription and activity trackers to promote physical activity in children with congenital heart disease. Canadian Journal of Cardiology 2015;31(10 Suppl 1):S123-4.
Neidenbach 2017 {published data only}
    1. Neidenbach RC, Oberhoffer R, Nagdyman N, Seitz U, Ewert P, Kaemmerer H, et al. Inspiratory muscle training in children after fontan operation increases oxygen saturation. Cogent Medicine 2017;4(1):18. [DOI: ]
Nilsson 2019 {published data only}
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References to ongoing studies

Ganzoni 2019 {published data only}
    1. Ganzoni C, Arslani K, Pfister O, Freese M, Strobel W, Muller C, et al. Regular phonation and respiratory muscle training improve respiratory muscle strength and quality of life in patients with structural heart disease-the HeartChoir randomized clinical controlled trial. Cardiovascular Medicine 2019;22:P29. [DOI: ] - PubMed
ISRCTN74643496 {published data only}
    1. ISRCTN74643496. Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway: a single-blind randomised controlled trial. www.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN74643496 (date assigned 8 April 2015).
NCT01397110 {published data only}
    1. NCT01397110. Respiratory and physical therapy in patients with associated pulmonary arterial hypertension (APAH) with congenital heart defects. clinicaltrials.gov/show/nct01397110 (first posted 19 July 2011).
NCT02240147 {published data only}
    1. NCT02240147. Start-to-Sport - home-based exercise for adolescents and adults with congenital heart disease. clinicaltrials.gov/show/nct02240147 (first posted 15 September 2014).
NCT02283255 {unpublished data only}
    1. NCT02283255. Cardiovascular, pulmonary and skeletal muscle evaluation in late postoperative period of the Fontan surgery. clinicaltrials.gov/ct2/show/NCT02283255 (first posted 5 November 2014).
NCT02658266 {unpublished data only}
    1. NCT02658266. Effect of resistance training in adults with complex congenital heart disease. clinicaltrials.gov/ct2/show/NCT02658266 (first posted 18 January 2016).
NCT03335475 {published data only}
    1. NCT03335475. Congenital heart disease physical activity lifestyle study. clinicaltrials.gov/show/nct03335475 (first posted 7 November 2017).
NCT03435354 {published data only}
    1. NCT03435354. Enhanced physical activity support in congenital heart disease clinical care. clinicaltrials.gov/show/nct03435354 (first posted 19 February 2018).
NCT03479957 {published data only}
    1. NCT03479957. Remotely monitored and coached cardiac rehabilitation northern Sweden. clinicaltrials.gov/show/nct03479957 (first posted 27 March 2018).
NCT03690518 {published data only}
    1. NCT03690518. Rehabilitation of adolescents and young adults with congenital heart diseases. clinicaltrials.gov/show/nct03690518 (first posted 1 October 2018).
NCT03999320 {published data only}
    1. NCT03999320. Sophrology and congenital heart disease. clinicaltrials.gov/show/nct03999320 (first posted 26 June 2019).
NCT04135859 (YACHD‐PALS) {published data only}
    1. NCT04135859. Young adult congenital heart disease physical activity lifestyle study (YACHD-PALS). clinicaltrials.gov/ct2/show/NCT04135859 (first posted 23 October 2019).
NCT04208893 {published and unpublished data}
    1. NCT04208893. Exercise training strategies for children with repaired Tetralogy of Fallot. clinicaltrials.gov/ct2/show/NCT04208893 (first posted 23 December 2019).
NCT04264650 {published data only}
    1. NCT04264650. Effectiveness of an mHealth intervention for youth with congenital heart disease. clinicaltrials.gov/ct2/show/NCT04264650 (first posted 11 February 2020).
UMIN000021661 {published data only}
    1. UMIN000021661. Evaluation test about safety and efficacy of the respiratory muscle training therapy by abdominal respiratory weight exercises in chronic cardiovascular disease patients. www.who.int/trialsearch/Trial2.aspx?TrialID=JPRN-UMIN000021661 (date of disclosure 1 April 2016).

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References to other published versions of this review

Williams 2019
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Publication types

Associated data