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

NCT07612384 | Completed

• 1 other identifier: FUCP/CTR/2026/07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Dyspnea; control pause; quality of life

Outcome Measures

Primary Outcomes (3)

• Dyspnea

  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 )

  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

  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

Study Arms (2)

Experimental group abdominal binder-assisted diaphragmatic breathing exercises

EXPERIMENTAL

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

Control group conventional diaphragmatic breathing exercises

ACTIVE COMPARATOR

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

Interventions

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.

Experimental group abdominal binder-assisted diaphragmatic breathing exercises

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.

Control group conventional diaphragmatic breathing exercises

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Asthma; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: November 18, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

PA (1)