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

21 mai 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

32

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pakistan
      • Islamabad, Pakistan
        • Foundation University Islamabad

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dyspnea
Délai: 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 )
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Foundation University Islamabad

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 novembre 2025

Achèvement primaire (Réel)

1 mai 2026

Achèvement de l'étude (Réel)

1 mai 2026

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

21 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FUCP/CTR/2026/07

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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