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The goal of this clinical trial is to learn if "Prehabilitation model for Internet+ devices"improve patients' preoperative status and reduce the postoperative recovery time, postoperative complications,comparing to trditional prehabilitation model. The main questions it aims to answer are:
Participants will:
Take Internet+devices model or traditional model to prehabilitation for 2-4weeks.
Test 6MWT before operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet+wearble device prehabilitation model | Experimental | Pre-rehabilitation components include smoking cessation, aerobic training, anaerobic exercise, nutritional optimization and psychological support. "Internet+" group using online application + wearable device management model |
|
| traditional prehabilitation model | Active Comparator | The traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet + wearble device multimodal prehabilitation | Behavioral | Use the Prehabilitation Learning Platform to learn what to do and follow along with the videos for follow up exercises |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walking test distance, 6MWD | Using 6MWD as the primary assessment of patients' perioperative functional status and the primary endpoint of the study, patients were evaluated at enrollment, before surgery, and 30 days after surgery, respectively. | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery | |
| postoperative complication | 30 days after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zijia Liu | Contact | +86 18501155710 | liu-zj02@126.com | |
| Fan Bu | Contact | +86 18511891786 | bf5205@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zijia Liu | Peking Union Medical College Hospital | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2024 | Aug 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2024 | Aug 16, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Prospective randomized clinical trial
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Block randomized number will be prepared in advance and be hidden in the envelope. At the time of collecting the participants' baseline information, neither the participants nor the investigator knew which intervention the patients would receive. After the information was collected, the envelopes were opened to determine whether participants were assigned to the intervention or control group.
| traditional multimodal prehabilitation | Behavioral | The researchers used a prehabilitation manual to explain to subjects what they needed to do, and the patients went home and practiced on their own, recording the exercises daily |
|
| pulmonary function |
FVC |
| About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| pulmonary function | FEV1 | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| pulmonary function | FEV1/FVC | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| pulmonary function | MVV | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| grip | Using grip dynamometer to measure the grip strength of the patient's hand, measured in kg | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| NRS2002 Nutritional Risk Screening | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| Hospital Anxiety and Depression Scale(HADS) | There are 14 questions in total, with four options for each question ranging from 0 to 3;0 to 7 indicating no symptoms, 8 to 10 indicating suspected anxiety or depression symptoms, and 11 to 21 indicating certain symptoms | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| Quality of Recovery-15(QOR-15) | A total of 15 questions, each question have 0-10 points, the higher the score means the better the recovery effect | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| World Health Organization Disability Assessment Schedule 2.0(WHODAS 2.0) | Questions are on a scale of 1-5, with a lower score indicating that the patient is generally better. | About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |