Lung Cancer
Conditions
Keywords
Lung Cancer, preoperative exercise, moderate-to-high perioperative risk, cardiorespiratory function, postoperative outcomes
Brief summary
The goal of this clinical trail is to compare the effects of preoperative exercise training of different intensities on short-term cardiorespiratory function and postoperative outcomes in patients scheduled for lung resections.
Detailed description
Guangdong Provincial People's Hospital will recruit a total of 100 consenting patients. Following informed consent and baseline testing, participants will be randomized into one of the three groups in a 2:2:1 ratio: MICT, HIIT, or usual care (UC). Participants in the MICT and HIIT groups perform a total of 12 sessions of supervised exercise training, while participants randomized to the UC group receive no extra rehabilitation or physical activity. All participants are followed-up at the completion of the intervention period.Primary outcomes including cardiopulmonary exercise function and pulmonary function will be measured at diagnosis (lung cancer patients scheduled for surgical treatment) (V1), baseline (V2), and post-intervention (V3). The baseline assessment includes medical history and examination. To lessen the psychological burden of the study on the patients, the baseline examination phase could not be repeated if the examinations had been completed during the screening phase and the date of completion was within 7 days prior to enrollment. The patient's postoperative complications, chest tube removal time and hospital length of stay (LOS) will be recorded on the day of discharge (V4). Patient-reported outcomes (PROs) will be measured at baseline (V2), post-intervention (V3), day of discharge (V4), 1 month postoperative (V5), and 3 months postoperative (V6) with ongoing follow-up.
Interventions
BEHAVIORALmoderate-intensity continuous training
Each MICT session consists of 30 minutes of cycling. Workload will be gradually titrated from 50% to 60% peak WR throughout training to sustain a target RPE of 12-14 on the Borg 6-20 scale.
BEHAVIORALhigh-intensity interval training
Each HIIT session consists of15 cycles, includes a 60-second high-intensity interval at 80-95% peak WR (target RPE 15-17) followed by a 60-second active recovery phase at 25% peak WR.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the study intervention, this study was an open trial and was not blinded to the patients and study executives. Only the outcome assessors and statistical analysts of the study will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>18 years. 2. Suspected or confirmed primary lung cancer with scheduled surgical treatment. 3. Moderate-to-high perioperative risk, defined as FEV1\<60% of predicted value (wedge) or ppo FEV1\<60% of predicted value (lobectomy/segmentectomy) or VO2peak\<20 ml/kg/ min. 4. Sign informed consent and accept to comply with the requirements of the study protocol. 5. Completion of a baseline Complete cardiopulmonary exercise testing (CPET).
Exclusion criteria
1. Concurrent or previous history of other malignant tumors. 2. Life expectancy less than 1 year. 3. Dementia; infirmity; or inability to participate in sports (musculoskeletal limitations, namely, injuries, frailty, and weakness). 4. Inability to maintain exercise training. 5. Irregular vital signs (heart rate: \< 40 or \> 120 bpm at rest; blood pressure: systolic blood pressure \> 200 mm Hg or diastolic pressure \> 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; SpO2 ≤ 90%). 6. Currently enrolling in any other clinical trials. 7. Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiopulmonary fitness | baseline，2 weeks | The post-training change in cardiorespiratory fitness will be measured by the VO2peak in ml/kg/min.VO2peak will be evaluated by a cardiopulmonary exercise test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pulmonary function | baseline，2 weeks | Pulmonary function will be measured as the guidelines recommended, including FVC, FEV1, FEV1/FVC. |
| postoperative complications | postoperative hospital stay, 1 month after surgery | Postoperative complications will be recorded and graded specifically according to the Society of Thoracic Surgeons. In addition, chest tube duration and hospital LOS will be recorded. |
| postoperative mortality | 3 months, 1 year, 3 years and 5 years postoperative | Postoperative mortality will be recorded by calling. |
| patient-reported outcomes | baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative | The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a validated lung cancer-specific scale, will be utilized to assesses patients' symptoms to measure patient-reported outcomes(PROs).MDASI-LC includes 16 symptom items with scores ranging from 0 (no symptom) to 10 (worst symptom imaginable) and six functional items with scores ranging from 0 (no interference) to 10 (complete interference). |
Countries
China
Contacts
CONTACTHuan Ma, PhD
Outcome results
None listed