Exercise Prehabilitation for Patients With NSCLC Before Surgery

Tongji Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prehabilitation Non Small Cell Lung Cancer Cardiorespiratory Fitness Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Study feasibility

Assessed by the following indicators: study participation rate, screening and enrollment rates, intervention completion rate, number of completed exercise days, wearable-device wearing days and wearing rate, analyzable activity days, paper-log completion, app-based electronic-log completion, alert generation and closure, intervention discontinuation, adverse events, and serious adverse events

Time frame: Baseline, 4 weeks after prehabilitation exercise

Secondary Outcomes

Pre-post changes in cardiopulmonary exercise testing

Peak oxygen uptake, peak workload, anaerobic-threshold measures

Time frame: Baseline, 4 weeks of prehabilitation exercise

Forced expiratory volume in 1 s(FEV1)

Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters

Time frame: 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.

Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

Change in quality of life

as assessed by the EORTC QLQ C30 questionnaire

Time frame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery

Post-operative complications

Classified using the Clavien Dindo Classification

Time frame: 30-days after surgery (T4)

Moderate to vigorous physical activity

Daily total minutes of moderate to vigorous physical activity (MVPA)

Time frame: Baseline, 4 weeks of prehabilitation exercise

Exercise Prehabilitation for Patients With NSCLC Before Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes