Exercise Prehabilitation for Patients With NSCLC Before Surgery

Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608759
• Other study ID #: TJ-IRB20220564
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: Tongji Hospital
• Contact: Ni Zhang, Doctor
• Phone: +8613006315393
• Email: zhangnidoc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cardiorespiratory Fitness
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Prehabilitation
• Surgery

Intervention

Behavioral:
• Multimodal prehabilitation
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Exercise testing on a cycloergometer(VO2 max)	Baseline, 4 weeks after prehabilitation exercise
Secondary	Forced expiratory volume in 1 s(FEV1)	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
Secondary	Forced vital capacity (FVC)	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
Secondary	Acceptance of technology	number of hours the fitness tracker was worn in pre-operative period	4 weeks of prehabilitation exercise
Secondary	Change in quality of life	as assessed by the EORTC QLQ C30 questionnaire	Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Secondary	Change in grip-strength	Grip strength per dynamometer	Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Secondary	Length of stay in hospital	Number of days from surgery to discharge home	Up to 30 postoperative days
Secondary	Post-operative complications	Classified using the Clavien Dindo Classification	From day of surgery to 30-days afterwards
Secondary	Adherence to exercise	number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log	4 weeks of prehabilitation exercise