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Completed

NCT Number: NCT05608759

Exercise Prehabilitation for Patients With NSCLC Before Surgery

To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores.

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Key information

Conditions

Prehabilitation Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiorespiratory Fitness Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capacity to give informed consent.
  • Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.
  • Patients who can use a smartphone application.
  • Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
  • Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.

Exclusion criteria

  • Known contraindication for cardiopulmonary exercise testing.
  • Patients who have a major medical or psychiatric disorder that is expected to affect exercise.
  • Pregnancy or lactating women.

Treatment and study plan

Multimodal prehabilitation

Behavioral

4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.

Primary outcomes

  1. Study feasibility

    Time frame: Baseline, 4 weeks after prehabilitation exercise

    Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events

Secondary outcomes

  1. Pre-post changes in cardiopulmonary exercise testing

    Time frame: Baseline, 4 weeks of prehabilitation exercise

    Peak oxygen uptake, peak workload, anaerobic-threshold measures

  2. Forced expiratory volume in 1 s(FEV1)

    Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

    Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters

  3. Forced vital capacity (FVC)

    Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

    Forced vital capacity (FVC) of pulmonary function will be measured in liters.

  4. Change in quality of life

    Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

    as assessed by the EORTC QLQ C30 questionnaire

  5. Post-operative complications

    Time frame: 30-days after surgery (T4)

    Classified using the Clavien Dindo Classification

  6. Moderate to vigorous physical activity

    Time frame: Baseline, 4 weeks of prehabilitation exercise

    Daily total minutes of moderate to vigorous physical activity (MVPA)

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Effect of a Home-based, Supervised Prehabilitation With Wearable Technology for Patients With Non-small Cell Lung Cancer Before Lung Resection: a Single-arm, Prospective Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 8, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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