- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07713043
Effects of Autogenic Drainage and Flutter Device in COPD
17 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
42
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Muhammad Iqbal Tariq Tariq, Phd*
- Numero di telefono: 333826752
- Email: iqbal.tariq@riphah.edu.pk
Backup dei contatti dello studio
- Nome: Nimra Noor Noor, MS-CPPT
- Numero di telefono: 03030684869
- Email: nimranoor358@gmail.com
Luoghi di studio
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-
Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- Nimra Noor
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Contatto:
- Nimra Noor Noor, MS-CPPT
- Numero di telefono: 03030684869
- Email: nimranoor358@gmail.com
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
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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
Altri nomi:
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Sperimentale: 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.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dyspnea
Lasso di tempo: Baseline and after 6 weeks of intervention
|
The modified medical research council; (mMRC) Dyspnea Scale is a simple and widely used scale
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Baseline and after 6 weeks of intervention
|
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Forced Vital Capacity
Lasso di tempo: Baseline and after 6 weeks of intervention
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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.
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Baseline and after 6 weeks of intervention
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Forced Expiratory Volume in One Second
Lasso di tempo: Baseline and after 6 weeks of intervention
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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.
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Baseline and after 6 weeks of intervention
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FEV₁/FVC ratio
Lasso di tempo: Baseline and after 6 weeks of intervention
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The FEV₁/FVC ratio will be expressed as a percentage (%) and calculated from spirometric measurements to assess the degree of airflow limitation.
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Baseline and after 6 weeks of intervention
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Peak Expiratory Flow
Lasso di tempo: Baseline and after 6 weeks of intervention
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Peak Expiratory Flow (PEF) will be measured in liters per minute (L/min) and represents the maximum expiratory flow achieved during forced expiration.
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Baseline and after 6 weeks of intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Arjumand Bano, MS, Riphah International University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 agosto 2026
Completamento dello studio (Stimato)
1 agosto 2026
Date di iscrizione allo studio
Primo inviato
8 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 luglio 2026
Primo Inserito (Effettivo)
20 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REC/RCR & AHS/25/0309
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .