Chronic Obstructive Pulmonary DiseaseNCT06476769
Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
A study testing blow bottle technique 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 clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. 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?
- blow bottle technique and percussion
- 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 Jul 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
- Diagnosed moderate to severe GOLD (2017) COPD
- 40-60 years old
- Both male and female
- Patients hemodynamically stable
- PFT showing irreversible airflow limitation.
Who cannot join
- Type II diabetic mellitus
- Systemic illness
- Thoracic deformation or rib fracture.
- Pulmonale decompensation and signs of an unstable heart condition.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Wazirabad Institute of Cardiology
Multan Khurd, Punjab Province, 54000
Sidra Faisal, MS.CPPT, 03022001847, sidra.faisal@riphah.edu.pk
About this study
It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- blow bottle technique, percussion
- Keywords
- Dyspnea, Postural drainage
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blow bottle techniqueOther
Also called postural drainage
There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.
percussionOther
Also called postural drainage
Group B: There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| blow bottle technique | Experimental | There were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. Receives: Other: blow bottle technique |
| percussion | Active comparator | There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. Receives: Other: percussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness cough sputum scale
Breathlessness, Cough and Sputum scale (BCSS) was developed to effectively measure the severity of respiratory symptoms. The BCSS records symptoms in a 5-point Likert like scale in which zero represents improvement symptoms and scores towards 4 indicating worsening of symptoms. It is commonly used in patients with COPD. BCSS provides a simple and robust quantification of symptoms that is sensitive to the effects of treatment and could therefore be used to assess therapeutic interventions. It has good reliability and validity for use in patients with respiratory disorders.
Measured: 4 weeks
Modified borg RPE scale:
The Modified Borg Dyspnea Scale (MBS) is rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise, one of the most common and frequently used measures to assess the severity of dyspnea.
Measured: 4 weeks
Incentive spirometry
Incentive spirometry is frequently used after thoracic surgery as an adjunct to physiotherapy. Despite its widespread use, it has remained challenging to demonstrate a clinical benefit in terms of either incidence of pulmonary complications or hospital stay.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Jan 2024
- Primary completion10 Jul 2024 (estimated)
- Study completion15 Jul 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 Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476769
- Sponsor's protocol ID
- REC/RCR & AHS/23/0376
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kullowatz A, Kanniess F, Dahme B, Magnussen H, Ritz T. Association of depression and anxiety with health care use and quality of life in asthma patients. Respir Med. 2007 Mar;101(3):638-44. doi: 10.1016/j.rmed.2006.06.002. Epub 2006 Aug 7.
PubMed 16891108Goodwin RD, Eaton WW. Asthma and the risk of panic attacks among adults in the community. Psychol Med. 2003 Jul;33(5):879-85. doi: 10.1017/s0033291703007633.
PubMed 12877402Wright RJ, Rodriguez M, Cohen S. Review of psychosocial stress and asthma: an integrated biopsychosocial approach. Thorax. 1998 Dec;53(12):1066-74. doi: 10.1136/thx.53.12.1066.
PubMed 10195081
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
- ClinicalTrials.gov ID
- NCT06476769
- Acronym / sponsor ID
- REC/RCR & AHS/23/0376
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Dyspnea, Postural drainage
- 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
- 10 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 26 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.
It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.
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 | Experimental | Other: blow bottle techniqueThere were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. |
| percussion | Active comparator | Other: percussionThere were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed moderate to severe GOLD (2017) COPD
- 40-60 years old
- Both male and female
- Patients hemodynamically stable
- PFT showing irreversible airflow limitation.
Key exclusion criteria (4 listed)
- Type II diabetic mellitus
- Systemic illness
- Thoracic deformation or rib fracture.
- Pulmonale decompensation and signs of an unstable heart condition.
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 bottle techniqueAlso: postural drainageThere were 20 patients in group A received blow bottle device and postural drainage for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. | Other | blow bottle technique |
| percussionAlso: postural drainageGroup B: There were 20 patients in group B received postural drainage with percussion for 20- 25 minutes per session twice a day for 4 days per week, for 8 weeks. | Other | percussion |
Primary outcome
Breathlessness cough sputum scale
Time frame: 4 weeks
Breathlessness, Cough and Sputum scale (BCSS) was developed to effectively measure the severity of respiratory symptoms. The BCSS records symptoms in a 5-point Likert like scale in which zero represents improvement symptoms and scores towards 4 indicating worsening of symptoms. It is commonly used in patients with COPD. BCSS provides a simple and robust quantification of symptoms that is sensitive to the effects of treatment and could therefore be used to assess therapeutic interventions. It has good reliability and validity for use in patients with respiratory disorders.
Modified borg RPE scale:
Time frame: 4 weeks
The Modified Borg Dyspnea Scale (MBS) is rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise, one of the most common and frequently used measures to assess the severity of dyspnea.
Incentive spirometry
Time frame: 4 weeks
Incentive spirometry is frequently used after thoracic surgery as an adjunct to physiotherapy. Despite its widespread use, it has remained challenging to demonstrate a clinical benefit in terms of either incidence of pulmonary complications or hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 16891108Kullowatz A, Kanniess F, Dahme B, Magnussen H, Ritz T. Association of depression and anxiety with health care use and quality of life in asthma patients. Respir Med. 2007 Mar;101(3):638-44. doi: 10.1016/j.rmed.2006.06.002. Epub 2006 Aug 7.
- Background: PubMed 12877402Goodwin RD, Eaton WW. Asthma and the risk of panic attacks among adults in the community. Psychol Med. 2003 Jul;33(5):879-85. doi: 10.1017/s0033291703007633.
- Background: PubMed 10195081Wright RJ, Rodriguez M, Cohen S. Review of psychosocial stress and asthma: an integrated biopsychosocial approach. Thorax. 1998 Dec;53(12):1066-74. doi: 10.1136/thx.53.12.1066.
- 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 Faisal, MS.CPPT 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 technique 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 5 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: status not confirmed, as of the sponsor's last update on 26 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 (O3338236752, 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?
Breathlessness cough sputum scale (time frame: 4 weeks). 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 NCT06476769, 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 26 Jun 2024.