AsthmaNCT07612384
Effects of Abdominal Binder on Dysnea, Control Pause and Quality of Life in Asthmatic Patients
A study testing Abdominal binder -assisted diaphragmatic breathing and Conventional diaphragmatic breathing exercise in people with Asthma, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study investigates the effects of using an abdominal binder as an adjunct to diaphragmatic breathing in asthma patients. The goal is to determine if the binder improves respiratory mechanics, specifically reducing dyspnea ,and increasing breath-hold time (control pause) and quality of life over a four-week period Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Abdominal binder -assisted diaphragmatic breathing and Conventional diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Nov 2025to 1 May 2026
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age :18 to 65
- Diagnosed asthma (persistent, not solely intermittent, seasonal, or exercise-induced).
- Mild to moderate asthma; > 2 days/week (not daily) Minor activity limitation* FEV₁ ≥80.
- Capable of performing dyspnea control pause (DCP) testing and completing QoL questionnaires.
- No recent hospitalization due to asthma.
Who cannot join
- Intermittent, seasonal-only, or exercise-induced asthma.
- Presence of other major respiratory diseases (COPD, bronchitis, pneumonia, fibro tic disorders)
- Severe comorbidity: cardiac arrhythmia, CHF, CAD, uncontrolled hypertension/diabetes, renal/hepatic
- Severe asthma (Symptoms all day Frequent night awakenings* FEV₁ <60% predicted.) ▪️ Unable to perform breathing exercises
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of using an abdominal binder as an adjunct to diaphragmatic breathing in asthma patients. The goal is to determine if the binder improves respiratory mechanics, specifically reducing dyspnea ,and increasing breath-hold time (control pause) and quality of life over a four-week period
Read the detailed description
This randomized controlled trial (RCT) investigates the efficacy of an abdominal binder as an adjunct to diaphragmatic breathing in 32 asthma patients (aged 18-60). Participants are allocated into two groups: the experimental group receives binder-assisted diaphragmatic breathing exercises (14 sessions/week for 4 weeks), while the control group performs conventional diaphragmatic breathing exercises. The study aims to evaluate improvements in respiratory mechanics, specifically focusing on reducing dyspnea, increasing breath-hold duration (control pause), and enhancing asthma-related quality of life. The intervention involves applying an external abdominal binder to provide resistance and tactile feedback during diaphragmatic breathing. Training intensity progresses from light resistance (weeks 1-2) to high resistance (weeks 3-4). The primary goal is to optimize diaphragmatic excursion and reduce the work of breathing associated with asthmatic hyperinflation.
- Conditions
- Asthma
- Being tested
- Abdominal binder -assisted diaphragmatic breathing, Conventional diaphragmatic breathing exercise
- Keywords
- Dyspnea, control pause, quality of life
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal binder -assisted diaphragmatic breathingOther
Participants perform slow, deep diaphragmatic inhalations and exhalations Mechanism: The abdominal binder is applied to increase intro-abdominal pressure, helping to reposition the flattened diaphragm in asthma patients into a more efficient, dome-like shape (zone of apposition). Dosage: 4 weeks total; Progression: Intensity is increased by tightening the binder/increasing resistance over the final 2 weeks of the study.
Conventional diaphragmatic breathing exerciseOther
This group receives standard medical management for asthma and performs conventional diaphragmatic breathing exercises alone. Unlike the experimental group, these exercises are performed without the use of an abdominal binder.
Frequency and Duration: The sessions are conducted 14 times per week for a total of 4 weeks. This matches the experimental group's schedule to ensure the results accurately control for the effects of the breathing exercises themselves.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group abdominal binder-assisted diaphragmatic breathing exercises | Experimental | This group will receive standard medical management for asthma along with abdominal binder-assisted diaphragmatic breathing exercises. The abdominal binder will be used to provide external resistance and tactile feedback to the diaphragm. The intervention will be conducted for 4 weeks ( supervised and home-based sessions). Training intensity will progress from light resistance (Weeks 1-2) to high resistance (Weeks 3-4). Receives: Other: Abdominal binder -assisted diaphragmatic breathing |
| Control group conventional diaphragmatic breathing exercises | Active comparator | This group will receive standard medical management for asthma and perform conventional diaphragmatic breathing exercises alone without the use of an abdominal binder. The frequency and duration will match the experimental group (for week for 4 weeks) to control for the effects of the breathing exercises themselves. Receives: Other: Conventional diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Dyspnea was assessed using the Dyspnea-12 Questionnaire, a validated self-administered instrument designed to measure the severity of breathlessness. The questionnaire consists of 12 items that evaluate both the physical and affective components of dyspnea experienced by the participant. Each item is scored on a 4-point Likert scale ranging from 0 (none) to 3 (severe), with a total score ranging from 0 to 36. Higher scores indicate greater severity of dyspnea and a greater impact of breathlessness on daily functioning. The Dyspnea-12 has demonstrated good reliability and validity for assessing multidimensional breathlessness across clinical populations
Measured: 04 weeks
control pause (Breath- hold time )
Control pause was assessed using the breath-hold time test, a measure commonly used to evaluate breathing pattern efficiency and carbon dioxide tolerance in individuals with Asthma. Participants were instructed to sit comfortably and breathe normally for several breaths. At the end of a normal exhalation, they were asked to gently hold their breath by pinching the nose until the first natural urge to breathe was experienced, such as diaphragmatic contraction or mild air hunger. The breath-hold duration was recorded in seconds using a stopwatch. Lower control pause values in asthma are often associated with dysfunctional breathing patterns, airway hyperresponsiveness, and poor symptom control, whereas higher values indicate improved respiratory regulation, greater carbon dioxide tolerance, and enhanced breathing efficiency.
Measured: 04 weeks
Asthma-Related Quality of Life
Asthma-related quality of life was assessed using the Asthma Quality of Life Questionnaire (AQLQ), a validated 32-item questionnaire designed to evaluate the impact of Asthma on daily functioning and well-being. The questionnaire assesses four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Each item is scored on a 7-point Likert scale, with total scores ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicate better quality of life, reflecting minimal impact of asthma on daily activities and overall well-being, whereas lower scores indicate poorer functional status, greater symptom burden, and significant lifestyle restriction due to asthma.
Measured: 04 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start18 Nov 2025
- Primary completion1 May 2026
- Study completion1 May 2026
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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612384
- Sponsor's protocol ID
- FUCP/CTR/2026/07
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Binder on Dysnea, Control Pause and Quality of Life in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT07612384
- Acronym / sponsor ID
- FUCP/CTR/2026/07
- Conditions
- Asthma
- Keywords
- Dyspnea, control pause, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 28 May 2026 (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.
This study investigates the effects of using an abdominal binder as an adjunct to diaphragmatic breathing in asthma patients. The goal is to determine if the binder improves respiratory mechanics, specifically reducing dyspnea ,and increasing breath-hold time (control pause) and quality of life over a four-week period
Detailed description
This randomized controlled trial (RCT) investigates the efficacy of an abdominal binder as an adjunct to diaphragmatic breathing in 32 asthma patients (aged 18-60). Participants are allocated into two groups: the experimental group receives binder-assisted diaphragmatic breathing exercises (14 sessions/week for 4 weeks), while the control group performs conventional diaphragmatic breathing exercises. The study aims to evaluate improvements in respiratory mechanics, specifically focusing on reducing dyspnea, increasing breath-hold duration (control pause), and enhancing asthma-related quality of life. The intervention involves applying an external abdominal binder to provide resistance and tactile feedback during diaphragmatic breathing. Training intensity progresses from light resistance (weeks 1-2) to high resistance (weeks 3-4). The primary goal is to optimize diaphragmatic excursion and reduce the work of breathing associated with asthmatic hyperinflation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group abdominal binder-assisted diaphragmatic breathing exercises | Experimental | Other: Abdominal binder -assisted diaphragmatic breathingThis group will receive standard medical management for asthma along with abdominal binder-assisted diaphragmatic breathing exercises. The abdominal binder will be used to provide external resistance and tactile feedback to the diaphragm. The intervention will be conducted for 4 weeks ( supervised and home-based sessions). Training intensity will progress from light resistance (Weeks 1-2) to high resistance (Weeks 3-4). |
| Control group conventional diaphragmatic breathing exercises | Active comparator | Other: Conventional diaphragmatic breathing exerciseThis group will receive standard medical management for asthma and perform conventional diaphragmatic breathing exercises alone without the use of an abdominal binder. The frequency and duration will match the experimental group (for week for 4 weeks) to control for the effects of the breathing exercises themselves. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age :18 to 65
- Diagnosed asthma (persistent, not solely intermittent, seasonal, or exercise-induced).
- Mild to moderate asthma; > 2 days/week (not daily) Minor activity limitation* FEV₁ ≥80.
- Capable of performing dyspnea control pause (DCP) testing and completing QoL questionnaires.
- No recent hospitalization due to asthma.
Key exclusion criteria (4 listed)
- Intermittent, seasonal-only, or exercise-induced asthma.
- Presence of other major respiratory diseases (COPD, bronchitis, pneumonia, fibro tic disorders)
- Severe comorbidity: cardiac arrhythmia, CHF, CAD, uncontrolled hypertension/diabetes, renal/hepatic
- Severe asthma (Symptoms all day Frequent night awakenings* FEV₁ <60% predicted.) ▪️ Unable to perform breathing exercises
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 |
|---|---|---|
| Abdominal binder -assisted diaphragmatic breathingParticipants perform slow, deep diaphragmatic inhalations and exhalations Mechanism: The abdominal binder is applied to increase intro-abdominal pressure, helping to reposition the flattened diaphragm in asthma patients into a more efficient, dome-like shape (zone of apposition). Dosage: 4 weeks total; Progression: Intensity is increased by tightening the binder/increasing resistance over the final 2 weeks of the study. | Other | Experimental group abdominal binder-assisted diaphragmatic breathing exercises |
| Conventional diaphragmatic breathing exerciseThis group receives standard medical management for asthma and performs conventional diaphragmatic breathing exercises alone. Unlike the experimental group, these exercises are performed without the use of an abdominal binder. Frequency and Duration: The sessions are conducted 14 times per week for a total of 4 weeks. This matches the experimental group's schedule to ensure the results accurately control for the effects of the breathing exercises themselves. | Other | Control group conventional diaphragmatic breathing exercises |
Primary outcome
Dyspnea
Time frame: 04 weeks
Dyspnea was assessed using the Dyspnea-12 Questionnaire, a validated self-administered instrument designed to measure the severity of breathlessness. The questionnaire consists of 12 items that evaluate both the physical and affective components of dyspnea experienced by the participant. Each item is scored on a 4-point Likert scale ranging from 0 (none) to 3 (severe), with a total score ranging from 0 to 36. Higher scores indicate greater severity of dyspnea and a greater impact of breathlessness on daily functioning. The Dyspnea-12 has demonstrated good reliability and validity for assessing multidimensional breathlessness across clinical populations
control pause (Breath- hold time )
Time frame: 04 weeks
Control pause was assessed using the breath-hold time test, a measure commonly used to evaluate breathing pattern efficiency and carbon dioxide tolerance in individuals with Asthma. Participants were instructed to sit comfortably and breathe normally for several breaths. At the end of a normal exhalation, they were asked to gently hold their breath by pinching the nose until the first natural urge to breathe was experienced, such as diaphragmatic contraction or mild air hunger. The breath-hold duration was recorded in seconds using a stopwatch. Lower control pause values in asthma are often associated with dysfunctional breathing patterns, airway hyperresponsiveness, and poor symptom control, whereas higher values indicate improved respiratory regulation, greater carbon dioxide tolerance, and enhanced breathing efficiency.
Asthma-Related Quality of Life
Time frame: 04 weeks
Asthma-related quality of life was assessed using the Asthma Quality of Life Questionnaire (AQLQ), a validated 32-item questionnaire designed to evaluate the impact of Asthma on daily functioning and well-being. The questionnaire assesses four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Each item is scored on a 7-point Likert scale, with total scores ranging from 1 (severely impaired) to 7 (not impaired). Higher scores indicate better quality of life, reflecting minimal impact of asthma on daily activities and overall well-being, whereas lower scores indicate poorer functional status, greater symptom burden, and significant lifestyle restriction due to asthma.
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 28 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal binder -assisted diaphragmatic breathing and Conventional diaphragmatic breathing exercise 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 5 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 28 May 2026. 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?
Dyspnea (time frame: 04 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 28 May 2026.