Chronic Obstructive Pulmonary DiseaseNCT05651958
Effects of Pranayama Breathing Technique in Patients With Chronic Obstructive Pulmonary Disease
A study testing Nebulizer and Breathing Technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
It will be randomized controlled trial. The research will be conducted at Bahawal Victoria hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nebulizer and Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 31 Jan 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender of age group 30 to 55
- Patient with diagnosed COPD.
- Moderate to severe COPD.
- Patient with productive cough and SOB.
- No surgical procedure perform.
Who cannot join
- Patient of lung surgery
- Lung cancer patient
- Patient above 70 years age.
- Patient with open wound.
- Patient with cardiovascular issues
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital and Civil Hospital
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: Effects of Pranayama Breathing Technique on Dyspnea, Exercise Tolerance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
It will be randomized controlled trial. The research will be conducted at Bahawal Victoria hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed Chronic obstructive pulmonary disease ,Moderate to severe Chronic obstructive pulmonary disease with productive cough, Shortness of breathe and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.
Read the detailed description
It will be randomized controlled trial. After approval of synopsis the research will be conducted at Bahawal Victoria hospital Bahawalpur and Sadiq abbasi hospital Bahawalpur. Written informed consent will be obtained. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A and group B. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed COPD, Moderate to severe COPD with productive cough, SOB and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nebulizer, Breathing Technique
- Keywords
- Pranayama, COPD, Dyspnea, Exercise tolerance
- 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.
NebulizerOther
Active Comparator: Nebulization every 3 days with the other medicine to the active comparator.
Breathing TechniqueOther
15 repeatations of Breathing in morning and evening
| Study group | Role | What they receive |
|---|---|---|
| Pranayma Breathing Technique | Experimental | Pranayma Breathing Technique protocol includes 15 breaths in the morning and 15 breaths in evening for atleast weeks. Receives: Other: Breathing Technique |
| Conventional Treatment | Active comparator | Long-acting beta-2 agonist, nebulizers and long acting anti-mucosic drugs. Receives: Other: Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walk test.
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Six Weeks
IPAQ- quality of life
The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants.
Measured: Six Weeks
VSAQ-exercise capacity
The VSAQ, capturing patient-reported outcome measures, is an efficient and quantifiable measure of exercise capacity that can be readily employed in clinical services particularly where patients have normal to high exercise tolerance
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- madiha younas, MS, Principal investigator, riphah internationl university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651958
- Sponsor's protocol ID
- REC/22/0351 Amina Muqaddas
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pranayama Breathing Technique on Dyspnea, Exercise Tolerance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05651958
- Acronym / sponsor ID
- REC/22/0351 Amina Muqaddas
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pranayama, COPD, Dyspnea, Exercise tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 15 Dec 2022 (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 randomized controlled trial. The research will be conducted at Bahawal Victoria hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed Chronic obstructive pulmonary disease ,Moderate to severe Chronic obstructive pulmonary disease with productive cough, Shortness of breathe and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.
Detailed description
It will be randomized controlled trial. After approval of synopsis the research will be conducted at Bahawal Victoria hospital Bahawalpur and Sadiq abbasi hospital Bahawalpur. Written informed consent will be obtained. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A and group B. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed COPD, Moderate to severe COPD with productive cough, SOB and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pranayma Breathing Technique | Experimental | Other: Breathing TechniquePranayma Breathing Technique protocol includes 15 breaths in the morning and 15 breaths in evening for atleast weeks. |
| Conventional Treatment | Active comparator | Other: NebulizerLong-acting beta-2 agonist, nebulizers and long acting anti-mucosic drugs. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender of age group 30 to 55
Key exclusion criteria (5 listed)
- Patient of lung surgery
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 |
|---|---|---|
| NebulizerActive Comparator: Nebulization every 3 days with the other medicine to the active comparator. | Other | Conventional Treatment |
| Breathing Technique15 repeatations of Breathing in morning and evening | Other | Pranayma Breathing Technique |
Primary outcome
6 min walk test.
Time frame: Six Weeks
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
IPAQ- quality of life
Time frame: Six Weeks
The International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants.
VSAQ-exercise capacity
Time frame: Six Weeks
The VSAQ, capturing patient-reported outcome measures, is an efficient and quantifiable measure of exercise capacity that can be readily employed in clinical services particularly where patients have normal to high exercise tolerance
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 21 Feb 2023.
- 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.
madiha younas, MS principal investigator
riphah internationl 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 Nebulizer and 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 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 21 Feb 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?
6 min walk test. (time frame: Six 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?
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 21 Feb 2023.