Back to resultsExercise Prehabilitation for Patients With NSCLC Before Surgery
Primary Purpose
Prehabilitation, Non Small Cell Lung Cancer, Cardiorespiratory Fitness
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multimodal prehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Prehabilitation focused on measuring Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery
Eligibility Criteria
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.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
4 weeks of multimodal pre-rehabilitation
Outcomes
Primary Outcome Measures
Exercise capacity
Exercise testing on a cycloergometer(VO2 max)
Secondary Outcome Measures
Forced expiratory volume in 1 s(FEV1)
Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters
Forced vital capacity (FVC)
Forced vital capacity (FVC) of pulmonary function will be measured in liters.
Acceptance of technology
number of hours the fitness tracker was worn in pre-operative period
Change in quality of life
as assessed by the EORTC QLQ C30 questionnaire
Change in grip-strength
Grip strength per dynamometer
Length of stay in hospital
Number of days from surgery to discharge home
Post-operative complications
Classified using the Clavien Dindo Classification
Adherence to exercise
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05608759
Brief Title
Exercise Prehabilitation for Patients With NSCLC Before Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehabilitation, Non Small Cell Lung Cancer, Cardiorespiratory Fitness, Surgery
Keywords
Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
4 weeks of multimodal pre-rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Multimodal prehabilitation
Intervention Description
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Exercise testing on a cycloergometer(VO2 max)
Time Frame
Baseline, 4 weeks after prehabilitation exercise
Secondary Outcome Measure Information:
Title
Forced expiratory volume in 1 s(FEV1)
Description
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
Title
Forced vital capacity (FVC)
Description
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
Title
Acceptance of technology
Description
number of hours the fitness tracker was worn in pre-operative period
Time Frame
4 weeks of prehabilitation exercise
Title
Change in quality of life
Description
as assessed by the EORTC QLQ C30 questionnaire
Time Frame
Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Title
Change in grip-strength
Description
Grip strength per dynamometer
Time Frame
Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
Title
Length of stay in hospital
Description
Number of days from surgery to discharge home
Time Frame
Up to 30 postoperative days
Title
Post-operative complications
Description
Classified using the Clavien Dindo Classification
Time Frame
From day of surgery to 30-days afterwards
Title
Adherence to exercise
Description
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Time Frame
4 weeks of prehabilitation exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ni Zhang, Doctor
Phone
+8613006315393
Email
zhangnidoc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Biyun Zhou, Doctor
Phone
+8613517275908
Email
biyun.zz@gmail.com
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ping, Doctor
Phone
+8613437101581
Email
247046170@qq.com
12. IPD Sharing Statement
Learn more about this trial
Exercise Prehabilitation for Patients With NSCLC Before Surgery
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