Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction

NCT ID: NCT06573788

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-03-31

Brief Summary

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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:

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

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Conditions

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Lung Cancer Prehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

Internet + wearble device multimodal prehabilitation

Intervention Type BEHAVIORAL

Use the Prehabilitation Learning Platform to learn what to do and follow along with the videos for follow up exercises

traditional prehabilitation model

The traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals

Group Type ACTIVE_COMPARATOR

traditional multimodal prehabilitation

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZIJIA LIU

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zijia Liu

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Central Contacts

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Zijia Liu

Role: CONTACT

+86 18501155710

Fan Bu

Role: CONTACT

+86 18511891786

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ZJL-005

Identifier Type: -

Identifier Source: org_study_id

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