Shortness of BreathNCT05586217
Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog
A study testing INCENTIVE SPIROMETRY and Active cycle of breathing in people with Shortness of Breath, run by Riphah International University at 1 site in Pakistan.
Trial summary
EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Shortness of Breath
- What is being tested?
- INCENTIVE SPIROMETRY and Active cycle of breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2022to 10 Dec 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group:30-45
- Patients of bronchial Asthma
- Patients who have difficulty in breathing
Who cannot join
- Age:<30 yrs->45 yrs
- Patients of COPD,Bronchiectasis,Pneumonia,Pulmonary TB or any other chronic lung disease.
- Patients of HTN, IHD, patients of fever or any other chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG
Read the detailed description
Asthma is a serious and life threatening chronic respiratory disease that affects the quality of life of more than 23 million Americans- with exposure to air pollution. Air pollution can make asthma symptoms worse and trigger asthma attacks. Particle pollution can cause breathing problems. It's created when tiny bits of dust, dirt, smoke, soot, and other stuff hang in the air. The smaller the particles, the deeper they can get into the lungs and cause breath problems. Seasonal smog aggravates asthma, irritates the lungs, and makes it difficult to breathe. Long-term inflammation from breathing in too much ground-level ozone can permanently scar lung tissue. Smog with high levels of ozone is also particularly damaging for people with asthma. During seasonal smog asthma patients are more affected than normal people. Various consecutive treatments are used to treat the asthma patients for the improvement of quality of life. But at this check the effects of incentive spirometry on dyspnea and chest clearance in asthmatic patients.
This study will be randomized controlled trial. This study will be conducted in Ittefaq Hospital Lahore. Subjects meeting the predetermined inclusion and exclusion criteria. Sample size will be 44 including both male and female. QUESTIONNAIRE used as subjective measurements and ASHMA CONTROL TEST as objective measurement. Dyspnea-12 will be used to check the dyspnea severity in asthma patients and asthma control test will be used to check asthma severity during seasonal smog. Cough and sputum assessment questionnaire will be used to check effectiveness of chest clearance. Subjects of one group will be treated with active cycle of breathing and incentive spirometry and the other group will be treated with only spirometry. Each group will receive 12 treatment sessions with one treatment session per week and it will take less than 1 hour. Pre- treatment reading of dynpnea-12, cough and sputum assessment questionnaire and asthma control test will be recorded. And post-treatment readings will also be recorded.
Outcome variables will be dyspnea-12, incentive spirometry, cough and sputum assessment questionnaire and asthma control test. Most commonly used incentive spirometry to clear the dyspnea and chest clearance in asthma patients. Data will be analyzed on SPSS-25.
- Conditions
- Shortness of Breath
- Being tested
- INCENTIVE SPIROMETRY, Active cycle of breathing
- Keywords
- Spirometry,Asthma,Dyspnea and Chest clearance
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCENTIVE SPIROMETRYOther
- Sit up and hold the device.
- Then Place the mouthpiece spirometer in mouth and make a good seal over the mouthpiece with lips.
- Breathe out (exhale) normally.
- Breathe in (inhale) slowly. A piece in the incentive spirometer will rise as you breathe in. And try to get this piece to rise as high as you can.
- Usually, there is a marker placed by your doctor that tells you how big of a breath you should take.
A smaller piece in the spirometer looks like a ball or disk.
- Your goal should be to make sure this ball stays in the middle of the chamber while you breathe in.
- If you breathe in too fast, the ball will shoot to the top.
- If you breathe in too slowly, the ball will stay at the bottom. Hold your breath for 3 to 5 seconds. Then slowly exhale.
Active cycle of breathingOther
Breathe in and out gently through your nose if you can. If you cannot, breathe through your mouth instead. If you breathe out through your mouth, it's best to use breathing control with 'pursed lips breathing'. keep your shoulders relaxed.
Try closing your eyes to help you to focus on your breathing and to relax. Breathing control should continue until the person feels ready to progress to the other stages in the cycle. Try to keep your chest and shoulders relaxed.
At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing out. Breathe out gently and relaxed. Repeat 3 - 5 times. Sit up straight with chin tilted slightly up and mouth open.
Take a slow deep breath to fill lungs about three quarters full. Hold breath for two or three seconds. Exhale forcefully, but slowly, in a continuous exhalation to move mucus from the smaller to the larger airways
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry | Experimental | 12 weeks, 1 session per week; each session took about 1 hour. Receives: Other: INCENTIVE SPIROMETRY; Other: Active cycle of breathing |
| Active Cycle of Breathing | Active comparator | Breathing Control Deep Breathing Exercises or Thoracic Expansion Exercises Huffing or Forced Expiratory Technique (FET) Receives: Other: Active cycle of breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control test
In asthma control test we use spirometer to check out the respiratory functions.
Measured: 12 weeks
Incentive Spirometry
An incentive spirometer is a handheld medical device that measures the volume of our breath.
It helps our lungs recover after surgery or lung illness, keeping them active and free of fluid.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start10 Sep 2022
- Primary completion1 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of BreathStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sumera abdulhameed, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586217
- Sponsor's protocol ID
- REC/0332 Muhadsa Chaudhary
- Status last verified
- Jul 2023
- First submitted
- 17 Oct 2022
- Last updated
- 25 Jul 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog
- ClinicalTrials.gov ID
- NCT05586217
- Acronym / sponsor ID
- REC/0332 Muhadsa Chaudhary
- Conditions
- Shortness of Breath
- Keywords
- Spirometry,Asthma,Dyspnea and Chest clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 19 Oct 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.
EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG
Detailed description
Asthma is a serious and life threatening chronic respiratory disease that affects the quality of life of more than 23 million Americans- with exposure to air pollution. Air pollution can make asthma symptoms worse and trigger asthma attacks. Particle pollution can cause breathing problems. It's created when tiny bits of dust, dirt, smoke, soot, and other stuff hang in the air. The smaller the particles, the deeper they can get into the lungs and cause breath problems. Seasonal smog aggravates asthma, irritates the lungs, and makes it difficult to breathe. Long-term inflammation from breathing in too much ground-level ozone can permanently scar lung tissue. Smog with high levels of ozone is also particularly damaging for people with asthma. During seasonal smog asthma patients are more affected than normal people. Various consecutive treatments are used to treat the asthma patients for the improvement of quality of life. But at this check the effects of incentive spirometry on dyspnea and chest clearance in asthmatic patients.
This study will be randomized controlled trial. This study will be conducted in Ittefaq Hospital Lahore. Subjects meeting the predetermined inclusion and exclusion criteria. Sample size will be 44 including both male and female. QUESTIONNAIRE used as subjective measurements and ASHMA CONTROL TEST as objective measurement. Dyspnea-12 will be used to check the dyspnea severity in asthma patients and asthma control test will be used to check asthma severity during seasonal smog. Cough and sputum assessment questionnaire will be used to check effectiveness of chest clearance. Subjects of one group will be treated with active cycle of breathing and incentive spirometry and the other group will be treated with only spirometry. Each group will receive 12 treatment sessions with one treatment session per week and it will take less than 1 hour. Pre- treatment reading of dynpnea-12, cough and sputum assessment questionnaire and asthma control test will be recorded. And post-treatment readings will also be recorded.
Outcome variables will be dyspnea-12, incentive spirometry, cough and sputum assessment questionnaire and asthma control test. Most commonly used incentive spirometry to clear the dyspnea and chest clearance in asthma patients. Data will be analyzed on SPSS-25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry | Experimental | Other: INCENTIVE SPIROMETRY, Other: Active cycle of breathing12 weeks, 1 session per week; each session took about 1 hour. |
| Active Cycle of Breathing | Active comparator | Other: Active cycle of breathingBreathing Control Deep Breathing Exercises or Thoracic Expansion Exercises Huffing or Forced Expiratory Technique (FET) |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group:30-45
- Patients of bronchial Asthma
- Patients who have difficulty in breathing
Key exclusion criteria (3 listed)
- Age:<30 yrs->45 yrs
- Patients of COPD,Bronchiectasis,Pneumonia,Pulmonary TB or any other chronic lung disease.
- Patients of HTN, IHD, patients of fever or any other chronic 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 |
|---|---|---|
| INCENTIVE SPIROMETRY* Sit up and hold the device. * Then Place the mouthpiece spirometer in mouth and make a good seal over the mouthpiece with lips. * Breathe out (exhale) normally. * Breathe in (inhale) slowly. A piece in the incentive spirometer will rise as you breathe in. And try to get this piece to rise as high as you can. * Usually, there is a marker placed by your doctor that tells you how big of a breath you should take. A smaller piece in the spirometer looks like a ball or disk. * Your goal should be to make sure this ball stays in the middle of the chamber while you breathe in. * If you breathe in too fast, the ball will shoot to the top. * If you breathe in too slowly, the ball will stay at the bottom. Hold your breath for 3 to 5 seconds. Then slowly exhale. | Other | Incentive Spirometry |
| Active cycle of breathingBreathe in and out gently through your nose if you can. If you cannot, breathe through your mouth instead. If you breathe out through your mouth, it's best to use breathing control with 'pursed lips breathing'. keep your shoulders relaxed. Try closing your eyes to help you to focus on your breathing and to relax. Breathing control should continue until the person feels ready to progress to the other stages in the cycle. Try to keep your chest and shoulders relaxed. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing out. Breathe out gently and relaxed. Repeat 3 - 5 times. Sit up straight with chin tilted slightly up and mouth open. Take a slow deep breath to fill lungs about three quarters full. Hold breath for two or three seconds. Exhale forcefully, but slowly, in a continuous exhalation to move mucus from the smaller to the larger airways | Other | Active Cycle of Breathing, Incentive Spirometry |
Primary outcome
Asthma Control test
Time frame: 12 weeks
In asthma control test we use spirometer to check out the respiratory functions.
Incentive Spirometry
Time frame: 12 weeks
An incentive spirometer is a handheld medical device that measures the volume of our breath. It helps our lungs recover after surgery or lung illness, keeping them active and free of fluid.
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 25 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Shortness of Breath
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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.
sumera abdulhameed, MS 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 INCENTIVE SPIROMETRY and Active cycle of breathing in people with Shortness of Breath, 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 3 inclusion and 3 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 25 Jul 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?
Asthma Control test (time frame: 12 weeks). The study lists 2 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 25 Jul 2023.