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NCT Number: NCT07612384

Effects of Abdominal Binder on Dysnea, Control Pause and Quality of Life in Asthmatic Patients

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

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Key information

Conditions

Asthma Bronchial Diseases Dyspnea Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University Islamabad

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal binder -assisted diaphragmatic breathing

Other

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.

Conventional diaphragmatic breathing exercise

Other

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.

Primary outcomes

  1. Dyspnea

    Time frame: 04 weeks

    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

  2. control pause (Breath- hold time )

    Time frame: 04 weeks

    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.

  3. Asthma-Related Quality of Life

    Time frame: 04 weeks

    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.

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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