Non-Small Cell Lung Cancer (NSCLC)NCT07809763
Wireless Wearable Home Prehabilitation for Older Adults With NSCLC
A study testing Digital Home-Based Prehabilitation and Standard Perioperative Care in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China Hospital at 1 site in China.
Trial summary
This randomized controlled trial evaluates the efficacy and safety of a home-based prehabilitation program using wireless wearable monitoring devices in older patients (aged 65-85 years) with non-small cell lung cancer scheduled for curative lung resection. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
- What is being tested?
- Digital Home-Based Prehabilitation and Standard Perioperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 31 Jul 2028
- Phase
- Interventional
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 and ≤85 years
- Histopathologically confirmed primary non-small cell lung cancer (NSCLC), scheduled for elective curative-intent lobectomy or segmentectomy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or Karnofsky Performance Status (KPS) score ≥70
- Planned admission for surgery within 2 months, and judged by the investigator to have stable disease suitable for participation in a home-based rehabilitation program
- 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, hepatic insufficiency, or renal insufficiency
- Other diseases that seriously 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, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Xuelei Ma, 18708305692, drmaxuelei@gmail.com
Hu Liao, Professor
About this study
Official title: Home-Based Prehabilitation Using Wireless Wearable Mobile Monitoring Devices for Elderly Patients With Non-Small Cell Lung Cancer
This randomized controlled trial evaluates the efficacy and safety of a home-based prehabilitation program using wireless wearable monitoring devices in older patients (aged 65-85 years) with non-small cell lung cancer scheduled for curative lung resection. Participants are randomized 1:1 to either the intervention group, receiving a personalized exercise regimen (aerobic, resistance, and inspiratory muscle training) with continuous remote monitoring of steps, heart rate, and SpO₂ from 2-4 weeks preoperatively through 90 days postoperatively, or the control group receiving standard perioperative care. The primary endpoint is the between-group difference in FEV₁% predicted at 90 days post-surgery, adjusted for baseline. Secondary endpoints include functional capacity (6-minute walk distance), daily physical activity, hypoxemic burden (time with SpO₂<90%, nocturnal oxygen desaturation index), patient-reported outcomes (EORTC QLQ-C30/LC13, mMRC), postoperative complications, readmission rates, days alive and at home, and safety outcomes. The target sample size is 198 participants enrolled at West China Hospital of Sichuan University. Anticipated risks include exercise-related musculoskeletal strain, fatigue, and transient cardiopulmonary symptoms, as well as mild skin reactions from devices, all managed through individualized exercise prescriptions, remote safety thresholds, and a graded response protocol.
- Being tested
- Digital Home-Based Prehabilitation, Standard Perioperative Care
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery, Prehabilitation
- 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.
Digital Home-Based PrehabilitationBehavioural
A home-based multimodal prehabilitation and rehabilitation program delivered via a digital health platform, supported by wireless wearable monitoring devices (smartwatch/ring and fingertip pulse oximeter). The intervention includes: (1) moderate-intensity aerobic exercise (≥5 days/week, 30-45 min/session, Borg scale 3-4), (2) inspiratory muscle training (twice daily), (3) functional and chest expansion exercises, and (4) nutritional guidance, smoking cessation advice, and complication education. The program starts 2-4 weeks preoperatively and continues through 90 days post-surgery. Continuous remote monitoring of steps, heart rate, SpO₂, and activity levels with automated safety alerts (e.g., SpO₂<90% for ≥5 min, step drop ≥40%) triggers a graded clinical response. Participants receive regular remote follow-up and individualized exercise adjustments based on real-time data.
Standard Perioperative CareBehavioural
Participants receive the institution's standard enhanced recovery after surgery (ERAS) pathway, including routine preoperative education, postoperative chest physiotherapy, early mobilization guidance, and standard nursing care. No wearable monitoring devices, structured remote exercise prescriptions, digital health platform, or continuous remote supervision are provided. Follow-up visits are scheduled at the same time points as the intervention group for outcome assessment, but no programmatic home-based prehabilitation or tele-monitoring is delivered.
| Study group | Role | What they receive |
|---|---|---|
| Wearable-Based Home Prehabilitation | Experimental | Participants receive a wireless wearable monitoring system (smartwatch/ring and fingertip pulse oximeter) to continuously track steps, moderate-to-vigorous physical activity, heart rate, SpO₂, and sleep. A personalized home-based exercise program is prescribed, including moderate-intensity aerobic exercise (≥5 days/week, 30-45 min/session), inspiratory muscle training (twice daily), and functional/chest expansion exercises, starting 2-4 weeks before surgery and continuing until 90 days postoperatively. Remote monitoring with automated safety alerts (e.g., SpO₂<90% for ≥5 min, step count drop ≥40%) triggers a graded response protocol. Participants also receive nutritional guidance, smoking cessation advice, and complication education. All interventions are delivered via a digital health platform with regular remote follow-up. Receives: Behavioral: Digital Home-Based Prehabilitation |
| Standard Perioperative Care | Active comparator | Participants receive the institution's standard enhanced recovery after surgery (ERAS) pathway, including routine preoperative education, postoperative physical therapy (chest physiotherapy, early mobilization), and standard nursing care. They do not receive the wearable monitoring devices, the structured remote exercise prescription, or the continuous digital supervision. The frequency and content of follow-up visits are identical to those of the intervention group for outcome assessment purposes, but no programmatic home prehabilitation or remote monitoring is provided. Receives: Behavioral: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV₁% Predicted at 90 Days Post-Surgery
Forced expiratory volume in 1 second as a percentage of the predicted value, measured by spirometry according to ATS/ERS standards. The measurement is taken at the 90-day (±14 days) follow-up visit. The primary analysis compares the adjusted between-grou
Measured: 90 days after surgery (±14 days)
Secondary outcomes (17)
Change From Baseline in FVC Percent Predicted
Forced vital capacity measured by spirometry according to ATS/ERS standards and expressed as a percentage of the predicted value. Change from the preoperative baseline value will be determined at 30 and 90 days after surgery.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Change From Baseline in FEV1/FVC Ratio
The ratio of forced expiratory volume in 1 second to forced vital capacity, measured by spirometry according to ATS/ERS standards. Change from the preoperative baseline value will be determined at 30 and 90 days after surgery.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Change From Baseline in 6-Minute Walk Distance
Distance walked during a 6-minute walk test performed on a flat, marked course according to ATS guidelines. Change from the preoperative baseline distance will be determined at 30 and 90 days after surgery.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Change in Borg Dyspnea Score During the 6-Minute Walk Test
Borg dyspnea scores will be recorded immediately before and immediately after each 6-minute walk test. The outcome is calculated as the post-test score minus the pre-test score.
Measured: Baseline, 30 days after surgery with an allowable window of ±7 days, and 90 days after surgery with an allowable window of ±14 days
Mean Daily Step Count
The mean number of steps per day recorded by the wearable device. For the intervention group, step count will be recorded throughout the intervention period. For the control group, step count will be recorded during protocol-specified 7-day assessment periods. Daily values will be averaged across valid wear days, defined as days with at least 10 hours of wear time.
Measured: Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90
Mean Daily Moderate-to-Vigorous Physical Activity
The mean duration of moderate-to-vigorous physical activity recorded by the wearable device. For the intervention group, activity will be recorded throughout the intervention period. For the control group, activity will be recorded during protocol-specified 7-day assessment periods. Values will be averaged across valid wear days, defined as days with at least 10 hours of wear time.
Measured: Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90
Percentage of Monitoring Time With SpO2 Below 90%
The percentage of valid pulse-oximetry monitoring time during which peripheral oxygen saturation is below 90%, calculated from continuous or minute-level SpO2 recordings.
Measured: Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90
Nocturnal Oxygen Desaturation Index
The mean number of nocturnal oxygen desaturation events per hour of valid overnight recording. An oxygen desaturation event is defined as a decrease in SpO2 of at least 3% from the preceding baseline level.
Measured: Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90
Change From Baseline in EORTC QLQ-C30 Score
Health-related quality of life assessed using the EORTC QLQ-C30 Global Health Status/Quality of Life scale. Scores are transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better global health status and quality of life. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Change From Baseline in EORTC QLQ-LC13 Score
Lung cancer-related symptoms assessed using the prespecified EORTC QLQ-LC13 scale or item. Scores will be calculated according to the EORTC scoring manual and transformed to a 0-100 scale. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery. The direction of a higher score should be stated for the selected scale or item.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Change From Baseline in mMRC Dyspnea Scale Score
Dyspnea assessed using the modified Medical Research Council scale, ranging from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. Change from the preoperative baseline score will be determined at 30 and 90 days after surgery.
Measured: Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days
Incidence of All-Cause Hospital Readmission Within 90 Days
Percentage of participants who have at least one unplanned hospital readmission for any cause during the first 90 days after surgery.
Measured: Within 90 days after surgery
Incidence of Emergency Department Visits Within 90 Days
Percentage of participants who have at least one emergency department visit for any cause during the first 90 days after surgery.
Measured: Within 90 days after surgery
Incidence of Postoperative Pulmonary Complications Within 90 Days
Percentage of participants who experience at least one postoperative pulmonary complication meeting the protocol-specified EPCO or CHEST criteria. Pulmonary complications include pneumonia, respiratory failure or re-intubation, atelectasis requiring intervention, acute respiratory distress syndrome, pleural effusion requiring drainage, bronchospasm requiring treatment, or pulmonary embolism. Each participant will be counted once regardless of the number of complications experienced.
Measured: Within 90 days after surgery
Days Alive and at Home During the First 90 Days After Surgery
Number of days during the first 90 postoperative days that the participant is alive and not admitted to a hospital, rehabilitation facility, or other inpatient institutional care facility. The value is calculated as 90 minus the total number of days spent in hospital or institutional care. Participants who die within 90 days after surgery will be assigned a value of zero days.
Measured: Within 90 days after surgery
Incidence of Adverse Events
Percentage of participants who experience at least one adverse event after providing informed consent. Adverse events will be identified and graded according to CTCAE version 5.0. Events of special interest include exercise-related, wearable-device-related, and oxygen-related adverse events. Each participant will be counted once regardless of the number of adverse events experienced.
Measured: From signing informed consent through 90 days after surgery
Incidence of Serious Adverse Events
Percentage of participants who experience at least one serious adverse event after providing informed consent. Serious adverse events will be classified and graded according to the protocol and CTCAE version 5.0. Each participant will be counted once regardless of the number of serious adverse events experienced.
Measured: From signing informed consent through 90 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 posted9 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by West China 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809763
- Sponsor's protocol ID
- 2025(2641)
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No