Wireless Wearable Home Prehabilitation for Older Adults With NSCLC

NCT07809763 | Recruiting DMC

• 1 other identifier: 2025(2641)
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC); Rehabilitation; Thoracic Surgery; Prehabilitation

Keywords

Non-Small Cell Lung Cancer (NSCLC); Rehabilitation; Thoracic Surgery; Prehabilitation

Outcome Measures

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

  90 days after surgery (±14 days)

Secondary Outcomes (17)

• 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

• 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

• 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

• 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

• Mean Daily Step Count

  Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90

Other Outcomes (2)

• Wearable-Device Adherence Rate

  From baseline through 90 days after surgery

• Exercise Prescription Completion Rate

  From baseline through 90 days after surgery

Study Arms (2)

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.

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.

Behavioral: Standard Perioperative Care

Interventions

Digital Home-Based Prehabilitation BEHAVIORAL

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.

Wearable-Based Home Prehabilitation

Standard Perioperative Care BEHAVIORAL

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.

Standard Perioperative Care

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xuelei Ma, MD

CONTACT

18708305692; linnan@stu.scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: September 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)