Exercise Prehabilitation for Patients With NSCLC Before Surgery

Not Applicable

Recruiting

• Conditions: Prehabilitation; Surgery; Non Small Cell Lung Cancer; Cardiorespiratory Fitness

• Registration Number: NCT05608759
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study Start: 2022-11-01
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Exercise capacity	Baseline, 4 weeks after prehabilitation exercise	Exercise testing on a cycloergometer(VO2 max)

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	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.
Change in grip-strength	Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery	Grip strength per dynamometer
Forced expiratory volume in 1 s(FEV1)	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
Acceptance of technology	4 weeks of prehabilitation exercise	number of hours the fitness tracker was worn in pre-operative period
Change in quality of life	Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery	as assessed by the EORTC QLQ C30 questionnaire
Length of stay in hospital	Up to 30 postoperative days	Number of days from surgery to discharge home
Post-operative complications	From day of surgery to 30-days afterwards	Classified using the Clavien Dindo Classification
Adherence to exercise	4 weeks of prehabilitation exercise	number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China