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

Tongji Hospital1 site in 1 country30 target enrollmentNovember 1, 2022

ConditionsPrehabilitation Non Small Cell Lung Cancer Cardiorespiratory Fitness Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prehabilitation
Sponsor: Tongji Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Exercise capacity
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2022

End Date

March 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tongji Hospital

Responsible Party

Principal Investigator

Zhang Ni

Professor

Tongji Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Exercise capacity

Time Frame: Baseline, 4 weeks after prehabilitation exercise

Exercise testing on a cycloergometer(VO2 max)

Secondary Outcomes

Change in grip-strength(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
Forced expiratory volume in 1 s(FEV1)(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
Forced vital capacity (FVC)(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
Acceptance of technology(4 weeks of prehabilitation exercise)
Change in quality of life(Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery)
Adherence to exercise(4 weeks of prehabilitation exercise)
Length of stay in hospital(Up to 30 postoperative days)
Post-operative complications(From day of surgery to 30-days afterwards)