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临床试验/NCT07206641
NCT07206641尚未招募不适用

The Effect of Inspiratory Exercises on Diaphragm and Intercostal Muscle Thickness in Stroke Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年12月1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
35
试验地点
1
主要终点
Diaphragm muscle thickness

研究概览

简要总结

The aim of this study is to investigate the effect of inspiratory muscle strengthening exercises on bilateral parasternal intercostal muscle thickness and bilateral diaphragm muscle thickness in stroke patients and to present new data on whether the possible effect on the affected side can be associated with changes in respiratory parameters. Furthermore, as previous literature has shown that 4-week exercise programs are more effective than >6-week exercise programs, an interim assessment is planned for the second week of treatment in this study to evaluate shorter-term changes. Four weeks after completion of the exercise program (in the 8th week), patients will be re-evaluated to track potential short-term effects.

详细描述

Respiratory muscles consist of three main groups that control ventilation: primary inspiratory muscles, secondary inspiratory muscles, and expiratory muscles. The primary inspiratory muscle is the diaphragm, a thin dome-shaped muscle located between the thorax and the abdomen. The diaphragm, the most important respiratory muscle, contributes to 60-80% of the ventilation needs of the human body. However, the diaphragm is not the only inspiratory muscle involved in ventilation. When the load on the diaphragm increases, accessory inspiratory muscles such as the parasternal intercostal muscles, external intercostal muscles, scalene muscles, and sternocleidomastoid muscles are recruited to assist inspiration.

Involvement of the diaphragm and other respiratory muscle groups is a common condition after stroke. Due to the loss of central motor control in stroke patients, contralateral diaphragmatic weakness is observed. The thickness of the diaphragm affected by stroke is approximately 50% of that of age- and sex-matched healthy adults, as shown in studies.

After stroke, the decrease in respiratory muscle strength on the hemiplegic side may lead to pulmonary ventilation and diffusion dysfunction, reduced coughing ability, increased incidence of pulmonary complications, and reduced cardiopulmonary endurance and trunk balance control. Respiratory muscle strengthening exercises are used as an effective method in reducing these problems.

Patients diagnosed with stroke who will be followed with inspiratory strengthening exercises will be monitored by comparing the muscle thicknesses of the affected side and the healthy side. After receiving training on inspiratory strengthening exercises to be given to them, patients will regularly perform these exercises at home, and the consistent correct performance of these exercises will be monitored by a researcher through video calls with the participants over the internet.

Intercostal Muscle Thickness Measurement:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a history of ischemic or hemorrhagic stroke
  • Aged 18-65 years

排除标准

  • Presence of concomitant acute or chronic lung disease
  • History of thoracic or abdominal surgery
  • Presence of another neuromuscular disease
  • Patients with aphasia or impaired cognition
  • Severe heart disease
  • Active cancer
  • Mini-Mental State Examination (MMSE) score ≤ 24
  • Active smoking

结局指标

主要结局

Diaphragm muscle thickness

时间窗: Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

Intercostal muscle thickness

时间窗: Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

次要结局

  • Berg Balance Scale(Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).)
  • Tinetti Test(Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).)
  • Stroke-Specific Quality of Life Scale(Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).)
  • Forced Vital Capacity(Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week))
  • Forced Expiratory Volume(Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).)
  • Maximum Inspiratory Pressure(Will be measured using respiratory pressure meter before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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