Chronic Obstructive Pulmonary DiseaseNCT06480422
Combined Effects Of Autogenic Drainage and Segmental Breathing Techniques in Chronic Obstructive Pulmonary Disease
A study testing Segmental breathing technique and autogenic drainage in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic obstructive pulmonary disease is one of the most common life threatening disease affecting population. It is a preventable and treatable lung disease. People with COPD must work harder to breathe, which can lead to shortness of breath and/or feeling tired. 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?
- Segmental 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 Jan 2024to 15 Sep 2024
- 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
- Age between 40 - 60 years.
- Diagnosed moderate COPD patients according to GOLD criteria.
- FEV / FVC ratio < 70 years
- Stable patients can understand written and oral english,urdu trial information.
Who cannot join
- Pregnancy, due to the Pressure on pelvic and Abdomen muscles.
- Malignant disease
- Severe (RA)
- Diagnosis of Asthma and major diseases, functionally limiting diseases, life expectancy < 3 months.
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ever Care Hospital
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Chronic obstructive pulmonary disease is one of the most common life threatening disease affecting population. It is a preventable and treatable lung disease. People with COPD must work harder to breathe, which can lead to shortness of breath and/or feeling tired. Autogenic drainage (AD) works by adapting your breathing and maximizing airflow within the airways to improve ventilation and clear sputum. Segmental breathing, also referred to as localized expansion breathing, is the exercise used to improve ventilation and oxygenation. This research of randomized controlled trial will check the combined effects of segmental breathing technique and autogenic drainage technique in chronic obstructive pulmonary disease by taking sample of 40 patients through non probability convenient sampling and randomly allocating them into two groups A and B out of which A will receive both autogenic drainage and segmental breathing technique, B will receive autogenic drainage only for upto the duration of 3 days per week(20-45 min) for upto 4 weeks.Pre and post training outcomes will be measured through pulse oximeter,spirometer and BCSS.The data will be analyzed through SPSS 25.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Segmental breathing technique, autogenic drainage
- Keywords
- Autogenic Drainage,, Segmental breathing technique, Chronic Obstructive Pulmonary Disease.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental breathing techniqueOther
Also called Autogenic drainage
To begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow patient's nose and huff, cough to clear your upper airways to mucus. This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath. Hold the breath for three seconds. With some gentle force exhale all the air out of your lungs. Repeat three times. Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. Repeat the cycle untill you have cleared your lungs as much as possible, 20 and 45 minutes.
autogenic drainageOther
To begin an autogenic drainage sit in a relaxed seated position with neck extended slightly.Blow ptient's nose and huff, cough to clear your upper airways to mucus.This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath.Hold the breath for three seconds.With some gentle force exhale all the air out of your lungs. Repeat three times.Do not cough untill after the third breath.
Repeat sessions 3 times in a week for 4 almost weeks. Repeat the cycle untill you have cleared your lungs as much as possible, which should take between 20 and 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| segmental breathing technique + Autogenic drainage | Experimental | For Segmental Breathing instruction, the therapist's hand is placed on the chest area to be expanded. The patient is encouraged to deeply breath and to preferentially "Send Air"to that area of chest where tactile stimulation is being applied by the therapist. On full expiration moderate compression is applied. To begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow patient's nose and huff, cough to clear your upper airways to mucus. This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways (Evacuation) Take in a deep breath. Hold the breath for three seconds. With some gentle force exhale all the air out of your lungs. Repeat three times. Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. Receives: Other: Segmental breathing technique; Other: autogenic drainage |
| Autogenic drainage | Active comparator | To begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow ptient's nose and huff, cough to clear your upper airways to mucus.This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath.Hold the breath for three seconds.With some gentle force exhale all the air out of your lungs. Repeat three times.Do not cough untill after the third breath.
Repeat sessions 3 times in a week for 4 almost weeks. Receives: Other: autogenic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPIROMETER
The most used pulmonary function test is spirometry. It assesses the capacity of the lungs to breathe in and out, especially the volume and/or velocity of air that can be expelled. When evaluating breathing patterns to detect diseases including asthma, pulmonary fibrosis, cystic fibrosis, and COPD, spirometry is useful. An FEV1/FVC ratio larger than 0.70 with both FEV1 and FVC over 80% of the expected value are considered normal spirometry data. TLC exceeding 80% of the predicted value is typical in the event that lung volumes are measured. Diffusion capacity that is more than 75% of the expected value is likewise regarded as typical
Measured: baseline and fourth week
PULSE OXIMETER
Pulse oximetry operates by shining a light through the skin at two different wavelengths_660 nm(red) and 940nm(infrared)_ and measuring the difference in light absorbance at the two wavelengths to estimate an arterial oxygen saturation
Measured: baseline and fourth week
BREATHLESSNESS COUGH SPUTUM SCALE(BCSS)
The breathlessness cough sputum scale tool is an effective means for measuring the impact of Pulmonary rehabilitation on improving patient tolerance and self reported symptoms as the result of COPD
Measured: baseline and 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 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
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 (estimated)
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
- NCT06480422
- Sponsor's protocol ID
- REC/RCR&AHS/23/0381
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali RA, Obeisat SM, Tarawneh LH. Improving nursing knowledge and care for neonates with respiratory distress in Jordan. Int Nurs Rev. 2019 Sep;66(3):338-345. doi: 10.1111/inr.12510. Epub 2019 Apr 1.
PubMed 30937901Fink JB. Forced expiratory technique, directed cough, and autogenic drainage. Respir Care. 2007 Sep;52(9):1210-21; discussion 1221-3.
PubMed 17716387Zak M, Gauchez H, Boberski M, Stangret A, Kempinska-Podhorodecka A. Effectiveness of Autogenic Drainage in Improving Pulmonary Function in Patients with Cystic Fibrosis. Int J Environ Res Public Health. 2023 Feb 21;20(5):3822. doi: 10.3390/ijerph20053822.
PubMed 36900829
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects Of Autogenic Drainage and Segmental Breathing Techniques in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06480422
- Acronym / sponsor ID
- REC/RCR&AHS/23/0381
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Autogenic Drainage,, Segmental breathing technique, Chronic Obstructive Pulmonary Disease.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 28 Jun 2024 (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.
Chronic obstructive pulmonary disease is one of the most common life threatening disease affecting population. It is a preventable and treatable lung disease. People with COPD must work harder to breathe, which can lead to shortness of breath and/or feeling tired. Autogenic drainage (AD) works by adapting your breathing and maximizing airflow within the airways to improve ventilation and clear sputum. Segmental breathing, also referred to as localized expansion breathing, is the exercise used to improve ventilation and oxygenation. This research of randomized controlled trial will check the combined effects of segmental breathing technique and autogenic drainage technique in chronic obstructive pulmonary disease by taking sample of 40 patients through non probability convenient sampling and randomly allocating them into two groups A and B out of which A will receive both autogenic drainage and segmental breathing technique, B will receive autogenic drainage only for upto the duration of 3 days per week(20-45 min) for upto 4 weeks.Pre and post training outcomes will be measured through pulse oximeter,spirometer and BCSS.The data will be analyzed through SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| segmental breathing technique + Autogenic drainage | Experimental | Other: Segmental breathing technique, Other: autogenic drainageFor Segmental Breathing instruction, the therapist's hand is placed on the chest area to be expanded. The patient is encouraged to deeply breath and to preferentially "Send Air"to that area of chest where tactile stimulation is being applied by the therapist. On full expiration moderate compression is applied. To begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow patient's nose and huff, cough to clear your upper airways to mucus. This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways (Evacuation) Take in a deep breath. Hold the breath for three seconds. With some gentle force exhale all the air out of your lungs. Repeat three times. Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. |
| Autogenic drainage | Active comparator | Other: autogenic drainageTo begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow ptient's nose and huff, cough to clear your upper airways to mucus.This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath.Hold the breath for three seconds.With some gentle force exhale all the air out of your lungs. Repeat three times.Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 40 - 60 years.
- Diagnosed moderate COPD patients according to GOLD criteria.
- FEV / FVC ratio < 70 years
- Stable patients can understand written and oral english,urdu trial information.
Key exclusion criteria (5 listed)
- Pregnancy, due to the Pressure on pelvic and Abdomen muscles.
- Malignant disease
- Severe (RA)
- Diagnosis of Asthma and major diseases, functionally limiting diseases, life expectancy < 3 months.
- Neurological disorders
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 |
|---|---|---|
| Segmental breathing techniqueAlso: Autogenic drainageTo begin an autogenic drainage sit in a relaxed seated position with neck extended slightly. Blow patient's nose and huff, cough to clear your upper airways to mucus. This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath. Hold the breath for three seconds. With some gentle force exhale all the air out of your lungs. Repeat three times. Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. Repeat the cycle untill you have cleared your lungs as much as possible, 20 and 45 minutes. | Other | segmental breathing technique + Autogenic drainage |
| autogenic drainageTo begin an autogenic drainage sit in a relaxed seated position with neck extended slightly.Blow ptient's nose and huff, cough to clear your upper airways to mucus.This technique has three phases. Moving mucus from small airways (Unsticking), Moving mucus from small airways to medium sized airways(Collecting), Moving mucus from medium sized airways to large airways(Evacuation) Take in a deep breath.Hold the breath for three seconds.With some gentle force exhale all the air out of your lungs. Repeat three times.Do not cough untill after the third breath. Repeat sessions 3 times in a week for 4 almost weeks. Repeat the cycle untill you have cleared your lungs as much as possible, which should take between 20 and 45 minutes. | Other | Autogenic drainage, segmental breathing technique + Autogenic drainage |
Primary outcome
SPIROMETER
Time frame: baseline and fourth week
The most used pulmonary function test is spirometry. It assesses the capacity of the lungs to breathe in and out, especially the volume and/or velocity of air that can be expelled. When evaluating breathing patterns to detect diseases including asthma, pulmonary fibrosis, cystic fibrosis, and COPD, spirometry is useful. An FEV1/FVC ratio larger than 0.70 with both FEV1 and FVC over 80% of the expected value are considered normal spirometry data. TLC exceeding 80% of the predicted value is typical in the event that lung volumes are measured. Diffusion capacity that is more than 75% of the expected value is likewise regarded as typical
PULSE OXIMETER
Time frame: baseline and fourth week
Pulse oximetry operates by shining a light through the skin at two different wavelengths_660 nm(red) and 940nm(infrared)_ and measuring the difference in light absorbance at the two wavelengths to estimate an arterial oxygen saturation
BREATHLESSNESS COUGH SPUTUM SCALE(BCSS)
Time frame: baseline and fourth week
The breathlessness cough sputum scale tool is an effective means for measuring the impact of Pulmonary rehabilitation on improving patient tolerance and self reported symptoms as the result of COPD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 30937901Ali RA, Obeisat SM, Tarawneh LH. Improving nursing knowledge and care for neonates with respiratory distress in Jordan. Int Nurs Rev. 2019 Sep;66(3):338-345. doi: 10.1111/inr.12510. Epub 2019 Apr 1.
- Background: PubMed 17716387Fink JB. Forced expiratory technique, directed cough, and autogenic drainage. Respir Care. 2007 Sep;52(9):1210-21; discussion 1221-3.
- Background: PubMed 36900829Zak M, Gauchez H, Boberski M, Stangret A, Kempinska-Podhorodecka A. Effectiveness of Autogenic Drainage in Improving Pulmonary Function in Patients with Cystic Fibrosis. Int J Environ Res Public Health. 2023 Feb 21;20(5):3822. doi: 10.3390/ijerph20053822.
- 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 Segmental 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 5 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPIROMETER (time frame: baseline and fourth week). The study lists 3 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 NCT06480422, 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 28 Jun 2024.