Balloon Blowing Breathing Exercise in School-age Children With Asthma.

Asthma in Children Clinical Trial

Official title:

Effects of Balloon Blowing Breathing Exercise on Respiratory Muscle Strength and Symptoms in School-age Children With Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874649
• Other study ID #: EX PHYSIO SPSC 1
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Respiratory Aspiration

Intervention

Other:
• Balloon-blowing breathing
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
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

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. English, Portuguese. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline respiratory muscle strength at 8 weeks.
Primary	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)	Change from Baseline Asthma control at 8 weeks.
Secondary	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.	Change from Baseline Force Vital Capacity at 8 weeks.
Secondary	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.	Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
Secondary	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.	Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
Secondary	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.	Change from Baseline Peak Expiratory Flow at 8 weeks.
Secondary	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.	Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
Secondary	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.	Change from Baseline Maximum Voluntary Ventilation at 8 weeks.