Williams Craig A, Wadey Curtis, Pieles Guido, Stuart Graham, Taylor Rod S, Long Linda
Children's Health and Exercise Research Centre, University of Exeter, Exeter, UK.
National Institute for Health Research (NIHR) Cardiovascular Biomedical Research Centre, Bristol Heart Institute, Bristol, UK.
Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
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.
To assess the effectiveness and safety of all types of physical activity interventions versus standard care in individuals with congenital heart disease.
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.
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.
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/min (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.
先天性心脏病(ConHD)影响约1%的活产婴儿。由于医疗干预的改善,患有先天性心脏病的人寿命延长,并有患非传染性疾病的风险。先天性心脏病患者的心肺适能(CRF)降低,与健康人相比,其身体机能衰退更快。已知心肺适能可预测未来的死亡率和发病率:因此,评估该人群体育活动干预的证据基础对于指导决策很重要。
评估各类体育活动干预措施相对于标准护理对先天性心脏病患者的有效性和安全性。
我们于2019年9月23日对以下数据库进行了系统检索:Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库、护理学与健康领域数据库、联合和补充医学数据库、生物学文摘数据库、科学引文索引核心合集、拉丁美洲和加勒比卫生科学数据库以及循证医学数据库。我们还检索了美国国立医学图书馆临床试验注册库,并查阅了相关系统评价的参考文献列表。
我们纳入了将任何类型的体育活动干预与“无体育活动”(常规护理)对照进行比较的随机对照试验(RCT)。我们纳入了所有诊断为先天性心脏病的个体,无论其年龄或既往医疗干预情况如何。
两位综述作者(CAW和CW)独立筛选所有识别出的参考文献以确定是否纳入。我们检索并阅读了所有全文;如果需要进一步信息,我们会联系研究作者。同样由这两位独立评审员提取数据,然后对纳入的论文进行处理,使用RoB 2评估其偏倚风险,并使用GRADE方法评估证据的确定性。主要结局包括:通过峰值耗氧量评估的最大心肺适能(CRF);通过经过验证的问卷确定的健康相关生活质量(HRQoL);以及佩戴设备的身体活动“客观”测量值。
我们纳入了15项随机对照试验,共924名参与者。干预时长/随访时长的中位数为12周(四分位间距(IQR)为12至26周)。有5项针对儿童和青少年的随机对照试验(n = 500)以及10项针对成人的随机对照试验(n = 424)。我们确定了三种干预类型:促进体育活动;运动训练;以及吸气肌训练。由于干预人员未设盲,我们将CRF结果的偏倚风险评估为有些担忧(n = 12)或高偏倚风险(n = 2)。一项研究未报告此结局。使用GRADE方法,我们评估了各测量结局的证据确定性为中等至非常低。当我们汇总所有类型的干预措施(促进体育活动、运动训练和吸气肌训练)时,与“无运动”对照相比,CRF可能略有增加,平均差值(MD)为1.89 mL/kg/min(95%CI -0.22至3.99;n = 732;中等确定性证据)。关于体育活动和运动干预对HRQoL的影响,证据非常不确定。HRQoL的标准化平均差值(SMD)为0.76(95%CI -0.13至