跳至主要内容
临床试验/NCT01887080
NCT01887080已完成不适用

Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program in Patients With Acute Myocardial Infarction

Escola Superior de Tecnologia da Saúde do Porto2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Computerized axial tomography

研究概览

简要总结

The aim of this study was to investigate the effects of electric stimulation (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with acute myocardial infarction

详细描述

Cardiovascular disease is the leading cause of death in most industrialized countries.

It is widely accepted that cardiac rehabilitation has a beneficial role in the control of modifiable cardiovascular risk factors. However, these cardiovascular rehabilitation programs are scarce and only a small fraction of the population who needs has access. So, it is pertinent to the displacement of these programs to the community context.

Obesity has become a truly global epidemic among children and adults, as well as changing the metabolic profile: when occurs an excessive accumulation of adipose tissue (mainly central distribution) there are a set of changes / adjustments to the cardiac structure and function. The electrical stimulation of abdominal subcutaneous (electrolipolysis) is a procedure often used in physical therapy clinics to reduce waist circumference. However, the effectiveness of this intervention, the selection of parameters, and the duration of its effects in cardiac patients are not yet clarified in the literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals admitted to the coronary care unit for acute myocardial infarction for more than one year;
  • Individuals of both sexes;
  • Ages between 40 and 75 years;
  • Heart disease stabilized;
  • Motivation to perform physical activity for 8 weeks;
  • Cognitive level sufficient to understand the particulars of the study.

排除标准

  • Contraindications of micro-current (pacemaker, osteosynthesis material, tumor areas and open wounds or skin changes in the abdominal region);
  • Pregnant at the time, in the preceding 6 months or wishing to become pregnant during the intervention period;
  • Neurological, musculoskeletal or respiratory disorders;
  • Individuals who are to carry out other therapies.

研究组 & 干预措施

Exercise

Experimental

Experimental group 1 performed cardiovascular rehabilitation home-based program

干预措施: Exercise (Other)

Exercise

Experimental

Experimental group 1 performed cardiovascular rehabilitation home-based program

干预措施: Cardiovascular Risk Factors (Other)

Exercise afther Microcurrent

Experimental

Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.

干预措施: Exercise (Other)

Exercise afther Microcurrent

Experimental

Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.

干预措施: Microcurrent (Device)

Exercise afther Microcurrent

Experimental

Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.

干预措施: Cardiovascular Risk Factors (Other)

Cardiovascular Risk Factors

Other

Education about risk factors

干预措施: Cardiovascular Risk Factors (Other)

结局指标

主要结局

Computerized axial tomography

时间窗: Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program

It was measured subcutaneous, visceral and total abdominal fat.

Cardiorespiratory Fitness

时间窗: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program

The stress test was performed according to the Bruce protocol on a treadmill. The test begins with the treadmill set to a low speed (2.7 km/h) and a 10% incline, and every 3 minutes the speed and angle of incline are increased. Generally the incline is increased by 2% at every level, until exhaustion. It was measured resting, maximum and recovery heart rate; resting, maximum and recovery systolic blood pressure; resting, maximum and recovery diastolic blood pressure; resting, maximum and recovery double product; time and recovery time; speed; slope; and changes in functional capacity.

Blood tests

时间窗: Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program

They were performed in the morning after fasting for about 12 hours, to avoid the interference of postprandial lipemia. It was measured glucose, cholesterol and triglycerides.

次要结局

  • Skinfolds measurements(Change from Baseline in Skinfolds measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)
  • Flexicurve spinal measurement(Change from Baseline in Flexicurve Spinal Measurement at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)
  • Daily Physical Activity(Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)
  • Y-Balance Test(Change from Baseline in Y-Balance Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)
  • Bioimpedance values(Change from Baseline in Bioimpedance values at 8 weeks of Cardiac Rehabilitation Home-Based Program and 4 Weeks After Finishing the Protocol)
  • One Leg Standing Test(Change from Baseline in One Leg Standing Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)
  • Perimeters measurements(Change from Baseline in Perimeters measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreia Noites

Professor

Escola Superior de Tecnologia da Saúde do Porto

研究点 (2)

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