Cardiorespiratory Fitness, Non Small Cell Lung Cancer, Prehabilitation, Surgery
Conditions
Keywords
Prehabilitation, Cardiorespiratory fitness, Non-small cell lung cancer, Exercise, Wearable technology, Surgery
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.
Interventions
BEHAVIORALMultimodal prehabilitation
4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study feasibility | Baseline, 4 weeks after prehabilitation exercise | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post changes in cardiopulmonary exercise testing | Baseline, 4 weeks of prehabilitation exercise | Peak oxygen uptake, peak workload, anaerobic-threshold measures |
| Forced expiratory volume in 1 s(FEV1) | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery | Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters |
| Forced vital capacity (FVC) | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery | Forced vital capacity (FVC) of pulmonary function will be measured in liters. |
| Change in quality of life | Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery | as assessed by the EORTC QLQ C30 questionnaire |
| Post-operative complications | 30-days after surgery (T4) | Classified using the Clavien Dindo Classification |
| Moderate to vigorous physical activity | Baseline, 4 weeks of prehabilitation exercise | Daily total minutes of moderate to vigorous physical activity (MVPA) |
Countries
China
Outcome results
None listed