Effects of Blowing Balloon Therapy FUNCTION, DYSPNEA AND QUALITY OF LIFE IN OBESE CHILDREN

Official title

Effects of Blowing Balloon Therapy on Pulmonary Function, Dyspnea and Quality of Life in Obese Children

Overview

The respiratory system is divided into upper and lower tracts and functions through gaseous exchange, ventilation, and perfusion, with normal breathing depending on lung compliance, airway resistance, and muscular strength. Pulmonary function is assessed using spirometry, particularly Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁), which are often reduced in obese children due to excess adipose tissue restricting chest wall expansion and diaphragmatic movement, contributing to dyspnea. This randomized controlled trial will be conducted over 10 months in Lahore at selected hospitals and schools, involving 38 obese children (BMI ≥30), aged 6-12 years with mild to moderate dyspnea (RPE 8-14), who will be randomly assigned to either an experimental group receiving blowing balloon therapy or a control group performing splint running (n=19 each). Participants will be screened using the Borg RPE Scale, and data will be analyzed using SPSS version 20.

Detailed description

The respiratory system is anatomically divided into the upper and lower respiratory tracts and performs essential functions including gaseous exchange, ventilation, and perfusion. Effective breathing depends on optimal lung compliance, minimal airway resistance, and adequate respiratory muscle strength. Pulmonary function is commonly evaluated using spirometry, which measures key parameters such as Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV₁). In obese children, these values are often reduced due to the accumulation of excessive adipose tissue around the thoracic cage and abdomen, leading to impaired respiratory mechanics, restricted chest wall expansion, limited diaphragmatic movement, and increased work of breathing, which contributes to dyspnea. This study will be conducted as a randomized controlled trial over a period of 10 months following approval of the research synopsis. Data will be collected from multiple healthcare and educational institutions in Lahore, including Fatima Memorial Hospital, Gulab Devi Hospital, Evercare Hospital, Lahore Grammar School (LGS), The Trust School, and Beaconhouse School System. A total of 38 obese children with a Body Mass Index (BMI) of 30 kg/m² or greater, aged between 6 and 12 years, and experiencing mild to moderate dyspnea (Rated 8-14 on the Borg Rating of Perceived Exertion scale) will be recruited. BMI will be calculated using the standard formula: weight in kilograms divided by height in meters squared (kg/m²). Eligible participants will be screened using the Borg RPE Scale questionnaire and then randomly allocated into two groups: an experimental group (n=19) and a control group (n=19). The experimental group will receive blowing balloon therapy as an intervention aimed at improving respiratory function, while the control group will perform splint running as a comparative physical activity. Pre- and post-intervention spirometry measurements will be taken to assess changes in FVC and FEV₁. The collected data will be statistically analyzed using SPSS version 20 to determine the effectiveness of the intervention.

Interventions

• Other Blowing Balloon Therapy Group
  Blowing balloon therapy involves the child inhaling deeply through the nose and exhaling slowly into a balloon, repeated for several sets under supervision. This technique strengthens respiratory muscles, improves lung expansion, and enhances breathing control. Sessions are performed regularly with rest intervals to avoid fatigue and ensure safety.

Primary outcome measures

• Pulmonary Function [Time frame: 4th day]

Eligibility criteria

Inclusion criteria

• Obese children having 30 or greater than 30 BMI

• Age: 6 to 12 years .
• Children with atleast light to moderate intensity dyspnea (RPE 8-14)

Exclusion criteria

• Recent asthma exacerbation or respiratory infection in the past 4 weeks.

• Other chronic respiratory (e.g. cystic fibrosis) or cardiac diseases.
• Musculoskeletal, neurological, or other conditions that contraindicate exercise.
• Non-ambulatory status or inability to perform the exercise protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Paraplegic Center — Peshawar

Publications

• Motomura C, Matsuzaki H, Odajima H, Oki T, Yasunari Y, Kawano T, Iwata M, Okabe K, Wakatsuki M, Murakami Y, Taba N, Honjo S, Ohga S. Effect of age on exercise-induced bronchoconstriction in children and adolescents with asthma. J Asthma. 2022 Feb;59(2):297-305. doi: 10.1080/02770903.2020.1853767. Epub 2020 Dec 7. PMID 33207980
• Hurvitz M, Weinberger M. Functional Respiratory Disorders in Children. Pediatr Clin North Am. 2021 Feb;68(1):223-237. doi: 10.1016/j.pcl.2020.09.013. PMID 33228934
• Abulimiti A, Robson LS, Pawelczyk JA, Balmain BN, Zia A, Babb TG. Elevated risk of dyspnea in pediatric patients three months after pulmonary embolism. Respir Med. 2025 Jul;243:108113. doi: 10.1016/j.rmed.2025.108113. Epub 2025 Apr 21. PMID 40268060

Identifiers

NCT: NCT07576478 · REC/RCR&AHS/25/EMAN AZAM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗