Effects of Blowing Balloon Therapy FUNCTION, DYSPNEA AND QUALITY OF LIFE IN OBESE CHILDREN
4 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
38
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: imran amjad, phd
- Telefoonnummer: 3324390125
- E-mail: imran.amjad@riphah.edu.pk
Studie Locaties
-
-
Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Werving
- Paraplegic Center
-
Onderonderzoeker:
- muhammad mannan, phd
-
Contact:
- misbah ghous, msnmpt
- Telefoonnummer: 03337636752
- E-mail: misbah.ghous@riphah.edu.pk
-
Hoofdonderzoeker:
- abdul wasay, msnmpt
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pulmonary Function
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Aruba Saeed, PhD, Riphah International University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 april 2026
Primaire voltooiing (Geschat)
15 juli 2026
Studie voltooiing (Geschat)
15 augustus 2026
Studieregistratiedata
Eerst ingediend
4 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
4 mei 2026
Eerst geplaatst (Werkelijk)
8 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
4 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC/RCR&AHS/25/EMAN AZAM
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .