Exercise Prehabilitation for Patients With NSCLC Before Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prehabilitation, Non Small Cell Lung Cancer, Cardiorespiratory Fitness, Surgery

Intervention / Treatment
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* Behavioral: Multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Exercise testing on a cycloergometer(VO2 max) | Baseline, 4 weeks after prehabilitation exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Acceptance of technology | number of hours the fitness tracker was worn in pre-operative period | 4 weeks of prehabilitation exercise | 
| 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 | 
| Change in grip-strength | Grip strength per dynamometer | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery | 
| Length of stay in hospital | Number of days from surgery to discharge home | Up to 30 postoperative days | 
| Post-operative complications | Classified using the Clavien Dindo Classification | From day of surgery to 30-days afterwards | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery