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NCT Number: NCT07576478

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Paraplegic Center

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location status: Recruiting

Location contact

abdul wasay, msnmpt

PRINCIPAL_INVESTIGATOR

misbah ghous, msnmpt

CONTACT

[email protected]

03337636752

muhammad mannan, phd

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pulmonary Function

    Time frame: 4th day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad, phd

CONTACT

[email protected]

3324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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