Clinical trial NCT05608759: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prehabilitation
Non Small Cell Lung Cancer
Cardiorespiratory Fitness
Surgery
Keywords: Prehabilitation
Cardiorespiratory fitness
Non-small cell lung cancer
Exercise
Wearable technology
Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Exercise capacity
timeFrame: Baseline, 4 weeks after prehabilitation exercise
Secondary outcomes:
measure: Forced expiratory volume in 1 s(FEV1)
timeFrame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
measure: Forced vital capacity (FVC)
timeFrame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
measure: Acceptance of technology
timeFrame: 4 weeks of prehabilitation exercise
measure: Change in quality of life
timeFrame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
measure: Change in grip-strength
timeFrame: Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery
measure: Length of stay in hospital
timeFrame: Up to 30 postoperative days
measure: Post-operative complications
timeFrame: From day of surgery to 30-days afterwards
measure: Adherence to exercise
timeFrame: 4 weeks of prehabilitation exercise
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: