Clinical trial NCT04874649: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: Balloon blowing breathing
respiratory muscle strength
school-age children with asthma
Sustained maximal inspiration (SMI) breathing
Asthma symptoms
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Respiratory muscle strength change
timeFrame: Change from Baseline respiratory muscle strength at 8 weeks.
measure: Asthma control change
timeFrame: Change from Baseline Asthma control at 8 weeks.
Secondary outcomes:
measure: Force Vital Capacity (FVC) change
timeFrame: Change from Baseline Force Vital Capacity at 8 weeks.
measure: Forced expiratory volume in 1 second (FEV1) change
timeFrame: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
measure: The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
timeFrame: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
measure: Peak Expiratory Flow (PEF) change
timeFrame: Change from Baseline Peak Expiratory Flow at 8 weeks.
measure: Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
timeFrame: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
measure: Maximal Voluntary Ventilation (MVV) change
timeFrame: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
Study officials:
References:
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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.
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