Vetrovsky Tomas, Siranec Michal, Parenica Jiri, Griva Martin, Stastny Jiri, Precek Jan, Pelouch Radek, Bunc Vaclav, Linhart Ales, Belohlavek Jan
Faculty of Physical Education and Sport, Charles University, Jose Martiho 31, 162 52, Prague 6, Czech Republic.
2nd Department of Medicine-Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, U Nemocnice 2, 128 00, Prague 2, Czech Republic.
J Transl Med. 2017 Jul 3;15(1):153. doi: 10.1186/s12967-017-1257-x.
Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients.
Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score.
To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF).
建议慢性心力衰竭患者进行规律的体育活动以提高其功能能力，而步行是一种流行、有效且安全的体育活动形式。计步器已显示出在一系列慢性疾病中增加步行量的潜力，但基于计步器的干预是否能改善心力衰竭患者的功能能力和神经体液调节尚不清楚。
将并行开展两项多中心随机对照试验：一项针对射血分数降低的慢性心力衰竭（HFrEF）患者，另一项针对射血分数保留的慢性心力衰竭（HFpEF）患者。每项试验将包括为期6个月的干预，并在基线、3个月、干预结束时以及完成干预后6个月进行评估。每项试验旨在纳入总共200名身体活动不足的慢性心力衰竭参与者，他们将被随机分配至干预组或对照组。为期6个月的干预将包括基于计步器的个性化步行计划及每周步数目标、与医生进行面对面行为指导以及与研究护士定期电话沟通。干预将基于有效的行为原则（目标设定、自我监测、个性化反馈）。主要结局是6个月干预结束时6分钟步行距离的变化。次要结局包括血清生物标志物水平的变化、超声评估的肺淤血、加速度计测量的平均每日步数、人体测量指标、抑郁症状、健康相关生活质量、自我效能以及MAGGIC风险评分。
据我们所知，这些是首批评估基于计步器的步行干预对射血分数降低或保留的慢性心力衰竭患者影响的研究。这些研究将有助于更好地理解心力衰竭患者的体育活动促进情况，为未来的体育活动建议和心力衰竭指南提供依据。试验注册 这些试验已在ClinicalTrials.gov注册，标识符分别为：NCT03041610，于2017年1月29日注册（HFrEF）；NCT03041376，于2017年2月1日注册（HFpEF）。
