ChiCTR2400082302 版本V1.0 版本创建时间2024/03/26 11:49:29 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400082302 

最近更新日期：

Date of Last Refreshed on：

 2024-03-26 11:49:19 

注册时间：

Date of Registration：

 2024-03-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项单中心、双盲、随机对照，观察和评估营养联合运动康复方案对胃癌患者围术期肌少症改善效果的临床研究。

Public title：

A single-center, double-blind and randomized controlled clinical study to observe and evaluate the effect of nutrition combined with exercise rehabilitation intervention on perioperative sarcopenia in patients with gastric cancer.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

胃癌合并肌少症患者围手术期营养联合运动康复方案 的构建及实证研究

Scientific title：

Construction and empirical study of nutrition combined with exercise rehabilitation program in patients with gastric cancer complicated with sarcopenia during perioperative period

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

蒋小曼 

研究负责人：

朱慧娣 

Applicant：

XIAOMAN JIANG 

Study leader：

HUIDI ZHU  

申请注册联系人电话：

Applicant telephone：

 +86 571 8723 7931

研究负责人电话：

Study leader's
telephone：

+86 571 8723 7931

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 1244279760@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1191068@zju.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省杭州市西湖区梧桐路366号

研究负责人通讯地址：

浙江省杭州市西湖区梧桐路366号

Applicant address：

366 Wutong Road, Xihu District, Hangzhou City, Zhejiang Province

Study leader's address：

366 Wutong Road, Xihu District, Hangzhou City, Zhejiang Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

浙江大学医学院附属第一医院胃肠外科

Applicant's institution：

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine

研究负责人所在单位：

浙江大学医学院附属第一医院胃肠外科

Affiliation of the Leader：

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 浙大一院伦审2022研第059号-会

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

浙江大学医学院附属第一医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of the First Affiliated Hospital of Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-27 00:00:00

伦理委员会联系人：

励有名

Contact Name of the ethic committee：

YOUMING LI

伦理委员会联系地址：

浙江省杭州市庆春路79号浙江大学医学院附属第一医院

Contact Address of the ethic committee：

79 qingchun Road, Hangzhou 310003, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8723 3418

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

浙江大学医学院附属第一医院胃肠外科

Primary sponsor：

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

浙江省杭州市西湖区梧桐路366号

Primary sponsor's address：

366 Wutong Road, Xihu District, Hangzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

CHINA

Province：

ZHEJIANG

City：

HANGZHOU

单位(医院)：

浙江大学医学院附属第一医院胃肠外科

具体地址：

浙江省杭州市西湖区梧桐路366号

Institution
hospital：

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine

Address：

366 Wutong Road, Xihu District, Hangzhou City, Zhejiang Province

经费或物资来源：

浙江省卫生健康委员会

Source(s) of funding：

Health Commission of Zhejiang Province

研究疾病：

胃癌合并肌少症  

Target disease：

Gastric cancer with sarcopenia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1构建胃癌肌少症患者围手术期营养联合运动康复方案。 2验证胃癌肌少症患者围手术期营养联合运动康复方案的可行性和有效性。  

Objectives of Study：

1. To establish a rehabilitation program of nutrition combined with exercise for patients with gastric cancer sarcopenia during perioperative period. 2. To verify the feasibility and effectiveness of perioperative nutrition combined with exercise rehabilitation program for patients with gastric cancer sarcopenia.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①.经病理确诊为胃癌；②.术前1月行腹部CT检查并符合以CT诊断为标准的肌少症；③.接受根治性胃切除术；④.年龄≥18 周岁；⑤.ASA分级为Ⅰ-Ⅲ级；⑥.无幽门梗阻及肠梗阻等不能口服进食情况；⑦.知情同意且自愿参加本研究者。

Inclusion criteria

①. Gastric cancer was confirmed by pathology; 2. Abdominal CT examination was performed 1 month before surgery and met the criteria for diagnosing sarcopenia with CT. ③. Undergo radical gastrectomy; ④. Age ≥18 years old; 5.ASA grade is Ⅰ-Ⅲ; 6. no pyloric obstruction and intestinal obstruction can not eat orally; ⑦. Informed consent and voluntary participation in this researcher.

排除标准：

①.因穿孔、出血等原因行急诊手术者；②.有精神疾病症状及精神疾病病史者；③.合并其他肿瘤者；④.合并影响肢体运动的疾病，如骨折、腰椎间盘突出等；⑤.无法完成6米步速测试或握力测试者；⑥.正在参与其他干预研究者。

Exclusion criteria：

①. Emergency operation due to perforation, bleeding and other reasons; (2) People with mental illness symptoms and history of mental illness; ③. Patients with other tumors; (4) Diseases that affect limb movement, such as fractures and lumbar disc herniation; ⑤. Unable to complete the 6-meter pace test or grip strength test; ⑥. Other intervention researchers are being involved.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2025-01-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 26

Group：

intervention group

Sample size：

干预措施：

干预组在对照组的基础上，实施营养联合运动康复方案，包括成立由医生（主管医生）、护士（护士长、责任护士）、营养师、康复治疗师组成的多学科合作团队，共同负责指导、监督患者的营养及运动康复锻炼。术前术后在康复师介入下增加抗阻运动和有氧运动锻炼，营养师介入下保证在每日能量和蛋白质达目标需要量的基础上给予口服营养补充ONS，责任护士加强出院宣教，居家延续性护理期间继续抗阻运动和补充ONS。运动标准：①.屈腕举哑铃训练：取坐位、站位或仰卧位，哑铃约1kg（或等量矿泉水瓶），运动时保持前臂与上臂垂直90°，肱二头肌须感觉绷紧。②.股四头肌静力性收缩训练：取坐位或平卧位，全身放松，双下肢缓慢收缩股四头肌，至大腿有酸胀感后5-8s再放松。③.直抬腿训练：取仰卧位，双下肢尽量伸直，然后抬高双下肢，高度以足后跟距床面15cm为宜，1min后休息10-15s。④.踩单车运动：取坐位或仰卧位，吸气时，伸直右膝向下30度屈膝，左腿向下30度屈膝同时伸直右膝向上至90度，右膝向下30度屈膝时换左腿向上90度，以此循环。 口服营养补充（ONS）标准：肠内营养粉剂（安素粉）主要成分每 100 g 含能量450Kcal、蛋白质15.9g、碳水化合物60.7 g、脂肪15.9g和30种维生素和矿物质，不含乳糖。1.0 6Kcal/ml。

干预措施代码：

Intervention：

On the basis of the control group, the intervention group implemented the nutrition and exercise rehabilitation program, including the establishment of a multidisciplinary team composed of doctors (in charge of the doctor), nurses (head nurse, responsible nurse), dietitians, and rehabilitation therapists, who were jointly responsible for guiding and supervising the nutrition and exercise rehabilitation of patients. Before and after surgery, resistance exercise and aerobic exercise were increased with the intervention of rehabilitators. Nutritionist intervention ensured that oral nutritional supplement ONS was given on the basis of meeting the daily energy and protein requirements. Responsible nurses strengthened discharge education and continued resistance exercise and ONS supplementation during continuous nursing at home. Exercise standards: ①. Wrist flexion dumbbell training: take a sitting, standing or supine position, dumbbell about 1kg (or the equivalent amount of water bottle), exercise to keep the forearm and upper arm perpendicular to 90°, the biceps must feel tight. (2) quadriceps static contraction training: take a sitting or flat position, relax the whole body, slowly contract the quadriceps muscles in both lower limbs, and then relax after 5-8s after the thigh feels swollen. 3. Straight leg lift training: take the supine position, straighten both lower limbs as far as possible, and then raise both lower limbs, the height of the heel of the foot 15cm away from the bed is appropriate, and rest 10-15s after 1min. Cycling exercise: take the sitting or supine position, inhale, straighten the right knee down 30 degrees bend the knee, the left leg down 30 degrees bend the knee at the same time straighten the right knee up to 90 degrees, the right knee down 30 degrees bend the knee, change the left leg up 90 degrees, this cycle. Oral nutrition supplement (ONS) standard: The main components of enteral nutrition powder (anso powder) contain 450Kcal of energy, 15.9g of protein, 60.7g of carbohydrates, 15.9g of fat and 30 kinds of vitamins and minerals per 100g, lactose free. 1.0 6Kcal/ml.

Intervention code：

组别：

对照组

样本量：

 26

Group：

control group

Sample size：

干预措施：

以传统医生护士团队合作管理为主，入院后由责任护士进行营养和生活自理能力评估，给予饮食健康教育（如有规律地进食、细嚼慢咽，饮食不宜过饱，注意营养，易消化，少量多餐，避免酒精、咖啡及辣、醋、酸等刺激性食物及瓜子、花生等坚硬食物）；给予术前常规功能锻炼宣教（如深呼吸、有效咳嗽、踝泵运动）。术后遵医嘱逐步恢复饮食，术后饮食恢复原则遵循少量饮水、半量流质（50-80ml|次）、全量流质（100-150ml|次）、半流质、软食至正常饮食。整个围术期医生评估其能量是否充足进行营养补充，包括肠外营养和肠内营养以满足患者每日所需热量。术后鼓励早期活动（如Q2h翻身、踝泵运动、鼓励早期下床活动）。患者出院时生活基本能自理。责任护士进行常规出院健康宣教（如合理饮食，少量多餐，细嚼慢咽，避免暴饮暴食，术后1月内应每日5-6餐，进食新鲜、清淡、易消化半流质饮食，以后逐步过渡到软食，术后仍应禁忌生硬、油炸、浓茶等食物，饮食富有营养如鱼汤、碎肉、水蒸蛋等；出院后1月内休息，日常生活可自理，2-3月后根据恢复情况从事轻便工作；遵医嘱定期复查）。出院1月内电话随访。

干预措施代码：

Intervention：

After admission, the responsible nurse will conduct nutrition and self-care ability assessment, and give diet health education (such as eating regularly, eating slowly, eating should not be too full, paying attention to nutrition, easy digestion, small and frequent meals, avoiding alcohol, coffee, spicy, vinegar, acid and other irritating foods and hard foods such as melon seeds and peanuts); Preoperative routine functional exercises (e.g., deep breathing, effective cough, ankle pump exercises) were given. After surgery, diet was gradually restored according to the doctor's advice. The principles of diet recovery after surgery were small amount of water, half amount of liquid (50-80ml| times), full amount of liquid (100-150ml| times), half amount of liquid, soft food to normal diet. Throughout the perioperative period, the physician assessed energy adequacy for nutritional supplementation, including parenteral nutrition and enteral nutrition to meet the patient's daily calorie requirements. Encourage early movement after surgery (e.g., Q2h roll over, ankle pump exercise, encourage early movement out of bed). The patient can basically take care of himself when he is discharged from hospital. The responsible nurse should carry out routine health education for discharge (such as reasonable diet, small and frequent meals, eating slowly, avoiding overeating, eating 5-6 meals a day within 1 month after surgery, eating fresh, light and digestible semi-liquid diet, gradually transitioning to soft food, still avoiding harsh, fried, strong tea and other foods after surgery, and eating a nutritious diet such as fish soup, minced meat, steamed eggs, etc.); Rest within 1 month after discharge, daily life can take care of themselves, 2-3 months after the recovery of light work; Follow your doctor's advice regularly). Telephone follow-up within 1 month of discharge.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

CHINA

Province：

ZHEJIANG

City：

单位(医院)：

 浙江大学医学院附属第一医院胃肠外科 

单位级别：

 三级 

Institution
hospital：

Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhejiang University School of Medicine

Level of the institution：

Teriary

测量指标：

Outcomes：

指标中文名：

肌力

指标类型：

主要指标

Outcome：

grip strength

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉功能评估

指标类型：

主要指标

Outcome：

Muscle function assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌量评估

指标类型：

主要指标

Outcome：

Muscle mass assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日常生活能力评定

指标类型：

次要指标

Outcome：

Assessment of daily living ability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后康复状况评估

指标类型：

次要指标

Outcome：

Evaluation of postoperative rehabilitation status

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究者本人采用数字随机抽样法确定是否纳入研究，单数排除，双数保留，样本收足即可。选取2024年4月至2024年6月符合纳入排除标准的患者，由研究者本人采用数字随机抽样法确定纳入干预组或对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

A numerical random sampling method was adopted by the researcher to determine whether to include in the study, singular numbers were excluded, even numbers were retained, and sufficient samples were collected. Patients meeting the inclusion and exclusion criteria From April to June 2024 were selected to be included in the intervention group or the control group by numerical random sampling by the investigators themselves.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用单盲法，受试者不知道自己是在试验组还是对照组，而研究者知道。

Blinding：

Single blind method was used in this study, and the subjects did not know whether they were in the test group or the control group, but the investigators did.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

可向研究负责人发送邮件获取原始数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Raw data can be obtained by emailing the study leader.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病历记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-26 11:49:19