The Comparison of a Short Home-based Multimodal Prehabilitation Strategy to Preoperative Aerobic Training Program on the Perioperative Functional Capacity and Outcomes in Patients Undergoing Thoracoscopic Lobectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- post-operative 6-minute walk distance
研究概览
简要总结
In recent years, many studies have shown that prehabilitation based on aerobic training strategies could have a positive effect on the recovery of postoperative functional capacity in patients undergoing lung cancer surgery. Investigators are proposing a prospective randomized controlled trial to compare the impact of a short home-based multimodal prehabilitation strategy to preoperative aerobic training on patients scheduled for video-assisted thorascopic lobectomy for lung cancer. The multimodal prehabilitation strategy includes guided aerobic and resistance exercise, breathing exercises, nutrition supplement and physiology management preoperatively, while the aerobic strategy offers the same aerobic training guidance without the other parts. The prehabilitation lasts 2-3 weeks in our center. Investigators follow-up patients until 30 days after surgery, to investigate whether multimodal prehabilitation strategy differs from aerobic training program in postoperative functional capability improvement, health-related quality of life scorings, incidence of postoperative complications and other outcomes.
详细描述
This is a randomized controlled trial comparing the impact of a short home-based multimodal prehabilitaiton strategy to preoperative aerobic training program on patients undertaking video-assisted thoracoscopic (VATS) lobectomy for lung cancer.
The purpose of prehabilitation is to enhance an individual's functional capacity to reach the optimal physiological state before surgery, helping them withstand the stress of surgery and receive an enhanced recovery post operation. Recent studies have shown that trimodal or multimodal prehabilitation strategy including exercise, diet and psychologic guidance could improve postoperative functional recovery for patients undergoing colorectal resection. However, researches regarding to the effect of multi-modal prehabilitation in other types of operations remain scarce.
Studies have shown that the postoperative functional capacity decreases in patients undergoing lung cancer surgery. Therefore, many clinical trials were designed to explore the impact of prehabilitation on these patients, and many of them yielded positive results, showing preoperative exercise for patients undergoing lung cancer surgery is safe and beneficial in postoperative functional capacity recovery. However, the majority of the trials conducted adopted preoperative exercises, specifically aerobic exercises, as the sole means of prehabilitation. In 2017, our team conducted a randomized controlled trial (registration number NCT03068507) to examine the efficacy of a 2-week multimodal home-based prehabilitation strategy in patients undergoing VATS lobectomy for lung cancer. The preliminary results indicate that patients who received the short multimodal home-based prehabilitation have a significantly higher 6-minute walk distance (6MWD) perioperatively.
Investigators are proposing a new randomized controlled trial to compare the efficacy of a short multimodal home-based prehabilitation with the sole aerobic prehabilitation strategy adopted by the previous studies.
A total of 100 patients scheduled to have elective VATS lobectomy for primary lung cancer will be recruited in this research at Peking Union Medical College Hospital. After informed consent is obtained, the patients will be evenly assigned to two groups randomly based on computer-generated sequence, the multimodal prehabilitation group and the aerobic prehabilitation group. The random allocation will be concealed using sealed opaque envelops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient of thoracic surgery department in Peking Union Medical College Hospital
- •From 18y/o to 70y/o
- •Suspected of lung cancer
- •Decide to take the elective thoracoscopic surgery in Peking Union Medical College Hospital
排除标准
- •Decline to participant the study (due to any reason)
- •American Society of Anesthesiologists (ASA) grade >III
- •TNM stage I-III
- •Patients plan to receive neoadjuvant therapy
- •Unable to tolerate prehabilitaion or aerobic strategy (including exercise guide, whey protein and psycho-relaxation exercise)
- •Other severe cardio-pulmonary diseases that would affect the 6MWD
结局指标
主要结局
post-operative 6-minute walk distance
时间窗: 30 days postoperatively
Use 6-minute walk distance (6MWD) to evaluate the physical functional capability objectively. The primary outcome will be analyzed after stratification by age and baseline functional capacity.
次要结局
- Prognosis information2: morbidity(30 days postoperatively)
- Prognosis information4: ICU stay time(30 days postoperatively)
- Perioperative 6MWD(baseline, 1 day before surgery)
- WHO disability assessment schedule 2.0 (WHODAS 2.0)(Baseline, 1 day before surgery, 30 days postoperatively)
- Postoperative quality of recovery score -15 (QoR-15)(the 1st, 2nd and 3rd day postoperatively)
- Prognosis information1: mortality(30 days postoperatively)
- Prognosis information5: duration of chest tube(30 days postoperatively)
- Perioperative pulmonary functional test(Baseline, 1 day before surgery, 30 days postoperatively)
- Perioperative Hospital Anxiety and Depression Scale (HADS)(Baseline, 1 day before surgery, 30 days postoperatively)
- Prognosis information3: length of hospital stay(30 days postoperatively)