- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07713043
Effects of Autogenic Drainage and Flutter Device in COPD
17 juillet 2026 mis à jour par: Riphah International University
Comparative Effects of Autogenic Drainage and Flutter Device on Dyspnea, Pulmonary Function Test and Functional Capacity in COPD
COPD is a progressive lung disease that includes emphysema and chronic bronchitis and is a major cause of morbidity and mortality worldwide.
Airway clearance techniques help improve mucus removal, reduce dyspnea, and enhance quality of life in COPD patients.
This study aims to compare the effects of autogenic drainage and flutter device on dyspnea, pulmonary function, and functional capacity in patients with COPD.
A randomized clinical trial will be conducted at Gulab Devi Teaching Hospital using convenient sampling.
Participants will be divided into two groups: Group A will receive autogenic drainage, while Group B will use the flutter device.
Interventions will be performed daily for 20-30 minutes over 6 weeks.
Outcome measures will include dyspnea severity scale, spirometry, and 6-minute walk test.
Data will be analyzed using SPSS with significance set at p < 0.05.
The study may provide evidence for effective, non-invasive, and cost-effective management strategies for COPD patients.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
Chronic obstructive pulmonary disease is progressive damage to lungs with a combination of airway diseases that are emphysema and chronic bronchitis.
COPD is the major cause of chronic mortality and morbidity throughout the world.
It's third leading cause of death in the world.
Non pharmacological intervention Airway clearance techniques plays crucial role in managing COPD and enhancing patients quality of life by removal of bronchial secretions.
Two popular techniques autogenic drainage and flutter are based on the same principle of mobilization and removal of secretions.
These non-invasive techniques aimed at enhancing mucus clearance and reducing dyspnea.
The objective of the study's primary goal is to compare the effect of autogenic drainage and flutter device on the dyspnea, pulmonary function test and functional capacity in the patients with COPD.
The study design will be ramdomized clinical trial.
It will be conducted at Ghulab Devi |Teaching Hospital.
Sample size will be conducted through non- probability convenient sampling as per inclusion criteria.
Participants will be randomly added into two groups.
Group A will receive autogenic drainage intervention and the Group B will receive flutter device intervention.
Both interventions will be practiced daily for 5 days 6 weeks for 20-30 minutes.
Pre and post intervention data will be collected.
Outcome measures include dyspnea severity scale, spirometer and 6-minute walk test.
Data will be analyzed by using SPSS.
Data will be tested for normality distribution.
Paired or Independent t-test will be used to compare variables between the two groups and within the two groups, with significance set at p< 0.05.
This study will provide evidence for the integration of non-invasive, cost effective strategies for the enhancement of PFT's and functional capacity and dyspnea.
Type d'étude
Interventionnel
Inscription (Estimé)
42
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.
Coordonnées de l'étude
- Nom: Muhammad Iqbal Tariq Tariq, Phd*
- Numéro de téléphone: 333826752
- E-mail: iqbal.tariq@riphah.edu.pk
Sauvegarde des contacts de l'étude
- Nom: Nimra Noor Noor, MS-CPPT
- Numéro de téléphone: 03030684869
- E-mail: nimranoor358@gmail.com
Lieux d'étude
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- Nimra Noor
-
Contact:
- Nimra Noor Noor, MS-CPPT
- Numéro de téléphone: 03030684869
- E-mail: nimranoor358@gmail.com
-
-
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
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age group: Middle age adults (40-60 years), medically stable
- Both gender
- Diagnosis based on GOLD criteria ((FEV₁/FVC ratio < 0.70).
- Moderate COPD with no acute exacerbations in the past 4-6 weeks.
- Participants must be able to perform Autogenic drainage and Flutter device physically and mentally.
- Voluntary participation with consent.
Exclusion Criteria:
- Cardic Diseases (Acute MI, Congestive Heart Failure)
- Musculoskeletal Impairements
- Using Non-invasive Ventilation
- Recent lung diseases (Respiratory failure, pneumothorax)
- Hemodynamic instability
- Uncoorperative patients
- Cognitive Impairement scale
- Participants excluded if they did not consent
- Comorbidities affecting exercise tolerance
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: Autogenic drainage
The participants in this group will be instructed to sit comfortably with the neck slightly extended and clear the upper airways by huffing or blowing the nose.
Autogenic drainage begins with slow diaphragmatic breathing at low lung volumes, followed by a 3-second pause and gentle high-velocity expiration with an open glottis.
As secretions move upward, breathing gradually shifts to medium and high lung volumes until mucus reaches the trachea for expectoration.
The cycle of breathing exercises is repeated for 15-20 minutes while suppressing unnecessary coughing.
|
The patient begins by performing the diaphragmatic breathing at low lung volume inspiration will slow with a pause of three seconds allowing the collateral ventilation, and expiration will done as a sigh with an open glottis and with high velocity as possible but no forced expiration.
During this low lung volume breathing, expiration will encourage to the expiratory reserve volume.
When the patient feel secretions to be moving, the volume of inspiration became deeper and expiration did not go down as far as expiratory reserve volume.
As the secretions moved up the bronchial tree to the large airways then the patient will ask to perform higher lung volume breathing, tidal volume to inspiratory reserve volume range.
This middle to high lung volume breathing continued until the secretions will in the trachea and ready to be expectorated
Autres noms:
|
|
Expérimental: Flutter Device (Positive expiratory pressure technique)
The participant in this group will be instructed to sit comfortably while leaning forward with elbows supported and the neck slightly extended to open the airway.
The flutter device is held horizontally with a slight upward tilt and placed in the mouth.
The patient inhales slowly through the nose, holds the breath for 3-5 seconds, and exhales through the flutter device slightly faster than normal.
After 4-8 breaths, a deep inhalation followed by forced expiration through the device helps mobilize secretions.
Breathing control is maintained, followed by coughing or huffing if needed.
The procedure is repeated for 10-15 minutes.
|
The flutter device will hold horizontally and tilted slightly upwards to get maximal oscillatory effect and then it was placed in the mouth.
Inspiration was done through the nose.
A slow breath in, only slightly deeper than normal with a breath hold of 3-5 seconds will followed by breath out through the flutter device at a slightly faster rate than normal.
After 4-8 breaths, a deep breath with a hold' at full inspiration will followed by a force expiration through the flutter device.
This precipitated expectoration and will followed by a pause for breathing control, and then according to the subjects' preference a cough or huff was done
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dyspnea
Délai: Baseline and after 6 weeks of intervention
|
The modified medical research council; (mMRC) Dyspnea Scale is a simple and widely used scale
|
Baseline and after 6 weeks of intervention
|
|
Forced Vital Capacity
Délai: Baseline and after 6 weeks of intervention
|
Forced Vital Capacity (FVC) will be measured in liters (L) using spirometry.
FVC represents the maximum volume of air that can be forcefully exhaled after a maximal inspiration.
|
Baseline and after 6 weeks of intervention
|
|
Forced Expiratory Volume in One Second
Délai: Baseline and after 6 weeks of intervention
|
Forced Expiratory Volume in One Second (FEV₁) will be measured in liters (L) using spirometry.
FEV₁ represents the volume of air exhaled during the first second of a forced expiratory maneuver.
|
Baseline and after 6 weeks of intervention
|
|
FEV₁/FVC ratio
Délai: Baseline and after 6 weeks of intervention
|
The FEV₁/FVC ratio will be expressed as a percentage (%) and calculated from spirometric measurements to assess the degree of airflow limitation.
|
Baseline and after 6 weeks of intervention
|
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Peak Expiratory Flow
Délai: Baseline and after 6 weeks of intervention
|
Peak Expiratory Flow (PEF) will be measured in liters per minute (L/min) and represents the maximum expiratory flow achieved during forced expiration.
|
Baseline and after 6 weeks of intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Arjumand Bano, MS, Riphah International University
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 (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 août 2026
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juillet 2026
Première publication (Réel)
20 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies des voies respiratoires
- Maladies pulmonaires
- Troubles respiratoires
- Maladies pulmonaires obstructives
- Signes et symptômes respiratoires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladie pulmonaire obstructive chronique
- Dyspnée
Autres numéros d'identification d'étude
- REC/RCR & AHS/25/0309
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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
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