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Not yet recruitingNCT06573788Updated Aug 27, 2024

Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction

An interventional study of Internet + wearble device multimodal prehabilitation and traditional multimodal prehabilitation in Lung Cancer and Prehabilitation, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer
  • Prehabilitation
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralInternet + wearble device multimodal prehabilitation

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

  • Behavioraltraditional 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

06

What researchers measure

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.

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

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

    FVC

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

  4. pulmonary function

    FEV1

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

  5. pulmonary function

    FEV1/FVC

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

  6. pulmonary function

    MVV

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

  7. grip

    Using grip dynamometer to measure the grip strength of the patient's hand, measured in kg

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

  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)

    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

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

  10. 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

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

  11. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 16, 2024
  • Informed consent form · Aug 16, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06573788
Lead sponsor
Peking Union Medical College Hospital
Responsible party
ZIJIA LIU (associate chief physician, Peking Union Medical College Hospital) — Principal investigator
First posted
Aug 27, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Oct 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Aug 27, 2024

Study contacts

Zijia Liu
Contact
liu-zj02@126.com
+86 18501155710
Fan Bu
Contact
bf5205@126.com
+86 18511891786
Zijia Liu
principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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