AsthmaNCT06460597
Comparative Effects of Papworth Technique Versus Pranayama in Asthmatic Patients
A study testing Papworth Technique and Pranayama in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
Asthma is a chronic and heterogeneous disease characterized by reversible airway obstruction, airway inflammation and bronchial damage causing dyspnea, wheezing, chest tightness, coughing and impaired quality of life. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Papworth Technique and Pranayama
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 15 Aug 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders(male and female)
- Age 20-40 years
- Patients with adverse mood effects
- Mild to moderate chronic asthma
Who cannot join
- Acute severe asthma
- Chronic chest infections like TB
- Chest deformity
- Bronchiectasis
- Cardiac Disease
- Substance abusers
- Chronic Obstructive Pulmonary Disease
- Neurological Disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Chest Hospital Lahore
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Asthma is a chronic and heterogeneous disease characterized by reversible airway obstruction, airway inflammation and bronchial damage causing dyspnea, wheezing, chest tightness, coughing and impaired quality of life. Papworth technique and Pranayama modify the pattern of breathing to reduce the hyperventilation resulting in normalization of CO2 levels, reduction of bronchospasm and resulting breathlessness
.These techniques also change the emotional stresses, improve the immunity system and improve the strength /endurance of respiratory muscles. After taking the consent form from the participants, data will be collected from Gulab Devi Chest Hospital. Non-Probability Convenience Sampling will be applied on asthmatic patients according to inclusion criteria. Patients will be allocated through simple random sampling into group A and B to collect data. Group A will be treated by Papworth technique. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Group B will be treated by Pranayama. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Papworth Technique and Pranayama are used and are assessed to see their effectiveness in asthmatic patients by using four questionnaires on dyspnea, fatigue, anxiety, depression and quality of life. These four standardized questionnaires are Borg Dyspnea Scale (BDS), Modified Fatigue Impact Scale (MFIS), Hospital Anxiety Depression Scale (HADS) and Asthma Quality of life. Pulse oximeter will be used to check the oxygen saturation. The study duration will be completed within time duration of 7 months.
- Conditions
- Asthma
- Being tested
- Papworth Technique, Pranayama
- Keywords
- asthma,, Anxiety,, Papworth Technique
- Medical subject headings
- Asthma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papworth TechniqueOther
The Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times
PranayamaOther
Pranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced.
| Study group | Role | What they receive |
|---|---|---|
| Papworth Technique | Experimental | The Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times Receives: Other: Papworth Technique |
| Pranayama | Active comparator | Pranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced. Receives: Other: Pranayama |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter
oxygen saturation
Measured: baseline and fourth week
Hospital Anxiety Depression Scale
It is a self- assessment scale. It is a reliable instrument for detecting the anxiety and depression in patients with asthma. The anxiety and depressive subscales are also valid measures of severity of emotional stresses. The HADS is a self-report rating scale consists of 14 items on a 4 point Likert Scale range from 0-3.It measures anxiety and depression, 7 items for each subscale. The total score is the sum of 14 items and for each subscale is the sum of respective seven items, ranging from 0-21
Measured: baseline and fourth week
Asthma Quality of life
It has 32 questions that contains four sub domains, these are symptoms 11 items, activity limitations 12, emotional function 5, environmental stimuli 4 items. This is marked on a 7 point Likert scale that is changing from 1 to 7 where higher scores indicate better quality of life,1 indicates severely impaired patients with asthma while 7 indicates no impairments. Asthma quality of life has strong measurement properties and is valid for measuring health related quality of life in asthma.
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 Aug 2024 (estimated)
- Study completion15 Aug 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 AsthmaStudies 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
- 44 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
- NCT06460597
- Sponsor's protocol ID
- REC/RCR&AHS/23/0382
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sockrider M, Fussner L. What Is Asthma? Am J Respir Crit Care Med. 2020 Nov 1;202(9):P25-P26. doi: 10.1164/rccm.2029P25. No abstract available.
PubMed 33124914Gans MD, Gavrilova T. Understanding the immunology of asthma: Pathophysiology, biomarkers, and treatments for asthma endotypes. Paediatr Respir Rev. 2020 Nov;36:118-127. doi: 10.1016/j.prrv.2019.08.002. Epub 2019 Oct 9.
PubMed 31678040Miller RL, Grayson MH, Strothman K. Advances in asthma: New understandings of asthma's natural history, risk factors, underlying mechanisms, and clinical management. J Allergy Clin Immunol. 2021 Dec;148(6):1430-1441. doi: 10.1016/j.jaci.2021.10.001. Epub 2021 Oct 14.
PubMed 34655640
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Papworth Technique Versus Pranayama in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT06460597
- Acronym / sponsor ID
- REC/RCR&AHS/23/0382
- Conditions
- Asthma
- Keywords
- asthma,, Anxiety,, Papworth Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- 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.
Asthma is a chronic and heterogeneous disease characterized by reversible airway obstruction, airway inflammation and bronchial damage causing dyspnea, wheezing, chest tightness, coughing and impaired quality of life. Papworth technique and Pranayama modify the pattern of breathing to reduce the hyperventilation resulting in normalization of CO2 levels, reduction of bronchospasm and resulting breathlessness
.These techniques also change the emotional stresses, improve the immunity system and improve the strength /endurance of respiratory muscles. After taking the consent form from the participants, data will be collected from Gulab Devi Chest Hospital. Non-Probability Convenience Sampling will be applied on asthmatic patients according to inclusion criteria. Patients will be allocated through simple random sampling into group A and B to collect data. Group A will be treated by Papworth technique. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Group B will be treated by Pranayama. Four weeks will be required to complete the treatment plan. Three sessions will be given for one week so total 12 sessions will be given in one month. Papworth Technique and Pranayama are used and are assessed to see their effectiveness in asthmatic patients by using four questionnaires on dyspnea, fatigue, anxiety, depression and quality of life. These four standardized questionnaires are Borg Dyspnea Scale (BDS), Modified Fatigue Impact Scale (MFIS), Hospital Anxiety Depression Scale (HADS) and Asthma Quality of life. Pulse oximeter will be used to check the oxygen saturation. The study duration will be completed within time duration of 7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papworth Technique | Experimental | Other: Papworth TechniqueThe Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times |
| Pranayama | Active comparator | Other: PranayamaPranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders(male and female)
- Age 20-40 years
- Patients with adverse mood effects
- Mild to moderate chronic asthma
Key exclusion criteria (8 listed)
- Acute severe asthma
- Chronic chest infections like TB
- Chest deformity
- Bronchiectasis
- Cardiac Disease
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 |
|---|---|---|
| Papworth TechniqueThe Papworth breathing technique is used by respiratory physiotherapists to control and correct breathing. Instead of using the chest, Papworth technique encourages to take more relaxed breathing by using the abdomen. Breathing in slowly through the nose and breathing out through pursed lips as if blowing out a candle. Repeat this cycle for 3-5 times | Other | Papworth Technique |
| PranayamaPranayama is an ancient breath technique that originates from yogic practices in India. Sitting comfortably, slowly inhale through the nose and count to five. Direct the breath across the back of the throat as you inhale so the air makes a slight hissing sound keeping the lips sealed, breathe out through the nose and try to match the length of your inhale. The breath should make a noise like waves crashing as you exhale. Continue to inhale and exhale using the same process for 5 to 8 minutes. Aim to do this exercise for 10 to 15 minutes as become more practiced. | Other | Pranayama |
Primary outcome
Pulse Oximeter
Time frame: baseline and fourth week
oxygen saturation
Hospital Anxiety Depression Scale
Time frame: baseline and fourth week
It is a self- assessment scale. It is a reliable instrument for detecting the anxiety and depression in patients with asthma. The anxiety and depressive subscales are also valid measures of severity of emotional stresses. The HADS is a self-report rating scale consists of 14 items on a 4 point Likert Scale range from 0-3.It measures anxiety and depression, 7 items for each subscale. The total score is the sum of 14 items and for each subscale is the sum of respective seven items, ranging from 0-21
Asthma Quality of life
Time frame: baseline and fourth week
It has 32 questions that contains four sub domains, these are symptoms 11 items, activity limitations 12, emotional function 5, environmental stimuli 4 items. This is marked on a 7 point Likert scale that is changing from 1 to 7 where higher scores indicate better quality of life,1 indicates severely impaired patients with asthma while 7 indicates no impairments. Asthma quality of life has strong measurement properties and is valid for measuring health related quality of life in asthma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 33124914Sockrider M, Fussner L. What Is Asthma? Am J Respir Crit Care Med. 2020 Nov 1;202(9):P25-P26. doi: 10.1164/rccm.2029P25. No abstract available.
- Background: PubMed 31678040Gans MD, Gavrilova T. Understanding the immunology of asthma: Pathophysiology, biomarkers, and treatments for asthma endotypes. Paediatr Respir Rev. 2020 Nov;36:118-127. doi: 10.1016/j.prrv.2019.08.002. Epub 2019 Oct 9.
- Background: PubMed 34655640Miller RL, Grayson MH, Strothman K. Advances in asthma: New understandings of asthma's natural history, risk factors, underlying mechanisms, and clinical management. J Allergy Clin Immunol. 2021 Dec;148(6):1430-1441. doi: 10.1016/j.jaci.2021.10.001. Epub 2021 Oct 14.
- 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 Papworth Technique and Pranayama in people with Asthma, 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 8 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 23 Jul 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 NCT06460597, 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 23 Jul 2024.