Lung CancerNCT06573788
Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
A study testing Internet + wearble device multimodal prehabilitation and traditional multimodal prehabilitation in people with Lung Cancer and Prehabilitation, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Prehabilitation
- What is being tested?
- Internet + wearble device multimodal prehabilitation and traditional multimodal prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-75 years;
- adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- Does the Prehabilitation model for Internet+ devices works out?
- 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.
- Conditions
- Lung Cancer, Prehabilitation
- Being tested
- Internet + wearble device multimodal prehabilitation, traditional multimodal prehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet + wearble device multimodal prehabilitationBehavioural
Use the Prehabilitation Learning Platform to learn what to do and follow along with the videos for follow up exercises
traditional multimodal prehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: traditional multimodal prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Secondary outcomes (11)
Length of hospitalization
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
postoperative complication
Measured: 30 days after surgery
pulmonary function
FVC
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
FEV1
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
FEV1/FVC
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
MVV
Measured: 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
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
NRS2002 Nutritional Risk Screening
Measured: 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
Measured: 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
Measured: 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.
Measured: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZIJIA LIU, Peking Union Medical College Hospital
- Investigators
- Zijia Liu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573788
- Sponsor's protocol ID
- ZJL-005
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
- ClinicalTrials.gov ID
- NCT06573788
- Acronym / sponsor ID
- ZJL-005
- Conditions
- Lung Cancer, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the Prehabilitation model for Internet+ devices works out?
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Internet+wearble device prehabilitation model | Experimental | Behavioral: Internet + wearble device multimodal prehabilitationPre-rehabilitation components include smoking cessation, aerobic training, anaerobic exercise, nutritional optimization and psychological support. "Internet+" group using online application + wearable device management model |
| traditional prehabilitation model | Active comparator | Behavioral: traditional multimodal prehabilitationThe traditional prehabilitation group used the traditional management model of preoperative education + paper records + regular weekly reminders from healthcare professionals |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-75 years;
- adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet + wearble device multimodal prehabilitationUse the Prehabilitation Learning Platform to learn what to do and follow along with the videos for follow up exercises | Behavioural | Internet+wearble device prehabilitation model |
| traditional multimodal prehabilitationThe 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 | Behavioural | traditional prehabilitation model |
Primary outcome
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.
11 secondary outcomes
Length of hospitalization
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
postoperative complication
Time frame: 30 days after surgery
pulmonary function
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
pulmonary function
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
grip
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
NRS2002 Nutritional Risk Screening
Time frame: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zijia Liu principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Internet + wearble device multimodal prehabilitation and traditional multimodal prehabilitation in people with Lung Cancer and Prehabilitation, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijia Liu (+86 18501155710, liu-zj02@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.