Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma (Asthma PBM)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Asthma is a chronic inflammatory disease characterized by airway hyperresponsiveness, persistent inflammation, airflow limitation, and structural airway remodeling. Pediatric asthma remains a major public health concern due to its impact on lung development, exercise tolerance, quality of life, and healthcare utilization. Despite advances in pharmacological therapies, many children continue to experience symptoms, exacerbations, and functional limitations, highlighting the need for complementary therapeutic strategies.
Photobiomodulation therapy (PBMT) has emerged as a promising non-invasive intervention capable of modulating biological processes through light energy absorption by cellular photoreceptors. By stimulating mitochondrial activity and enhancing ATP production, PBMT may reduce inflammatory responses, improve tissue repair, and optimize microcirculatory function without inducing thermal damage. Experimental studies have demonstrated anti-inflammatory effects associated with reductions in pro-inflammatory cytokines and oxidative stress markers.
This randomized clinical trial aims to investigate the chronic effects of an LED vest-based photobiomodulation intervention on functional capacity, inflammatory markers, and pulmonary outcomes in children aged 6-17 years diagnosed with mild to moderate asthma. Participants will be randomly assigned to either an intervention group receiving active LED treatment or a control group receiving sham treatment through an inactive vest. Clinical and functional assessments will include spirometry, Asthma Control Test (ACT), GINA assessment, and the Incremental Step Test (IST) to evaluate exercise tolerance. Additional physiological parameters may be analyzed to investigate underlying mechanisms associated with treatment response.
The findings of this study may contribute to the development of innovative, accessible, and clinically applicable therapeutic strategies for pediatric asthma management.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Luciana M Sampaio, Dra
- Numéro de téléphone: +55011996002075
- E-mail: lucianamalosa@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Emilia R Nascimento
- Numéro de téléphone: +55019997924782
- E-mail: ernemilia@gmail.com
Lieux d'étude
-
-
-
São Paulo, Brésil, 01525000
- Uninove
-
Contact:
- Luciana M Sampaio, Dra
- Numéro de téléphone: +55011996002075
- E-mail: lucianamalosa@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
School-aged children aged 6 to 17 years, diagnosed with mild to moderate asthma, undergoing regular pharmacological treatment, clinically stable, and whose parents/legal guardians provide informed consent and who agree to participate through signed informed consent and assent forms (ICF and AF).
Exclusion Criteria:
History of asthma exacerbation within 30 days prior to study initiation, failure to complete the questionnaires, or failure to provide signed informed consent and assent forms (ICF and AF).
Plan d'étude
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: Photobiomodulation and exercise
20 minutes using PTBM after 30 minutes making aerobic exercise
|
1. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator. |
|
Comparateur factice: Exercise
30 minutes making aerobic exercise
|
Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional exercise capacity
Délai: From enrollment to the end of treatment at 8 week
|
Oxugen consumption measured during cardiopulmonary testing
|
From enrollment to the end of treatment at 8 week
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
FVC
Délai: From enrollment to the end of treatment at 8 week
|
lung function- forced vital capacity
|
From enrollment to the end of treatment at 8 week
|
|
FEV1
Délai: From enrollment to the end of treatment at 8 week
|
lung function- expiratory volume in 1 second
|
From enrollment to the end of treatment at 8 week
|
|
Global Initiative for Asthma
Délai: From enrollment to the end of treatment at 8 week
|
score
|
From enrollment to the end of treatment at 8 week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Luciana M Sampaio, Dra, University of Nove de Julho
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Conditions pathologiques, signes et symptômes
- Asthme
- Maladie
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Thérapie au laser
- Photothérapie
- Exercice
- Thérapie lumineuse de bas niveau
Autres numéros d'identification d'étude
- Asthma and photobiomodulation
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .