- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07576478
Effects of Blowing Balloon Therapy FUNCTION, DYSPNEA AND QUALITY OF LIFE IN OBESE CHILDREN
4 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
38
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: imran amjad, phd
- Numéro de téléphone: 3324390125
- E-mail: imran.amjad@riphah.edu.pk
Lieux d'étude
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Recrutement
- Paraplegic Center
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Sous-enquêteur:
- muhammad mannan, phd
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Contact:
- misbah ghous, msnmpt
- Numéro de téléphone: 03337636752
- E-mail: misbah.ghous@riphah.edu.pk
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Chercheur principal:
- abdul wasay, msnmpt
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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,
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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.
|
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Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pulmonary Function
Délai: 4th day
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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.
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4th day
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Aruba Saeed, PhD, Riphah International University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 avril 2026
Achèvement primaire (Estimé)
15 juillet 2026
Achèvement de l'étude (Estimé)
15 août 2026
Dates d'inscription aux études
Première soumission
4 mai 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
8 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/RCR&AHS/25/EMAN AZAM
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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