NCT04874649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 21, 2021

Last Update Submit

April 30, 2021

Conditions

Keywords

Balloon blowing breathingrespiratory muscle strengthschool-age children with asthmaSustained maximal inspiration (SMI) breathingAsthma symptoms

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (6)

  • Force Vital Capacity (FVC) change

    Change from Baseline Force Vital Capacity at 8 weeks.

  • Forced expiratory volume in 1 second (FEV1) change

    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

    Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.

  • Peak Expiratory Flow (PEF) change

    Change from Baseline Peak Expiratory Flow at 8 weeks.

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

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

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.

Other: Sustained maximal inspiration breathing

Interventions

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

Balloon-blowing 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

Sustained maximal inspiration breathing

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related 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).

    BACKGROUND
  • 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.

    PMID: 18612902BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21876968BACKGROUND
  • 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.

    PMID: 21668321BACKGROUND
  • 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.

    PMID: 27390394BACKGROUND
  • 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.

    PMID: 27064889BACKGROUND
  • 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.

    PMID: 18797738BACKGROUND
  • 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.

    PMID: 25991978BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 21, 2021

First Posted

May 6, 2021

Study Start

October 2, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

May 6, 2021

Record last verified: 2021-04

Locations