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临床试验/NCT05854394
NCT05854394招募中不适用

Effect of Multimodal Prehabilitation on Functional Recovery and Quality of Life After Colorectal Cancer Surgery

Xiamen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023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
招募中
发起方
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 Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal 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 1~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.

详细描述

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. Although many clinical studies have confirmed that preoperative exercise for patients undergoing colorectal cancer surgery is safe and useful, but 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. Investigators therefore designed this study to investigate if a 1~2 week multimodal prehabilitation strategy benefits the patients undergoing laparoscopic colorectal cancer resection. There will be 100 patients awaiting operation for primary colorectal cancer recruited in this research at The First Affiliated Hospital of Xiamen University.

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 drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about surgery process. The functional capability will be examined for both groups at several time points (baseline, the day before surgery,4 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively, health-related quality of life scales and cancer-related fatigue. The secondary end points include self-reported physical activity, and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •From 18 y/o to 75 y/o
  • •Suspected of colorectal cancer
  • •Decide to take the colorectal cancer radical surgery in The First Hospital Affiliated to Xiamen University
  • •Patients with post-operative pathological diagnosis of colorectal cancer

排除标准

  • •Refuse or fail to cooperate the study (due to any reason)
  • •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

Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization#whey protein supplement#, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).

干预措施: Multimodal prehabilitation management Multimodal prehabilitation management (Behavioral)

Control group

No Intervention

The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including 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: [Time Frame: 4 weeks postoperatively]

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

次要结局

  • Cancer-related fatigue([Time Frame: 4 weeks postoperatively])
  • Quality of Life Scale([Time Frame: 4 weeks postoperatively])

研究者

发起方
Xiamen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

JiaJun Zhang

Principal Investigator

Xiamen University

研究点 (1)

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