Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06573788

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Prehabilitation Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. 6 minute walking test distance, 6MWD

    Time frame: 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 outcomes

  1. Length of hospitalization

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

  2. postoperative complication

    Time frame: 30 days after surgery

  3. pulmonary function

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

    FVC

  4. pulmonary function

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

    FEV1

  5. pulmonary function

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

    FEV1/FVC

  6. pulmonary function

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

    MVV

  7. grip

    Time frame: 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

  8. NRS2002 Nutritional Risk Screening

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

  9. Hospital Anxiety and Depression Scale（HADS）

    Time frame: 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

  10. Quality of Recovery-15（QOR-15）

    Time frame: 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

  11. World Health Organization Disability Assessment Schedule 2.0（WHODAS 2.0）

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fan Bu

CONTACT

[email protected]

+86 18511891786

Zijia Liu

CONTACT

[email protected]

+86 18501155710

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.