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临床试验/NCT04152187
NCT04152187已完成不适用

Investigation of the Effects of Inspiratory Muscle Training in Patients With Pulmonary Hypertension

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年11月11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
24
试验地点
2
主要终点
6 minute walk test

研究概览

简要总结

This study aims to determine the possible effects of inspiratory muscle training on cardiovascular, respiratory, physical and psychosocial functions in patients with PH.

详细描述

Pulmonary Hypertension (PH) is a hemodynamic finding related to increase in pulmonary artery pressure. Because PH disease is a progressive, rare disease, it is important for this disease group to prolong the life span and to increase the quality of life and functional capacity. PH patients have been shown to have weakness in peripheral and respiratory muscles.

Patients will be randomly assigned to the inspiratory muscle training and control group. Inspiratory muscle training will be initiated in accordance with the patient at a range of 40-60%. İnspiratory muscle training will be given based on the assessments by the physiotherapist. Patients with PH who come to the routine outpatient clinic and volunteer will be included in the study. The first session will be the evaluation session and the 8-week inspiratory muscle training will be given, the other group will be the control group only. Dyspnoea, diaphragm thickness, pulmonary function, respiratory and peripheral muscle strength, blood pressure, arterial stiffness, physical activity, anxiety, depression and quality of life assessments will be repeated before and after the treatment.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis of Pulmonary Hypertension
  • According to the New York Heart Association functional class II - III
  • Cases receiving stable medication for 3 months

排除标准

  • Conditions which can limit the assessments
  • Severe ischemic heart disease
  • Acute cor pulmonale

结局指标

主要结局

6 minute walk test

时间窗: Change from Baseline at 8 weeks

functional capacity

次要结局

  • Mouth pressures(Change from Baseline at 8 weeks)
  • Modified Medical Research Council Dyspnea Scale(Change from Baseline at 8 weeks)
  • Forced vital capacity(Change from Baseline at 8 weeks)
  • Forced expiratory volume in 1 second(Change from Baseline at 8 weeks)
  • Diaphragma thickness(Change from Baseline at 8 weeks)
  • Levels of blood pressure(Change from Baseline at 8 weeks)
  • Isometric muscle strength(Change from Baseline at 8 weeks)
  • Arterial stiffness(Change from Baseline at 8 weeks)
  • Upper extremity exercise capacity(Change from Baseline at 8 weeks)
  • International Physical Activity Questionnaire-Short Form(Change from Baseline at 8 weeks)
  • Fatigue Impact Scale(Change from Baseline at 8 weeks)
  • Nottingham Health Profile(Change from Baseline at 8 weeks)
  • Changes in Anxiety and Depression(Change from Baseline at 8 weeks)
  • Changes in Dyspnea(Change from Baseline at 8 weeks)

研究者

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

Buse Ozcan Kahraman

Research Assistant

Dokuz Eylul University

研究点 (2)

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