Wireless Wearable Home Prehabilitation for Older Adults With NSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Home-Based Prehabilitation
BehavioralA 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 Care
BehavioralParticipants 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.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: Wearable-Based Home PrehabilitationExperimental treatment 1 intervention
Group B: Standard Perioperative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
90 days after surgery (±14 days)Secondary outcomes
1
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.
Time frame
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 days2
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.
Time frame
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 days3
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.
Time frame
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 days4
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.
Time frame
Baseline, 30 days after surgery with an allowable window of ±7 days, and 90 days after surgery with an allowable window of ±14 daysOther outcomes
1
Wearable-Device Adherence Rate
Percentage of observed days on which the wearable device is worn for at least 12 hours. The numerator is the number of days meeting the required wear-time threshold, and the denominator is the total number of expected observation days.
Time frame
From baseline through 90 days after surgery2
Exercise Prescription Completion Rate
Percentage of prescribed exercise sessions completed by participants in the intervention group. The numerator is the number of completed prescribed sessions, and the denominator is the total number of prescribed sessions during the intervention period.
Time frame
From baseline through 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov