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临床试验/NCT04834336
NCT04834336尚未招募不适用

Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure

Dokuz Eylul University0 个研究点目标入组 28 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
28
主要终点
Maximal Inspiratory Pressure

研究概览

简要总结

Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF.

详细描述

The participants will randomly be allocated into two groups: (1) Physical training plus inspiratory muscle training, (2) Physical training

Participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. Inspiratory muscle training will be applied with an electronic device. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. The physical training group will perform only physical training. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, physical training will be carried out once a day. For the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. For effects of inspiratory muscle training, data will be collected at baseline and hospital discharge.

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
Single (Participant)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The management of a diagnosis of ADHF over 24 hours in a hospital setting
  • Hemodynamic stability
  • The independence of basic activities of daily life before admission

排除标准

  • Acute myocardial infarction
  • Congenital heart disease
  • Endocarditis, miyocarditis or pericarditis
  • Morbid obesity
  • Already participating in cardiac rehabilitation

结局指标

主要结局

Maximal Inspiratory Pressure

时间窗: baseline and hospital discharge, an average of 4 to 10 days

Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)

次要结局

  • New York Heart Association Functional Classification(baseline and hospital discharge, an average of 4 to 10 days)
  • Adverse events(During the hospitalization, daily, during an average of 4 to 10 days)
  • Recruitment rate(During the hospitalization, daily, during an average of 4 to 10 days)
  • Retention rate(During the hospitalization, daily, during an average of 4 to 10 days)
  • Physical Performance(baseline and hospital discharge, an average of 4 to 10 days)
  • Frailty(baseline and hospital discharge, an average of 4 to 10 days)
  • Cardiac autonomic function(baseline and hospital discharge, an average of 4 to 10 days)
  • Arterial Stiffness(baseline and hospital discharge, an average of 4 to 10 days)
  • Dyspnea(baseline and hospital discharge, an average of 4 to 10 days)
  • Hand Grip Strength(baseline and hospital discharge, an average of 4 to 10 days)
  • Disability(baseline and hospital discharge, an average of 4 to 10 days)
  • One-year mortality(one year after discharge)
  • Adherence rate(During the hospitalization, daily, during an average of 4 to 10 days)

研究者

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

Aylin Tanriverdi

Research assistant

Dokuz Eylul University

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