Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery, Prehabilitation
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery, Prehabilitation
Brief 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. 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.
Interventions
BEHAVIORALDigital Home-Based Prehabilitation
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.
BEHAVIORALStandard Perioperative Care
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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
In this assessor-blinded trial, participants and the research team delivering the intervention cannot be masked due to the nature of the intervention (wearable devices vs. standard care). However, all outcome assessors responsible for the primary and key secondary endpoints-specifically the technicians performing pulmonary function tests (spirometry) and the physical therapists conducting the 6-minute walk tests-are fully masked to group allocation. These assessors are not involved in randomization, intervention delivery, or remote monitoring, and they remain blinded throughout all follow-up assessments to minimize detection bias.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV₁% Predicted at 90 Days Post-Surgery | 90 days after surgery (±14 days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FVC Percent Predicted | 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 | 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. |
| Change From Baseline in FEV1/FVC Ratio | 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 | 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. |
| Change From Baseline in 6-Minute Walk Distance | 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 | 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. |
| Change in Borg Dyspnea Score During the 6-Minute Walk Test | Baseline, 30 days after surgery with an allowable window of ±7 days, and 90 days after surgery with an allowable window of ±14 days | 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. |
| Mean Daily Step Count | Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90 | 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. |
| Mean Daily Moderate-to-Vigorous Physical Activity | Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90 | 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. |
| Percentage of Monitoring Time With SpO2 Below 90% | Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90 | The percentage of valid pulse-oximetry monitoring time during which peripheral oxygen saturation is below 90%, calculated from continuous or minute-level SpO2 recordings. |
| Nocturnal Oxygen Desaturation Index | Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90 | 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. |
| Change From Baseline in EORTC QLQ-C30 Score | 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 | 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. |
| Change From Baseline in EORTC QLQ-LC13 Score | 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 | 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. |
| Change From Baseline in mMRC Dyspnea Scale Score | 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 | 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. |
| Incidence of All-Cause Hospital Readmission Within 90 Days | Within 90 days after surgery | Percentage of participants who have at least one unplanned hospital readmission for any cause during the first 90 days after surgery. |
| Incidence of Emergency Department Visits Within 90 Days | Within 90 days after surgery | Percentage of participants who have at least one emergency department visit for any cause during the first 90 days after surgery. |
| Incidence of Postoperative Pulmonary Complications Within 90 Days | Within 90 days after surgery | 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. |
| Days Alive and at Home During the First 90 Days After Surgery | Within 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. |
| Incidence of Adverse Events | From signing informed consent through 90 days after surgery | 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. |
| Incidence of Serious Adverse Events | From signing informed consent through 90 days after surgery | 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. |
Countries
China
Contacts
CONTACTXuelei Ma, MD
Outcome results
None listed