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临床试验/NCT06215326
NCT06215326招募中不适用

Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Prospective Randomized Controlled Clinical Trial

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月23日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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