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

21 mei 2026 bijgewerkt door: 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

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Islamabad, Pakistan
        • Foundation University Islamabad

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
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.
Actieve vergelijker: 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.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dyspnea
Tijdsspanne: 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 )
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 november 2025

Primaire voltooiing (Werkelijk)

1 mei 2026

Studie voltooiing (Werkelijk)

1 mei 2026

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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