- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922254
Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease
Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The term "COPD" refers to a range of illnesses that impair breathing and obstruct airflow.
Smoking or having smoked in the past increases the risk of developing COPD because tobacco smoke is the primary cause of the disease. The risk is further increased by family history, occupational or home, air pollution exposure and respiratory illnesses including pneumonia. The signs and symptoms include wheezing, coughing up mucus (sputum) and difficulty in breathing. It is frequently brought on by prolonged exposure to irritant gases or particulates most frequently from cigarette smoke. Heart disease, lung cancer and a number of other diseases are more likely to occur in people with COPD.
A randomised controlled trial will be conducted with COPD patients as its target population. There will be 40 individuals for both the control group and the intervention group. Group A is a control group while Group B is an experimental group (20 participants on Group A and 20 on group B). The baseline treatment for both groups were pursed lip breathing and ACBT. On the other hand, group B experimental group will also undergo (pursued lip breathing and ACBT) with autogenic drainage. Group A session lasts for 30 minutes and Group B session lasts for 45 minutes. There is only one session per day. There is a three session in a week for 4 weeks. Measurements are made of dyspnea, oxygen saturation, peak expiratory flow rate, pulse rate and fatigue both before and after the treatment, data were recorded. Participants in the trial must have mild to moderate COPD (GOLD Criteria) and be between the ages of 40 to 60 years. Data from Sheikh Zayed Hospital, Rahim Yar Khan will be collected. Follow-up for both completed tasks and changes in pulmonary status will be evaluated after 4 weeks. Modified Borg Dyspnea (RPE) Scale, Breathlessness, Cough and Sputum Scale (BCSS), Fatigue Severity Scale or Visual Analogue Scale, Peak flow meter, Oximeter will be used to measure the outcomes. Data will be analysed using the SPSS 21.0 Statistical Software.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rahim Yar Khan, Punjab, Pakistan, 64200
- Sheikh Zayed Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders (Male and Female)
- Age 40 to 60 years
- Mild to moderate COPD (According to GOLD Criteria)
- Patient is bilingual.
Exclusion Criteria:
- Patients having progressive respiratory muscle weakness (Mysthenia Gravis)
- Cardiovascular impairment
- Any recent surgery
- Systemic illness
- Angina
- Uncontrolled diabetes and hypertension
- TB
- Non-cooperative Patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Active cycle of breathing technique
Group A is a control group.
First, the patients will receive baseline treatment (pursed lip breathing).
Additionally, patients will be administered the Active Cycle of Breathing Technique after receiving the Baseline Treatment
|
The ACBT technique consists of three different breathing techniques: breathing control, thoracic expansion exercises and forced expiration technique.
1. Breathing Control 2. Thoracic Expansion Exercises: 3. Forced Expiration Technique:
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Experimental: Autogenic drainage
Both the physiotherapist's hand and the subject's hands were put on the subject's abdomen to feel the activity of the abdominal muscles.
The patient inhaled slowly through the nose while using their diaphragm and holding their breath for two to three seconds to allow collateral ventilation to bring air behind their secretions.
Exhalation was done through the mouth.
The palm of the therapist placed on the upper chest felt the vibration of the mucous.
Their positions were disclosed by the vibrations' frequency.
Secretions in tiny airways can be seen using high frequencies.
The method has phases for unsticking, collecting and evacuation.
The mucus was expelled by a stronger expiration or a high lung volume huff at the conclusion of the session.
|
The ACBT technique consists of three different breathing techniques: breathing control, thoracic expansion exercises and forced expiration technique.
1. Breathing Control 2. Thoracic Expansion Exercises: 3. Forced Expiration Technique:
Huffing or blowing the nose helped to get rid of any secretions in the upper airways.
The therapist was placed close enough to hear the subject's breathing while sitting to the side and slightly behind the patient.
Both the physiotherapist's hand and the subject's hands were put on the subject's abdomen to feel the activity of the abdominal muscles.
The patient inhaled slowly through the nose while using their diaphragm and holding their breath for two to three seconds to allow collateral ventilation to bring air behind their secretions.
Exhalation was done through the mouth.
The palm of the therapist placed on the upper chest felt the vibration of the mucous.
Their positions were disclosed by the vibrations' frequency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg Dyspnea (RPE) scale
Time Frame: fourth week
|
The most popular tool for evaluating symptoms of breathlessness is the Modified Borg Dyspnoea Scale.
RPE scales, despite being a subjective gauge of exercise intensity, are useful when utilised properly.
The RPE scale has a 0 to10 scale with 0 being no exertion and 10 being maximum effort
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fourth week
|
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Dyspnea Index Questionnaire
Time Frame: fourth week
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The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients.
It includes 10-item surveys
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fourth week
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Breathlessness, Cough and Sputum Scale (BCSS)
Time Frame: fourth week
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The breathlessness, cough and sputum scale (BCSS) are a three-item scale that rates symptoms of dyspnea, cough and sputum on a Likert scale from 0 (no symptoms) to 4 (severe symptoms).
The Breathlessness, Cough and Sputum Scale (BCSS), which assesses common symptoms found in the COPD population, is used to predict patient exacerbations
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fourth week
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Fatigue Severity Scale
Time Frame: fourth week
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You can assess the impact of fatigue on you using the Fatigue Severity Scale (FSS).
The FSS is a brief questionnaire that asks you to rate how tired you are.
Nine statements in the FSS questionnaire allow you to express how severe your tiredness symptoms are
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fourth week
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Peak Flow meter
Time Frame: baseline and fourth week
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A peak flow meter must be used by blowing forcefully into it.
In liters per minute, the meter measures the forced air flow.
When you exhale, the indicator on the device moves and gives you a reading on a scale of 1 to 10.
When a person's airway function changes, it may be a sign that their asthma or COPD symptoms are getting worse.
This is where a peak flow meter is useful
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baseline and fourth week
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Oximeter
Time Frame: fourth week
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The oxygen saturation level of your blood can be measured with a non-invasive procedure called pulse oximetry.
It can quickly identify even minute variations in oxygen levels.
These levels demonstrate how well blood transports oxygen to your arms and legs, which are the extremities that are farthest from your heart.
It looks like a little clip and is called a pulse oximeter.
It attaches to a body component, usually a finger
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fourth week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.
- Yadav UN, Lloyd J, Hosseinzadeh H, Baral KP, Harris MF. Do Chronic Obstructive Pulmonary Diseases (COPD) Self-Management Interventions Consider Health Literacy and Patient Activation? A Systematic Review. J Clin Med. 2020 Feb 28;9(3):646. doi: 10.3390/jcm9030646.
- Mendes LP, Moraes KS, Hoffman M, Vieira DS, Ribeiro-Samora GA, Lage SM, Britto RR, Parreira VF. Effects of Diaphragmatic Breathing With and Without Pursed-Lips Breathing in Subjects With COPD. Respir Care. 2019 Feb;64(2):136-144. doi: 10.4187/respcare.06319. Epub 2018 Aug 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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