基于营养和运动应用程序的肝硬化解决方案的开放标签可行性研究

K. Ismond, Christofer Cruz, A. Limon-Miro, Gavin Low, Carla M Prado, John C Spence, Maitreyi Raman, Margaret McNeely, Puneeta Tandon
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摘要

营养和运动是预防和治疗肝硬化虚弱的主要疗法。这项试点研究评估了在该人群中在线提供基于应用程序的半监督营养和运动干预的可行性。这项为期 11 周的试点研究招募了拥有联网设备的成年肝硬化患者。我们鼓励患者每周参加 3 次锻炼课程,包括在线集体锻炼(每周一次)和在家跟进锻炼(每两周一次)。他们还参加了小组营养课程(5 次)以及通过应用程序进行的一对一运动和营养检查。主要结果测量涉及计划的可行性:招募、保留、坚持和满意度。探索性指标包括身体表现(肝脏虚弱指数 [LFI]、6 分钟步行测试 [6MWT])、健康行为领域和生活质量。23 名患者完成了基线测量。其中 18 人(72%)完成了研究结束时的测量(平均 MELD-Na,9.2;女性,44.4%)。超过 70% 的参与者符合 75% 或更多的可行性标准。对计划的满意度很高(平均 89%)。有 17 名患者需要根据健康状况或能力修改运动计划。探索性评估结果显示,患者的 LFI 和 6MWT 分别提高了-0.58 个单位(95% CI:-0.91 至 -0.25)和 46.0 米(95% CI:22.7 至 69.3),但生活质量或健康行为领域没有发生变化。研究结果表明,基于应用程序的计划实施是可行的,对身体表现的功效具有探索性的影响。研究结果可为设计基于应用程序的大规模肝硬化随机对照试验提供指导。
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An open label feasibility study of a nutrition and exercise app-based solution in cirrhosis
Nutrition and exercise are the mainstay of therapy for the prevention and treatment of frailty in cirrhosis. This pilot study assessed feasibility of the online delivery of an app-based semi-supervised nutrition and exercise intervention in this population. The 11-week pilot recruited adults with cirrhosis who owned internet-connected devices. Patients were encouraged to participate in exercise sessions 3× per week including a combination of online group exercise (weekly) and home-based follow-along exercise (biweekly). They also participated in group nutrition classes (five sessions) and one-to-one exercise and nutrition check-ins delivered through the app. Primary outcome measures pertained to program feasibility: recruitment, retention, adherence, and satisfaction. Exploratory measures included physical performance (liver frailty index [LFI], 6-minute walk test [6MWT]), health behaviour domains, and quality of life. Twenty three patients completed baseline measures. Of these, 18 (72%) completed end of study measures (mean MELD-Na, 9.2; female, 44.4%). Over 70% of participants fulfilled 75% or more of the feasibility criteria. Satisfaction with the program was high (mean, 89%). Exercise program modifications were required for 17 patients to accommodate health events or abilities. Exploratory evaluation showed improvement in the LFI and the 6MWT by −0.58-units (95% CI: −0.91 to −0.25) and 46.0 m (95% CI: 22.7–69.3) respectively without changes in quality of life or health behaviour domains. Outcomes demonstrate feasibility of the app-based delivery of programming with promising exploratory impact on efficacy for physical performance. Findings can guide the design of a large-scale app-based randomized controlled trials in cirrhosis.
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