Chronic Obstructive Pulmonary DiseaseNCT06480435
Effects of Chest Physiotherapy and Lungs Squeezing Technique in Patients With Chronic Obstructive Pulmonary Disease.
A study testing Chest physical Therapy and Lungs squeezing technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic pulmonary obstructive disease refers to a group of lungs problems that includes blockage of airway and difficulty in breathing. It includes mostly emphysema, asthma and chronic bronchitis. 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?
- Chest physical Therapy and Lungs squeezing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 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
- Age 40_60 yrs. old male
- COPD diagnosed with GOLD guidelines stage 2 moderate to severe(14)
- FEV1/ FVC ratio below 70%
- No use of beta 2 receptor agonist or anticholinergic drugs at least 6 hours before attending the study
Who cannot join
- unstable cardiovascular diseases
- SpO2 at rest below 88%
- Active pulmonary Tuberculosis
- Neurological disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Tehsil Head Quarter Hospital
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: Comparative Effects of Chest Physiotherapy and Lungs Squeezing Technique in Patients With Chronic Obstructive Pulmonary Disease.
Chronic pulmonary obstructive disease refers to a group of lungs problems that includes blockage of airway and difficulty in breathing. It includes mostly emphysema, asthma and chronic bronchitis. Chronic pulmonary obstructive disease is the third main cause of death in the whole world .The diagnosis of chronic obstructive pulmonary disease can be made by spirometer and the ratio of forced expiratory volume in 1 second over forced vital capacity (FEV1/FVC) should be less than 70%. It shows severity of airway obstruction .First technique is Chest physiotherapy, in which slow and gentle cupped hand slaps are given on effected lobe of lungs while second technique is lungs squeezing technique, in which 3-4 chest compressions are applied on the chest wall.
The study design of this study will be randomized clinical trial. In this study non probability convenience sampling technique will be used to collect the data. Data management and analysis will be done by using SPSS 25. This randomized clinical trial will include 48 patients with chronic obstructive pulmonary disease. Their ages will be ranged from 40 to 60 years old male with the chronic obstructive pulmonary disease diagnosed with GOLD guidelines stage II moderate to severe .The participants will be randomly allocated into two equal groups, the Group I will receive Chest physiotherapy, while the Group II will receive lungs squeezing technique for 20 minutes duration per session, three sessions per week, for a period of 4 weeks. The status of airway clearance, oxygen saturation and lungs volumes will be measured pre and post intervention in each training session.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Chest physical Therapy, Lungs squeezing technique
- Keywords
- percussion, lungs squeezing technique, spirometry, 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.
Chest physical TherapyOther
Chest Percussion is a conventional method to clear airway and mobilize the thick mucus from the chest wall. Percussion can be applied by both manually and mechanically, but the mechanical percussion is more useful
Lungs squeezing techniqueOther
It improves the oxygen saturation and lung volumes better than percussion.
This technique has two phases:
- Squeezing phase
- Release phase
| Study group | Role | What they receive |
|---|---|---|
| Chest Physical Therapy | Experimental | Chest Percussion is a conventional method to clear airway and mobilize the thick mucus from the chest wall. Percussion can be applied by both manually and mechanically, but the mechanical percussion is more useful. Percussion should be given in comfortable and gravity assisted position. Therapist Position the hands in cupped shape and the patient in the supine position. Percussions are performed rhythmically striking patient's chest, the sound produced should be hollow. Percussion duration should be 5 minutes on each lobe. The rate of percussion must be 100-480/ minutes. Percussion will be applied for 20 minutes per session, 3 sessions per week for the periods of 4 weeks Receives: Other: Chest physical Therapy |
| Lungs squeezing technique | Active comparator | The hand position will be so that hands should be placed on the posterolateral side of the hemi thorax while the second hand will be at anterior chest extending from the lower ribs to above clavicle. In squeezing phase, in full expiration position, 3-4 chest wall compressions are applied to increase the expiratory flow rate to remove air trapped in lungs and mobilize secretions. This phase lasts only for 4-6 seconds. Chest wall compressions should be gentle and in comfortable position In release phase of lung squeezing technique at the end of expiration the compressed thoracic segment is quickly released. It increases the Trans pulmonary pressure and it opens the obstructed airways by plugging the mucus from small airways. creates the negative traction force on small airways which mobilize the thick and sticky mucus. The duration of each session will be of 20 minutes, 3 sessions per week for the periods of 4 weeks. Receives: Other: Lungs squeezing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter
An invasive technique for keeping an eye on someone's blood oxygen saturation is pulse oximetry. The accuracy of peripheral oxygen saturation measurements is usually 2% of the arterial oxygen saturation level obtained from arterial blood gas analysis, which is a more precise measurement. It may decrease and remain low owing to specific cardiovascular problems, or it may peak and climb after a run or other physical activity. Nonetheless, conventional research indicates that the usual range for pulse rate on an oximeter in healthy persons is between 60 and 100 beats per minute
Measured: baseline and fourth week
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
Breathlessness, Cough and Sputum Scale
A three-item questionnaire used to evaluate the patient's cough, sputum, and dyspnea forms the basis of the BCSS. Using a Likert scale, with 0 denoting improved symptoms and a 4 denoting deteriorating symptoms, individuals can register their symptoms on the BCSS. Patients are asked to assess the severity of each of the three symptoms on a 5-point scale as part of the BCSS, a patient-reported outcome measure. Higher scores denote more severe symptoms. A total score is obtained by adding the item scores
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 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
- 48 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
- NCT06480435
- Sponsor's protocol ID
- REC/RCR&AHS/23/0384
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fazleen A, Wilkinson T. Early COPD: current evidence for diagnosis and management. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620942128. doi: 10.1177/1753466620942128.
PubMed 32664818Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026.
PubMed 30286833Lee KY, Wu SM, Kou HY, Chen KY, Chuang HC, Feng PH, Chung KF, Ito K, Chen TT, Sun WL, Liu WT, Tseng CH, Ho SC. Association of air pollution exposure with exercise-induced oxygen desaturation in COPD. Respir Res. 2022 Mar 31;23(1):77. doi: 10.1186/s12931-022-02000-1.
PubMed 35361214
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
- Comparative Effects of Chest Physiotherapy and Lungs Squeezing Technique in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT06480435
- Acronym / sponsor ID
- REC/RCR&AHS/23/0384
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- percussion, lungs squeezing technique, spirometry, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 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 Jul 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 pulmonary obstructive disease refers to a group of lungs problems that includes blockage of airway and difficulty in breathing. It includes mostly emphysema, asthma and chronic bronchitis. Chronic pulmonary obstructive disease is the third main cause of death in the whole world .The diagnosis of chronic obstructive pulmonary disease can be made by spirometer and the ratio of forced expiratory volume in 1 second over forced vital capacity (FEV1/FVC) should be less than 70%. It shows severity of airway obstruction .First technique is Chest physiotherapy, in which slow and gentle cupped hand slaps are given on effected lobe of lungs while second technique is lungs squeezing technique, in which 3-4 chest compressions are applied on the chest wall.
The study design of this study will be randomized clinical trial. In this study non probability convenience sampling technique will be used to collect the data. Data management and analysis will be done by using SPSS 25. This randomized clinical trial will include 48 patients with chronic obstructive pulmonary disease. Their ages will be ranged from 40 to 60 years old male with the chronic obstructive pulmonary disease diagnosed with GOLD guidelines stage II moderate to severe .The participants will be randomly allocated into two equal groups, the Group I will receive Chest physiotherapy, while the Group II will receive lungs squeezing technique for 20 minutes duration per session, three sessions per week, for a period of 4 weeks. The status of airway clearance, oxygen saturation and lungs volumes will be measured pre and post intervention in each training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Physical Therapy | Experimental | Other: Chest physical TherapyChest Percussion is a conventional method to clear airway and mobilize the thick mucus from the chest wall. Percussion can be applied by both manually and mechanically, but the mechanical percussion is more useful. Percussion should be given in comfortable and gravity assisted position. Therapist Position the hands in cupped shape and the patient in the supine position. Percussions are performed rhythmically striking patient's chest, the sound produced should be hollow. Percussion duration should be 5 minutes on each lobe. The rate of percussion must be 100-480/ minutes. Percussion will be applied for 20 minutes per session, 3 sessions per week for the periods of 4 weeks |
| Lungs squeezing technique | Active comparator | Other: Lungs squeezing techniqueThe hand position will be so that hands should be placed on the posterolateral side of the hemi thorax while the second hand will be at anterior chest extending from the lower ribs to above clavicle. In squeezing phase, in full expiration position, 3-4 chest wall compressions are applied to increase the expiratory flow rate to remove air trapped in lungs and mobilize secretions. This phase lasts only for 4-6 seconds. Chest wall compressions should be gentle and in comfortable position In release phase of lung squeezing technique at the end of expiration the compressed thoracic segment is quickly released. It increases the Trans pulmonary pressure and it opens the obstructed airways by plugging the mucus from small airways. creates the negative traction force on small airways which mobilize the thick and sticky mucus. The duration of each session will be of 20 minutes, 3 sessions per week for the periods of 4 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 40_60 yrs. old male
- COPD diagnosed with GOLD guidelines stage 2 moderate to severe(14)
- FEV1/ FVC ratio below 70%
- No use of beta 2 receptor agonist or anticholinergic drugs at least 6 hours before attending the study
Key exclusion criteria (4 listed)
- unstable cardiovascular diseases
- SpO2 at rest below 88%
- Active pulmonary Tuberculosis
- 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 |
|---|---|---|
| Chest physical TherapyChest Percussion is a conventional method to clear airway and mobilize the thick mucus from the chest wall. Percussion can be applied by both manually and mechanically, but the mechanical percussion is more useful | Other | Chest Physical Therapy |
| Lungs squeezing techniqueIt improves the oxygen saturation and lung volumes better than percussion. This technique has two phases: 1. Squeezing phase 2. Release phase | Other | Lungs squeezing technique |
Primary outcome
Pulse Oximeter
Time frame: baseline and fourth week
An invasive technique for keeping an eye on someone's blood oxygen saturation is pulse oximetry. The accuracy of peripheral oxygen saturation measurements is usually 2% of the arterial oxygen saturation level obtained from arterial blood gas analysis, which is a more precise measurement. It may decrease and remain low owing to specific cardiovascular problems, or it may peak and climb after a run or other physical activity. Nonetheless, conventional research indicates that the usual range for pulse rate on an oximeter in healthy persons is between 60 and 100 beats per minute
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
Breathlessness, Cough and Sputum Scale
Time frame: baseline and fourth week
A three-item questionnaire used to evaluate the patient's cough, sputum, and dyspnea forms the basis of the BCSS. Using a Likert scale, with 0 denoting improved symptoms and a 4 denoting deteriorating symptoms, individuals can register their symptoms on the BCSS. Patients are asked to assess the severity of each of the three symptoms on a 5-point scale as part of the BCSS, a patient-reported outcome measure. Higher scores denote more severe symptoms. A total score is obtained by adding the item scores
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 32664818Fazleen A, Wilkinson T. Early COPD: current evidence for diagnosis and management. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620942128. doi: 10.1177/1753466620942128.
- Background: PubMed 30286833Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026.
- Background: PubMed 35361214Lee KY, Wu SM, Kou HY, Chen KY, Chuang HC, Feng PH, Chung KF, Ito K, Chen TT, Sun WL, Liu WT, Tseng CH, Ho SC. Association of air pollution exposure with exercise-induced oxygen desaturation in COPD. Respir Res. 2022 Mar 31;23(1):77. doi: 10.1186/s12931-022-02000-1.
- 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 Chest physical Therapy and Lungs squeezing technique 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 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 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?
Pulse Oximeter (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 NCT06480435, 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.