Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma (Asthma PBM)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Luciana M Sampaio, Dra
- 電話番号：+55011996002075
- メール：lucianamalosa@gmail.com
研究連絡先のバックアップ
- 名前：Emilia R Nascimento
- 電話番号：+55019997924782
- メール：ernemilia@gmail.com
研究場所
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São Paulo、ブラジル、01525000
- Uninove
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コンタクト：
- Luciana M Sampaio, Dra
- 電話番号：+55011996002075
- メール：lucianamalosa@gmail.com
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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偽コンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional exercise capacity
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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FVC
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Luciana M Sampaio, Dra、University of Nove de Julho
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Asthma and photobiomodulation
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Photobiomodulationの臨床試験
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LTBIO Co., Ltd.Samsung Medical Center; Korea University Anam Hospital; Inje University; Gangnam Severance Hospital と他の協力者まだ募集していません膝関節全置換術を受けている患者のリハビリテーション中の術後疼痛管理
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Vita CareTegos S.A.完了
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NYU Langone HealthNational Institute of Mental Health (NIMH)完了