跳至主要内容
临床试验/NCT02088138
NCT02088138已完成不适用

Effects of Functional Electrical Stimulation on Physical Performance of Patients in Cardiac Rehabilitation

Prof. Dr. Antônio Marcos Vargas da Silva6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
6
主要终点
Distance on the six minute walk test

研究概览

简要总结

The purpose of this study was to determine the effects of Functional Electrical Stimulation (FES) on physical performance and quality of life of patients in cardiac rehabilitation.

详细描述

This randomized controlled trial aimed to evaluate the effects of functional electrical stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the variables strength, endurance and muscle tropism lower limb, functional capacity and quality of life. To this were invited to participate in the study cardiac patients registered in the database of the cardiology department of the University Hospital of Santa Maria. The sample included patients of both sexes undergoing coronary artery bypass grafting or valve replacement. The subjects were divided into two groups: placebo group (PG) or functional electrical stimulation group (FESG). To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: one repetition maximum test, sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in phase II and III of cardiac rehabilitation undergoing coronary artery bypass grafting or valve replacement

排除标准

  • Patients with some cognitive impairment that prevents the completion of assessments, inability to understand the term of free and informed consent or with the following contraindications to the use of FES: epidermal lesions at the site of application, change of skin sensitivity or intolerance electrical stimulator;
  • Patients undergoing cardiac surgery other than coronary artery bypass grafting or valve replacement;
  • Patients who use pacemakers;
  • Subjects with peripheral vascular changes in the lower limbs;
  • Presence of comorbidities such as chronic obstructive pulmonary disease (COPD), cerebrovascular disease or skeletal muscle disease.

结局指标

主要结局

Distance on the six minute walk test

时间窗: Two Years

次要结局

  • Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test(Two years)
  • Quality of life through The Medical Study 36-Item Short-Form Health Survey (SF-36) questionnaire(Two years)
  • Lower limb muscle tropism evaluated by measuring the thigh circumference by tape(Two years)
  • Lower limb muscle endurance assessed by sit-and-stand test(Two years)

研究者

发起方
Prof. Dr. Antônio Marcos Vargas da Silva
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Antônio Marcos Vargas da Silva

PhD in Physiology

Universidade Federal de Santa Maria

研究点 (6)

Loading locations...

相似试验