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Air Stacking-Assisted Diaphragmatic Breathing in Stroke

2026年5月5日 更新者:jang ji-hun

Effects of Diaphragmatic Breathing Exercise Using the Air Stacking Technique on Respiratory and Trunk Function in Patients With Stroke: A Randomized Controlled Trial

The purpose of this study is to investigate whether a diaphragmatic breathing exercise using the air stacking technique can improve respiratory function and trunk control in patients with stroke. The experimental group will perform an air stacking-based diaphragmatic breathing exercise using an Ambu-bag, combined with neurodevelopmental treatment, three times per week for 20 minutes over a 4-week period. The control group will receive therapist-guided diaphragmatic breathing exercises with the same frequency and duration, together with the same neurodevelopmental treatment. All participants will be assessed before and after the intervention for pulmonary function, chest wall expansion, and trunk control ability, as well as the Korean version of the Trunk Impairment Scale (K-TIS), the Five Times Sit-to-Stand Test (FTSTS), and the Borg Rating of Perceived Exertion (Borg RPE). Changes between the two groups will be compared to determine the therapeutic effectiveness of the air stacking technique.

研究概览

详细说明

This clinical trial is a randomized controlled study designed to evaluate the effects of a diaphragmatic breathing exercise using the air stacking technique on respiratory and trunk function in patients with stroke. Patients with stroke are prone to respiratory muscle weakness, reduced chest wall expansion, and impaired trunk control, which can limit functional recovery and increase the risk of pulmonary complications. The air stacking technique increases lung volume and chest expansion through consecutive inspirations without exhalation and is known to facilitate more effective breathing and coughing, but its therapeutic effects in patients with stroke have not yet been fully established.

In this study, 20 patients with stroke will be randomly assigned to an experimental group (n = 10) or a control group (n = 10), using blocked randomization to ensure balance between groups. To enhance the objectivity of outcome assessment, all evaluations will be performed by an assessor who is blinded to group allocation. The experimental group will perform an air stacking-based diaphragmatic breathing exercise using an Ambu-bag, three times per week for 20 minutes over a 4-week period, in addition to neurodevelopmental treatment. The control group will receive therapist-guided diaphragmatic breathing exercises with the same frequency and duration, combined with the same neurodevelopmental treatment program. Both groups will receive the interventions for 4 weeks in the same rehabilitation setting.

All participants will undergo assessments before the start of the intervention and after completion of the 4-week program. Outcome measures will include pulmonary function tests (for example, FVC and FEV1), chest wall expansion, and trunk control ability. In addition, trunk function and functional mobility will be evaluated using the Korean version of the Trunk Impairment Scale (K-TIS) and the Five Times Sit-to-Stand Test (FTSTS), and perceived exertion during exercise will be assessed using the Borg Rating of Perceived Exertion (Borg RPE). Pre- to post-intervention changes will be calculated for each participant, and differences in these changes between the experimental and control groups will be analyzed.

The aim of this study is to determine whether a diaphragmatic breathing exercise using the air stacking technique provides additional benefits over conventional diaphragmatic breathing in improving pulmonary function, chest wall expansion, trunk control, and functional performance in patients with stroke. The findings are expected to demonstrate the therapeutic potential and clinical feasibility of an Ambu-bag-assisted air stacking technique and to contribute to the development of more effective respiratory and trunk rehabilitation strategies for individuals with stroke.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Daegu
      • Daegu、Daegu、韩国、41199
        • Daegu Fatima Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Inpatients diagnosed with stroke (intracerebral hemorrhage or cerebral infarction) at a general hospital in Daegu, currently receiving physical therapy
  • Onset of stroke at least 3 months prior to enrollment
  • Spasticity grade of 2 or less on the Modified Ashworth Scale
  • No congenital deformity or fracture of the thorax or other orthopedic conditions affecting the chest wall
  • No history of pulmonary disease before or after the stroke
  • Able to perform respiratory exercises as instructed
  • Mini-Mental State Examination-Korean version (MMSE-K) score of 24 or higher, indicating sufficient cognitive ability to understand the study procedures
  • Presence of decreased pulmonary function (reduced pulmonary function test parameters) at baseline

Exclusion Criteria:

  • Acute stroke status or onset of stroke less than 3 months prior to enrollment
  • Severe cardiovascular or respiratory disease that makes participation in respiratory exercise unsafe or impossible
  • Cognitive impairment or communication disorder that prevents understanding or performing the study procedures
  • Any other medical or safety condition judged by the investigator to make participation in the study inappropriate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Air stacking-assisted diaphragmatic breathing
articipants in this arm will receive diaphragmatic breathing exercises using the air stacking technique with an Ambu-bag three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.
Diaphragmatic breathing exercise using the air stacking technique with an Ambu-bag, performed three times per week for 20 minutes over 4 weeks, in addition to routine neurodevelopmental treatment.
有源比较器:diaphragmatic breathing
Participants in this arm will receive diaphragmatic breathing exercises three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.
diaphragmatic breathing exercise performed three times per week for 20 minutes over 4 weeks, together with the same neurodevelopmental treatment as the experimental group.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Forced Vital Capacity (FVC)
大体时间:Baseline and 4 weeks after the start of intervention
Forced vital capacity (FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FVC from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Forced Expiratory Volume in 1 Second (FEV1)
大体时间:Baseline and 4 weeks after the start of intervention
Forced expiratory volume in 1 second (FEV1) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FEV1 from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in FEV1/FVC ratio
大体时间:Baseline and 4 weeks after the start of intervention
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in FEV1/FVC from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Peak Expiratory Flow (PEF)
大体时间:Baseline and 4 weeks after the start of intervention
Peak expiratory flow (PEF) will be assessed using spirometry at baseline and 4 weeks after the start of the intervention. The outcome measure is the change in PEF from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention

次要结果测量

结果测量
措施说明
大体时间
Change in Trunk Function (Korean Version of the Trunk Impairment Scale, K-TIS)
大体时间:Baseline and 4 weeks after the start of intervention
Trunk function will be assessed using the Korean version of the Trunk Impairment Scale (K-TIS) at baseline and 4 weeks after the start of the intervention. The K-TIS is a clinical scale ranging from 0 to 23, with higher scores indicating better trunk function. The outcome measure is the change in K-TIS total score from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Functional Lower Extremity Performance (Five Times Sit-to-Stand Test, FTSTS)
大体时间:Baseline and 4 weeks after the start of intervention
Functional lower extremity performance will be assessed using the Five Times Sit-to-Stand Test (FTSTS) at baseline and 4 weeks after the start of the intervention. The FTSTS records the time in seconds required to complete five repetitions of rising from and returning to a seated position. Higher times indicate poorer functional performance. The outcome measure is the change in FTSTS completion time from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention
Change in Perceived Exertion (Borg Rating of Perceived Exertion Scale)
大体时间:Baseline and 4 weeks after the start of intervention
Perceived exertion during breathing exercises will be assessed using the Borg Rating of Perceived Exertion Scale at baseline and 4 weeks after the start of the intervention. The Borg scale ranges from 6 to 20, with higher scores indicating greater perceived exertion. The outcome measure is the change in Borg scale score from baseline to 4 weeks in each group.
Baseline and 4 weeks after the start of intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月25日

初级完成 (实际的)

2026年2月21日

研究完成 (实际的)

2026年2月21日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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