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Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma (Asthma PBM)

28. maj 2026 opdateret af: LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
Asthma is a chronic inflammatory disease of the airways that results in tissue remodeling, airflow limitation, and bronchial hyperresponsiveness. This study aims to evaluate the long-term effects of photobiomodulation using an LED vest in the management of pediatric asthma. It is a randomized clinical trial involving children aged 6 to 17 years diagnosed with mild to moderate asthma, divided into two groups: an intervention group (using a vest with active LEDs) and a control group (using the vest turned off, simulating the intervention without light emission). The methodology includes clinical and functional assessments such as spirometry, the Asthma Control Test (ACT), the GINA questionnaire, and the Incremental Step Test (IST), which measures exercise tolerance. Photobiomodulation through LEDs promotes cellular biostimulation without thermal effects, modulating inflammatory processes and optimizing tissue regeneration. It is expected that the LED vest will contribute to improving pulmonary function, enhancing quality of life, and complementing conventional treatments. This project aims to advance the clinical application of photobiomodulation as an accessible and effective therapeutic alternative for pediatric asthma.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Photobiomodulation and exercise
20 minutes using PTBM after 30 minutes making aerobic exercise
Andet: Photobiomodulation

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.
Sham-komparator: Exercise
30 minutes making aerobic exercise
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional exercise capacity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
FVC
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment to the end of treatment at 8 week
score
From enrollment to the end of treatment at 8 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nove de Julho

Efterforskere

  • Ledende efterforsker: Luciana M Sampaio, Dra, University of Nove de Julho

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

30. januar 2028

Studieafslutning (Anslået)

30. januar 2028

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Asthma and photobiomodulation

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Confidentiality

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Astma (diagnose)

Kliniske forsøg med Photobiomodulation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner