Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma (Asthma PBM)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Luciana M Sampaio, Dra
- 전화번호: +55011996002075
- 이메일: lucianamalosa@gmail.com
연구 연락처 백업
- 이름: Emilia R Nascimento
- 전화번호: +55019997924782
- 이메일: ernemilia@gmail.com
연구 장소
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São Paulo, 브라질, 01525000
- Uninove
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연락하다:
- Luciana M Sampaio, Dra
- 전화번호: +55011996002075
- 이메일: lucianamalosa@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Photobiomodulation and exercise
20 minutes using PTBM after 30 minutes making aerobic exercise
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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. |
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가짜 비교기: Exercise
30 minutes making aerobic exercise
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Functional exercise capacity
기간: From enrollment to the end of treatment at 8 week
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Oxugen consumption measured during cardiopulmonary testing
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From enrollment to the end of treatment at 8 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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FVC
기간: From enrollment to the end of treatment at 8 week
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lung function- forced vital capacity
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From enrollment to the end of treatment at 8 week
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FEV1
기간: From enrollment to the end of treatment at 8 week
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lung function- expiratory volume in 1 second
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From enrollment to the end of treatment at 8 week
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Global Initiative for Asthma
기간: From enrollment to the end of treatment at 8 week
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score
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From enrollment to the end of treatment at 8 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Luciana M Sampaio, Dra, University of Nove de Julho
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Asthma and photobiomodulation
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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