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临床试验/NCT03068507
NCT03068507已完成不适用

The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer:a Randomized Controlled Trail

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
6-minute-walking-distance (6MWD)

研究概览

简要总结

The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 2~3 week in our hospital. And we follow-up patients until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve the postoperative functional recovery,reduce complications and improve prognosis.

详细描述

This is a prospective randomized controlled trail, which focus on the impact of family prehabilitaiton strategy on the patients undertaking thoracoscopic lobectomy for lung cancer.

The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. But there has been no research about the impact of trimodal prehabilitation in other operations.

Although many clinical studies have confirmed that preoperative exercise for patients undergoing lung cancer surgery is safe and useful, but so far there are few studies investigated perioperative functional capability in population undergoing thoracoscopic lobectomy. And no study extends preoperative exercise to trimodal prehabilitation adding nutritional and psychological management. In addition, the prehabilitation strategy in previous studies usually takes 4~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. We therefore designed this study to investigate if a 2~3 week family trimodal prehabilitation strategy benefits the patients undergoing thoracoscopic lobectomy for lung caner.

There will be 100 patients awaiting elective thoracoscopic lobectomy for primary lung cancer recruited in this research at Peking Union Medical College Hospital. After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group.

The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about anesthesia and surgery process.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The participant didn't know their group allocation. The doctor of assessment was blinded to group allocation.

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

入选标准

  • Outpatient of thoracic surgery department in Peking Union Medical College Hospital
  • From 18 y/o to 70 y/o
  • Suspected of lung cancer
  • Decide to take the elective thoracoscopic surgery in Peking Union Medical College Hospital

排除标准

  • Refuse or fail to cooperate the study (due to any reason)
  • ASA grade ≥ III
  • Unable to tolerate prehabilitaion strategy (including exercise guide, whey protein and psycho-relaxation exercise)
  • Other severe cardio-pulmonary diseases that would affect the 6MWD

研究组 & 干预措施

Prehabilitation group

Experimental

Trimodal prehabilitation management

干预措施: Trimodal prehabilitation management (Behavioral)

Control group

No Intervention

The patients will receive the conventional clinical guidance according to Peking Union Medical College Hospital, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

结局指标

主要结局

6-minute-walking-distance (6MWD)

时间窗: 4 weeks postoperatively

Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.

次要结局

  • Quality of Life Scale(the 1st, 2nd and 3rd day postoperatively)
  • Hospital Anxiety and Depression Scale (HADS)(4 weeks postoperatively)
  • the version 2 of 12-items Short Form Health Survey(SF 12-v2(4 weeks postoperatively)
  • WHO disability assessment schedule 2.0 (WHODAS 2.0(4 weeks postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang YuGuang

Chairman of anesthesisology department

Peking Union Medical College Hospital

研究点 (1)

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