リハビリテーションの運動と非尿症のマイコバクテリア肺疾患における気道クリアランス技術の教育：前向きコホート研究（NTM-Rehab） (NTM-Rehab)
リハビリテーションの運動と、非尿症のマイコバクテリア肺疾患における気道クリアランス技術の教育：前向きコホート研究
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The goal of this observational study is to evaluate the effects of pulmonary rehabilitation and airway clearance education in adults with nontuberculous mycobacterial pulmonary disease (NTM-PD). The main questions it aims to answer are:
- Does pulmonary rehabilitation and airway clearance training improve lung function, symptom relief, and quality of life in patients with NTM-PD?
- Does this non-pharmacological intervention contribute to better sputum culture conversion rates?
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Participants will:
- Undergo pulmonary rehabilitation and airway clearance training over an 8-week period (biweekly sessions).
- Receive evaluations at baseline, during the intervention, and follow-up assessments at 2 months, 6 months, and final study visit.
- Undergo tests including pulmonary function tests (PFT), symptom assessments, bacteriologic evaluations, radiographic imaging (CT/X-ray), and quality of life surveys (EQ-5D-5L, CAT score).
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This study aims to provide clinical evidence supporting the role of non-pharmacological treatments in the management of NTM-PD, potentially informing future treatment guidelines and improving patient outcomes.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Hyung-Jun Kim, MD
- 電話番号：+82-31-787-7844
- メール：dr.hjkim@snu.ac.kr
研究場所
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Beitou Dist
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Taipei、Beitou Dist、台湾、112201
- 募集
- Taipei Veterans General Hospital
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コンタクト：
- Jia-Yih Feng
- 電話番号：+886-2-2871-2121
- メール：peterofeng@gmail.com
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コンタクト：
- Chih-Jung Chang
- メール：rhonda610273@gmail.com
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Gyeonggi-do
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Seongnam-si、Gyeonggi-do、韓国、13620
- 募集
- Seoul National University Bundang Hospital
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コンタクト：
- Hyung-Jun Kim, MD
- 電話番号：+82-31-787-7844
- メール：dr.hjkim@snu.ac.kr
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主任研究者：
- Hyung-Jun Kim, MD
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副調査官：
- Jaewon Beom, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
This study will enroll adult patients (≥20 years old) diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on the 2020 ATS guidelines. Participants will be recruited from outpatient pulmonary clinics at study sites. Eligible participants will undergo pulmonary rehabilitation and airway clearance training as part of a prospective observational study. The study focuses on assessing the effects of non-pharmacological interventions on lung function, symptom relief, and quality of life in patients with NTM-PD.
The cohort will include patients with clinically significant NTM species such as Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium abscessus, Mycobacterium massiliense, and Mycobacterium kansasii. Participants will undergo baseline assessment, structured rehabilitation sessions, and follow-up evaluations at 2 months and 6 months. The study aims to provide real-world clinical evidence sup
説明
Inclusion Criteria:
- Age 20 years or older at the time of enrollment.
- Diagnosis of nontuberculous mycobacterial pulmonary disease (NTM-PD) according to the 2020 American Thoracic Society (ATS) guidelines.
- Identification of clinically significant NTM species, including:
Mycobacterium avium / Mycobacterium intracellulare / Mycobacterium abscessus / Mycobacterium massiliense / Mycobacterium kansasii /
- Able to undergo pulmonary rehabilitation and airway clearance training as part of the study protocol.
- Willing to provide written informed consent to participate in the study.
Exclusion Criteria:
- Currently pregnant or actively breastfeeding.
- Unable to participate in pulmonary rehabilitation due to severe mobility impairment or neuromuscular disorders.
- History of massive hemoptysis or other medical conditions where airway clearance techniques may be contraindicated.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
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NTM-PD Pulmonary Rehabilitation Cohort
This cohort consists of adults diagnosed with nontuberculous mycobacterial pulmonary disease (NTM-PD) who will undergo pulmonary rehabilitation and airway clearance training as part of a prospective observational study. Participants will receive an 8-week biweekly pulmonary rehabilitation program, including oscillating positive expiratory pressure (OPEP) therapy, high-frequency chest wall oscillation (HFCWO), huffing and coughing techniques, breathing exercises, and aerobic/strength training. They will be monitored at baseline, during treatment, and at 2-month and 6-month follow-ups, undergoing pulmonary function tests (PFT), bacteriologic assessments, radiographic imaging (CT/X-ray), symptom evaluations, and quality of life assessments (EQ-5D-5L, CAT score). This study aims to assess the effectiveness of non-pharmacological interventions in improving respiratory function, reducing symptoms, and enhancing quality of life in NTM-PD patients. |
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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Change in Pulmonary Function (FEV1 and FVC) from Baseline to 6 Months
時間枠：Baseline, 2 months, 6 months
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Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be measured using pulmonary function tests (PFTs) at baseline, after 2 months, and at 6 months to assess improvements in lung function following pulmonary rehabilitation and airway clearance training. |
Baseline, 2 months, 6 months
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Sputum Culture Conversion Rate
時間枠：Baseline, 2 months, 6 months
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The percentage of participants achieving sputum culture conversion, defined as three consecutive negative mycobacterial cultures from respiratory samples collected at least one month apart, will be assessed. |
Baseline, 2 months, 6 months
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6MWT
時間枠：Baseline, 2 months, 6 months
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6 minute walk test distance in meters |
Baseline, 2 months, 6 months
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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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Change in Questionnaire-Bronchiectasis (QOL-B) from Baseline to 6 Months
時間枠：Baseline, 2 months, 6 months
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Quality of life improvements will be assessed using Questionnaire-Bronchiectasis (QOL-B). The questionnaire comprised a total of 37 items, covering domains such as physical functioning (5 items), role functioning (5 items), vitality (3 items), emotional functioning (4 items), social functioning (4 items), health perception (4 items), respiratory symptoms (9 items), and treatment burden (3 items). Each domain score ranged from 0 to 100, with higher scores indicating better quality of life. |
Baseline, 2 months, 6 months
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Change in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) from Baseline to 6 Months
時間枠：Baseline, 2 months, 6 months
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EuroQoL 5-Dimension 5-Level (EQ-5D-5L) includes quality of life assessments including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores can range from 11111 to 55555, with lower scores referring tobetter quality of life. |
Baseline, 2 months, 6 months
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Severity of radiographic findings
時間枠：Baseline, 2 months, 6 months
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High-resolution computed tomography (HRCT) and chest X-rays will be used to evaluate changes in lung structure, including bronchiectasis severity and cavitary lesions. Presence and size of cavities will be measured in chest CT, and artificial intelligenced-based scoring systems will be used to measure radiographic severity in chest X-rays. |
Baseline, 2 months, 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Physical Function (Grip Strength, 4-Meter Walk Test, Sit-to-Stand Test) from Baseline to 6 Months
時間枠：Baseline, 2 months, 6 months
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Physical function will be assessed using hand-grip strength measurements, a 4-meter walk test, and a sit-to-stand test to evaluate improvements in muscle strength and mobility. |
Baseline, 2 months, 6 months
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Adverse Events Related to Pulmonary Rehabilitation and Airway Clearance Techniques
時間枠：Throughout study period (up to 6 months)
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The incidence of adverse events such as fatigue, muscle pain, hemoptysis, and respiratory distress related to pulmonary rehabilitation interventions will be monitored and documented. |
Throughout study period (up to 6 months)
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Change in body composition: bioimpeance analysis
時間枠：Baseline, 2 months, 6 months
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Change in body composition will be assesed using the bioimpedance analysis. It provides resistance and reactance measured at different frequency currents, providing estimations of the body fat mass (kg), protein mass (kg), and skeletal muscle mass (kg). Volume of body water (L) and percentage of body fat (%) will be calculated as well. |
Baseline, 2 months, 6 months
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- B-2501-949-303
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
At this time, there is no plan to publicly share individual participant data (IPD) due to patient confidentiality and ethical considerations. However, de-identified, aggregated data may be made available upon reasonable request for collaborative research purposes, subject to appropriate ethical approvals and institutional review board (IRB) regulations. If data sharing becomes feasible, it will follow applicable regulations and data protection guidelines.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。