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To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | 4 weeks of multimodal pre-rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation | Behavioral | 4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study feasibility | Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events | Baseline, 4 weeks after prehabilitation exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-post changes in cardiopulmonary exercise testing | Peak oxygen uptake, peak workload, anaerobic-threshold measures | Baseline, 4 weeks of prehabilitation exercise |
| Forced expiratory volume in 1 s(FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39351312 | Derived | Sun Q, Omindo WW, Liu W, Huang Y, Zhang R, Qian Y, Li X, Qiu R, Zheng S, Ping W, Zhang N. Your preoperative rehabilitation assistant: A study protocol for the impact of a telemedicine-supported preoperative home rehabilitation program on the prognosis of patients undergoing thoracoscopic surgery. Digit Health. 2024 Jun 5;10:20552076241258362. doi: 10.1177/20552076241258362. eCollection 2024 Jan-Dec. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters
| Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery |
| Forced vital capacity (FVC) | Forced vital capacity (FVC) of pulmonary function will be measured in liters. | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery |
| Change in quality of life | as assessed by the EORTC QLQ C30 questionnaire | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery |
| Post-operative complications | Classified using the Clavien Dindo Classification | 30-days after surgery (T4) |
| Moderate to vigorous physical activity | Daily total minutes of moderate to vigorous physical activity (MVPA) | Baseline, 4 weeks of prehabilitation exercise |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |