Exercise Prehabilitation for Patients With NSCLC Before Surgery

June 13, 2026 updated by: Zhang Ni, Tongji Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Capacity to give informed consent.
  2. 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.
  3. Patients who can use a smartphone application.
  4. Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.
  5. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
4 weeks of multimodal pre-rehabilitation
Behavioral: Multimodal prehabilitation
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 weeks after prehabilitation exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
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.
Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
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
Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Pre-post changes in cardiopulmonary exercise testing
Time Frame: Baseline, 4 weeks of prehabilitation exercise
Peak oxygen uptake, peak workload, anaerobic-threshold measures
Baseline, 4 weeks of prehabilitation exercise
Post-operative complications
Time Frame: 30-days after surgery (T4)
Classified using the Clavien Dindo Classification
30-days after surgery (T4)
Moderate to vigorous physical activity
Time Frame: Baseline, 4 weeks of prehabilitation exercise
Daily total minutes of moderate to vigorous physical activity (MVPA)
Baseline, 4 weeks of prehabilitation exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 28, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20220564

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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