Back to resultsBalloon Blowing Breathing Exercise in School-age Children With Asthma.
Primary Purpose
Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Balloon-blowing breathing
Sustained maximal inspiration breathing
Sponsored by
About this trial
This is an interventional basic science trial for Asthma in Children focused on measuring Balloon blowing breathing, respiratory muscle strength, school-age children with asthma, Sustained maximal inspiration (SMI) breathing, Asthma symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Faculty of Sports Science, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Balloon-blowing breathing
Sustained maximal inspiration breathing
Arm Description
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. 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
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.
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04874649
First Posted
April 21, 2021
Last Updated
April 30, 2021
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT04874649
Brief Title
Balloon Blowing Breathing Exercise in School-age Children With Asthma.
Official Title
Effects of Balloon Blowing Breathing Exercise on Respiratory Muscle Strength and Symptoms in School-age Children With Asthma.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
Balloon blowing breathing, respiratory muscle strength, school-age children with asthma, Sustained maximal inspiration (SMI) breathing, Asthma symptoms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balloon-blowing breathing
Arm Type
Experimental
Arm Description
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.
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
Arm Title
Sustained maximal inspiration breathing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Balloon-blowing breathing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sustained maximal inspiration breathing
Intervention Description
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
Primary Outcome Measure Information:
Title
Respiratory muscle strength change
Description
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.
Time Frame
Change from Baseline respiratory muscle strength at 8 weeks.
Title
Asthma control change
Description
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)
Time Frame
Change from Baseline Asthma control at 8 weeks.
Secondary Outcome Measure Information:
Title
Force Vital Capacity (FVC) change
Description
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.
Time Frame
Change from Baseline Force Vital Capacity at 8 weeks.
Title
Forced expiratory volume in 1 second (FEV1) change
Description
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.
Time Frame
Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
Title
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
Description
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.
Time Frame
Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
Title
Peak Expiratory Flow (PEF) change
Description
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.
Time Frame
Change from Baseline Peak Expiratory Flow at 8 weeks.
Title
Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
Description
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.
Time Frame
Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
Title
Maximal Voluntary Ventilation (MVV) change
Description
The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.
Time Frame
Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Citations:
Citation
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).
Results Reference
background
PubMed Identifier
18612902
Citation
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.
Results Reference
background
Citation
Das, 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.
Results Reference
background
PubMed Identifier
21876968
Citation
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.
Results Reference
background
PubMed Identifier
21668321
Citation
Grammatopoulou 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.
Results Reference
background
PubMed Identifier
27390394
Citation
Jun 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.
Results Reference
background
PubMed Identifier
27064889
Citation
Kang 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.
Results Reference
background
PubMed Identifier
18797738
Citation
Lima 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.
Results Reference
background
PubMed Identifier
25991978
Citation
Marcelino 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.
Results Reference
background
Learn more about this trial
Balloon Blowing Breathing Exercise in School-age Children With Asthma.
We'll reach out to this number within 24 hrs