Chronic Obstructive Pulmonary DiseaseNCT06459843
Effects Of of Pursed Lip Breathing and Coordinated Breathing in Adult Patients With COPD
A study testing pursed lip breathing techniques and coordinated breathing technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
COPD is the chronic lung condition characterized by the damage and enlargement of the air sacs in the lungs, leading to breathing difficulties. A blockage may develop, which traps air inside your lungs. The patient shows clinical manifestation of cough, wheezing, chest tightness, shortness of breath. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pursed lip breathing techniques and coordinated breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 25 -45 years(5)
- Adult patient diagnosed with (chronic obstructive pulmonary disease) based on clinical and diagnostic criteria.
- Patient willing and able to participate in an pursed lip breathing and coordinated breathing exercise program
- Gender both male and female
Who cannot join
- Those who cognitive impairment that might affect their ability to comprehend and follow instructions
- Any contraindication to the use of pursed lip breathing or coordinated breathing exercise as determined by the health care provider.
- Individual with severe musculoskeletal limitations or other physical condition that may hinder the ability to perform exercise
- Individual who have experienced the recent exacerbation of COPD symptoms within past three month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects Of of Pursed Lip Breathing and Coordinated Breathing During Aerobic Exercise on Aerobic Capacity, Dyspnea and Anxiety Level in Adult Patients With COPD
COPD is the chronic lung condition characterized by the damage and enlargement of the air sacs in the lungs, leading to breathing difficulties. A blockage may develop, which traps air inside your lungs. The patient shows clinical manifestation of cough, wheezing, chest tightness, shortness of breath. This research of randomized clinical trial will check the combined effects of pursed lip breathing and coordinated breathing techniques to improve aerobic capacity and dyspnea in patients with COPD by taking sample of 54 patients through convenience sampling and randomly allocating them to two groups A and B out of which A will receive pursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min, B will receive coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min.Pre and post training outcomes of aerobic capacity and dyspnea will be measured through Six minute walk test and dyspnea Borg scale, and Saint George respiratory questionnaire. The data will be analyzed through SPSS 21.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pursed lip breathing techniques, coordinated breathing technique
- Keywords
- Aerobic capacity, Coordinated breathing technique, Pursed lip breathing technique.
- 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.
pursed lip breathing techniquesOther
Relax your neck and shoulder muscles. For the use of PLB exercise, the intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets. In each set, 10 times will be included. Then, instruct the patient to take deep breath through nose for two counts, and keep mouth closed. Inhale for 2 seconds. Now, ask the patient to purse the lips as if the patient was going to gently flicker the flame of candle. Now the patient will breathe out gently while counting for 4 seconds.
coordinated breathing techniqueOther
Put one hand on your abdomen. Make your abdomen push out while you breathe in through your nose. Suck in your abdominal muscles. Breathe out using the pursed-lip technique. You should feel your abdomen go down. Repeat three times and rest for two minutes.
| Study group | Role | What they receive |
|---|---|---|
| pursed lip breathing techniques | Experimental | Pursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min. Relax your neck and shoulder muscles. For the use of PLB exercise, the intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets Receives: Other: pursed lip breathing techniques |
| coordinated breathing technique | Active comparator | The intervention will be given un every day till the patient discharge from hospital. Coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min Receives: Other: coordinated breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
Patients were instructed to walk back and forth at their own pace in a 35 m corridor. A physiotherapist supervised the test through the course, telling the patient the remaining exercise time every 2 min
Measured: baseline and fourth week
Borg dyspnea scale
Dyspnea during the test was evaluated with the modified Borg dyspnea score. Pulmonary function test, inspiratory capacity, and dyspnea score, together with the walking distance were recorded before and after walking. Modified Borg scale is valid patient self-report scale for measuring breathlessness after exercise with the scaling from 0 to 10.
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 posted14 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 54 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
- NCT06459843
- Sponsor's protocol ID
- REC/RCR & AHS/23/0366
- Status last verified
- Jan 2025
- First submitted
- 11 Jun 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thurlbeck WM, Muller NL. Emphysema: definition, imaging, and quantification. AJR Am J Roentgenol. 1994 Nov;163(5):1017-25. doi: 10.2214/ajr.163.5.7976869.
PubMed 7976869Rodrigues A, Munoz Castro G, Jacome C, Langer D, Parry SM, Burtin C. Current developments and future directions in respiratory physiotherapy. Eur Respir Rev. 2020 Dec 15;29(158):200264. doi: 10.1183/16000617.0264-2020. Print 2020 Dec 31.
PubMed 33328280
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects Of of Pursed Lip Breathing and Coordinated Breathing During Aerobic Exercise on Aerobic Capacity, Dyspnea and Anxiety Level in Adult Patients With COPD
- ClinicalTrials.gov ID
- NCT06459843
- Acronym / sponsor ID
- REC/RCR & AHS/23/0366
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Aerobic capacity, Coordinated breathing technique, Pursed lip breathing technique.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 14 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.
COPD is the chronic lung condition characterized by the damage and enlargement of the air sacs in the lungs, leading to breathing difficulties. A blockage may develop, which traps air inside your lungs. The patient shows clinical manifestation of cough, wheezing, chest tightness, shortness of breath. This research of randomized clinical trial will check the combined effects of pursed lip breathing and coordinated breathing techniques to improve aerobic capacity and dyspnea in patients with COPD by taking sample of 54 patients through convenience sampling and randomly allocating them to two groups A and B out of which A will receive pursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min, B will receive coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min.Pre and post training outcomes of aerobic capacity and dyspnea will be measured through Six minute walk test and dyspnea Borg scale, and Saint George respiratory questionnaire. The data will be analyzed through SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pursed lip breathing techniques | Experimental | Other: pursed lip breathing techniquesPursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min. Relax your neck and shoulder muscles. For the use of PLB exercise, the intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets |
| coordinated breathing technique | Active comparator | Other: coordinated breathing techniqueThe intervention will be given un every day till the patient discharge from hospital. Coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range 25 -45 years(5)
- Adult patient diagnosed with (chronic obstructive pulmonary disease) based on clinical and diagnostic criteria.
- Patient willing and able to participate in an pursed lip breathing and coordinated breathing exercise program
- Gender both male and female
Key exclusion criteria (4 listed)
- Those who cognitive impairment that might affect their ability to comprehend and follow instructions
- Any contraindication to the use of pursed lip breathing or coordinated breathing exercise as determined by the health care provider.
- Individual with severe musculoskeletal limitations or other physical condition that may hinder the ability to perform exercise
- Individual who have experienced the recent exacerbation of COPD symptoms within past three month
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 |
|---|---|---|
| pursed lip breathing techniquesRelax your neck and shoulder muscles. For the use of PLB exercise, the intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets. In each set, 10 times will be included. Then, instruct the patient to take deep breath through nose for two counts, and keep mouth closed. Inhale for 2 seconds. Now, ask the patient to purse the lips as if the patient was going to gently flicker the flame of candle. Now the patient will breathe out gently while counting for 4 seconds. | Other | pursed lip breathing techniques |
| coordinated breathing techniquePut one hand on your abdomen. Make your abdomen push out while you breathe in through your nose. Suck in your abdominal muscles. Breathe out using the pursed-lip technique. You should feel your abdomen go down. Repeat three times and rest for two minutes. | Other | coordinated breathing technique |
Primary outcome
Six minute walk test
Time frame: baseline and fourth week
Patients were instructed to walk back and forth at their own pace in a 35 m corridor. A physiotherapist supervised the test through the course, telling the patient the remaining exercise time every 2 min
Borg dyspnea scale
Time frame: baseline and fourth week
Dyspnea during the test was evaluated with the modified Borg dyspnea score. Pulmonary function test, inspiratory capacity, and dyspnea score, together with the walking distance were recorded before and after walking. Modified Borg scale is valid patient self-report scale for measuring breathlessness after exercise with the scaling from 0 to 10.
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 13 Jan 2025.
- Background: PubMed 7976869Thurlbeck WM, Muller NL. Emphysema: definition, imaging, and quantification. AJR Am J Roentgenol. 1994 Nov;163(5):1017-25. doi: 10.2214/ajr.163.5.7976869.
- Background: PubMed 33328280Rodrigues A, Munoz Castro G, Jacome C, Langer D, Parry SM, Burtin C. Current developments and future directions in respiratory physiotherapy. Eur Respir Rev. 2020 Dec 15;29(158):200264. doi: 10.1183/16000617.0264-2020. Print 2020 Dec 31.
- 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 pursed lip breathing techniques and coordinated breathing 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: finished, as of the sponsor's last update on 13 Jan 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 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?
Six minute walk test (time frame: baseline and fourth week). The study lists 2 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 NCT06459843, which also lists 2 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 13 Jan 2025.