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Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Active cycle of breathing technique
Autogenic drainage
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive, Drainage, Postural, Pulmonary Disease, Respiratory Therapy.

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheikh Zayed Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active cycle of breathing technique

Autogenic drainage

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Modified Borg Dyspnea (RPE) scale
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
Dyspnea Index Questionnaire
The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients. It includes 10-item surveys
Breathlessness, Cough and Sputum Scale (BCSS)
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
Fatigue Severity Scale
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
Peak Flow meter
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
Oximeter
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

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05922254
Brief Title
Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive, Drainage, Postural, Pulmonary Disease, Respiratory Therapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active cycle of breathing technique
Arm Type
Active Comparator
Arm Description
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
Arm Title
Autogenic drainage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active cycle of breathing technique
Intervention Description
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:
Intervention Type
Other
Intervention Name(s)
Autogenic drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Borg Dyspnea (RPE) scale
Description
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
Time Frame
fourth week
Title
Dyspnea Index Questionnaire
Description
The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients. It includes 10-item surveys
Time Frame
fourth week
Title
Breathlessness, Cough and Sputum Scale (BCSS)
Description
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
Time Frame
fourth week
Title
Fatigue Severity Scale
Description
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
Time Frame
fourth week
Title
Peak Flow meter
Description
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
Time Frame
baseline and fourth week
Title
Oximeter
Description
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
Time Frame
fourth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IQBAL TARIQ, PHD
Phone
03338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheikh Zayed Hospital,
City
Rahim Yar Khan
State/Province
Punjab
ZIP/Postal Code
64200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Afzal, PP-DPT
Phone
03124378540
Email
sidra.afzal@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32121180
Citation
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.
Results Reference
background
PubMed Identifier
16738033
Citation
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.
Results Reference
background
PubMed Identifier
30154127
Citation
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.
Results Reference
background

Learn more about this trial

Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease

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