Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction

Not Applicable

Not yet recruiting

• Conditions: Prehabilitation; Lung Cancer
• Interventions: Behavioral: traditional multimodal prehabilitation; Behavioral: Internet + wearble device multimodal prehabilitation

• Registration Number: NCT06573788
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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:

1. Does the Prehabilitation model for Internet+ devices works out?

2. Does"Prehabilitation model for Internet+ devices" better increase the patient's six-minute walk test distance?

Participants will:

Take Internet+devices model or traditional model to prehabilitation for 2-4weeks.

Test 6MWT before operation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Start: 2024-09-01
• Primary Completion: 2025-10-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Age: 18-75 years;
2. adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.

Exclusion Criteria

1. Patient refusal;
2. ASA classification IV or higher;
3. Pre-neoadjuvant chemotherapy;
4. Inability to cooperate (psychiatric abnormalities, impaired consciousness, mental retardation);
5. Comorbidities cannot tolerate home rehabilitation or functional motor examination;
6. Inability to use a smartphone or read Chinese;
7. Average weekly moderate-intensity/high-intensity exercise of >90min/>60min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional prehabilitation model	traditional multimodal prehabilitation	The traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals
Internet+wearble device prehabilitation model	Internet + wearble device multimodal prehabilitation	Pre-rehabilitation components include smoking cessation, aerobic training, anaerobic exercise, nutritional optimization and psychological support. "Internet+" group using online application + wearable device management model

Primary Outcome Measures

Name	Time	Method
6 minute walking test distance, 6MWD	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
grip	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	Using grip dynamometer to measure the grip strength of the patient's hand, measured in kg
pulmonary function	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	MVV
Hospital Anxiety and Depression Scale（HADS）	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	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
NRS2002 Nutritional Risk Screening	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
postoperative complication	30 days after surgery
World Health Organization Disability Assessment Schedule 2.0（WHODAS 2.0）	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	Questions are on a scale of 1-5, with a lower score indicating that the patient is generally better.
Length of hospitalization	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Quality of Recovery-15（QOR-15）	About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery	A total of 15 questions, each question have 0-10 points, the higher the score means the better the recovery effect