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临床试验/NCT03501355
NCT03501355已完成不适用

Effects of Inspiratory Muscle and Endurance Training on Exercise Capacity, Respiratory Muscle Strength and Endurance and Quality of Life in Heart Failure Patients With Pacemaker

Gazi University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Maximal Exercise capacity

研究概览

简要总结

It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and quality of life in patients with heart disease. However, hearth failure patients with pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing exercise. No study investigated the effects of different inspiratory muscle training protocols. For this reason, we aimed to investigate the effects of inspiratory muscle training on outcomes in hearth failure patients with pacemaker

详细描述

Heart failure patients with pacemaker will be included. Primary outcome measurement is respiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression, physical activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Heart failure patients with Pacemaker who are clinically stable
  • After 12 weeks of pacemaker implantation
  • No change in medications over one month

排除标准

  • Patients with
  • Severe cognitive disorders
  • Pulmonary, neurological and orthopedic diseases
  • Pregnant and lactating patients
  • Acute infection or exacerbation

结局指标

主要结局

Maximal Exercise capacity

时间窗: First day

Incremental Shuttle Walk Test

次要结局

  • Peripheral muscle strength(First day)
  • Inspiratory and expiratory muscle strength (MIP, MEP)(First day)
  • Pulmonary functions(First day)
  • Depression(Second day)
  • Fatigue(Second day)
  • Quality of life(Second day)
  • Health-related quality of life(Second day)
  • Functional exercise capacity(Second day)
  • Physical activity(Second day)
  • Cognitive function(First day)

研究者

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

Meral Boşnak Güçlü

Assoc. Prof

Gazi University

研究点 (2)

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