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Non-Small Cell Lung Cancer (NSCLC)WEAR-LUNGNCT07733492

Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

A study testing Wireless Wearable Vital Sign and Activity Monitor, Digital Postoperative Rehabilitation Program and Standard Postoperative Rehabilitation Education in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Wireless Wearable Vital Sign and Activity Monitor, Digital Postoperative Rehabilitation Program and Standard Postoperative Rehabilitation Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
31 Aug 2026to 31 Aug 2028
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤85 years
  • Histopathologically confirmed primary non-small cell lung cancer (NSCLC) who have undergone elective curative-intent lobectomy or segmentectomy
  • Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based rehabilitation
  • Able to operate a smartphone application and wearable devices independently or with caregiver assistance
  • Willing and able to provide written informed consent

Who cannot join

  • Pre-existing long-term home oxygen therapy, or severe resting respiratory dysfunction
  • Concurrent severe, uncontrolled cardiovascular disease, severe hepatic insufficiency, or severe renal insufficiency
  • Other diseases or conditions that significantly affect motor function or compliance
  • Known or suspected contact allergy to medical adhesives or materials used in the wearable devices
  • Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation

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
  • West China Hospital

    Chengdu, Sichuan, 610041

    Xuelei ma, 18708305692, drmaxuelei@gmail.com

    Hu Liao, Professor

Other trials in China

About this study

Official title: A Clinical Trial of Postoperative Rehabilitation for Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC).

Eligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up.

Read more

The primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ <90% time burden, quality of life (EORTC QLQ-C30/LC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes.

A total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.

Read the detailed description

Study Design

This is a prospective, single-center, parallel-group, 1:1 randomized controlled superiority trial conducted at West China Hospital of Sichuan University. Enrollment is planned from June 2026 to August 2027, with final data analysis by October 2027. The study protocol has been approved by the local ethics committee (Approval No. 2025-2643, dated December 30, 2025).

Study Population

We will enroll 126 patients aged 18-85 years with histopathologically confirmed primary NSCLC who have undergone elective curative-intent lobectomy or segmentectomy. Eligible participants must be planned for discharge between postoperative days 2-7, clinically stable for home-based rehabilitation, and able to operate a smartphone and wearable devices independently or with caregiver assistance.

Randomization and Blinding

Participants are randomized 1:1 using a central web-based block randomization system. This is a single-blind trial: participants and rehabilitation instructors are aware of group assignment, but outcome assessors (pulmonary function technicians, 6MWD operators) and statisticians are blinded to group allocation.

Intervention

Control group receives standard postoperative rehabilitation education, including breathing exercises and progressive walking recommendations, with routine follow-up at 1 month and 3 months.

Intervention group receives, in addition to standard education: (1) a wireless wearable patch or wristband for continuous monitoring of SpO₂, single-lead ECG, respiratory rate, and activity data; (2) a smartphone-based digital rehabilitation program with individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training) and daily symptom diaries; and (3) remote feedback and threshold-triggered alerts (e.g., SpO₂ <90% for >1 minute) with graded clinical responses.

Follow-up and Assessments

The observation period spans from discharge to postoperative day 90. Assessments include pulmonary function tests (FEV1%, FVC%, FEV1/FVC), 6-minute walk distance, quality of life (EORTC QLQ-C30/LC13, mMRC), continuous physiological monitoring (intervention group only), adherence metrics, and healthcare utilization (readmissions, ED visits, complications).

Primary Endpoint

The primary endpoint is the FEV1% predicted at postoperative day 90 (±14 days), analyzed by ANCOVA with baseline FEV1% predicted as covariate.

Sample Size

With two-sided α=0.05, 80% power, an expected between-group difference of 7% in FEV1% predicted, and a pooled standard deviation of 12%, 53 participants per group are required. Accounting for 18% dropout, the final sample size is 126 (63 per group).

Statistical Analysis

Primary analysis will be performed on the intention-to-treat population using ANCOVA. Secondary continuous endpoints will be analyzed using ANCOVA or repeated-measures ANOVA; categorical endpoints using chi-square or Fisher's exact test. Safety outcomes will be summarized descriptively. A two-sided p-value <0.05 is considered statistically significant.

Safety and Data Quality

Adverse events are graded per CTCAE v5.0. Serious adverse events are reported within 24 hours. All study personnel follow standardized operating procedures, and electronic data capture with dual entry and logic checks ensures data quality.

Ethics and Dissemination

The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations. Written informed consent will be obtained from all participants. Results will be published regardless of outcome.

Being tested
Wireless Wearable Vital Sign and Activity Monitor, Digital Postoperative Rehabilitation Program, Standard Postoperative Rehabilitation Education
Keywords
Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wireless Wearable Vital Sign and Activity MonitorDevice

    Wireless wearable chest patchs or wristband integrating SpO₂, single-lead ECG, respiratory rate, and accelerometer sensors for continuous monitoring of vital signs and physical activity during daily living.

  • Digital Postoperative Rehabilitation ProgramBehavioural

    A 90-day home-based digital rehabilitation program delivered via smartphone application, including individualized exercise prescriptions (aerobic walking, resistance training with elastic bands, inspiratory muscle training), daily symptom diaries (cough, sputum, dyspnea), and remote feedback with threshold-triggered alerts and weekly telehealth follow-ups.

  • Standard Postoperative Rehabilitation EducationOther

    Standardized verbal and written postoperative rehabilitation education including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine outpatient follow-up at 1 month and 3 months per institutional practice.

Study groups in NCT07733492
Study groupRoleWhat they receive
Digital Rehabilitation with Wearable MonitoringExperimentalParticipants receive standard postoperative rehabilitation education plus a wireless wearable mobile monitoring and digital rehabilitation program for 90 days post-discharge. This includes: (1) continuous vital sign and activity monitoring via a wearable chest patch or wristband (SpO₂, heart rate, respiratory rate, physical activity); (2) individualized digital rehabilitation prescriptions (aerobic, resistance, and inspiratory muscle training) with daily symptom diaries; and (3) remote feedback with threshold-triggered graded responses.
Receives: Device: Wireless Wearable Vital Sign and Activity Monitor; Behavioral: Digital Postoperative Rehabilitation Program
Standard Postoperative RehabilitationActive comparatorParticipants receive standard postoperative rehabilitation education, including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine follow-up visits at 1 month and 3 months. No wearable monitoring or digital rehabilitation prescription is provided.
Receives: Other: Standard Postoperative Rehabilitation Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1% Predicted at Postoperative Day 90

    Forced expiratory volume in 1 second (FEV1) as a percentage of predicted value, measured by spirometry according to ATS/ERS standards. The best value from at least three acceptable maneuvers is recorded. The between-group difference is analyzed using ANCOVA with baseline FEV1% predicted as covariate.

    Measured: Postoperative day 90 (±14 days)

Secondary outcomes (17)
  1. FVC% Predicted at Postoperative Day 90

    Forced vital capacity (FVC) as a percentage of predicted value, measured by spirometry at postoperative day 90.

    Measured: Postoperative day 90 (±14 days)

  2. FEV1/FVC Ratio at Postoperative Day 90

    Ratio of FEV1 to FVC, measured by spirometry at postoperative day 90.

    Measured: Postoperative day 90 (±14 days)

  3. 6-Minute Walk Distance at Postoperative Day 90

    Total walking distance (in meters) during a 6-minute walk test performed in a 30-meter corridor by a blinded assessor according to standardized protocols.

    Measured: Postoperative day 90 (±14 days)

  4. Daily Step Count

    Mean daily step count derived from the accelerometer of the wearable device, calculated as the average over the 90-day post-discharge period.

    Measured: Continuous from discharge to postoperative day 90 (intervention group only)

  5. Moderate-to-Vigorous Physical Activity (MVPA) Duration

    Daily minutes of moderate-to-vigorous physical activity derived from the accelerometer of the wearable device.

    Measured: Continuous from discharge to postoperative day 90 (intervention group only)

  6. Time Proportion with SpO₂ Below 90%

    Percentage of total monitoring time with SpO₂ <90% during the 90-day post-discharge period.

    Measured: Continuous from discharge to postoperative day 90 (intervention group only)

  7. Mean SpO₂ and Lowest SpO₂

    Mean oxygen saturation (SpO₂) and the lowest recorded SpO₂ value during the 90-day post-discharge period.

    Measured: Continuous from discharge to postoperative day 90 (intervention group only)

  8. EORTC QLQ-C30 Global Health Status Score

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status and functional scale scores at postoperative day 90, compared to baseline.

    Measured: Baseline (pre-discharge) and postoperative day 90

  9. EORTC QLQ-LC13 Lung Cancer Module Scores

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13-item module (EORTC QLQ-LC13) domain scores assessing lung cancer-specific symptoms at postoperative day 90.

    Measured: Baseline (pre-discharge) and postoperative day 90

  10. mMRC Dyspnea Scale Score

    Modified Medical Research Council (mMRC) dyspnea scale score (0-4) assessed at postoperative day 90.

    Measured: Baseline (pre-discharge) and postoperative day 90

  11. 90-Day Unplanned Readmission Rate

    Proportion of participants with any unplanned all-cause hospital readmission within 90 days after the index surgery.

    Measured: Within 90 days after surgery

  12. 90-Day Emergency Department Visit Rate

    Proportion of participants with any unplanned emergency department visit within 90 days after the index surgery.

    Measured: Within 90 days after surgery

  13. 90-Day Pulmonary Complication Rate

    Proportion of participants developing pulmonary complications (e.g., pneumonia, atelectasis, prolonged air leak) within 90 days after surgery.

    Measured: Within 90 days after surgery

  14. Days Alive and Out of Hospital Within 90 Days

    Number of days alive and not hospitalized (in hospital or rehabilitation facility) during the 90-day post-surgery period.

    Measured: Within 90 days after surgery

  15. Wearable Device Adherence Rate

    Proportion of valid wear days, defined as days with ≥20 hours of monitoring data from the wearable device during the 90-day post-discharge period.

    Measured: From discharge to postoperative day 90 (intervention group only)

  16. Incidence of Device-Related Skin Reactions

    Proportion of participants experiencing device-related skin reactions (e.g., erythema, pruritus, rash, contact dermatitis, skin breakdown) graded by severity per CTCAE v5.0.

    Measured: From discharge to postoperative day 90

  17. Incidence of Any Adverse Event and Serious Adverse Event

    Proportion of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study period. AEs are graded per CTCAE v5.0; SAEs are defined per ICH criteria.

    Measured: From enrollment through postoperative day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733492
Sponsor's protocol ID
2025(2643)
Acronym
WEAR-LUNG
Status last verified
Aug 2026
First submitted
24 Jul 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Wireless Wearable Vital Sign and Activity Monitor, Digital Postoperative Rehabilitation Program and Standard Postoperative Rehabilitation Education in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China 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 5 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: opening soon, as of the sponsor's last update on 2 Sep 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?

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 Xuelei ma (+8618708305692, drmaxuelei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1% Predicted at Postoperative Day 90 (time frame: Postoperative day 90 (±14 days)). 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 2 Sep 2026.

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