Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cardiopulmonary fitness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years.
- •Suspected or confirmed primary lung cancer with scheduled surgical treatment.
- •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.
- •Sign informed consent and accept to comply with the requirements of the study protocol.
- •Completion of a baseline Complete cardiopulmonary exercise testing (CPET).
排除标准
- •Concurrent or previous history of other malignant tumors.
- •Life expectancy less than 1 year.
- •Dementia; infirmity; or inability to participate in sports (musculoskeletal limitations, namely, injuries, frailty, and weakness).
- •Inability to maintain exercise training.
- •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%).
- •Currently enrolling in any other clinical trials.
- •Patient refusal.
研究组 & 干预措施
Moderate-intensity Continuous Training (MICT) Group
MICT plan is containing usual care protocol and additional complete a total of 12 supervised moderate-intensity continuous training sessions in 2 weeks.
干预措施: moderate-intensity continuous training (Behavioral)
High-intensity Interval Training (HIIT) Group
HIIT plan is containing usual care protocol and additional complete a total of 12 supervised high-intensity interval training training sessions in 2 weeks.
干预措施: high-intensity interval training (Behavioral)
Usual care group
Usual care includes standard preoperative assessments and receive routine preoperative health education according to institutional practice
结局指标
主要结局
cardiopulmonary fitness
时间窗: 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.
pulmonary function
时间窗: baseline,2 weeks
Pulmonary function will be measured as the first step of the CPET. Predicted postoperative (PPO) lung functions will be calculated by the Forced Expiratory Volume in one second (FEV1). Pulmonary function in patients scheduled for wedge resection will be assessed as a predicted percentage of FEV1. Whereas participants planning to have segmentectomy or lobectomy will be evaluated with PPO FEV1 as a percentage of predicted value.
次要结局
- postoperative complications(1 week postoperative)
- postoperative mortality(3 months, 1 year, 3 years and 5 years postoperative)
- patient-reported outcomes(baseline,2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative)
- pulmonary function(baseline,2 weeks)
- postoperative complications(postoperative hospital stay, 1 month after surgery)
