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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma (Diagnosis)
• Intervention / Treatment: Other: Photobiomodulation; Other: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciana M Sampaio, Dra; Phone Number: +55011996002075; Email: lucianamalosa@gmail.com
• Study Contact Backup: Name: Emilia R Nascimento; Phone Number: +55019997924782; Email: ernemilia@gmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 01525000
    • Uninove
    • Contact: Luciana M Sampaio, Dra; Phone Number: +55011996002075; Email: lucianamalosa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation and exercise; 20 minutes using PTBM after 30 minutes making aerobic exercise	Other: 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 Comparator: Exercise; 30 minutes making aerobic exercise	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity	Oxugen consumption measured during cardiopulmonary testing	From enrollment to the end of treatment at 8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC	lung function- forced vital capacity	From enrollment to the end of treatment at 8 week
FEV1	lung function- expiratory volume in 1 second	From enrollment to the end of treatment at 8 week
Global Initiative for Asthma	score	From enrollment to the end of treatment at 8 week

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Luciana M Sampaio, Dra, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: asthma; Pulmonary Function; Photobiomodulation Therapy; pediatric asthma; Inflammatory Biomarkers; Low-Level Light Therapy (LLLT)
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Asthma; Disease; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Laser Therapy; Phototherapy; Exercise; Low-Level Light Therapy
• Other Study ID Numbers: Asthma and photobiomodulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No