Effects of Neuromuscular Electrostimulation in Patients With Acute Heart Failure - Results of a Single-centre Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- evaluate the impact of NMES therapy applied during hospitalization on the functional capacity
研究概览
简要总结
The investigators evaluated the effects of neuromuscular electrical stimulation (NMES) therapy on functional capacity and oxidative stress in patients hospitalized for an episode of acute heart failure (AHF). The NMES therapy was used on top of the conventional rehabilitation program. After randomization the investigators followed the patients by measuring the evolution of functional capacity, oxidative stress and adverse events.
详细描述
In this program the investigators will include patients with acute heart failure (AHF) with left ventricular ejection fraction (LVEF) lower than 50%, admitted to our clinic.
Patients prior to being included in this research will sign an informed consent form in two samples, one remaining with the patient. This form will contain the study protocol, risks, potential benefits as well as assuring patients that personal data will be used strictly for research purposes. The inclusion and exclusion criteria are presented below. The patients will be randomized into two groups: neuromuscular electrostimulation (NMES) therapy and conventional rehabilitation or a conventional rehabilitation program alone (respiratory gymnastics and strength / endurance exercises in bed).
Patients will receive optimal medical therapy for AHF according to current management guidelines. Patients will complete different questionnaires (Kansas, Beck for Depression). In the first phase, patients will be given a form with questions regarding notions about heart failure and cardiovascular recovery to assess the level of knowledge about their disease.
All patients included will perform the following:
- Clinical evaluation
- ECG
- Biological samples (including NT pro BNP, CK, oxidized LDL plus standard samples)
- Cardiac ultrasound
- 6-minute walk test (6MWT) The duration of NMES therapy will be equal to the duration of hospitalization. At the time of discharge, all patients will undergo a 6MWT and biological samples (NT pro BNP and oxidized LDL) and receive a cardiac rehabilitation program that they will follow at home. They will be given advice on initiating and maintaining a healthy diet, as well as discontinuing smoking if this risk factor is identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
After the patients were evaluated for inclusion in the study and after signing the informed consent form, they were randomized using the website www.randomization.com (1 complete randomized block). Considering our intervention protocol, it was not possible to blind the patients and/or the investigator who performed the electrostimulation. However, the other investigators who conducted the 6MWT and performed the randomization were blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute heart failure and a LVEF below 50% (echocardiography), admitted consecutively to the cardiology clinic of "Sfantul Pantelimon" Hospital, Bucharest
排除标准
- •age under 18 years,
- •acute coronary syndrome in the last month,
- •recent myocardial revascularization (in the last 6 weeks),
- •severe ischemic lesions at the level of the lower limbs,
- •life-threatening arrhythmias,
- •uncontrolled blood pressure,
- •high-grade atrioventricular block,
- •acute myocarditis,
- •acute pericarditis,
- •obstructive hypertrophic cardiomyopathy,
- •acute systemic disease,
- •deep vein thrombosis,
- •severe uncorrected primary valvular disease,
- •psychiatric disorders or marked cognitive impairment,
- •active neoplastic disorders except basal or squamous cell carcinoma,
- •other conditions that in the opinion of the investigator do not allow the participation to the study
- •patient's refusal.
结局指标
主要结局
evaluate the impact of NMES therapy applied during hospitalization on the functional capacity
时间窗: up to one month (30 days)
The investigators will measure 6 minute walk test at the inclusion in the trial ans at the time of discharge
evaluate the impact of NMES therapy on oxidative stress
时间窗: up to one month (30 days)
The investigator will measure oxidized LDL plasmatic levels at the inclusion in the trial ans at the time of discharge
次要结局
未报告次要终点
研究者
Ploesteanu Rodica Lucia
principal investigator
Sfantul Pantelimon Emergency Hospital