Lung CancerNCT06458894
Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
A study testing Prerehabilitation in people with Lung Cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides… Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Prerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2024to 26 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 60 years old; 2. A preliminary diagnosis of pulmonary结节 or lung tumor by chest CT; 3. Planning to undergo thoracoscopic lung resection surgery; 4. Voluntary participation of patients.
Who cannot join
- 1. Patients with severe condition who cannot tolerate pre-rehabilitation training; 2. Patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. Patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
chaoqian li
About this study
This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。
Read the detailed description
This study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.
- Conditions
- Lung Cancer
- Being tested
- Prerehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrerehabilitationBehavioural
Also called ulmonary function
Home prerehabilitation was performed on the basis of routine preoperative preparation
| Study group | Role | What they receive |
|---|---|---|
| There were no interventions | Other | Give guidance on respiratory function exercise Receives: Behavioral: Prerehabilitation |
| Prerehabilitation | Other | Give guidance on respiratory function exercise Receives: Behavioral: Prerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first ambulation after surgery
Patients can complete the time of walking at the bed, and unplanned extubation
Measured: 3 Weeks after intervention
Dwelling time of chest drain and chest drainage flow
The duration of the postoperative chest drain and the chest on postoperative day 1 and postoperative day 2 were recorded Lead the flow
Measured: Two days after the intervention
Secondary outcomes (1)
Lung function index
Pulmonary function test was performed with the pulmonary function detector on the day of the patient and 30 days after surgery Guide the patient to do inhale or exhale with maximum effort, make three consecutive measurements, and record the best results, including Forced expiratory volume at second 1
Measured: 30 Days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start24 Aug 2024
- Primary completion25 Dec 2025 (estimated)
- Study completion26 Dec 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 The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458894
- Sponsor's protocol ID
- KY-2024-102
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
- ClinicalTrials.gov ID
- NCT06458894
- Acronym / sponsor ID
- KY-2024-102
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 14 Jun 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.
This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。
Detailed description
This study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| There were no interventions | Other | Behavioral: PrerehabilitationGive guidance on respiratory function exercise |
| Prerehabilitation | Other | Behavioral: PrerehabilitationGive guidance on respiratory function exercise |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥ 60 years old; 2. A preliminary diagnosis of pulmonary结节 or lung tumor by chest CT; 3. Planning to undergo thoracoscopic lung resection surgery; 4. Voluntary participation of patients.
Key exclusion criteria (1 listed)
- 1. Patients with severe condition who cannot tolerate pre-rehabilitation training; 2. Patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. Patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.
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 |
|---|---|---|
| PrerehabilitationAlso: ulmonary functionHome prerehabilitation was performed on the basis of routine preoperative preparation | Behavioural | Prerehabilitation, There were no interventions |
Primary outcome
Time to the first ambulation after surgery
Time frame: 3 Weeks after intervention
Patients can complete the time of walking at the bed, and unplanned extubation
Dwelling time of chest drain and chest drainage flow
Time frame: Two days after the intervention
The duration of the postoperative chest drain and the chest on postoperative day 1 and postoperative day 2 were recorded Lead the flow
1 secondary outcome
Lung function index
Time frame: 30 Days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prerehabilitation in people with Lung Cancer, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chaoqian li (13858066862, 13858066862@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first ambulation after surgery (time frame: 3 Weeks after intervention). The study lists 2 primary outcomes in all. 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 17 Feb 2025.