ObesityNCT07576478
Effects of Blowing Balloon Therapy FUNCTION, DYSPNEA AND QUALITY OF LIFE IN OBESE CHILDREN
A study testing Blowing Balloon Therapy Group in people with Obesity, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Blowing Balloon Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Apr 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Blowing Balloon Therapy Group
- Keywords
- Blowing Balloon Therapy, Dyspnea, Pulmonary function
- Medical subject headings
- Obesity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blowing Balloon Therapy GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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. Receives: Other: Blowing Balloon Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start13 Apr 2026
- Primary completion15 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Azam, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576478
- Sponsor's protocol ID
- REC/RCR&AHS/25/0726
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33207980Hurvitz 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.
PubMed 33228934Abulimiti 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.
PubMed 40268060
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blowing Balloon Therapy on Pulmonary Function, Dyspnea and Quality of Life in Obese Children
- ClinicalTrials.gov ID
- NCT07576478
- Acronym / sponsor ID
- REC/RCR&AHS/25/0726
- Conditions
- Obesity
- Keywords
- Blowing Balloon Therapy, Dyspnea, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blowing Balloon Therapy Group | Experimental | Other: Blowing Balloon Therapy GroupThis 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, |
| Running Group | Active comparator | Other: Blowing Balloon Therapy GroupThis 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Obese children having 30 or greater than 30 BMI
Key exclusion criteria (4 listed)
- Recent asthma exacerbation or respiratory infection in the past 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blowing Balloon Therapy GroupBlowing 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. | Other | Blowing Balloon Therapy Group, Running Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 33207980Motomura 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.
- Background: PubMed 33228934Hurvitz 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.
- Background: PubMed 40268060Abulimiti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Azam, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blowing Balloon Therapy Group in people with Obesity, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (time frame: 4th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07576478, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.