Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction

NCT06573788 | Not Yet Recruiting

• 1 other identifier: ZJL-005
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lung Cancer; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery

• pulmonary function

  About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery

• pulmonary function

  About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery

Study Arms (2)

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

Behavioral: Internet + wearble device multimodal prehabilitation

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

Behavioral: traditional multimodal prehabilitation

Interventions

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

Internet+wearble device prehabilitation model

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

traditional prehabilitation model

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zijia Liu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zijia Liu

CONTACT

+86 18501155710; liu-zj02@126.com

Fan Bu

CONTACT

+86 18511891786; bf5205@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Model Details: Prospective randomized clinical trial

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08