Zeid Silav, Prochaska Jürgen H, Schuch Alexander, Tröbs Sven Oliver, Schulz Andreas, Münzel Thomas, Pies Tanja, Dinh Wilfried, Michal Matthias, Simon Perikles, Wild Philipp Sebastian
Preventive Cardiology and Preventive Medicine, Department of Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Mainz, Langenbeckstraße 1, 55131 Mainz, Germany.
Eur Heart J Digit Health. 2025 Jan 30;6(2):298-309. doi: 10.1093/ehjdh/ztae096. eCollection 2025 Mar.
Patients suffering from heart failure with preserved ejection fraction (HFpEF) often exhibit a sedentary lifestyle, contributing to the worsening of their condition. Although there is an inverse relationship between physical activity (PA) and adverse cardiovascular outcomes, the implementation of Class Ia PA guidelines is hindered by low participation in supervised and structured programmes, which are not suitable for a diverse population of HFpEF patients. The MyoMobile study has been designed to assess the effect of a 12-week, app-based coaching programme on promoting PA in patients with HFpEF.
The MyoMobile study was a single-centre, randomized, controlled three-armed parallel group clinical trial with prospective data collection to investigate the effect of a personalized mobile app health intervention compared with usual care on PA levels in patients with HFpEF. Major inclusion criteria were age ≥ 45 years, a diagnosis of HFpEF, LVEF > 40%, and current HF symptoms (NYHA Class I-III). Major exclusion criteria included acute decompensated HF, non-ambulatory status, recent acute coronary syndrome or cardiac surgery, alternative diagnoses for HF symptoms, active cancer treatment, and physical or medical conditions affecting mobility. Participants were recruited from hospitals, general practices, and practices specialized in internal medicine and cardiology in the Rhine-Main area, Germany. Participants underwent an objective 7-day PA measurement with a 3D accelerometer (Dynaport, McRoberts) at screening and after the 12-week intervention period. Following the screening, eligible participants were randomized into one of three groups: standard care (PA consulting), the intervention arm with app-based PA tracking and coaching, or the intervention arm with tracking but without coaching. The primary efficacy endpoint was the change in average daily step count between the average step count at baseline and at the end of the intervention, comparing standard care to a 12-week app-based PA coaching intervention.
Exercise intolerance is a primary symptom in HFpEF patients, leading to poor quality of life and HF-related adverse outcomes due to physical inactivity. The MyoMobile study was designed to investigate the use of app-based coaching to improve PA in patients with HFpEF with a personalized, home-based intervention, focusing on simple step counts for flexibility and ease of integration into daily routines.
URL: https://clinicaltrials.gov/ct2/show/NCT04940312.
NCT04940312.
射血分数保留的心力衰竭（HFpEF）患者通常生活方式久坐不动，这会导致病情恶化。尽管体力活动（PA）与不良心血管结局之间存在负相关关系，但Ia类PA指南的实施受到监督和结构化项目参与率低的阻碍，这些项目并不适合不同类型的HFpEF患者群体。MyoMobile研究旨在评估一项为期12周的基于应用程序的指导计划对促进HFpEF患者进行PA的效果。
MyoMobile研究是一项单中心、随机、对照的三臂平行组临床试验，采用前瞻性数据收集，以研究与常规护理相比，个性化移动应用程序健康干预对HFpEF患者PA水平的影响。主要纳入标准为年龄≥45岁、HFpEF诊断、左心室射血分数（LVEF）>40%以及当前存在HF症状（纽约心脏协会心功能分级I-III级）。主要排除标准包括急性失代偿性HF、非步行状态、近期急性冠状动脉综合征或心脏手术、HF症状的其他诊断、积极的癌症治疗以及影响活动能力的身体或医疗状况。参与者从德国莱茵-美因地区的医院、全科诊所以及内科和心脏病专科诊所招募。参与者在筛查时和12周干预期结束后，使用三维加速度计（Dynaport，McRoberts）进行为期7天的客观PA测量。筛查后，符合条件的参与者被随机分为三组之一：标准护理（PA咨询）、基于应用程序的PA跟踪和指导的干预组，或仅跟踪但无指导的干预组。主要疗效终点是比较标准护理与为期12周的基于应用程序的PA指导干预，干预结束时与基线时平均每日步数的变化。
运动不耐受是HFpEF患者的主要症状，由于缺乏体力活动，导致生活质量差和与HF相关的不良结局。MyoMobile研究旨在通过个性化的家庭干预，研究使用基于应用程序的指导来改善HFpEF患者的PA，重点关注简单的步数计数，以实现灵活性并易于融入日常生活。
网址：https://clinicaltrials.gov/ct2/show/NCT04940312。
NCT04940312。
