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临床试验/NCT02668419
NCT02668419已完成不适用

Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Forstieri

PT

Federal University of São Paulo

研究点 (2)

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