Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Prehabilitation
• Intervention / Treatment: Behavioral: Internet + wearble device multimodal prehabilitation; Behavioral: traditional multimodal prehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zijia Liu; Phone Number: +86 18501155710; Email: liu-zj02@126.com
• Study Contact Backup: Name: Fan Bu; Phone Number: +86 18511891786; Email: bf5205@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet+wearble device prehabilitation model; Pre-rehabilitation components include smoking cessation, aerobic training, anaerobic exercise, nutritional optimization and psychological support. "Internet+" group using online application + wearable device management model	Behavioral: Internet + wearble device multimodal prehabilitation; Use the Prehabilitation Learning Platform to learn what to do and follow along with the videos for follow up exercises
Active Comparator: traditional prehabilitation model; The traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals	Behavioral: traditional multimodal prehabilitation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Zijia Liu, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZJL-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No