Exercise Prehabilitation for Patients With NSCLC Before Surgery

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

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 Overview

• Status: Recruiting
• Conditions: Surgery; Non Small Cell Lung Cancer; Cardiorespiratory Fitness; Prehabilitation
• Intervention / Treatment: Behavioral: Multimodal prehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ni Zhang, Doctor; Phone Number: +8613006315393; Email: zhangnidoc@163.com
• Study Contact Backup: Name: Biyun Zhou, Doctor; Phone Number: +8613517275908; Email: biyun.zz@gmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Wei Ping, Doctor; Phone Number: +8613437101581; Email: 247046170@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Surgery; Non-small cell lung cancer; Prehabilitation; Cardiorespiratory fitness; Wearable technology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TJ-IRB20220564

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No