Chronic Obstructive Pulmonary DiseaseNCT05922293
Combined Effects of Blow Bottle Technique and Percussion Technique in COPD Patients
A study testing blow bottle and percussion in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30… Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- blow bottle and percussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild-to-Moderate COPD (according to GOLD criteria)
- Both gender (male and female)
- Aged between 35 and 80 years
Who cannot join
- Clinically unstable
- cardiovascular impairment,
- musculoskeletal dysfunction
- neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Blow Bottle Technique and Percussion Technique in Patients With Chronic Obstructive Pulmonary Disease
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life (QoL) is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, a lung function exercise bottle is designed, which is capable of adjusting the pressure according to the patient's needs. The exercise bottle is composed of three components, including bottle body, threaded round cap and air blow pipe. Furthermore, manual chest percussion is the rhythmic clapping on the chest wall with relaxed wrist and cupped hand, creating an energy wave that is transmitted to the airways. It is applied with a frequency of approximately 3-6 Hz. To reduce any adverse consequences, the technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises.
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- blow bottle, percussion
- Keywords
- Airway Obstruction, COPD, Dyspnea, Expiratory flow rate, Percussion.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Airway Obstruction, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blow bottleOther
When you blow through a tube into water in a bottle, the pressure in the airways increases. This opens up the passageways between bronchioles, allowing air to flow behind the mucus and push it into the larger airways. This way, it will be easy to remove the mucus by coughing or huffing.
percussionOther
Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises.
- Do this for a total of 10 breaths,
- Perform two huffs, and
- Cough.
- Close their mouth around the tube and exhale slightly forcefully for 3 seconds to produce bubbles. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized
| Study group | Role | What they receive |
|---|---|---|
| Blow Bottle technique | Active comparator | Blowing with a straw into a water bottle is a good exercise to improve breathing capacity. The user, who has poor pulmonary function, always has his "blow bottle" handy Receives: Other: blow bottle |
| percussion | Experimental | Percussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises Receives: Other: blow bottle; Other: percussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea (Modified Medical Research council)
The mMRC grade is a five-point scale based on the degree of dyspnea a patient. The use of this scale to evaluate symptoms is encouraged by current standards
Measured: fourth week
Breathlessness, cough and sputum scale (BCSS)
In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness
Measured: fourth week
Expiratory flow rate (peak flow meter)
A peak flow rate should be used to capture the highest flow rates. The patient must record the highest reading out of a possible three. The best at the moment is this. A typical chart has dates with AM and PM times, a left margin, and a scale that ranges from 0 litres per minute at the bottom to 600 litres per minute at the top
Measured: fourth week
O2 n pulse rate by Oximeter
A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen
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 (4)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
- 30 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
- NCT05922293
- Sponsor's protocol ID
- REC/RCR&AHS/23/0320
- 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
Jones PW, Watz H, Wouters EF, Cazzola M. COPD: the patient perspective. Int J Chron Obstruct Pulmon Dis. 2016 Feb 19;11 Spec Iss(Spec Iss):13-20. doi: 10.2147/COPD.S85977. eCollection 2016.
PubMed 26937186Raherison C, Girodet PO. Epidemiology of COPD. Eur Respir Rev. 2009 Dec;18(114):213-21. doi: 10.1183/09059180.00003609.
PubMed 20956146Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.
PubMed 30827317Celli BR. Update on the management of COPD. Chest. 2008 Jun;133(6):1451-1462. doi: 10.1378/chest.07-2061.
PubMed 18574288
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 Blow Bottle Technique and Percussion Technique in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05922293
- Acronym / sponsor ID
- REC/RCR&AHS/23/0320
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Airway Obstruction, COPD, Dyspnea, Expiratory flow rate, Percussion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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.
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by nonreversible airway obstruction. A diagnosis of COPD is determined by clinical assessment of airflow limitation and symptoms such as cough and wheeze; however, the detrimental effect of COPD symptoms on a patient's quality of life (QoL) is often underestimated. Rehabilitation exercise can lessen the possibility of the progressive exacerbation of the patient's condition, exerting an active role in improving their lung function and the quality of the patients' life. Therefore, a lung function exercise bottle is designed, which is capable of adjusting the pressure according to the patient's needs. The exercise bottle is composed of three components, including bottle body, threaded round cap and air blow pipe. Furthermore, manual chest percussion is the rhythmic clapping on the chest wall with relaxed wrist and cupped hand, creating an energy wave that is transmitted to the airways. It is applied with a frequency of approximately 3-6 Hz. To reduce any adverse consequences, the technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises.
It will be a randomized control trial. Participants will be recruited according to inclusion criteria and will be allocated into 2 groups using convenience sampling technique. Group 1 will be treated with percussion technique for 30 min and group 2 with blow bottle technique combined with percussion technique for 30 min at DHQ Teaching Hospital Gujranwala. Intervention will be carried out for total 4 weeks of duration with 3 sessions per week. Outcome measures such as dyspnea, breathlessness, sputum and cough, O2 and pulse rate, expiratory flow rate will be measured by tools as mMRC, BCSS, peak flow meter respectively. Assessment will be done before and after intervention and result will be analyzed using statistical package for social sciences SPSS 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blow Bottle technique | Active comparator | Other: blow bottleBlowing with a straw into a water bottle is a good exercise to improve breathing capacity. The user, who has poor pulmonary function, always has his "blow bottle" handy |
| percussion | Experimental | Other: blow bottle, Other: percussionPercussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild-to-Moderate COPD (according to GOLD criteria)
- Both gender (male and female)
- Aged between 35 and 80 years
Key exclusion criteria (4 listed)
- Clinically unstable
- cardiovascular impairment,
- musculoskeletal dysfunction
- neurological disease
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 |
|---|---|---|
| blow bottleWhen you blow through a tube into water in a bottle, the pressure in the airways increases. This opens up the passageways between bronchioles, allowing air to flow behind the mucus and push it into the larger airways. This way, it will be easy to remove the mucus by coughing or huffing. | Other | Blow Bottle technique, percussion |
| percussionPercussion technique should be performed for about 30 seconds and simultaneously with no more than three or four lower thoracic expansion exercises. * Do this for a total of 10 breaths, * Perform two huffs, and * Cough. * Close their mouth around the tube and exhale slightly forcefully for 3 seconds to produce bubbles. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized | Other | percussion |
Primary outcome
Dyspnea (Modified Medical Research council)
Time frame: fourth week
The mMRC grade is a five-point scale based on the degree of dyspnea a patient. The use of this scale to evaluate symptoms is encouraged by current standards
Breathlessness, cough and sputum scale (BCSS)
Time frame: fourth week
In order to give a rapid and simple means of assessing the severity of respiratory symptoms frequent in COPD patients, the Breathlessness, Cough, and Sputum Scale (BCSS) was created. The BCSS is based on a three-item questionnaire that evaluates the patient's sputum production, coughing, and breathlessness
Expiratory flow rate (peak flow meter)
Time frame: fourth week
A peak flow rate should be used to capture the highest flow rates. The patient must record the highest reading out of a possible three. The best at the moment is this. A typical chart has dates with AM and PM times, a left margin, and a scale that ranges from 0 litres per minute at the bottom to 600 litres per minute at the top
O2 n pulse rate by Oximeter
Time frame: fourth week
A pulse oximeter measures the amount of oxygen that is carried by your blood. Typically, a little clip is attached to the tip of your finger. (On sometimes, the toe or earlobe are used.) A light beam is projected through the skin using the gadget. By measuring the proportion of your blood that is carrying oxygen, it calculates your oxygen level. Your oxygen saturation, often known as SpO2, is displayed on the screen
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 26937186Jones PW, Watz H, Wouters EF, Cazzola M. COPD: the patient perspective. Int J Chron Obstruct Pulmon Dis. 2016 Feb 19;11 Spec Iss(Spec Iss):13-20. doi: 10.2147/COPD.S85977. eCollection 2016.
- Background: PubMed 20956146Raherison C, Girodet PO. Epidemiology of COPD. Eur Respir Rev. 2009 Dec;18(114):213-21. doi: 10.1183/09059180.00003609.
- Background: PubMed 30827317Liu H, Zhang X, Zhang Y. [Design and application of a pulmonary function exercise bottle]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2019 Feb;31(2):236-237. doi: 10.3760/cma.j.issn.2095-4352.2019.02.023. Chinese.
- Background: PubMed 18574288Celli BR. Update on the management of COPD. Chest. 2008 Jun;133(6):1451-1462. doi: 10.1378/chest.07-2061.
- 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 blow bottle and percussion 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 3 inclusion and 4 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?
Dyspnea (Modified Medical Research council) (time frame: fourth week). The study lists 4 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 NCT05922293, which also lists 4 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.