AsthmaNCT04624425
Additional Effects of Segmental Breathing In Asthma
A study testing Segmental breathing exercises and Buteyko breathing exercises in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of segmental breathing exercise and buteyko breathing exercises on chest expansion in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on pulmonary function (FEV1, FVC, FEV1/FVC) in individuals with asthma. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Segmental breathing exercises and Buteyko breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Sep 2020to 20 Dec 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with clinical diagnosis of asthma.
Who cannot join
- Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax.
- Participants with pleura disorder and chest trauma \& rib fracture.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nusrat Abdul Rauf Centre for Enablement (NACE)
Faisalābad, Punjab Province
About this study
To determine the effects of segmental breathing exercise and buteyko breathing exercises on chest expansion in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on pulmonary function (FEV1, FVC, FEV1/FVC) in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on Asthma Control Questionnaire in individuals with asthma.
Read the detailed description
The National Heart and Lung Institute determines asthma as a common chronic airway disease distinguished by variable and reoccurring manifestations, bronchial hypersensitivity, reducing the flow of air in and out of the lungs and inflammatory reactions with in air passages in the lungs.
Earlier in the first place asthma is also defined as existence of spontaneously reversible airway obstruction or with treatment and narrowing of airways also increased to different stimuli i.e. abrupt changes in weather, cold air, histamine, dust, pollen, feathers, exercise, viral upper respiratory infection, animal dander, cigarette smoke, fungal spores or respiratory allergens that increases bronchial hypersensitivity.
segmental breathing technique is used for increasing the expansion of chest in individual's having empyema whose expansion has been decreased. Total 40 individuals with empyema were included in this study. Chest expansion at three levels have been checked i.e. at axilla level, at sternum level and at xiphoid level were examined before and after implementation of segmental exercise technique. Segmental breathing techniques play a major role in expansion of damaged lungs and as a consequence integral to rehabilitation of Respiratory disease.
The effectiveness of segmental breathing technique and deep breathing exercise on expansion of chest and pulmonary function test. The physical therapy treatment comprises of dyspnea alleviating positions, simple breathing exercises, and exercises for thoracic expansion, inspiratory muscle training with incentive spirometers. Segmental breathing techniques are used to give support or enhance expansion of restricted lung in respiratory disorder. This technique is meant to have an effect on variation of mechanism, involving the stretch reflex process. Fast stretch on external intercostal muscles brings on assistance in contraction.
Intercostal stretching with breathing control exercises might be more effective in enhancing lung parameters. This may also take part in ventilator capacity like tidal volume, saturation of oxygen and minute ventilation. Intercostal stretching might have stimulated the receptors of stretch mechanism in chest wall, hence distend the thoracic cavity which would have connected to medulla oblongata with nerve cell.
The efficacy of buteyko method on control of asthma and quality of living in individuals with asthma. The buteyko breathing exercise is non-medical method that had shown to be better in reducing the frequency and seriousness of asthma. The interventional group manifested a considerable improvement in control of asthma score and quality of living score after four weeks. The other control group didn't manifest any improvement. This study suggested that buteyko breathing exercise may upgrade the physical, societal, spiritual and occupational effect on asthma and improved quality of living.
The combined effect of buteyko breathing exercise and walking exercise on peak expiratory flow. The experimental group was specified for the combination of buteyko exercises and walking exercise for duration of eight weeks, three times per week and of 55 minutes of training session. The benefit of this technique is hold interval that can decrease overuse of carbon dioxide (CO2) that will control breath rate with the help of medulla oblongata in respiratory center, providing Nitric oxide (NO) which particular has bronchodilator effect. These both exercises minimise inflammatory reaction so that they decrease the sign and symptoms of asthma.
- Conditions
- Asthma
- Being tested
- Segmental breathing exercises, Buteyko breathing exercises
- Keywords
- Asthma, Segmental Breathing
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental breathing exercisesOther
Segmental breathing exercises along with the Conventional Treatment of buteyko breathing exercises for two weeks of duration. Segmental breathing exercises include 18-20 breaths in one session (6 breaths/min) with rest interval after every 6 breaths.
Buteyko breathing exercisesOther
Buteyko exercises for two weeks of duration. Treatment session will be last for 10-15minutes.
| Study group | Role | What they receive |
|---|---|---|
| Segmental breathing exercises | Experimental | Segmental breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks Receives: Other: Segmental breathing exercises |
| Buteyko breathing exercises | Active comparator | Buteyko breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks Receives: Other: Buteyko breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 2 weeks
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 2 weeks
Modified Borg Scale of Perceived Exertion
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Measured: 2 weeks
Chest Expansion measurement at Axillary level
A measuring tape with centimeters scale will be used for measuring the expansion at Axillary level. Changes from the baseline will be measured.
Measured: 2 weeks
Chest Expansion measurement at Spinal cord T4 level
A measuring tape with centimeters scale will be used for measuring the expansion at at Spinal cord T4 level. Changes from the baseline will be measured.
Measured: 2 weeks
Chest Expansion measurement at xiphoid process
A measuring tape with centimeters scale will be used for measuring the expansion at xiphoid process level. Changes from the baseline will be measured.
Measured: 2 weeks
Asthma Control Questionnaire
Measurement of the adequateness of asthma control and modifications in asthma control which may occurs immediately or as a consequence of treatment. It is a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled) .The 7-items Asthma Control Questionnaire (ACQ) is valid to measure the goals of asthma management as defined by international guideline. Changes from the baseline will be measured.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start9 Sep 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MSPT-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624425
- Sponsor's protocol ID
- REC/00710 Asma Baig
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Segmental Breathing In Asthma
- ClinicalTrials.gov ID
- NCT04624425
- Acronym / sponsor ID
- REC/00710 Asma Baig
- Conditions
- Asthma
- Keywords
- Asthma, Segmental Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 10 Nov 2020 (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.
To determine the effects of segmental breathing exercise and buteyko breathing exercises on chest expansion in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on pulmonary function (FEV1, FVC, FEV1/FVC) in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on Asthma Control Questionnaire in individuals with asthma.
Detailed description
The National Heart and Lung Institute determines asthma as a common chronic airway disease distinguished by variable and reoccurring manifestations, bronchial hypersensitivity, reducing the flow of air in and out of the lungs and inflammatory reactions with in air passages in the lungs.
Earlier in the first place asthma is also defined as existence of spontaneously reversible airway obstruction or with treatment and narrowing of airways also increased to different stimuli i.e. abrupt changes in weather, cold air, histamine, dust, pollen, feathers, exercise, viral upper respiratory infection, animal dander, cigarette smoke, fungal spores or respiratory allergens that increases bronchial hypersensitivity.
segmental breathing technique is used for increasing the expansion of chest in individual's having empyema whose expansion has been decreased. Total 40 individuals with empyema were included in this study. Chest expansion at three levels have been checked i.e. at axilla level, at sternum level and at xiphoid level were examined before and after implementation of segmental exercise technique. Segmental breathing techniques play a major role in expansion of damaged lungs and as a consequence integral to rehabilitation of Respiratory disease.
The effectiveness of segmental breathing technique and deep breathing exercise on expansion of chest and pulmonary function test. The physical therapy treatment comprises of dyspnea alleviating positions, simple breathing exercises, and exercises for thoracic expansion, inspiratory muscle training with incentive spirometers. Segmental breathing techniques are used to give support or enhance expansion of restricted lung in respiratory disorder. This technique is meant to have an effect on variation of mechanism, involving the stretch reflex process. Fast stretch on external intercostal muscles brings on assistance in contraction.
Intercostal stretching with breathing control exercises might be more effective in enhancing lung parameters. This may also take part in ventilator capacity like tidal volume, saturation of oxygen and minute ventilation. Intercostal stretching might have stimulated the receptors of stretch mechanism in chest wall, hence distend the thoracic cavity which would have connected to medulla oblongata with nerve cell.
The efficacy of buteyko method on control of asthma and quality of living in individuals with asthma. The buteyko breathing exercise is non-medical method that had shown to be better in reducing the frequency and seriousness of asthma. The interventional group manifested a considerable improvement in control of asthma score and quality of living score after four weeks. The other control group didn't manifest any improvement. This study suggested that buteyko breathing exercise may upgrade the physical, societal, spiritual and occupational effect on asthma and improved quality of living.
The combined effect of buteyko breathing exercise and walking exercise on peak expiratory flow. The experimental group was specified for the combination of buteyko exercises and walking exercise for duration of eight weeks, three times per week and of 55 minutes of training session. The benefit of this technique is hold interval that can decrease overuse of carbon dioxide (CO2) that will control breath rate with the help of medulla oblongata in respiratory center, providing Nitric oxide (NO) which particular has bronchodilator effect. These both exercises minimise inflammatory reaction so that they decrease the sign and symptoms of asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental breathing exercises | Experimental | Other: Segmental breathing exercisesSegmental breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks |
| Buteyko breathing exercises | Active comparator | Other: Buteyko breathing exercisesButeyko breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with clinical diagnosis of asthma.
Key exclusion criteria (2 listed)
- Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax.
- Participants with pleura disorder and chest trauma \& rib fracture.
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 |
|---|---|---|
| Segmental breathing exercisesSegmental breathing exercises along with the Conventional Treatment of buteyko breathing exercises for two weeks of duration. Segmental breathing exercises include 18-20 breaths in one session (6 breaths/min) with rest interval after every 6 breaths. | Other | Segmental breathing exercises |
| Buteyko breathing exercisesButeyko exercises for two weeks of duration. Treatment session will be last for 10-15minutes. | Other | Buteyko breathing exercises |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 2 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 2 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Modified Borg Scale of Perceived Exertion
Time frame: 2 weeks
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Chest Expansion measurement at Axillary level
Time frame: 2 weeks
A measuring tape with centimeters scale will be used for measuring the expansion at Axillary level. Changes from the baseline will be measured.
Chest Expansion measurement at Spinal cord T4 level
Time frame: 2 weeks
A measuring tape with centimeters scale will be used for measuring the expansion at at Spinal cord T4 level. Changes from the baseline will be measured.
Chest Expansion measurement at xiphoid process
Time frame: 2 weeks
A measuring tape with centimeters scale will be used for measuring the expansion at xiphoid process level. Changes from the baseline will be measured.
Asthma Control Questionnaire
Time frame: 2 weeks
Measurement of the adequateness of asthma control and modifications in asthma control which may occurs immediately or as a consequence of treatment. It is a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled) .The 7-items Asthma Control Questionnaire (ACQ) is valid to measure the goals of asthma management as defined by international guideline. Changes from the baseline will be measured.
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 2021.
- 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.
Iqbal Tariq, MSPT-CPPT 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 Segmental breathing exercises and Buteyko breathing exercises 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 1 inclusion and 2 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 2021. 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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 2 weeks). The study lists 7 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 13 Jan 2021.