Single-Center Intelligent Pulmonary Rehabilitation After Lung Cancer Surgery
A Randomized Controlled Trial of an Intelligent Pulmonary Function Exercise Device Versus Usual Care for In-Hospital and Home-Based Pulmonary Rehabilitation After Lung Cancer Surgery
This study will compare an intelligent pulmonary function exercise device with usual care and natural recovery in patients recovering from lung cancer surgery.
After lung cancer surgery, many patients have reduced lung function, shortness of breath, lower exercise tolerance, and a risk of postoperative pulmonary complications. Standard care usually includes postoperative nursing, pain control, coughing and sputum clearance instruction, early mobilization, discharge education, and routine follow-up. However, patients often lack structured guidance, feedback, and monitoring after discharge.
Participants in this study will be randomly assigned to one of two groups. One group will use an intelligent pulmonary function exercise device for respiratory training during hospitalization and at home until 30 days after surgery. The prescribed training is two sessions per day, with each session including 30 expiratory training repetitions and 30 inspiratory training repetitions. The device records training completion and related training information and provides reminders and feedback. The other group will receive usual perioperative care, standard discharge education, and natural recovery follow-up without a study-specified respiratory training device or training prescription.
The main purpose of the study is to determine whether the intelligent pulmonary function exercise device improves recovery of forced expiratory volume in 1 second, or FEV1, from before surgery to 30 days after surgery. The study will also evaluate lung function at 90 days, symptoms, quality of life, walking capacity, training adherence, and postoperative complications.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1. Age 18 to 75 years. 2. Pathologically confirmed primary non-small cell lung cancer. 3. Scheduled to undergo elective thoracoscopic lobectomy or sublobar resection. 4. Able to understand the study and voluntarily sign written informed consent before surgery.
5. Able to communicate and complete study assessments and postoperative follow-up.
6. Able to use a smartphone independently or with assistance from a caregiver for training records.
7. Good lung re-expansion on postoperative chest imaging. 8. No chest tube drainage or no persistent air leak from chest tube drainage. 9. Clinical stage cT1-T2b, N0-N1, M0, stage IA-IIB. 10. Home environment allows safe training.
Exclusion Criteria:
1. Preoperative measured FEV1 less than 50% of predicted value. 2. Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.
3. Previous thoracic surgery or major thoracic trauma. 4. Significant cognitive impairment or psychiatric disorder that prevents cooperation with the study.
5. Pregnancy or breastfeeding. 6. Recent severe infection or active pulmonary disease.
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：単一グループの割り当て
- マスキング：独身
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：Intelligent Pulmonary Function Exercise Device Group
|
A digital pulmonary rehabilitation device used for active inspiratory and expiratory respiratory training.
The device records the number of completed training sessions, expiratory and inspiratory repetitions, training parameters, target completion, reminders, and interruptions.
Training data are synchronized to the study platform for adherence monitoring and remote follow-up.
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アクティブコンパレータ：Usual Care and Natural Recovery Group
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Usual perioperative care includes standard postoperative nursing, analgesia, coughing and sputum clearance instruction, early mobilization, wound and drainage tube management, discharge education, and routine follow-up.
No structured pulmonary rehabilitation program assigned by the study team will be provided to the control group.
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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 |
時間枠 |
|---|---|
|
Change in Forced Expiratory Volume in 1 Second From Baseline to 30 Days After Surgery
時間枠：Baseline and 30 days after surgery
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Baseline and 30 days after surgery
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in FEV1 From Baseline to 90 Days After Surgery
時間枠：Baseline and 90 days after surgery
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Baseline and 90 days after surgery
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Dyspnea-12 Score
時間枠：Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
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Baseline, postoperative day 1, before discharge, 1 week after surgery, and 30 days after surgery
|
|
MD Anderson Symptom Inventory-Lung Cancer Module Score
時間枠：Baseline, 30 days after surgery, and 90 days after surgery
|
Baseline, 30 days after surgery, and 90 days after surgery
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Six-Minute Walk Distance
時間枠：Baseline, 30 days after surgery, and 90 days after surgery
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Baseline, 30 days after surgery, and 90 days after surgery
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Postoperative Complications
時間枠：Up to 90 days after surgery
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Up to 90 days after surgery
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協力者と研究者
スポンサー
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
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。