AsthmaNCT06660537
Effects of Balloon-blowing Exercises in 90/90 Bridge Position With a Ball on Pulmonary Function Among Asthmatic Patients
A study testing Balloon-blowing exercises in 90/90 bridge position with a ball. and Buteyko breathing exercises management in people with Asthma, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
In asthma, the airways in the respiratory system can experience inflammation and constriction, causing increased difficulty in expelling air during exhalation. This results in disruptions to respiratory parameters, exercise intolerance, and a diminished overall quality of life.Engaging in balloon-blowing exercises… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Asthma
- What is being tested?
- Balloon-blowing exercises in 90/90 bridge position with a ball. and Buteyko breathing exercises management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 1 Feb 2025
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults: aged (18-59 years)
- Gender: Both male and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- Asthma severity ( level 1 mild intermediate, levell 2 mild persistent)
Who cannot join
- Level 3 and above asthmatics or status asthmatics.
- Any congenital deformities of chest wall/ Heart/ Lungs.
- Demonstrated neuromuscular or neurological deficit/ chest wall deformity.
- Cardiopulmonary diseases including coronary artery disease(CAD), Pulmonary HTN, ------Aortic Stenosis, regurgitation, etc.
- Any Autoimmune disease with manifestations of Chest wall/ heart/ Lungs.
- Any recent cardiothoracic or abdominal surgery or sternotomy.
Show all 9Show fewer
- Recent history of the blunt chest wall or abdominal trauma.
- Unstable hemodynamic parameters (arterial pressure >140mmhg systolic and >90mmhg for diastolic).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Sana Bashir, PhD*, 0321-8529475, sana.bashir65@gmail.com
About this study
In asthma, the airways in the respiratory system can experience inflammation and constriction, causing increased difficulty in expelling air during exhalation. This results in disruptions to respiratory parameters, exercise intolerance, and a diminished overall quality of life.Engaging in balloon-blowing exercises while in a 90/90 bridge position with the use of a ball will lead to enhanced pulmonary function and quality of life in individuals with asthma.
Read the detailed description
Asthma attacks and labored breathing can cause strain and weakness in the diaphragm, the main muscle supporting breathing, as well as the muscles of core.
The study objective is to determine the effects of balloon-blowing exercises in 90/90 bridge posotion with a ball on pulmonary function and quality of life among asthmatic patients.
- Conditions
- Asthma
- Being tested
- Balloon-blowing exercises in 90/90 bridge position with a ball., Buteyko breathing exercises management
- Keywords
- Dyspnea, asthma, spirometry, quality of life, oxygen saturation
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-blowing exercises in 90/90 bridge position with a ball.Procedure or surgery
In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their back off the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention.
Buteyko breathing exercises managementProcedure or surgery
In this group, patients will receive Buteyko breathing exercises, which consist of two main exercises; the control pause and the maximum pause. For control pause, patients exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds. In Maximum pause, patients exhale, plug their nose, and hold their breath as long as possible, aiming for double the control pause time, then inhale and breath normally for 10 seconds. This is a 4-week protocol with three sessions per week. Pre- and post-intervention values will be recorded to assess progress.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their backoff the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention. Receives: Procedure: Balloon-blowing exercises in 90/90 bridge position with a ball. |
| Control group | Experimental | In this group, patient will receive Buteyko breathing exercises consists of two main exercises; the control pause and the maximum pause .For control pause, patient exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds.In Maximum pause, patient exhale,plug their nose ,and hold their breath as long as posiible, aiming for double the control pause time, then inhale and breath normally for 10 seconds.This is a 4-week protocol with three sessions per week.Pre- and post- intervention values will be recorded to assess progress.n. Receives: Procedure: Buteyko breathing exercises management |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test
Evaluation will be done using Spirometry
Measured: 4 weeks
Dyspnea
Evaluation will be done using mMRC scale
Measured: 4 weeks
Quality of life of patient
Quality of life will be evaluated by asthma quality of life questionnaire with standardized Activities AQLQ(S)
Measured: 4 Weeks
Oxygen Saturation
Oxygen saturation will be evaluated by pulse oximeter
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Aug 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
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 Foundation University IslamabadThe 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
- Model description
- This is a randomized controlled trial having two groups. One group will receive (interventional group) balloon-blowing exercises in 90/90 bridge position with a ball and the other group (control group) will receive buteyko breathing exercises.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660537
- Sponsor's protocol ID
- FUI/CTR/2024/37
- Status last verified
- Sep 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balloon-blowing Exercises in 90/90 Bridge Position With a Ball on Pulmonary Function Among Asthmatic Patients
- ClinicalTrials.gov ID
- NCT06660537
- Acronym / sponsor ID
- FUI/CTR/2024/37
- Conditions
- Asthma
- Keywords
- Dyspnea, asthma, spirometry, quality of life, oxygen saturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 28 Oct 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.
In asthma, the airways in the respiratory system can experience inflammation and constriction, causing increased difficulty in expelling air during exhalation. This results in disruptions to respiratory parameters, exercise intolerance, and a diminished overall quality of life.Engaging in balloon-blowing exercises while in a 90/90 bridge position with the use of a ball will lead to enhanced pulmonary function and quality of life in individuals with asthma.
Detailed description
Asthma attacks and labored breathing can cause strain and weakness in the diaphragm, the main muscle supporting breathing, as well as the muscles of core.
The study objective is to determine the effects of balloon-blowing exercises in 90/90 bridge posotion with a ball on pulmonary function and quality of life among asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive (interventional group) balloon-blowing exercises in 90/90 bridge position with a ball and the other group (control group) will receive buteyko breathing exercises.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: Balloon-blowing exercises in 90/90 bridge position with a ball.In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their backoff the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention. |
| Control group | Experimental | Procedure: Buteyko breathing exercises managementIn this group, patient will receive Buteyko breathing exercises consists of two main exercises; the control pause and the maximum pause .For control pause, patient exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds.In Maximum pause, patient exhale,plug their nose ,and hold their breath as long as posiible, aiming for double the control pause time, then inhale and breath normally for 10 seconds.This is a 4-week protocol with three sessions per week.Pre- and post- intervention values will be recorded to assess progress.n. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults: aged (18-59 years)
- Gender: Both male and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- Asthma severity ( level 1 mild intermediate, levell 2 mild persistent)
Key exclusion criteria (9 listed)
- Level 3 and above asthmatics or status asthmatics.
- Any congenital deformities of chest wall/ Heart/ Lungs.
- Demonstrated neuromuscular or neurological deficit/ chest wall deformity.
- Cardiopulmonary diseases including coronary artery disease(CAD), Pulmonary HTN, ------Aortic Stenosis, regurgitation, etc.
- Any Autoimmune disease with manifestations of Chest wall/ heart/ Lungs.
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 |
|---|---|---|
| Balloon-blowing exercises in 90/90 bridge position with a ball.In this group patients will undergo balloon-blowing exercises in the 90/90 bridge position with a ball. In this intervention, patients lie on back with feet against a wall and knee bent at 90 degrees, holding a ball between their knees. While extending one arm overhead and holding a balloon in the other hand, perform a pelvic tilt without lifting their back off the mat. Inhale through the nose, exhale into the balloon for four breaths, then remove the balloon and repeat the sequence four times. The 4-week protocol includes three supervised sessions per week, each supervised by a physiotherapist. Progress will be monitored regularly to evaluate improvements throughout the intervention. | Procedure or surgery | Interventional group |
| Buteyko breathing exercises managementIn this group, patients will receive Buteyko breathing exercises, which consist of two main exercises; the control pause and the maximum pause. For control pause, patients exhale, plug the nose, and hold their breath until they feel the urge to breathe, then inhale and breathe normally for 10 seconds. In Maximum pause, patients exhale, plug their nose, and hold their breath as long as possible, aiming for double the control pause time, then inhale and breath normally for 10 seconds. This is a 4-week protocol with three sessions per week. Pre- and post-intervention values will be recorded to assess progress. | Procedure or surgery | Control group |
Primary outcome
pulmonary function test
Time frame: 4 weeks
Evaluation will be done using Spirometry
Dyspnea
Time frame: 4 weeks
Evaluation will be done using mMRC scale
Quality of life of patient
Time frame: 4 Weeks
Quality of life will be evaluated by asthma quality of life questionnaire with standardized Activities AQLQ(S)
Oxygen Saturation
Time frame: 4 Weeks
Oxygen saturation will be evaluated by pulse oximeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon-blowing exercises in 90/90 bridge position with a ball. and Buteyko breathing exercises management in people with Asthma, run by Foundation University Islamabad 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 9 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 Oct 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 Anam Anwar, MS-CPT* (0333-5226687, anam.anwar102@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function test (time frame: 4 weeks). The study lists 4 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 28 Oct 2024.