Asthma in ChildrenNCT04874649
Balloon Blowing Breathing Exercise in School-age Children With Asthma.
A study testing Balloon-blowing breathing and Sustained maximal inspiration breathing in people with Asthma in Children, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study were to investigate the effects of balloon blowing breathing exercise on respiratory muscle strength and asthma symptoms in school-age children with asthma. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Balloon-blowing breathing and Sustained maximal inspiration breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 2 Oct 2019to 15 Mar 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- has been diagnosed with asthma for at least 6 months. The severity rating is not higher than level 2, (Forced expiratory volume in one second; FEV1 is at least 80%)
- No history of diabetes, heart disease, and musculoskeletal disease
- Did not participate in exercise training for more than 20 minutes 3 times a week or more in the 6 months prior to the start of data collection.
Who cannot join
- Patient with a history of exercise-induced asthma.
- Recurrent of acute exacerbation
- Cannot participate at least 80% of training program (≤ 32 sessions of 40 sessions)
- Unwilling to continue practicing
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Bangkok, 10330
About this study
Official title: Effects of Balloon Blowing Breathing Exercise on Respiratory Muscle Strength and Symptoms in School-age Children With Asthma.
This study were to investigate the effects of balloon blowing breathing exercise on respiratory muscle strength and asthma symptoms in school-age children with asthma.
Read the detailed description
Thirty school-age children with asthma aged 7 - 12 years old who were admitted at the outpatient examination room, Phramongkutklao Hospital, divided into 2 groups. The first group was 15 individuals trained with sustained maximal inspiration (SMI) breathing exercise while the second group was 15 individuals training with balloon-blowing breathing exercise. Participants were required to complete breathing exercise 5 times per week for 8 weeks. Five breathing exercises were taken for 8 weeks before and after the experiment. Physiological characteristics data, pulmonary function, respiratory muscle strength, and asthma symptoms variables were comparatively analyzed before and after training. The mean values of variables before and after the experiment of each group were analyzed using paired t-test.
- Conditions
- Asthma in Children
- Being tested
- Balloon-blowing breathing, Sustained maximal inspiration breathing
- Keywords
- Balloon blowing breathing, respiratory muscle strength, school-age children with asthma, Sustained maximal inspiration (SMI) breathing, Asthma symptoms
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-blowing breathingOther
Participant sit on a chair. Inhale fully through their nose and hold for a full 3 second inhalation, then exhale through their mouth into the balloon fully. By having the balloon inflate until their touch the balloon size control device and hold the exhalation period for 1 second, cover the balloon immediately with your fingers count as 1 breath cycle, then replace the balloon immediately. Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks
Sustained maximal inspiration breathingOther
Participant sit on a chair. Inhale through their nose fully and hold for 3 seconds for a full breath, Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Balloon-blowing breathing | Experimental | 1. Start by measuring the vital capacity using a balloon to determine. The width of the balloon diameter for each blow and used the value to make a balloon size control device to give to the sample group and parents to use it for home training.
2. Participant sit on a chair. Inhale fully through their nose and hold for a full 3 second inhalation, then exhale through their mouth into the balloon fully. By having the balloon inflate until their touch the balloon size control device and hold the exhalation period for 1 second, cover the balloon immediately with your fingers count as 1 breath cycle, then replace the balloon immediately. Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks Receives: Other: Balloon-blowing breathing |
| Sustained maximal inspiration breathing | Experimental | Participants sitting in a chair, back and head close to the wall. Inhale through their nose fully and hold for 3 seconds for a full breath, then slowly exhale through their mouth and hold for 1 second of exhalation, counted as 1 breathing cycle.Do this 3 times in a row for 1 set. Practice each time doing a total of 3 sets, with 1 minute rest between sets. Participants were required to complete breathing exercise 5 times per week for 8 weeks. Receives: Other: Sustained maximal inspiration breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength change
Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity [FRC] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity [TLC] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds.
Measured: Change from Baseline respiratory muscle strength at 8 weeks.
Asthma control change
Asthma control was measured by Childhood Asthma Control Test (C - ACT) questionnaire. The range of C-ACT scores is 0 to 27 (27 = totally controlled, 20-26 = well controlled, <26 = insufficiently controlled)
Measured: Change from Baseline Asthma control at 8 weeks.
Secondary outcomes (6)
Force Vital Capacity (FVC) change
FVC is the total volume of air that can be exhaled during a maximal forced expiration effort. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FVC is measured in liters.
Measured: Change from Baseline Force Vital Capacity at 8 weeks.
Forced expiratory volume in 1 second (FEV1) change
FEV1 is the volume of air exhaled in the first second under force after a maximal inhalation. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1 was showed in liters.
Measured: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1/FVC was showed in percentage.
Measured: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
Peak Expiratory Flow (PEF) change
PEF is the amount and rate of air that can be forcefully breathed out of the lungs. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. PEF is measured in liters/seconds.
Measured: Change from Baseline Peak Expiratory Flow at 8 weeks.
Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
FEF25-75% is the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEF25-75% is forced expiratory flow over the middle one half of the FVC; the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled. FEF25-75% is measured in liters/seconds.
Measured: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
Maximal Voluntary Ventilation (MVV) change
The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.
Measured: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start2 Oct 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty school-age children with asthma aged 7 - 12 years old who were admitted at the outpatient examination room, Phramongkutklao Hospital, divided into 2 groups. The first group was 15 individuals trained with sustained maximal inspiration (SMI) breathing exercise while the second group was 15 individuals training with balloon-blowing breathing exercise. Participants were required to complete breathing exercise 5 times per week for 8 weeks. Physiological characteristics data and pulmonary function variables were comparatively analyzed before and after training. The dependent variables between pre-test and post-test were analyzed by a paired t-test. Independent t-test was used to compare the variables between groups. Differences were considered to be significant at p \< .05.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wannaporn Tongtako, Ph.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874649
- Sponsor's protocol ID
- EX PHYSIO SPSC 1
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chauhan, N., & Gunjal, S. (2018). Effect of Balloon Blowing Exercise on Peak Expiratory Flow Rate in Modified Radical Mastectomy. International Journal of Health Sciences & Research, 8(10).
Collins JE, Gill TK, Chittleborough CR, Martin AJ, Taylor AW, Winefield H. Mental, emotional, and social problems among school children with asthma. J Asthma. 2008 Aug;45(6):489-93. doi: 10.1080/02770900802074802.
PubMed 18612902Das, S. M., Nayak, G. R., & Pradhan, R. (2018). Effect of Balloon Therapy vs. Bubble Therapy on LRTI among 3-12 Years Children. International Journal of Health Sciences & Research, 8(1), 144-147.
Gomieiro LT, Nascimento A, Tanno LK, Agondi R, Kalil J, Giavina-Bianchi P. Respiratory exercise program for elderly individuals with asthma. Clinics (Sao Paulo). 2011;66(7):1163-9. doi: 10.1590/s1807-59322011000700007.
PubMed 21876968Grammatopoulou EP, Skordilis EK, Stavrou N, Myrianthefs P, Karteroliotis K, Baltopoulos G, Koutsouki D. The effect of physiotherapy-based breathing retraining on asthma control. J Asthma. 2011 Aug;48(6):593-601. doi: 10.3109/02770903.2011.587583. Epub 2011 Jun 13.
PubMed 21668321Jun HJ, Kim KJ, Nam KW, Kim CH. Effects of breathing exercises on lung capacity and muscle activities of elderly smokers. J Phys Ther Sci. 2016 Jun;28(6):1681-5. doi: 10.1589/jpts.28.1681. Epub 2016 Jun 28.
PubMed 27390394Kang JI, Jeong DK, Choi H. The effects of breathing exercise types on respiratory muscle activity and body function in patients with mild chronic obstructive pulmonary disease. J Phys Ther Sci. 2016 Jan;28(2):500-5. doi: 10.1589/jpts.28.500. Epub 2016 Feb 29.
PubMed 27064889Lima EV, Lima WL, Nobre A, dos Santos AM, Brito LM, Costa Mdo R. Inspiratory muscle training and respiratory exercises in children with asthma. J Bras Pneumol. 2008 Aug;34(8):552-8. doi: 10.1590/s1806-37132008000800003. English, Portuguese.
PubMed 18797738Marcelino AM, da Cunha DA, da Cunha RA, da Silva HJ. Respiratory muscle strength in asthmatic children. Int Arch Otorhinolaryngol. 2012 Oct;16(4):492-6. doi: 10.7162/S1809-97772012000400010.
PubMed 25991978
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balloon Blowing Breathing Exercise on Respiratory Muscle Strength and Symptoms in School-age Children With Asthma.
- ClinicalTrials.gov ID
- NCT04874649
- Acronym / sponsor ID
- EX PHYSIO SPSC 1
- Conditions
- Asthma in Children
- Keywords
- Balloon blowing breathing, respiratory muscle strength, school-age children with asthma, Sustained maximal inspiration (SMI) breathing, Asthma symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 6 May 2021 (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 were to investigate the effects of balloon blowing breathing exercise on respiratory muscle strength and asthma symptoms in school-age children with asthma.
Detailed description
Thirty school-age children with asthma aged 7 - 12 years old who were admitted at the outpatient examination room, Phramongkutklao Hospital, divided into 2 groups. The first group was 15 individuals trained with sustained maximal inspiration (SMI) breathing exercise while the second group was 15 individuals training with balloon-blowing breathing exercise. Participants were required to complete breathing exercise 5 times per week for 8 weeks. Five breathing exercises were taken for 8 weeks before and after the experiment. Physiological characteristics data, pulmonary function, respiratory muscle strength, and asthma symptoms variables were comparatively analyzed before and after training. The mean values of variables before and after the experiment of each group were analyzed using paired t-test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Thirty school-age children with asthma aged 7 - 12 years old who were admitted at the outpatient examination room, Phramongkutklao Hospital, divided into 2 groups. The first group was 15 individuals trained with sustained maximal inspiration (SMI) breathing exercise while the second group was 15 individuals training with balloon-blowing breathing exercise. Participants were required to complete breathing exercise 5 times per week for 8 weeks. Physiological characteristics data and pulmonary function variables were comparatively analyzed before and after training. The dependent variables between pre-test and post-test were analyzed by a paired t-test. Independent t-test was used to compare the variables between groups. Differences were considered to be significant at p < .05.
| Arm | Type | Receives |
|---|---|---|
| Balloon-blowing breathing | Experimental | Other: Balloon-blowing breathing1. Start by measuring the vital capacity using a balloon to determine. The width of the balloon diameter for each blow and used the value to make a balloon size control device to give to the sample group and parents to use it for home training. 2. Participant sit on a chair. Inhale fully through their nose and hold for a full 3 second inhalation, then exhale through their mouth into the balloon fully. By having the balloon inflate until their touch the balloon size control device and hold the exhalation period for 1 second, cover the balloon immediately with your fingers count as 1 breath cycle, then replace the balloon immediately. Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks |
| Sustained maximal inspiration breathing | Experimental | Other: Sustained maximal inspiration breathingParticipants sitting in a chair, back and head close to the wall. Inhale through their nose fully and hold for 3 seconds for a full breath, then slowly exhale through their mouth and hold for 1 second of exhalation, counted as 1 breathing cycle.Do this 3 times in a row for 1 set. Practice each time doing a total of 3 sets, with 1 minute rest between sets. Participants were required to complete breathing exercise 5 times per week for 8 weeks. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- has been diagnosed with asthma for at least 6 months. The severity rating is not higher than level 2, (Forced expiratory volume in one second; FEV1 is at least 80%)
- No history of diabetes, heart disease, and musculoskeletal disease
- Did not participate in exercise training for more than 20 minutes 3 times a week or more in the 6 months prior to the start of data collection.
Key exclusion criteria (4 listed)
- Patient with a history of exercise-induced asthma.
- Recurrent of acute exacerbation
- Cannot participate at least 80% of training program (≤ 32 sessions of 40 sessions)
- Unwilling to continue practicing
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 breathingParticipant sit on a chair. Inhale fully through their nose and hold for a full 3 second inhalation, then exhale through their mouth into the balloon fully. By having the balloon inflate until their touch the balloon size control device and hold the exhalation period for 1 second, cover the balloon immediately with your fingers count as 1 breath cycle, then replace the balloon immediately. Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks | Other | Balloon-blowing breathing |
| Sustained maximal inspiration breathingParticipant sit on a chair. Inhale through their nose fully and hold for 3 seconds for a full breath, Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks | Other | Sustained maximal inspiration breathing |
Primary outcome
Respiratory muscle strength change
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity [FRC] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity [TLC] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds.
Asthma control change
Time frame: Change from Baseline Asthma control at 8 weeks.
Asthma control was measured by Childhood Asthma Control Test (C - ACT) questionnaire. The range of C-ACT scores is 0 to 27 (27 = totally controlled, 20-26 = well controlled, <26 = insufficiently controlled)
6 secondary outcomes
Force Vital Capacity (FVC) change
Time frame: Change from Baseline Force Vital Capacity at 8 weeks.
Forced expiratory volume in 1 second (FEV1) change
Time frame: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
Time frame: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
Peak Expiratory Flow (PEF) change
Time frame: Change from Baseline Peak Expiratory Flow at 8 weeks.
Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
Time frame: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
Maximal Voluntary Ventilation (MVV) change
Time frame: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
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 6 May 2021.
- BackgroundChauhan, N., & Gunjal, S. (2018). Effect of Balloon Blowing Exercise on Peak Expiratory Flow Rate in Modified Radical Mastectomy. International Journal of Health Sciences & Research, 8(10).
- Background: PubMed 18612902Collins JE, Gill TK, Chittleborough CR, Martin AJ, Taylor AW, Winefield H. Mental, emotional, and social problems among school children with asthma. J Asthma. 2008 Aug;45(6):489-93. doi: 10.1080/02770900802074802.
- BackgroundDas, S. M., Nayak, G. R., & Pradhan, R. (2018). Effect of Balloon Therapy vs. Bubble Therapy on LRTI among 3-12 Years Children. International Journal of Health Sciences & Research, 8(1), 144-147.
- Background: PubMed 21876968Gomieiro LT, Nascimento A, Tanno LK, Agondi R, Kalil J, Giavina-Bianchi P. Respiratory exercise program for elderly individuals with asthma. Clinics (Sao Paulo). 2011;66(7):1163-9. doi: 10.1590/s1807-59322011000700007.
- Background: PubMed 21668321Grammatopoulou EP, Skordilis EK, Stavrou N, Myrianthefs P, Karteroliotis K, Baltopoulos G, Koutsouki D. The effect of physiotherapy-based breathing retraining on asthma control. J Asthma. 2011 Aug;48(6):593-601. doi: 10.3109/02770903.2011.587583. Epub 2011 Jun 13.
- Background: PubMed 27390394Jun HJ, Kim KJ, Nam KW, Kim CH. Effects of breathing exercises on lung capacity and muscle activities of elderly smokers. J Phys Ther Sci. 2016 Jun;28(6):1681-5. doi: 10.1589/jpts.28.1681. Epub 2016 Jun 28.
- Background: PubMed 27064889Kang JI, Jeong DK, Choi H. The effects of breathing exercise types on respiratory muscle activity and body function in patients with mild chronic obstructive pulmonary disease. J Phys Ther Sci. 2016 Jan;28(2):500-5. doi: 10.1589/jpts.28.500. Epub 2016 Feb 29.
- Background: PubMed 18797738Lima EV, Lima WL, Nobre A, dos Santos AM, Brito LM, Costa Mdo R. Inspiratory muscle training and respiratory exercises in children with asthma. J Bras Pneumol. 2008 Aug;34(8):552-8. doi: 10.1590/s1806-37132008000800003. English, Portuguese.
- Background: PubMed 25991978Marcelino AM, da Cunha DA, da Cunha RA, da Silva HJ. Respiratory muscle strength in asthmatic children. Int Arch Otorhinolaryngol. 2012 Oct;16(4):492-6. doi: 10.7162/S1809-97772012000400010.
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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 Balloon-blowing breathing and Sustained maximal inspiration breathing in people with Asthma in Children, run by Chulalongkorn University at 1 site in Thailand.
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 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 6 May 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 Thailand. 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?
Respiratory muscle strength change (time frame: Change from Baseline respiratory muscle strength at 8 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?
On the ClinicalTrials.gov record for NCT04874649, which also lists 9 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 6 May 2021.