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The goal of this clinical trial is to investigate the effect of a mobile application intervention on postoperative lung rehabilitation. The main purposes of this study are:
Researchers will compare the intervention group (using the pulmonary rehabilitation mobile application) to the usual care group to determine if the mobile application is effective in lung surgery rehabilitation.
Participants will join the study immediately after providing informed consent and will continue for up to 7 weeks post-surgery. Participants will be randomly allocated to either the intervention group or the control group. Both groups will receive regular pulmonary rehabilitation during their hospital stay (1 day before surgery and 2 to 3 days after surgery). Researchers will guide participants in the intervention group to use the mobile application for pulmonary rehabilitation exercises throughout the study period. Participants in the usual care group will receive health education and an exercise guide before discharge. Participants will undergo three study assessments: at baseline (within 1 week after enrollment), post-surgery (week 5), and at follow-up (week 8).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| application inttervention group | Experimental | The experimental group will receive standard postoperative care, including chest rehabilitation, a mobile application for remote self-training every day after surgery, and an interactive healthcare web platform for health education. |
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| Usual care group | Active Comparator | The usual care group will receive standard postoperative care, including chest rehabilitation and an interactive healthcare web platform for health education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RehabLung mobile application | Behavioral | Participants in the intervention group will receive in-person pulmonary rehabilitation during their surgical admission and access to a mobile pulmonary rehabilitation application for self-training. This program begins one month before surgery and continues for seven weeks after surgery. The application is designed to encourage participants to engage in pulmonary rehabilitation exercises from preoperative preparation through postoperative care. It offers guided chest breathing exercises, using visual and movement instructions created and remotely prescribed by a physical therapist. Participants will receive daily breathing exercise prescriptions throughout the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity-oxygen consumption | Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. Peak oxygen consumption (VO2 peak) will be measured during the exercise test, and values for the difference and change in percent predicted (peak oxygen uptake [mL/kg/min], VO2 peak difference [mL/kg/min], VO2 peak change [%], and [% predicted]) will be obtained from gas analysis. The predicted values will be referenced from the system based on race, age, height, biological sex, and weight. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Exercise capacity-workload | Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. The workload achieved during exercise test will be recored by peak work rate (watts), and peak work rate (%pred.) The predicted workload will be referenced from the system based on race, age, height, biological sex, and weight. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Exercise capacity-ventilatory efficiency | Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. The gas analysis of oxygen exchange efficiency includes maximal ventilation (L/min), maximal ventilation (% predicted), ventilatory equivalents slope, VE/VCO2 slope, ventilatory equivalents, and VE/VCO2 (% predicted). |
| Measure | Description | Time Frame |
|---|---|---|
| Global respiratory muscle strength | Global respiratory muscle strength is assessed using a pressure gauge and a mouthpiece. Participants are guided to perform maximal exhalation followed by full inhalation, and then maximal inhalation followed by full exhalation through the mouth. Measurements include maximal inspiratory pressure (PImax [cmH2O, % predicted]) and maximal expiratory pressure (PEmax [cmH2O, % predicted]). |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | Body mass index (Kg/m2) Age (years) Sex Smoking (%) (current smokers, never smoked, past smokers) Smoking history (packs/year) Presence of COPD Surgery (lobectomy, minor resection, pneumonectomy) Surgery type (thoracotomy, videothoracoscopy) Histological feature (adenocarcinoma, squamous cell carcinoma, other) Length of hospitalization | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun-Ling Tsai, Ph.D. | Contact | 886-6-2353535 | 6219 | kunlingtsai@mail.ncku.edu.tw |
| Hsin-lun Yang, MS. | Contact | 886-6-2353535 | 5078 | t66064043@pt.ncku.edu.tw |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41762649 | Derived | Yang HL, Hung CH, Huang YT, Cheng HC, Tseng YL, Su JM, Tsai KL. The effectiveness of the AI-based RehabLung mobile rehabilitation system on cardiopulmonary function and user satisfaction in lung cancer patients undergoing thoracic surgery: a protocol for a two-arm randomized clinical trial. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261427319. doi: 10.1177/17534666261427319. Epub 2026 Feb 28. |
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IPD sharing plan will be decided after summarized data being published.
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|
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| Lung cancer postoperative standard care | Behavioral | Participants in the usual care group will receive in-person pulmonary rehabilitation during surgical admission, pre-operative healthcare, and guidance on breathing exercises to practice before surgery. They will also receive post-operative breathing exercise prescriptions to follow at home. |
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| Healthcare interactive Web Platform | Other | The healthcare interactive Web Platform provides patients with surgical information through animations. This includes an introduction to lung surgery, preparation procedures, answers to common patient questions, post-surgery wound care, and a brief guide to pulmonary rehabilitation. |
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| Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Exercise capacity-Anaerobic threshold | Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. Anaerobic threshold (AT) (mL/kg/min) is defined as a nonlinear increase in CO2 production, which will be analyze during gas analysis in an incremental exercise test. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Pulmoanry function | The pulmonary function test, assessed by spirometry, is performed to evaluate lung volumes over time and ventilatory capacity. Participants will be guided by experienced therapists to take a maximal inspiration, then exhale with maximal effort for as long and as fast as possible. Measurements include forced vital capacity (FVC [L, % predicted]), forced expiratory volume in one second (FEV1 [L, % predicted]), and the ratio of the two volumes (FEV1/FVC [% predicted]). The predicted values will be referenced from large population studies of healthy adults, matched by race, age, height, biological sex, and weight. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Six Minute Walk Test, 6MWT | The six-minute walk test is conducted by having a therapist encourage the participant to walk continuously at a comfortable speed for six minutes. The distance covered during the six-minute walk test (m) will be recorded. Throughout the test, vital signs will be carefully monitored. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Postoperative pulmonary complications | Postoperative pulmonary complications (PPCs) will be recorded from medical records including atelectasis, pneumothorax, respiratory infection, respiratory failure, pleural effusion, bronchospasm, aspiration pneumonitis, acute respiratory distress syndrome, | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Quality of life - EORTC QLQ-C30 | Quality of life specific to lung cancer patients is assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30). This questionnaire evaluates various aspects of quality of life, including physical, role, cognitive, emotional, and social functioning, as well as cancer-related symptoms and overall health status. Scores range from 0 to 100 across the 30 items. A higher score on the global scale indicates a better quality of life. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Qulaity of life-WHOQOL-BREF | The measurement of quality of life in participants is assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Brief Version). This questionnaire includes 26 items that assess perceptions of quality of life across physical, psychological, social, and environmental domains, with scores ranging from 0 to 100. Higher scores indicate better quality of life. | Baseline, post-surgery assessment at week 5, follow-up assessment at week 8 |
| Adherence | Compliance will be assessed using a self-reported questionnaire that tracks participants' adherence to the protocol instructions related to breathing exercises, including frequency, technique, duration, and consistency. This self-reported questionnaire includes 28 scaled questions using a 5-point Likert scale, along with one open-ended question to capture any barriers to compliance or reasons for not following the protocol. The compliance score will be calculated based on participants' responses to the scaled questions and will be expressed as a total compliance score, with higher scores indicating better compliance. The measurement tool will be a customized compliance scale designed for this study, allowing participants to indicate the extent to which they followed the exercise instructions as prescribed. | Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8. |
| Compliance | Compliance will be assessed using a self-reported questionnaire that tracks participants' adherence to the protocol instructions related to breathing exercises, including frequency, technique, duration, and consistency. This self-reported questionnaire includes 28 scaled questions using a 5-point Likert scale, along with one open-ended question to capture any barriers to compliance or reasons for not following the protocol. The compliance score will be calculated based on participants' responses to the scaled questions and will be expressed as a total compliance score, with higher scores indicating better compliance. The measurement tool will be a customized compliance scale designed for this study, allowing participants to indicate the extent to which they followed the exercise instructions as prescribed | Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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