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临床试验/NCT02742350
NCT02742350已完成不适用

Effects of Inspiratory Muscle Training Hihg Intensity Linked to Cardiac Rehabilitation in Patients on Exercise Performance in the Post-operative of Coronary Artery Bypasssurgery: a Randomized Clinical Trial

Federal University of Health Science of Porto Alegre2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年9月10日最近更新:
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
2
主要终点
Six-minute walk test

研究概览

简要总结

Heart surgery procedures are still widely used worldwide for the treatment of patients with heart problems, and rates of complications in the postoperative period related to them remain high. In these patients, physical conditioning programs result in improved functional capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle training is also emerging as a valuable strategy in the treatment of cardiac patients. The study of the interaction between cardiac rehabilitation and high intensity IMT about these changes is not yet understood in this population. The aim of this study is to assess the effects of inspiratory muscle training high intensity associated with cardiac rehabilitation exercise performance of patients in the postoperative period of CABG surgery.

详细描述

It is a controlled, randomized clinical trial in which patients were randomly assigned randomly after referral to cardiac rehabilitation: Group 1 IMT-HI, group 2 - IMT-HI control. The evaluator of outcomes is blinded as to groups. The study protocol lasts 36 sessions for both groups. The group 1 patients performs cardiac rehabilitation protocol for 40 minutes with cardio and stretching and also inspiratory muscle training protocol of high intensity with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of MIP in third and fourth week, 70% of MIP in the fifth and sixth week and 80% MIP in the seventh and eighth week. The group 2 patients only perform the cardiac rehabilitation protocol for 40 minutes with aerobic exercise and stretching.

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, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the postoperative period of elective CABG
  • Between the fourteenth and the thirtieth day after surgery
  • Between 30 and 70 years old

排除标准

  • Decompensated heart failure
  • Unstable angina
  • Moderate respiratory disease severe
  • Active infectious disease or fever
  • Disabling peripheral vascular disease
  • Unstable ventricular arrhythmias
  • Use of cardiac pacemaker.

结局指标

主要结局

Six-minute walk test

时间窗: 1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week

The patient is set to walk in a corridor of 30 meters delimited cones for six minutes in order to go as far as possible. Every minute the patient is stimulated by the evaluator.

次要结局

  • 30-s chair-stand(1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week)
  • respiratory muscle strength test(1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week)
  • Quality of life(1 week, through study completion, an average of 12 week)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Della Méa Plentz

Clinical Professor

Federal University of Health Science of Porto Alegre

研究点 (2)

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