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Trial Title:
Exercise Prehabilitation for Patients With NSCLC Before Surgery
NCT ID:
NCT05608759
Condition:
Prehabilitation
Non Small Cell Lung Cancer
Cardiorespiratory Fitness
Surgery
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Prehabilitation
Cardiorespiratory fitness
Non-small cell lung cancer
Exercise
Wearable technology
Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal prehabilitation
Description:
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable
fitness device.
Arm group label:
single arm
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Ping, Doctor
Phone:
+8613437101581
Email:
247046170@qq.com
Start date:
November 1, 2022
Completion date:
March 31, 2024
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608759
