PrehabilitationNCT05608759
Exercise Prehabilitation for Patients With NSCLC Before Surgery
A study testing Multimodal prehabilitation in people with Prehabilitation and Non Small Cell Lung Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehabilitation, Non Small Cell Lung Cancer, Cardiorespiratory Fitness
- What is being tested?
- Multimodal prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 28 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capacity to give informed consent.
- Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
- Patients who can use a smartphone application.
- Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
- Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.
Who cannot join
- Known contraindication for cardiopulmonary exercise testing.
- Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
- Pregnancy or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Home-based, Supervised Prehabilitation With Wearable Technology for Patients With Non-small Cell Lung Cancer Before Lung Resection: a Single-arm, Prospective Study
To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.
- Being tested
- Multimodal prehabilitation
- Keywords
- Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitationBehavioural
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | 4 weeks of multimodal pre-rehabilitation Receives: Behavioral: Multimodal prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility
Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events
Measured: Baseline, 4 weeks after prehabilitation exercise
Secondary outcomes (6)
Pre-post changes in cardiopulmonary exercise testing
Peak oxygen uptake, peak workload, anaerobic-threshold measures
Measured: Baseline, 4 weeks of prehabilitation exercise
Forced expiratory volume in 1 s(FEV1)
Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters
Measured: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Forced vital capacity (FVC)
Forced vital capacity (FVC) of pulmonary function will be measured in liters.
Measured: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Change in quality of life
as assessed by the EORTC QLQ C30 questionnaire
Measured: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Post-operative complications
Classified using the Clavien Dindo Classification
Measured: 30-days after surgery (T4)
Moderate to vigorous physical activity
Daily total minutes of moderate to vigorous physical activity (MVPA)
Measured: Baseline, 4 weeks of prehabilitation exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608759
- Sponsor's protocol ID
- TJ-IRB20220564
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Q, Omindo WW, Liu W, Huang Y, Zhang R, Qian Y, Li X, Qiu R, Zheng S, Ping W, Zhang N. Your preoperative rehabilitation assistant: A study protocol for the impact of a telemedicine-supported preoperative home rehabilitation program on the prognosis of patients undergoing thoracoscopic surgery. Digit Health. 2024 Jun 5;10:20552076241258362. doi: 10.1177/20552076241258362. eCollection 2024 Jan-Dec.
PubMed 39351312
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Home-based, Supervised Prehabilitation With Wearable Technology for Patients With Non-small Cell Lung Cancer Before Lung Resection: a Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT05608759
- Acronym / sponsor ID
- TJ-IRB20220564
- Keywords
- Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 8 Nov 2022 (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.
To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Behavioral: Multimodal prehabilitation4 weeks of multimodal pre-rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capacity to give informed consent.
- Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
- Patients who can use a smartphone application.
- Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
- Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.
Key exclusion criteria (3 listed)
- Known contraindication for cardiopulmonary exercise testing.
- Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
- Pregnancy or lactating women.
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 |
|---|---|---|
| Multimodal prehabilitation4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device. | Behavioural | single arm |
Primary outcome
Study feasibility
Time frame: Baseline, 4 weeks after prehabilitation exercise
Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events
6 secondary outcomes
Pre-post changes in cardiopulmonary exercise testing
Time frame: Baseline, 4 weeks of prehabilitation exercise
Forced expiratory volume in 1 s(FEV1)
Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Forced vital capacity (FVC)
Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Change in quality of life
Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Post-operative complications
Time frame: 30-days after surgery (T4)
Moderate to vigorous physical activity
Time frame: Baseline, 4 weeks of prehabilitation exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 39351312Sun Q, Omindo WW, Liu W, Huang Y, Zhang R, Qian Y, Li X, Qiu R, Zheng S, Ping W, Zhang N. Your preoperative rehabilitation assistant: A study protocol for the impact of a telemedicine-supported preoperative home rehabilitation program on the prognosis of patients undergoing thoracoscopic surgery. Digit Health. 2024 Jun 5;10:20552076241258362. doi: 10.1177/20552076241258362. eCollection 2024 Jan-Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation in people with Prehabilitation and Non Small Cell Lung Cancer, run by Tongji Hospital 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility (time frame: Baseline, 4 weeks after prehabilitation exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608759, which also lists 1 linked publication.
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 16 Jun 2026.