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

NCT07613671 | Not Yet Recruiting DMC

• 1 other identifier: Asthma and photobiomodulation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma (Diagnosis)

Keywords

pediatric asthma; Photobiomodulation Therapy; Pulmonary Function; Inflammatory Biomarkers; Low-Level Light Therapy (LLLT); asthma

Outcome Measures

Primary Outcomes (1)

• Functional exercise capacity

  Oxugen consumption measured during cardiopulmonary testing

  From enrollment to the end of treatment at 8 week

Secondary Outcomes (3)

• FVC

  From enrollment to the end of treatment at 8 week

• FEV1

  From enrollment to the end of treatment at 8 week

• Global Initiative for Asthma

  From enrollment to the end of treatment at 8 week

Study Arms (2)

Photobiomodulation and exercise

EXPERIMENTAL

20 minutes using PTBM after 30 minutes making aerobic exercise

Other: Photobiomodulation

Exercise

SHAM COMPARATOR

30 minutes making aerobic exercise

Other: Exercise

Interventions

Photobiomodulation OTHER

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.

Photobiomodulation and exercise

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Critérios de Inclusão: Crianças em idade escolar de 6 a 17 anos Diagnosticado com asma leve a moderada (tratamento farmacológico regular) clinicamente estável Critérios de exclusão:Histórico de exacerbação da asma dentro de 30 dias antes do início do estudo, FAlha no preenchimento dos questionários

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Uninove

São Paulo, São Paulo, 01525000, Brazil

Location

MeSH Terms

Conditions

Asthma; Disease

Interventions

Low-Level Light Therapy; Exercise

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luciana M Sampaio, Dra

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana M Sampaio, Dra

CONTACT

+55011996002075; lucianamalosa@gmail.com

Emilia R Nascimento

CONTACT

+55019997924782; ernemilia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)