Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação de Tecnologias em Saúde, Departamento de Medicina de Urgência, Universidade Federal de São Paulo, Sao Paulo, Brazil.
Cochrane Database Syst Rev. 2023 Jun 9;6(6):CD014605. doi: 10.1002/14651858.CD014605.pub2.
Although exercise is recommended as part of the cystic fibrosis (CF) therapeutic routine, adherence to exercise is still limited. Digital health technologies can provide easy-to-access health information and may help improve healthcare and outcomes in individuals with long-term conditions. However, its effects for delivering and monitoring exercise programs in CF have not yet been synthesized.
To evaluate the benefits and harms of digital health technologies for delivering and monitoring exercise programs, increasing adherence to exercise regimens, and improving key clinical outcomes in people with CF.
We used standard, extensive Cochrane search methods. The latest search date was 21 November 2022.
We included randomized controlled trials (RCTs) or quasi-RCTs of digital health technologies for delivering or monitoring exercise programs in CF.
We used standard Cochrane methods. Our primary outcomes were 1. physical activity, 2. self-management behavior, and 3. pulmonary exacerbations. Our secondary outcomes were 4. usability of technologies, 5. quality of life, 6. lung function, 7. muscle strength, 8. exercise capacity, 9. physiologic parameters, and 10.
We used GRADE to assess certainty of evidence.
We identified four parallel RCTs (three single-center and one multicenter with 231 participants aged six years or older). The RCTs evaluated different modes of digital health technologies with distinct purposes, combined with diverse interventions. We identified important methodologic concerns in the RCTs, including insufficient information on the randomization process, blinding of outcome assessors, balance of non-protocol interventions across groups, and whether the analyses performed corrected for bias due to missing outcome data. Non-reporting of results may also be a concern, especially because some planned outcome results were reported incompletely. Furthermore, each trial had a small number of participants, resulting in imprecise effects. These limitations on the risk of bias, and on the precision of effect estimates resulted in overall low- to very low-certainty evidence. We undertook four comparisons and present the findings for our primary outcomes below. There is no information on the effectiveness of other modes of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, on adverse events related to the use of digital health technologies either for delivering or monitoring exercise programs in CF, and on their long-term effects (more than one year). Digital health technologies for monitoring physical activity Wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone One trial (40 adults with CF) evaluated this outcome, but did not report data for any of our primary outcomes. Wearable fitness tracker plus text message for personalized feedback and goal setting compared to wearable fitness tracker alone The evidence is very uncertain about the effects of a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to wearable technology alone on physical activity measured by step count at six-month follow-up (mean difference [MD] 675.00 steps, 95% confidence interval [CI] -2406.37 to 3756.37; 1 trial, 32 participants). The same study measured pulmonary exacerbation rates and reported finding no difference between groups. Web-based application to record, monitor, and set goals on physical activity plus usual care compared to usual care alone Using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference on time spent in moderate-to-vigorous physical activity measured via accelerometry compared to usual care alone at six-month follow-up (MD -4 minutes/day, 95% CI -37 to 29; 1 trial, 63 participants). Low certainty-evidence from the same trial suggests that the intervention may result in little to no difference on pulmonary exacerbations during 12 months of follow-up (median 1 respiratory hospitalization, interquartile range [IQR] 0 to 3) versus control (median 1 respiratory hospitalization, IQR 0 to 2; P = 0.6). Digital health technologies for delivering exercise programs Web-based versus face-to-face exercise delivery The evidence is very uncertain about the effects of web-based compared to face-to-face exercise delivery on adherence to physical activity as assessed by the number of participants who completed all exercise sessions after three months of intervention (risk ratio 0.92, 95% CI 0.69 to 1.23; 1 trial, 51 participants).
AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effects of an exercise program plus the use of a wearable fitness tracker integrated with a social media platform compared with exercise prescription alone and on the effects of receiving a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to a wearable fitness tracker alone. Low-certainty evidence suggests that using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference in time spent in moderate-to-vigorous physical activity, total time spent in activity, pulmonary exacerbations, quality of life, lung function, and exercise capacity compared to usual care alone. Regarding the use of digital health technologies for delivering exercise programs in CF, the evidence is very uncertain about the effects of using a wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone. Further high-quality RCTs, with blinded outcome assessors, reporting the effects of digital health technologies on clinically important outcome measures, such as physical activity participation and intensity, self-management behavior, and the occurrence of pulmonary exacerbations in the long term are needed. The results of six ongoing RCTs identified through our searches may help clarify the effects of different modes of digital health technologies for delivering and monitoring exercise programs in people with CF.
尽管运动被推荐作为囊性纤维化(CF)治疗方案的一部分,但对运动的坚持仍然有限。数字健康技术可以提供易于获取的健康信息,并可能有助于改善长期疾病患者的医疗保健和结果。然而,其在 CF 中提供和监测运动方案、提高运动方案依从性以及改善关键临床结果方面的效果尚未得到综合评估。
评估数字健康技术在提供和监测运动方案、提高对运动方案的依从性以及改善 CF 患者关键临床结局方面的益处和危害。
我们使用了标准的、广泛的 Cochrane 检索方法。最新检索日期为 2022 年 11 月 21 日。
我们纳入了关于数字健康技术用于提供或监测 CF 中运动方案的随机对照试验(RCT)或准 RCT。
我们使用了标准的 Cochrane 方法。我们的主要结局为 1. 身体活动量,2. 自我管理行为,和 3. 肺部恶化。我们的次要结局为 4. 技术的可用性,5. 生活质量,6. 肺功能,7. 肌肉力量,8. 运动能力,9. 生理参数,和 10. 不良事件。我们使用 GRADE 评估证据的确定性。
我们确定了四项平行 RCT(三项单中心和一项多中心,共有 231 名年龄在 6 岁及以上的参与者)。这些 RCT 评估了具有不同目的的不同模式的数字健康技术,结合了不同的干预措施。我们在 RCT 中发现了重要的方法学问题,包括随机过程信息不足、结果评估者的盲法、非方案干预在组间的平衡、以及是否对由于缺失结局数据导致的偏倚进行了分析校正。结果报告不完整也可能是一个关注点,特别是因为一些计划的结局结果报告不完整。此外,每个试验的参与者人数较少,导致效应估计的精度不高。这些偏倚风险和效应估计精度的局限性导致总体证据的确定性为低至非常低。我们进行了四项比较,并在下面呈现我们的主要结局的发现。关于数字健康技术监测身体活动或提供运动方案的其他模式在 CF 患者中的有效性、CF 中使用数字健康技术监测或提供运动方案的不良事件及其长期效果(超过一年),我们没有信息。
数字健康技术监测身体活动
可穿戴健身追踪器加个性化运动处方与仅个性化运动处方相比
一项试验(40 名 CF 成年人)评估了这一结局,但没有报告我们任何主要结局的数据。
可穿戴健身追踪器加个性化反馈和目标设定的短信与仅可穿戴健身追踪器相比
关于可穿戴健身追踪器加个性化反馈和目标设定的短信与仅可穿戴技术相比,在 6 个月随访时的身体活动(以步数衡量),我们的证据非常不确定(平均差异[MD] 675.00 步,95%置信区间[CI] -2406.37 至 3756.37;1 项试验,32 名参与者)。同一研究报告了肺部恶化率的结果,发现两组之间没有差异。
基于网络的应用程序记录、监测和设定身体活动目标加上常规护理与仅常规护理相比
使用基于网络的应用程序记录、监测和设定身体活动目标加上常规护理,与仅常规护理相比,在 6 个月随访时的中等到剧烈体力活动时间(通过加速度计测量)可能差异很小或无差异(MD -4 分钟/天,95%CI -37 至 29;1 项试验,63 名参与者)。来自同一试验的低确定性证据表明,与对照组相比(中位数 1 例呼吸道住院,四分位距[IQR] 0 至 2;P = 0.6),该干预措施在 12 个月的随访期间可能导致肺部恶化的次数差异很小或无差异(中位数 1 例呼吸道住院,IQR 0 至 3)。
数字健康技术提供运动方案
基于网络与面对面的运动交付
关于基于网络与面对面运动交付相比,我们的证据非常不确定对身体活动的依从性(通过完成所有运动方案的参与者数量来评估)的影响(风险比 0.92,95%CI 0.69 至 1.23;1 项试验,51 名参与者)。
关于运动方案加可穿戴健身追踪器集成社交媒体平台与仅运动处方相比的效果,以及关于与仅可穿戴健身追踪器相比,接受可穿戴健身追踪器加个性化反馈和目标设定短信的效果,我们的证据非常不确定。低确定性证据表明,与常规护理相比,使用基于网络的应用程序记录、监测和设定身体活动目标,可能在中等到剧烈体力活动时间、总活动时间、肺部恶化、生活质量、肺功能和运动能力方面差异很小或无差异。关于 CF 中使用数字健康技术提供运动方案,我们的证据非常不确定关于与仅运动处方相比,使用可穿戴健身追踪器加个性化运动处方的效果。需要进一步开展高质量 RCT,盲法评估结局,报告数字健康技术对身体活动参与和强度、自我管理行为以及肺部恶化等临床重要结局的影响,长期随访。我们检索到的六项正在进行的 RCT 可能有助于阐明不同模式的数字健康技术在 CF 患者中提供和监测运动方案的效果。