Chronic Obstructive Pulmonary DiseaseNCT05922254
Combined Effects of ACBT and AUTOGENIC DRAINAGE in Patients With Chronic Obstructive Pulmonary Disease
A study testing Active cycle of breathing technique and Autogenic drainage in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Active cycle of breathing technique and Autogenic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders (Male and Female)
- Age 40 to 60 years
- Mild to moderate COPD (According to GOLD Criteria)
- Patient is bilingual.
Who cannot join
- Patients having progressive respiratory muscle weakness (Mysthenia Gravis)
- Cardiovascular impairment
- Any recent surgery
- Systemic illness
- Angina
- Uncontrolled diabetes and hypertension
- TB
- Non-cooperative Patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
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
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Active cycle of breathing technique, Autogenic drainage
- Keywords
- Chronic Obstructive, Drainage, Postural, Pulmonary Disease, Respiratory Therapy.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing techniqueOther
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:
Autogenic drainageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Active comparator | 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 Receives: Other: Active cycle of breathing technique |
| Autogenic drainage | Experimental | 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. Receives: Other: Active cycle of breathing technique; Other: Autogenic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: fourth week
Dyspnea Index Questionnaire
The Dyspnoea Index questionnaire is a useful tool for quantifying upper airway dyspnea symptoms in patients. It includes 10-item surveys
Measured: fourth week
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
Measured: fourth week
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
Measured: fourth week
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
Measured: baseline and fourth week
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
Measured: fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922254
- Sponsor's protocol ID
- REC/RCR&AHS/23/0318
- Status last verified
- Dec 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32121180Garcia-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.
PubMed 16738033Mendes 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.
PubMed 30154127
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Active Cycle of Breathing Technique and Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05922254
- Acronym / sponsor ID
- REC/RCR&AHS/23/0318
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive, Drainage, Postural, Pulmonary Disease, Respiratory Therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Active comparator | Other: Active cycle of breathing techniqueGroup 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 |
| Autogenic drainage | Experimental | Other: Active cycle of breathing technique, Other: Autogenic drainageBoth 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders (Male and Female)
- Age 40 to 60 years
- Mild to moderate COPD (According to GOLD Criteria)
- Patient is bilingual.
Key exclusion criteria (8 listed)
- Patients having progressive respiratory muscle weakness (Mysthenia Gravis)
- Cardiovascular impairment
- Any recent surgery
- Systemic illness
- Angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cycle of breathing techniqueThe 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: | Other | Active cycle of breathing technique, Autogenic drainage |
| Autogenic drainageHuffing 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. | Other | Autogenic drainage |
Primary outcome
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
Dyspnea Index Questionnaire
Time frame: fourth week
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)
Time frame: fourth week
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
Time frame: fourth week
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
Time frame: baseline and fourth week
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
Time frame: fourth week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 32121180Yadav 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.
- Background: PubMed 16738033Garcia-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.
- Background: PubMed 30154127Mendes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing technique and Autogenic drainage in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Dyspnea (RPE) scale (time frame: fourth week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922254, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.