ChiCTR2300072594 版本V1.0 版本创建时间2023/06/19 10:49:07 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：

ChiCTR2300072594 

最近更新日期：

Date of Last Refreshed on：

2023-06-19 10:46:08 

注册时间：

Date of Registration：

2023-06-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

减量高强度间歇训练用于脑卒中非步行患者心肺耐力训练的安全性及有效性研究：一项前瞻性单臂临床试验

Public title：

Study on the safety and effectiveness of reduced-exertion high-intensity interval training for non-ambulatory stroke patients' cardiorespiratory fitness: A prospective single-arm clinical trial.

注册题目简写：

REHIT用于心肺耐力训练的安全性及有效性

English Acronym：

Safety and Effectiveness of REHIT for CRF

研究课题的正式科学名称：

减量高强度间歇训练用于脑卒中非步行患者心肺耐力训练的安全性及有效性研究：一项前瞻性单臂临床试验

Scientific title：

Study on the safety and effectiveness of reduced-exertion high-intensity interval training for non-ambulatory stroke patients' cardiorespiratory fitness: A prospective single-arm clinical trial.

研究课题代号(代码)：

Study subject ID：

 2023yjlcyj017

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：

周明超 

研究负责人：

周明超 

Applicant：

Mingchao Zhou 

Study leader：

Mingchao Zhou 

申请注册联系人电话：

Applicant telephone：

+86 189 9891 2628

研究负责人电话：

Study leader's telephone：

+86 189 9891 2628

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：

zhoumc06@email.szu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zhoumc06@email.szu.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：

深圳市福田区笋岗西路3002号

研究负责人通讯地址：

深圳市福田区笋岗西路3002号

Applicant address：

3002 Shungang West Road, Futian District, Shenzhen City.

Study leader's address：

3002 Shungang West Road, Futian District, Shenzhen City.

申请注册联系人邮政编码：

Applicant postcode：

518000

研究负责人邮政编码：

Study leader's postcode：

518000

申请人所在单位：

深圳市第二人民医院

Applicant's institution：

Shenzhen Second People's Hospital

研究负责人所在单位：

深圳市第二人民医院

Affiliation of the Leader：

Shenzhen Second People's Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-106-02PJ

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：

深圳市第二人民医院临床科研伦理委员会

Name of the ethic committee：

Shenzhen Second People's Hospital Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-06-12 00:00:00

伦理委员会联系人：

杨鸿瑜

Contact Name of the ethic committee：

Hongyu Yang

伦理委员会联系地址：

深圳市福田区笋岗西路3002号

Contact Address of the ethic committee：

3002 Shungang West Road, Futian District, Shenzhen City.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 8346 4301

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hyyoung95@163.com

研究实施负责（组长）单位：

深圳市第二人民医院

Primary sponsor：

Shenzhen Second People's Hospital

研究实施负责（组长）单位地址：

深圳市福田区笋岗西路3002号

Primary sponsor's address：

3002 Shungang West Road, Futian District, Shenzhen City.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

深圳市第二人民医院

具体地址：

深圳市福田区笋岗西路3002号

Institution
hospital：

Shenzhen Second People's Hospital

Address：

3002 Shungang West Road, Futian District, Shenzhen City.

经费或物资来源：

广东省高水平医院建设经费

Source(s) of funding：

Funds for the construction of high-level hospitals in Guangdong Province

Target disease：

Stroke

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：

单臂 

Study design：

Single arm 

研究目的：

主要研究目的：明确减量高强度间歇训练（REHIT）改善脑卒中非步行患者心肺耐力的作用及其安全性； 次要研究目的：了解REHIT在改善脑卒中非步行患者心肺耐力的同时是否能有效调节其运动功能、代谢水平及血压水平。  

Objectives of Study：

Main objective: To explore the safety and effectiveness of reduced-exertion high-intensity interval training (REHIT) in improving cardiorespiratory fitness in non-ambulatory stroke patients. Secondary objective: To investigate whether REHIT can effectively regulate the functional capacity, metabolic profile, and blood pressure levels in non-ambulatory stroke patients while improving their cardiorespiratory fitness.

药物成份或治疗方案详述：

本试验共需病例45例，采用单臂临床试验Simon两阶段设计。在第一阶段选择18个病例进入研究，若观察到有效病例数不超过5例则终止试验，如果超过则进入第二阶段，并增加总病例数到45例，若两阶段总共有效病例数不超过17个则拒绝该训练方法，若超过17例则继续完成全部试验。试验前由每位受试者本人或家属签署知情同意书。每位入组患者都接受基础训练和减量高强度间歇训练 基础康复训练：包括偏瘫肢体综合训练、起立床训练、关节活动度训练、抗阻训练、平衡训练等。研究者可根据患者病情使用踝足矫形器等常规训练辅助器具。入组患者的基础训练条目需保持基本一致，但也需要根据患者病情进行适当调整。每周训练5天。 减量高强度间歇训练：在基础康复训练之外，使用四肢联动训练器（曼纽科，HNK-LE-E001A）对试验组患者进行减量高强度间歇训练。训练模式为：两踏板与双下肢连接固定，使健侧下肢带动患侧下肢进行主动运动，在持续心电监护下，缓慢递增阻力热身2min-低强度运动2min-“全力以赴”运动20-30s-低强度维持2min-“全力以赴”运动20-30s-低强度运动2min，如此循环，持续10min，最后缓慢降低阻力恢复运动3min，每天训练15min，每周训练5次。训练过程中持续观察患者心电、血压、症状，若有不适症状及时调整或中止训练，并根据患者情况进行及时处理。 结局评价指标：①主要评价指标：在训练前、训练第4周、6周，采用用心肺运动试验评估峰值摄氧量 (VO2peak)改善有效率。②次要评价指标：在训练前、训练第4周、6周时，分别评估患者运动功能指标（Barthel指数、龙氏量表、Fugl-meyer量表）；人体成分（体重指数（BMI）、体脂率、肌肉量）；代谢指标（总胆固醇（TC）、空腹血糖）和血压水平 

Description for medicine or protocol of treatment in detail：

This study requires a total of 45 cases and adopts a single-arm clinical trial design using Simon's two-stage design. In the first stage, 18 cases are selected to enter the study. If the number of observed effective cases does not exceed 5, the trial is terminated. If it exceeds 5, the study proceeds to the second stage, and the total number of cases is increased to 45. If the total number of effective cases in both stages does not exceed 17, the training method is rejected. If it exceeds 17, the entire trial is completed. Prior to the trial, informed consent is obtained from each participant or their family members. Each enrolled patient undergoes baseline training and reduced-exertion high-intensity interval training. Baseline rehabilitation training includes comprehensive training for the affected limbs, sit-to-stand training, joint range of motion exercises, resistance training, balance training, etc. Researchers may use conventional training aids such as ankle-foot orthoses based on the patient's condition. The baseline training items for enrolled patients should be generally consistent but may be adjusted appropriately according to the patient's condition. Training is conducted 5 days per week. Reduced-exertion high-intensity interval training is conducted in addition to the baseline rehabilitation training using a limb coordination training device (Manukuo, HNK-LE-E001A). The training mode is as follows: both pedals are fixed and connected to the bilateral lower limbs, allowing the unaffected lower limb to actively move the affected limb. Under continuous electrocardiographic monitoring, the training protocol consists of a 2-minute warm-up with gradually increasing resistance, followed by 2 minutes of low-intensity exercise, 20-30 seconds of "all-out" exercise, 2 minutes of low-intensity maintenance, 20-30 seconds of "all-out" exercise, and 2 minutes of low-intensity exercise. This cycle is repeated for 10 minutes, followed by a gradual reduction in resistance and a 3-minute recovery exercise. Training is conducted for 15 minutes per day, 5 times per week. During training, continuous monitoring of the patient's electrocardiogram, blood pressure, and symptoms is performed. If any discomfort or symptoms arise, training is adjusted or discontinued, and appropriate measures are taken based on the patient's condition. Outcome measures: Primary outcome measure: Improvement rate of peak oxygen consumption (VO2peak) assessed by cardiopulmonary exercise testing at baseline, 4 weeks, and 6 weeks of training. Secondary outcome measures: Assessment of patient's functional capacity (Barthel Index, Rankin Scale, Fugl-Meyer Assessment) at baseline, 4 weeks, and 6 weeks; assessment of body composition (body mass index, body fat percentage, muscle mass); assessment of metabolic indicators (total cholesterol, fasting blood glucose); and blood pressure levels. 

纳入标准：

①符合脑卒中诊断标准；②生命体征平稳；③年龄18-75岁；④发病时间15天-1年；⑤功能水平为功能性步行量表（FAC）评分0-1分，即在不借助他人帮助的情况下无法独立行走；⑥至少一侧下肢可主动完成伸髋伸膝动作；⑦配合度量表S5Q≥3分，能理解并积极参与评估与训练方案；⑧患者签署知情同意书。

Inclusion criteria

①Meet the diagnostic criteria for stroke. ②Stable vital signs. ③Age between 18 and 75 years. ④Onset of stroke between 15 days and 1 year. ⑤Functional level with a Functional Ambulation Category (FAC) score of 0-1, indicating the inability to walk independently without assistance from others. ⑥At least one lower limb capable of actively performing hip extension and knee extension movements. ⑦Cooperation with the measurement scale S5Q ≥ 3, able to understand and actively participate in the assessment and training protocols. ⑧Signed informed consent form from the patient.

排除标准：

① 进展型卒中；脑卒中超急性期；短暂性脑缺血发作；有脑外伤史、脑炎、结核性脑膜炎等脑实质及中枢神经受累史的患者；② 急性冠脉综合征、失代偿心衰、未控制的严重心律失常、高度房室传导阻滞、重度心脏瓣膜病、肥厚型梗阻性心肌病、活动性心肌炎、心包炎等严重心脏疾病；③ 严重肝肾功能不全者，包括肾小球滤过率 GFR＜15%,丙氨酸氨基转移酶 ALT≥200U/L，或天门冬氨酸氨基转移酶 AST≥200U/L；④合并其他严重疾病者,如恶性肿瘤、慢性肾脏病末期、精神障碍、重度营养不良等；⑤下肢骨折未愈合、严重骨质疏松者；肌张力高，Ashworth分级2-4级者；⑥未经治疗的下肢深静脉血栓者；⑦妊娠或哺乳期妇女；⑧同期参加了其他的药物或医疗器械临床试验

Exclusion criteria：

①Patients with progressive stroke, hyperacute phase of stroke, transient ischemic attack, history of brain injury, encephalitis, tuberculous meningitis, or other central nervous system involvement. ②Patients with acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmias, high-degree atrioventricular block, severe valvular heart disease, hypertrophic obstructive cardiomyopathy, active myocarditis, pericarditis, or other severe cardiac diseases. ③Patients with severe liver or kidney dysfunction, including glomerular filtration rate (GFR) < 15%, alanine aminotransferase (ALT) ≥ 200 U/L, or aspartate aminotransferase (AST) ≥ 200 U/L. ④Patients with other serious conditions, such as malignant tumors, end-stage chronic kidney disease, mental disorders, severe malnutrition, etc. ⑤Patients with unhealed lower limb fractures or severe osteoporosis, and those with high muscle tone graded as 2-4 according to the Ashworth scale. ⑥Untreated patients with lower limb deep vein thrombosis. ⑦Pregnant or lactating women. ⑧Patients concurrently participating in other drug or medical device clinical trials.

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-06-12 00:00:00 至 To 2026-04-01 00:00:00  

干预措施：

Interventions：

组别：

干预组（单臂）

样本量：

45

Group：

Intervention Group (Single arm)

Sample size：

干预措施：

第一阶段：基础训练 第二阶段：减量高强度间歇训练

干预措施代码：

Intervention：

Stage 1: baseline training Stage 2: reduced-exertion high-intensity interval training.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 深圳 

Country：

China 

Province：

Guangdong 

City：

Shenzhen 

单位(医院)：

深圳市第二人民医院 

单位级别：

三甲 

Institution
hospital：

Shenzhen Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

峰值摄氧量 (VO2peak)改善有效率

指标类型：

主要指标

Outcome：

Peak oxygen uptake (VO2peak) improved efficiency

Type：

Primary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

心肺运动试验

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Cardiopulmonary exercise testing

指标中文名：

日常生活活动能力

指标类型：

次要指标

Outcome：

Activities of daily living

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

Barthel量表，龙氏量表

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Barthel Index, Longshi Scale

指标中文名：

肢体活动能力

指标类型：

次要指标

Outcome：

Limb mobility

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

Fugl-meyer量表

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Fugl-meyer Scale

指标中文名：

体脂率

指标类型：

次要指标

Outcome：

Body fat rate

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

人体成分检测仪

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Body composition detector

指标中文名：

肌肉量

指标类型：

次要指标

Outcome：

muscle mass

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

人体成分检测仪

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Body composition detector

指标中文名：

血清胆固醇

指标类型：

次要指标

Outcome：

Serum cholesterol

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周

测量方法：

生化检测

Measure time point of outcome：

Before training, 4 weeks and 6 weeks after training

Measure method：

Biochemical test

指标中文名：

空腹血糖

指标类型：

次要指标

Outcome：

FBG(fasting blood-glucose)

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周清晨

测量方法：

生化检测

Measure time point of outcome：

Early morning before training, 4 weeks and 6 weeks after training

Measure method：

Biochemical test

指标中文名：

晨间血压

指标类型：

次要指标

Outcome：

Morning blood pressure

Type：

Secondary indicator

测量时间点：

训练前、训练后第4周、6周清晨

测量方法：

血压计

Measure time point of outcome：

Early morning before training, 4 weeks and 6 weeks after training

Measure method：

Blood pressure monitor

指标中文名：

不良事件发生率

指标类型：

副作用指标

Outcome：

Adverse event rate

Type：

Adverse events

测量时间点：

6周训练全程

测量方法：

数据统计

Measure time point of outcome：

All 6 weeks of training

Measure method：

Data statistics

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

无

Sample Name：

Blood

Tissue：

None

人体标本去向

 使用后保存  

说明

所有样本最长保留时间为5年，5年后按照法律法规进行处理和销毁

Fate of sample：

Preservation after use  

Note：

The maximum retention time of all samples is 5 years, after which they are processed and destroyed in accordance with laws and regulations

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

无

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

None

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：

无

Blinding：

None

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

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）：

试验完成后（2026年5月31日）上传原始数据至ResMan

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

Upload the original data to ResMan after the research was completed.

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-06-19 10:46:08