Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Functional capacity evaluated using the 6-minute walk test (6MWT)
研究概览
简要总结
The purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced heart failure (Stage D - Left ventricle ejection fraction <30%)
- •New York Heart Association class III-IV
- •Standard medical therapy for heart failure management
- •Continuous inotropic infusion
排除标准
- •Unstable angina pectoris
- •Recent (6 months) acute coronary syndrome
- •Arrythmias
- •Chronic renal failure
- •Diabetes Mellitus
- •Peripheral vascular diseases
- •Inability to walk
研究组 & 干预措施
Usual Care
Patients in this group were subject to regular Physical Therapy Sessions in the hospital and each session consisted of breathing exercises and global active exercises of the upper and lower limbs in bed. The treatment was applied twice a day during the hospitalization period. The protocol was interrupted if the patient had signs or symptoms suggestive of poor tolerance to exercise.
干预措施: Physical Therapy Session (Other)
Neuromuscular Electrical Stimulator
Lower limb muscles of both legs were simultaneously stimulated using self adhesive surface rectangular electrodes. During all session period, the patients were maintained in the supine Fowler 45º position. The stimulation intensity was progressively increased according to the patient tolerance until a muscular contraction was observed. Stimulation was performed twice a day; the session duration was 60 min. Heart rate, blood pressure, respiratory rate and pulse oximetry were monitored throughout the sessions, in all patients.
干预措施: Neuromuscular Electrical Stimulator (Device)
结局指标
主要结局
Functional capacity evaluated using the 6-minute walk test (6MWT)
时间窗: Change from assessment at admission and at patient discharge
Functional capacity was evaluated using the 6-minute walk test (6MWT), by a single evaluator blinded to the group allotment, in accordance with American Thoracic Society criteria.
次要结局
- Change in the intravenous inotropic support dosage(Change from the first day of the protocol and patient discharge)
研究者
Patricia Forstieri
PT
Federal University of São Paulo
