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居家八段锦运动对老年CKD3b-4期合并肌少症患者的影响研究
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注册号：

Registration number：

 ChiCTR2500098761 

最近更新日期：

Date of Last Refreshed on：

 2025-03-13 10:23:18 

注册时间：

Date of Registration：

 2025-03-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

居家八段锦运动对老年CKD3b-4期合并肌少症患者的影响研究

Public title：

Effect of Baduanjin Exercise for Elderly CKD 3b-4 stage Patients with Sarcopenia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

居家八段锦运动对老年CKD3b-4期合并肌少症患者的影响研究

Scientific title：

Effect of Homebased Baduanjin Exercise for Elderly CKD 3b-4 stage Patients with Sarcopenia

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：

冯宪煊 

研究负责人：

冯宪煊 

Applicant：

Xianxuan Feng 

Study leader：

Xianxuan Feng 

申请注册联系人电话：

Applicant telephone：

 +86 136 0190 1519

研究负责人电话：

Study leader's
telephone：

+86 136 0190 1519

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：

 fengxianxuan0215@163.com

研究负责人电子邮件：

Study leader's E-mail：

 Wzihan0424@163.com

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：

上海市徐汇区宜山路600号

研究负责人通讯地址：

上海市徐汇区宜山路600号

Applicant address：

600 Yishan Road, Xuhui District, Shanghai

Study leader's address：

600 Yishan Road, Xuhui District, Shanghai

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：

上海市第六人民医院

Applicant's institution：

Shanghai Sixth People’s Hospital

研究负责人所在单位：

上海市第六人民医院

Affiliation of the Leader：

Shanghai Sixth People’s Hospital

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：

 2023-169-(1)

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：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-29 00:00:00

伦理委员会联系人：

庞路阳

Contact Name of the ethic committee：

Luyang Pang

伦理委员会联系地址：

上海市宜山路600号上海市第六人民医院伦理委员会

Contact Address of the ethic committee：

Ethics Committee of Department of Rehabilitation Medicine, Shanghai Sixth People’s Hospital, 600 Yishan Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6436 8920

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：

上海市第六人民医院

Primary sponsor：

Shanghai Sixth People’s Hospital

研究实施负责（组长）单位地址：

上海市徐汇区宜山路600号

Primary sponsor's address：

600 Yishan Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

徐汇区

Country：

China

Province：

Shanghai

City：

Xuhui District

单位(医院)：

上海市第六人民医院

具体地址：

上海市徐汇区宜山路600号

Institution
hospital：

Shanghai Sixth People’s Hospital

Address：

600 Yishan Road, Xuhui District, Shanghai

经费或物资来源：

上海市第六人民医院院级课题

Source(s) of funding：

Shanghai Sixth People’s Hospital

研究疾病：

老年CKD3b-4期合并肌少症  

Target disease：

Elderly CKD 3b-4 stage 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要研究目的：构建适合老年CKD3b-4期合并肌少症患者在社区进行的运动干预方案，探究运动方案的可行性，分析12周的八段锦干预对老年CKD3b-4期合并肌少症患者肌肉质量、肌肉力量、躯体活动能力水平的影响，验证八段锦运动对老年CKD3b-4期患者的肌少症症状及躯体活动能力的干预效果。 次要研究目的：探究八段锦干预对老年CKD3b-4期合并肌少症患者肾功能、生化指标、生活质量的影响。  

Objectives of Study：

Main research objectives: to construct an exercise intervention programme suitable for elderly patients with CKD stage 3b-4 combined with sarcopenia in the community, to explore the feasibility of the exercise programme, to analyse the effects of 12 weeks of the eight-danjins intervention on the levels of muscle mass, muscle strength, and somatic mobility in elderly patients with CKD stage 3b-4 combined with sarcopenia, and to validate the effect of eight-danjins exercise on the symptoms of sarcopenia and the intervention effects on somatic mobility. Secondary research objective: to investigate the effects of Baduanjin intervention on renal function, biochemical indexes, and quality of life of elderly patients with CKD3b-4 combined with sarcopenia.

药物成份或治疗方案详述：

运动组： 在给予对照组相同健康宣教的基础上进行为期12周的八段锦运动干预。运动前对患者生命体征及肢体情况进行评估，判定患者是否适合运动。运动中及运动后监测患者有无胸闷、头晕、肌肉关节疼痛等不良反应，如有不良反应及时停止运动。研究人员以国家体育总局在2003年颁布的“健身气功·八段锦”为运动标准，通过“微信”等APP与受试者进行视频互动，远程指导并监督患者居家进行运动，持续12周，每周3次，共36次运动干预。每次运动的内容包括热身运动、八段锦练习以及放松拉伸三部分，总时长50min。热身活动及放松活动各约10min。八段锦运动共有8节动作，每个动作重复3-7遍为1组，每次锻炼2-3组，组间休息1-2分钟，患者根据自己的耐受情况调整肢体运动幅度和运动次数。运动强度的评估以Borg主观疲劳感觉评分 (ratings of perceived exertion，RPE)为准，RPE是目前公认的对MHD患者的主观运动感觉进行良好评测的方法，运动应达中等强度，12-14分。患者每做完一组需自评一次RPE，若RPE值≤14分则继续在组间休息2-3min后继续在研究人员的指导下进行运动，若RPE值＞14分则在组间休息2-3min，在体力恢复后减少下组训练的重复次数，如患者体力无法恢复则停止运动，研究人员指导患者进行放松拉伸动作。此外，在每次运动结束时，受试者也需立刻自我评估运动后的RPE得分，若12≤RPE值≤14分则后续运动可继续保持原有的强度；若RPE值小于12分则下次运动可增加每个动作的重复次数；若RPE值＞14分则在下次运动时减少每个动作的重复次数。若受试者出现如心跳过速、头晕等不良反应，应立即告知研究人员并停止运动。研究人员要求受试者将每次运动结束时的RPE值以及每个动作的重复次数记录在运动日记上。 对照组： 对照组给予健康宣教，包括饮食、运动、用药指导及相关并发症的预防等内容，并通过每月1次的门诊随访询问患者最近的健康状况并解决其所遇问题。为保证公平性，在研究结束后，征得患者知情同意对对照组患者进行同样的运动干预教育，并发放运动干预手册。 

Description for medicine or protocol of treatment in detail：

Exercise group: Based on the same health education given to the control group, a 12-week exercise intervention of Baduanjin was carried out. Patients' vital signs and limb conditions were assessed before exercise to determine whether they were suitable for exercise. During and after exercise, the patients were monitored for adverse reactions such as chest tightness, dizziness, muscle and joint pain, and if there were any adverse reactions, the exercise was stopped in time. The researchers used ‘Fitness Qigong - Ba Duan Jin’ promulgated by the State General Administration of Sports in 2003 as the exercise standard, and interacted with the subjects via video via WeChat and other APPs to remotely guide and supervise the patients' exercise at home for 12 weeks, 3 times per week, for a total of 36 exercise interventions. A total of 36 exercise interventions were carried out in 12 weeks, 3 times per week. The total duration of each exercise session was 50 min, including warm-up, Badaanjin exercises, and relaxation and stretching, and the warm-up and relaxation activities each lasted about 10 min. 8 sections of Badaanjin exercises were performed, and each movement was repeated 3-7 times in a group, with 2-3 groups per session, and 1-2 min of rest in between groups, and the patients adjusted the amplitude of the body movement and the number of sessions of exercise according to their own tolerance level. The intensity of exercise was assessed by the Borg ratings of perceived exertion (RPE), which is currently recognised as a good method for assessing the subjective sensation of movement in patients with MHD, and the exercise should be of moderate intensity, with a score of 12-14. Patients were required to self-assess the RPE once after each group, if the RPE value was <=14 points, then continue to rest for 2-3 min between groups and continue to exercise under the guidance of the researchers, if the RPE value was >14 points, then rest for 2-3 min between groups, and reduce the number of repetitions of the next group training after physical strength was recovered, and if the patients were unable to recover their physical strength, then stop the exercise, and the researchers instructed the patients to carry out relaxation and stretching movements. In addition, at the end of each exercise, subjects were also required to immediately self-assess the RPE score after exercise, if 12 <= RPE value <= 14 points, then the subsequent exercise can continue to maintain the original intensity; if the RPE value is less than 12 points, then the number of repetitions of each movement can be increased for the next exercise; if the RPE value is more than 14 points, then reduce the number of repetitions of each movement in the next exercise. If subjects experienced any adverse effects such as tachycardia or dizziness, they should immediately inform the researchers and stop the exercise. The researchers asked the subjects to record the RPE value at the end of each exercise and the number of repetitions of each movement in the exercise diary. Control group: The control group was given health education, including diet, exercise, medication instruction and prevention of related complications, and the patients were asked about their recent health status and problems they encountered through outpatient follow-up visits once a month. To ensure fairness, at the end of the study, informed consent was obtained from patients to provide the same exercise intervention education to patients in the control group, and an exercise intervention manual was distributed. 

纳入标准：

Inclusion criteria

排除标准：

1.近一年内进行规律性运动习惯者（≥3次/周，≥20分钟/次，持续12个月以上）； 2.存在有禁忌证的患者：如严重的高血压（＞160/90mmHg），严重的心律失常，心脏协会（NYHA）分级Ⅲ、Ⅳ级、近期有骨折、手术史、不稳定心绞痛发作的患者等； 3.有精神疾病及认知功能障碍无法配合实验者； 4.不配合医务及工作人员完成问卷调查和检查项目，拒绝签署知情同意书，拒绝加入、不配合实验者。

Exclusion criteria：

1. Those who have performed regular exercise habits (>=3 times/week, >=20 minutes/time, for more than 12 months) within the last year; 2. Patients with contraindications: e.g. severe hypertension (>160/90mmHg), severe arrhythmia, NYHA class III or IV, recent fracture, history of surgery, unstable angina attack, etc; 3. Those with mental illness and cognitive dysfunction who are unable to co-operate with the experiment; 4. Those who do not co-operate with medical and staff members in completing the questionnaires and examination items, refuse to sign the informed consent form, refuse to join and do not co-operate with the experiment.

研究实施时间：

Study execute time：

从 From 2024-01-10 00:00:00至 To 2025-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-20 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

运动组

样本量：

 30

Group：

Exercise intervention group

Sample size：

干预措施：

居家八段锦干预

干预措施代码：

Intervention：

Homebased Baduanjin exercise

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control group

Sample size：

干预措施：

常规药物治疗

干预措施代码：

Intervention：

Conventional medication

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

 徐汇区 

Country：

China

Province：

Shanghai

City：

Xuhui District

单位(医院)：

 上海市第六人民医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Sixth People’s Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

起立-行走计时测试

指标类型：

主要指标

Outcome：

Time-up-go test

Type：

Primary indicator

测量时间点：

干预前/干预12周后

测量方法：

起立-行走计时测试

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Time-up-go test

指标中文名：

握力

指标类型：

次要指标

Outcome：

Grip

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

弹簧式握力器

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Spring grip

指标中文名：

下肢肌力

指标类型：

次要指标

Outcome：

Lower limb strength

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

5次座椅站立测试

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Five Times Sit-To-Stand

指标中文名：

四肢骨骼肌质量指数

指标类型：

次要指标

Outcome：

Skeletal muscle index

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

Inbody 770

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Inbody 770

指标中文名：

简易身体功能评估

指标类型：

次要指标

Outcome：

Short physical performance battery

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

简易身体功能测试量表

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Short physical performance battery

指标中文名：

6分钟步行实验

指标类型：

次要指标

Outcome：

6-minute walk test

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

六分钟步行试验

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

6-minute walk test

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

肾脏疾病生活质量简表

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Kidney Disease Quality of Life-Short Form

指标中文名：

生化指标

指标类型：

次要指标

Outcome：

Biochemical index

Type：

Secondary indicator

测量时间点：

干预前/干预12周后

测量方法：

血检 尿检

Measure time point of outcome：

Pre-intervention/12 weeks post-intervention

Measure method：

Blood test urine test

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉血液

Sample Name：

Blood

Tissue：

Venous blood

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 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）：

课题组成员选取上海市第六人民医院肾脏内科门诊就诊的老年慢性肾病合并肌少症患者60例，使用简单随机化方法将研究对象随机分为居家运动组和对照组，每组各30例。

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

Members of the group selected 60 cases of elderly patients with chronic kidney disease combined with sarcopenia attending the outpatient clinic of the Department of Nephrology of the Sixth People's Hospital of Shanghai, and randomly divided the study subjects into a home exercise group and a control group, with 30 cases in each group, using a simple randomisation method.

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：

对疗效评估者采取盲法

Blinding：

Blind method for efficacy evaluator

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）：

邮箱 Wzhan0424@163.com 2026.1

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

Email Wzihan0424@163.com 2026.1

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：

1.病例记录表 2.Excel Worksheet

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

1.Case Record Form; 2.Excel Worksheet

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-03-13 10:23:11
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