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

NCT07576478 | Recruiting

• 1 other identifier: REC/RCR&AHS/25/EMAN AZAM
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Childhood

Keywords

Blowing Balloon Therapy (BBT), Pulmonary Function, Dyspnea,

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function

  The primary outcome of this study is pulmonary function, specifically measured by Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁) using spirometry. These measurements will be taken at baseline (pre-intervention) and after completion of the intervention (post-intervention) to assess changes in lung function. Any improvement in FVC and FEV₁ values will reflect enhanced respiratory capacity and indicate the effectiveness of the intervention in obese children with dyspnea.

  4th day

Study Arms (2)

Blowing Balloon Therapy Group

EXPERIMENTAL

This arm will include 19 obese children (BMI ≥30), aged 6-12 years, experiencing mild to moderate dyspnea (RPE 8-14). Participants in this group will receive blowing balloon therapy, a structured respiratory intervention aimed at improving lung function by strengthening respiratory muscles,

Other: Blowing Balloon Therapy Group

Running Group

ACTIVE COMPARATOR

This arm will also consist of 19 obese children with similar inclusion criteria. Participants will perform splint running, which serves as the control activity involving general physical exercise without specific respiratory training.

Other: Blowing Balloon Therapy Group

Interventions

Blowing Balloon Therapy Group OTHER

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.

Blowing Balloon Therapy Group; Running Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Paraplegic Center

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Dyspnea

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• aruba saeed, phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

3324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)