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

Not Applicable

Completed

• Conditions: Asthma in Children

• Registration Number: NCT04874649
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2019-10-02
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2021-04
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-30
• Last Update Submitted: 2021-04-30
• Study First Posted: 2021-05-06
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma control change	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)
Respiratory muscle strength change	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.

Secondary Outcome Measures

Name	Time	Method
Force Vital Capacity (FVC) change	Change from Baseline Force Vital Capacity at 8 weeks.	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	Change from Baseline Forced expiratory volume in 1 second at 8 weeks.	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.
Maximal Voluntary Ventilation (MVV) change	Change from Baseline Maximum Voluntary Ventilation at 8 weeks.	The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change	Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.	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	Change from Baseline Peak Expiratory Flow at 8 weeks.	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	Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.	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.

Trial Locations

Locations (1)

Faculty of Sports Science, Chulalongkorn University; 🇹🇭 Bangkok, Thailand