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一项针对肝硬化患者的基于营养与运动应用程序解决方案的开放标签可行性研究。

An open label feasibility study of a nutrition and exercise app-based solution in cirrhosis.

作者信息

Ismond Kathleen P, Cruz Christofer, Limon-Miro Ana Teresa, Low Gavin, Prado Carla M, Spence John C, Raman Maitreyi, McNeely Margaret L, Tandon Puneeta

机构信息

Division of Gastroenterology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.

Department of Agricultural, Food and Nutritional Science, Faculty of Agricultural, Life and Environmental Sciences, University of Alberta, Edmonton, Alberta, Canada.

出版信息

Can Liver J. 2024 Feb 26;7(1):5-15. doi: 10.3138/canlivj-2023-0011. eCollection 2024 Feb.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

营养和运动是预防和治疗肝硬化患者衰弱的主要治疗手段。这项试点研究评估了在该人群中通过应用程序进行半监督式营养和运动干预的在线交付可行性。

方法

这项为期11周的试点研究招募了拥有联网设备的肝硬化成年患者。鼓励患者每周参加3次运动课程,包括在线团体运动(每周一次)和家庭跟进运动(每两周一次)。他们还参加了团体营养课程(五节)以及通过应用程序进行的一对一运动和营养检查。主要结局指标涉及项目可行性:招募、留存、依从性和满意度。探索性指标包括身体表现(肝脏衰弱指数[LFI]、6分钟步行试验[6MWT])、健康行为领域和生活质量。

结果

23名患者完成了基线测量。其中,18名(占72%)完成了研究结束时的测量(平均终末期肝病模型钠评分[MELD-Na]为9.2;女性占44.4%)。超过70%的参与者满足了75%或更多的可行性标准。对该项目的满意度很高(平均为89%)。17名患者需要对运动项目进行调整以适应健康状况或能力。探索性评估显示,LFI和6MWT分别改善了-0.58个单位(95%置信区间:-0.91至-0.25)和46.0米(95%置信区间:22.7 - 69.3),而生活质量或健康行为领域没有变化。

结论

结果表明通过应用程序进行项目交付是可行的,对身体表现的疗效具有有前景的探索性影响。研究结果可为肝硬化患者基于应用程序的大规模随机对照试验的设计提供指导。

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