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

May 21, 2026 updated by: 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan
        • Foundation University Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: Abdominal binder -assisted diaphragmatic breathing
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.
Active Comparator: 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.
Other: Conventional diaphragmatic breathing exercise

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
04 weeks
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.
04 weeks
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.
04 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2025

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUCP/CTR/2026/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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