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

ConditionAsthma (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity of Nove de Julho

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Photobiomodulation

    Other intervention

    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.

  • Exercise

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Photobiomodulation and exerciseExperimental treatment 1 intervention
Group B: ExerciseSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional exercise capacity

Oxugen consumption measured during cardiopulmonary testing

Time frame
From enrollment to the end of treatment at 8 week

Secondary outcomes

1

FVC

lung function- forced vital capacity

Time frame
From enrollment to the end of treatment at 8 week
2

FEV1

lung function- expiratory volume in 1 second

Time frame
From enrollment to the end of treatment at 8 week
3

Global Initiative for Asthma

score

Time frame
From enrollment to the end of treatment at 8 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nove de Julho

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: