Effects of Abdominal Binder on Dysnea, Control Pause and Quality of Life in Asthmatic Patients
2026年5月21日 更新者：Foundation University Islamabad
This study investigates the effects of using an abdominal binder as an adjunct to diaphragmatic breathing in asthma patients.
The goal is to determine if the binder improves respiratory mechanics, specifically reducing dyspnea ,and increasing breath-hold time (control pause) and quality of life over a four-week period
研究概览
地位
完全的
条件
详细说明
This randomized controlled trial (RCT) investigates the efficacy of an abdominal binder as an adjunct to diaphragmatic breathing in 32 asthma patients (aged 18-60).
Participants are allocated into two groups: the experimental group receives binder-assisted diaphragmatic breathing exercises (14 sessions/week for 4 weeks), while the control group performs conventional diaphragmatic breathing exercises.
The study aims to evaluate improvements in respiratory mechanics, specifically focusing on reducing dyspnea, increasing breath-hold duration (control pause), and enhancing asthma-related quality of life.
The intervention involves applying an external abdominal binder to provide resistance and tactile feedback during diaphragmatic breathing.
Training intensity progresses from light resistance (weeks 1-2) to high resistance (weeks 3-4).
The primary goal is to optimize diaphragmatic excursion and reduce the work of breathing associated with asthmatic hyperinflation.
研究类型
介入性
注册 (实际的)
32
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
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Islamabad、巴基斯坦
- Foundation University Islamabad
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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
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Age :18 to 65
- Diagnosed asthma (persistent, not solely intermittent, seasonal, or exercise-induced).
- Mild to moderate asthma; > 2 days/week (not daily) Minor activity limitation* FEV₁ ≥80.
- Capable of performing dyspnea control pause (DCP) testing and completing QoL questionnaires.
- No recent hospitalization due to asthma.
Exclusion Criteria:
- Intermittent, seasonal-only, or exercise-induced asthma.
- Presence of other major respiratory diseases (COPD, bronchitis, pneumonia, fibro tic disorders)
- Severe comorbidity: cardiac arrhythmia, CHF, CAD, uncontrolled hypertension/diabetes, renal/hepatic
- Severe asthma (Symptoms all day Frequent night awakenings* FEV₁ <60% predicted.) ▪️ Unable to perform breathing exercises
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Experimental group abdominal binder-assisted diaphragmatic breathing exercises
This group will receive standard medical management for asthma along with abdominal binder-assisted diaphragmatic breathing exercises.
The abdominal binder will be used to provide external resistance and tactile feedback to the diaphragm.
The intervention will be conducted for 4 weeks ( supervised and home-based sessions).
Training intensity will progress from light resistance (Weeks 1-2) to high resistance (Weeks 3-4).
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Participants perform slow, deep diaphragmatic inhalations and exhalations Mechanism: The abdominal binder is applied to increase intro-abdominal pressure, helping to reposition the flattened diaphragm in asthma patients into a more efficient, dome-like shape (zone of apposition).
Dosage: 4 weeks total; Progression: Intensity is increased by tightening the binder/increasing resistance over the final 2 weeks of the study.
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有源比较器：Control group conventional diaphragmatic breathing exercises
This group will receive standard medical management for asthma and perform conventional diaphragmatic breathing exercises alone without the use of an abdominal binder.
The frequency and duration will match the experimental group (for week for 4 weeks) to control for the effects of the breathing exercises themselves.
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This group receives standard medical management for asthma and performs conventional diaphragmatic breathing exercises alone. Unlike the experimental group, these exercises are performed without the use of an abdominal binder. Frequency and Duration: The sessions are conducted 14 times per week for a total of 4 weeks. This matches the experimental group's schedule to ensure the results accurately control for the effects of the breathing exercises themselves. |
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 |
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Dyspnea
大体时间：04 weeks
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Dyspnea was assessed using the Dyspnea-12 Questionnaire, a validated self-administered instrument designed to measure the severity of breathlessness.
The questionnaire consists of 12 items that evaluate both the physical and affective components of dyspnea experienced by the participant.
Each item is scored on a 4-point Likert scale ranging from 0 (none) to 3 (severe), with a total score ranging from 0 to 36.
Higher scores indicate greater severity of dyspnea and a greater impact of breathlessness on daily functioning.
The Dyspnea-12 has demonstrated good reliability and validity for assessing multidimensional breathlessness across clinical populations
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04 weeks
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control pause (Breath- hold time )
大体时间：04 weeks
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Control pause was assessed using the breath-hold time test, a measure commonly used to evaluate breathing pattern efficiency and carbon dioxide tolerance in individuals with Asthma.
Participants were instructed to sit comfortably and breathe normally for several breaths.
At the end of a normal exhalation, they were asked to gently hold their breath by pinching the nose until the first natural urge to breathe was experienced, such as diaphragmatic contraction or mild air hunger.
The breath-hold duration was recorded in seconds using a stopwatch.
Lower control pause values in asthma are often associated with dysfunctional breathing patterns, airway hyperresponsiveness, and poor symptom control, whereas higher values indicate improved respiratory regulation, greater carbon dioxide tolerance, and enhanced breathing efficiency.
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04 weeks
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Asthma-Related Quality of Life
大体时间：04 weeks
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Asthma-related quality of life was assessed using the Asthma Quality of Life Questionnaire (AQLQ), a validated 32-item questionnaire designed to evaluate the impact of Asthma on daily functioning and well-being.
The questionnaire assesses four domains: symptoms, activity limitation, emotional function, and environmental stimuli.
Each item is scored on a 7-point Likert scale, with total scores ranging from 1 (severely impaired) to 7 (not impaired).
Higher scores indicate better quality of life, reflecting minimal impact of asthma on daily activities and overall well-being, whereas lower scores indicate poorer functional status, greater symptom burden, and significant lifestyle restriction due to asthma.
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04 weeks
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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。
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11月18日
初级完成 (实际的)
2026年5月1日
研究完成 (实际的)
2026年5月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月21日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.