此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年5月4日 更新者:Riphah International University

Effects of Blowing Balloon Therapy on Pulmonary 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.

研究概览

地位

招聘中

详细说明

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.

研究类型

介入性

注册 (估计的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Khyber Pakhtunkhwa
      • Peshawar、Khyber Pakhtunkhwa、巴基斯坦、25000
        • 招聘中
        • Paraplegic Center
        • 副研究员:
          • muhammad mannan, phd
        • 接触:
        • 首席研究员:
          • abdul wasay, msnmpt

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Blowing Balloon Therapy Group
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,
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.
有源比较器:Running Group
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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pulmonary Function
大体时间: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.
4th day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aruba Saeed, PhD、Riphah International University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月13日

初级完成 (估计的)

2026年7月15日

研究完成 (估计的)

2026年8月15日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅