Exercise Prehabilitation for Patients With NSCLC Before Surgery

Sponsor

Tongji Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05608759

Collaborator

(none)

Enrollment

Location

Arm

13.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prehabilitation Non Small Cell Lung Cancer Cardiorespiratory Fitness Surgery	Behavioral: Multimodal prehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Exercise capacity [Baseline, 4 weeks after prehabilitation exercise]
Exercise testing on a cycloergometer(VO2 max)

Secondary Outcome Measures

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
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.
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
Change in grip-strength [Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery]
Grip strength per dynamometer
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.