Effects of Autogenic Drainage and Flutter Device in COPD

Official title

Comparative Effects of Autogenic Drainage and Flutter Device on Dyspnea, Pulmonary Function Test and Functional Capacity in COPD

Overview

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.

Detailed description

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.

Interventions

• Procedure Autogenic drainage
  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 do
• Device Flutter Device
  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 precip

Primary outcome measures

• Dyspnea [Time frame: Baseline and after 6 weeks of intervention]
• Forced Vital Capacity [Time frame: Baseline and after 6 weeks of intervention]
• Forced Expiratory Volume in One Second [Time frame: Baseline and after 6 weeks of intervention]
• FEV₁/FVC ratio [Time frame: Baseline and after 6 weeks of intervention]
• Peak Expiratory Flow [Time frame: Baseline and after 6 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Nimra Noor — Lahore

Identifiers

NCT: NCT07713043 · REC/RCR & AHS/25/0309

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗