Chronic Obstructive Pulmonary DiseaseNCT05922241
Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique in COPD Patients
A study testing Costophrenic assisted cough and Anterior chest compression in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. 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?
- Costophrenic assisted cough and Anterior chest compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 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
- Stable Patients
- Mild to Moderate Patients of COPD according to gold criteria
- Decreased O2 Saturation Levels
- Immobilized Mucus
Who cannot join
- Tachycardia
- Tachypnea
- Non Covid
- Cardiovascular Pathology
- Myopathy
- Neurogenic Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique on Sputum Diary, Oxygen Saturation, Expiratory Flow Rate, and Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. In Costophrenic assist, the therapist gives a quick stretch to the diaphragm and intercostals with repetitions. The patientt holds air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist. In Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion. A total 34 patients will be taken. 2 groups will be created to apply intervention. After signing consent form, 17 patients in group A will be given costophrenic assist technique and 17 patients in group B will be given anterior chest compression technique. Baseline treatment given to both groups will include percussion and tapping. The data collected will then be analyzed using IBM SPSS version 25
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Costophrenic assisted cough, Anterior chest compression
- Keywords
- Anterior chest compression, Chest Physio, Costophrenic assist, Sputum expectoration, Oxygen Saturation
- 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.
Costophrenic assisted coughOther
Therapist places the hands on the costophrenic angles of the patient's rib cage. During the patient's inspiration, the therapist applies a series of three repeated quick-stretch contractions down and in to encourage maximal inspiration. At the end of expiration, the therapist applies a quick stretch down and in on the patient's lower chest to facilitate a stronger diaphragmatic and intercostal muscle contraction. While instructing the patient to cough, the therapist applies strong pressure through the hands in toward the central tendon of the patient's diaphragm
Anterior chest compressionOther
The therapist puts one arm across the patient's pectoral region to stabilize or compress the upper chest while the other arm is placed either parallel on the lower chest or abdomen below the xiphoid process
| Study group | Role | What they receive |
|---|---|---|
| Costophrenic assisted cough | Experimental | While doing Costophrenic assist: at the end of expiration, the therapist gives a quick stretch to the diaphragm and intercostals to facilitate more complete inhalation by compressing the chest at the costophrenic angle toward the central tendon of the diaphragm. This is done several times to fill the lungs. The patient is then instructed to hold the air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist by applying a strong pressure up and in toward the central tendon Receives: Other: Costophrenic assisted cough |
| Anterior chest compression | Experimental | Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it on the lower abdomen. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion Receives: Other: Anterior chest compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: fourth week
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
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: fourth week
Pulse 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
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
- 34 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
- NCT05922241
- Sponsor's protocol ID
- REC/RCR&AHS/23/0317
- 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
Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
PubMed 18046898Lopez-Campos JL, Calero C, Quintana-Gallego E. Symptom variability in COPD: a narrative review. Int J Chron Obstruct Pulmon Dis. 2013;8:231-8. doi: 10.2147/COPD.S42866. Epub 2013 May 7.
PubMed 23687444Arık S, Çevik K. Effect of Postural Drainage and Deep Breathing-Cough Exercises on Oxygen Saturation, Triflo Volume and Pulmonary Function Test in Patients with COPD. Journal of Clinical & Experimental Investigations. 2021;12(4).
Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014.
PubMed 24493923
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
- Comparative Effects of Costophrenic Assisted Cough and Anterior Chest Compression Technique on Sputum Diary, Oxygen Saturation, Expiratory Flow Rate, and Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05922241
- Acronym / sponsor ID
- REC/RCR&AHS/23/0317
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Anterior chest compression, Chest Physio, Costophrenic assist, Sputum expectoration, Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 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.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing. In Costophrenic assist, the therapist gives a quick stretch to the diaphragm and intercostals with repetitions. The patientt holds air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist. In Anterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion. A total 34 patients will be taken. 2 groups will be created to apply intervention. After signing consent form, 17 patients in group A will be given costophrenic assist technique and 17 patients in group B will be given anterior chest compression technique. Baseline treatment given to both groups will include percussion and tapping. The data collected will then be analyzed using IBM 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 |
|---|---|---|
| Costophrenic assisted cough | Experimental | Other: Costophrenic assisted coughWhile doing Costophrenic assist: at the end of expiration, the therapist gives a quick stretch to the diaphragm and intercostals to facilitate more complete inhalation by compressing the chest at the costophrenic angle toward the central tendon of the diaphragm. This is done several times to fill the lungs. The patient is then instructed to hold the air in the lungs. As the patient gets ready to cough, the therapist performs a diaphragmatic assist by applying a strong pressure up and in toward the central tendon |
| Anterior chest compression | Experimental | Other: Anterior chest compressionAnterior chest compression: the therapist places one arm across the patient's pectorals and the other parallel to it on the lower abdomen. After the patient takes a maximal breath, the therapist pushes down to help the patient cough. The greatest force is applied through the lower chest during expulsion |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Stable Patients
- Mild to Moderate Patients of COPD according to gold criteria
- Decreased O2 Saturation Levels
- Immobilized Mucus
Key exclusion criteria (6 listed)
- Tachycardia
- Tachypnea
- Non Covid
- Cardiovascular Pathology
- Myopathy
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 |
|---|---|---|
| Costophrenic assisted coughTherapist places the hands on the costophrenic angles of the patient's rib cage. During the patient's inspiration, the therapist applies a series of three repeated quick-stretch contractions down and in to encourage maximal inspiration. At the end of expiration, the therapist applies a quick stretch down and in on the patient's lower chest to facilitate a stronger diaphragmatic and intercostal muscle contraction. While instructing the patient to cough, the therapist applies strong pressure through the hands in toward the central tendon of the patient's diaphragm | Other | Costophrenic assisted cough |
| Anterior chest compressionThe therapist puts one arm across the patient's pectoral region to stabilize or compress the upper chest while the other arm is placed either parallel on the lower chest or abdomen below the xiphoid process | Other | Anterior chest compression |
Primary outcome
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)
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
Peak Flow Meter
Time frame: 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
Pulse 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
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 18046898Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.
- Background: PubMed 23687444Lopez-Campos JL, Calero C, Quintana-Gallego E. Symptom variability in COPD: a narrative review. Int J Chron Obstruct Pulmon Dis. 2013;8:231-8. doi: 10.2147/COPD.S42866. Epub 2013 May 7.
- BackgroundArık S, Çevik K. Effect of Postural Drainage and Deep Breathing-Cough Exercises on Oxygen Saturation, Triflo Volume and Pulmonary Function Test in Patients with COPD. Journal of Clinical & Experimental Investigations. 2021;12(4).
- Background: PubMed 24493923Ramos FL, Krahnke JS, Kim V. Clinical issues of mucus accumulation in COPD. Int J Chron Obstruct Pulmon Dis. 2014 Jan 24;9:139-50. doi: 10.2147/COPD.S38938. eCollection 2014.
- 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 Costophrenic assisted cough and Anterior chest compression 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 6 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?
Breathlessness, Cough and Sputum Scale (BCSS) (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 NCT05922241, 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.