Pulmonary DiseaseNCT06518759
Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery
A study testing traditional chest techniques, Glossopharyngeal breathing exercise and Diaphragmatic breathing exercise in people with Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- traditional chest techniques, Glossopharyngeal breathing exercise and Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2024to 31 Mar 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2
- The patient will receive treatment after 24 hours after decortication
- The study will be in the intensive care unit (ICU).
- The patients have unilateral lung decortication
- Their vital capacity is 70% or less.
Who cannot join
- Cancerous patient.
- Inability to comprehend and follow instructions as in dementia
- paralytic involvement of thorax muscle
- Abdominal diseases that affect diaphragmatic function
- Diaphragmatic paralysis
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery
Read the detailed description
Lung decortication is a well-known procedure for the treatment of empyema. Persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma.
There is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. So this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises.
- Conditions
- Pulmonary Disease
- Being tested
- traditional chest techniques, Glossopharyngeal breathing exercise, Diaphragmatic breathing exercise
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional chest techniquesOther
patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks
Glossopharyngeal breathing exerciseOther
patients will receive Glossopharyngeal breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.
Diaphragmatic breathing exerciseOther
patients will receive diaphragmatic breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traditional chest techniques | Active comparator | the patients will receive traditional chest techniques only Receives: Other: traditional chest techniques |
| Traditional chest techniques +Glossopharyngeal breathing exercise | Experimental | the patients will receive traditional chest techniques and glossopharyngeal breathing exercise Receives: Other: traditional chest techniques; Other: Glossopharyngeal breathing exercise |
| Traditional chest techniques +diaphragmatic breathing exercise | Experimental | the patients will receive traditional chest techniques and diaphragmatic breathing exercise Receives: Other: traditional chest techniques; Other: Diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
The spirometer device (Meditech, made in China) will be used to measure tidal volume for all participants in all groups before and after the treatment program. It is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures about 400 ml in a healthy female.
Measured: within 2 weeks
Inspiratory reserve volume (IRV)
The spirometer device (Meditech, made in China) will be used to measure inspiratory reserve volume (IRV) for all participants in all groups before and after the treatment program.
- IRV: It is the amount of air that can be forcibly inhaled after normal tidal volume. The normal adult value is 1900-3300 ml.
Measured: within 2 weeks
Expiratory reserve volume (ERV)
The spirometer device (Meditech, made in China) will be used to measure expiratory reserve volume (ERV) for all participants in all groups before and after the treatment program.
ERV: It is the amount of extra air above normal breath-exhaled during forceful breath out, its average is about 800ml in females.
Measured: within 2 weeks
Measurement of the potential of hydrogen (PH)
Blood gas analyzer will be used to measure the potential of hydrogen (PH) for all participants in all groups before and after the treatment program.
The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.
The normative value of pH is7.35-7.45
Measured: within 2 weeks
Measurement of the partial arterial pressure of carbon dioxide(PaCO2)
Blood gas analyzer will be used to measure the partial arterial pressure of carbon dioxide(PaCO2) for all participants in all groups before and after the treatment program.
The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.
the normative value of PaCO2 is 4.7-6 KPa.
Measured: within 2 weeks
Measurement of the partial arterial pressure of oxygen (PaO2)
Blood gas analyzer will be used to measure the partial arterial pressure of oxygen (PaO2)for all participants in all groups before and after the treatment program.
The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.
the normative value of Pao2 is 1.7-13.3 KPa.
Measured: within 2 weeks
Measurement of the Bicarbonate (HCO3)
Blood gas analyzer will be used to measure the Bicarbonate (HCO3) for all participants in all groups before and after the treatment program.
The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.
The normative value of HCO3 is 22-26 mmol/L.
Measured: within 2 weeks
Measurement of oxygen saturation (SO2)
Blood gas analyzer will be used to measure oxygen saturation (SO2) for all participants in all groups before and after the treatment program.
The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device.
The normative value of SO2 is 95-100%..
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start30 Jul 2024
- Primary completion15 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Gamal El-Din Mostafa, Cairo University
- Investigators
- Nesreen El-Nahas, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518759
- Sponsor's protocol ID
- P.T.REC/012/003896
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery
- ClinicalTrials.gov ID
- NCT06518759
- Acronym / sponsor ID
- P.T.REC/012/003896
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 24 Jul 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.
This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery
Detailed description
Lung decortication is a well-known procedure for the treatment of empyema. Persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma.
There is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. So this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional chest techniques | Active comparator | Other: traditional chest techniquesthe patients will receive traditional chest techniques only |
| Traditional chest techniques +Glossopharyngeal breathing exercise | Experimental | Other: traditional chest techniques, Other: Glossopharyngeal breathing exercisethe patients will receive traditional chest techniques and glossopharyngeal breathing exercise |
| Traditional chest techniques +diaphragmatic breathing exercise | Experimental | Other: traditional chest techniques, Other: Diaphragmatic breathing exercisethe patients will receive traditional chest techniques and diaphragmatic breathing exercise |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2
- The patient will receive treatment after 24 hours after decortication
- The study will be in the intensive care unit (ICU).
- The patients have unilateral lung decortication
- Their vital capacity is 70% or less.
Key exclusion criteria (5 listed)
- Cancerous patient.
- Inability to comprehend and follow instructions as in dementia
- paralytic involvement of thorax muscle
- Abdominal diseases that affect diaphragmatic function
- Diaphragmatic paralysis
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 |
|---|---|---|
| traditional chest techniquespatients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks | Other | Traditional chest techniques, Traditional chest techniques +Glossopharyngeal breathing exercise, Traditional chest techniques +diaphragmatic breathing exercise |
| Glossopharyngeal breathing exercisepatients will receive Glossopharyngeal breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks. | Other | Traditional chest techniques +Glossopharyngeal breathing exercise |
| Diaphragmatic breathing exercisepatients will receive diaphragmatic breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks. | Other | Traditional chest techniques +diaphragmatic breathing exercise |
Primary outcome
Tidal volume
Time frame: within 2 weeks
The spirometer device (Meditech, made in China) will be used to measure tidal volume for all participants in all groups before and after the treatment program. It is the amount of air that moves in or out of the lungs with each respiratory cycle. It measures about 400 ml in a healthy female.
Inspiratory reserve volume (IRV)
Time frame: within 2 weeks
The spirometer device (Meditech, made in China) will be used to measure inspiratory reserve volume (IRV) for all participants in all groups before and after the treatment program. - IRV: It is the amount of air that can be forcibly inhaled after normal tidal volume. The normal adult value is 1900-3300 ml.
Expiratory reserve volume (ERV)
Time frame: within 2 weeks
The spirometer device (Meditech, made in China) will be used to measure expiratory reserve volume (ERV) for all participants in all groups before and after the treatment program. ERV: It is the amount of extra air above normal breath-exhaled during forceful breath out, its average is about 800ml in females.
Measurement of the potential of hydrogen (PH)
Time frame: within 2 weeks
Blood gas analyzer will be used to measure the potential of hydrogen (PH) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of pH is7.35-7.45
Measurement of the partial arterial pressure of carbon dioxide(PaCO2)
Time frame: within 2 weeks
Blood gas analyzer will be used to measure the partial arterial pressure of carbon dioxide(PaCO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of PaCO2 is 4.7-6 KPa.
Measurement of the partial arterial pressure of oxygen (PaO2)
Time frame: within 2 weeks
Blood gas analyzer will be used to measure the partial arterial pressure of oxygen (PaO2)for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of Pao2 is 1.7-13.3 KPa.
Measurement of the Bicarbonate (HCO3)
Time frame: within 2 weeks
Blood gas analyzer will be used to measure the Bicarbonate (HCO3) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of HCO3 is 22-26 mmol/L.
Measurement of oxygen saturation (SO2)
Time frame: within 2 weeks
Blood gas analyzer will be used to measure oxygen saturation (SO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of SO2 is 95-100%..
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 17 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Nesreen El-Nahas, professor study chair
Cairo 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 traditional chest techniques, Glossopharyngeal breathing exercise and Diaphragmatic breathing exercise in people with Pulmonary Disease, run by Cairo University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 17 Apr 2025. 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 Egypt. 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?
Tidal volume (time frame: within 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.