ChiCTR2300077597 版本V1.0 版本创建时间2023/11/14 09:35:09 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：

ChiCTR2300077597 

最近更新日期：

Date of Last Refreshed on：

2023-11-14 09:34:36 

注册时间：

Date of Registration：

2023-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于自我效能理论的运动干预对老年非透析慢性肾脏病患者体力活动水平的影响

Public title：

Effects of exercise intervention based on self-efficacy theory on physical activity level in elderly non-dialysis patients with chronic kidney disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于自我效能理论的运动干预对老年非透析慢性肾脏病患者体力活动水平的影响

Scientific title：

Effects of exercise intervention based on self-efficacy theory on physical activity level in elderly non-dialysis patients with chronic kidney disease

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：

李艳博 

研究负责人：

董雅楠 

Applicant：

Yanbo Li 

Study leader：

Yanan Dong 

申请注册联系人电话：

Applicant telephone：

+86 158 4307 9699

研究负责人电话：

Study leader's telephone：

+86 139 4493 4974

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：

5431620@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1194077024@qq.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：

吉林省长春市新民大街1号

研究负责人通讯地址：

吉林省长春市新民大街1号

Applicant address：

1 Xinmin Street, Changchun City, Jilin Province, China

Study leader's address：

1 Xinmin Street, Changchun City, Jilin Province, China

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：

吉林大学第一医院

Applicant's institution：

The First Hospital of Jilin University

研究负责人所在单位：

吉林大学第一医院

Affiliation of the Leader：

The First Hospital of Jilin University

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：

23K213-001

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：

吉林大学第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Hospital of Jilin University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-11-01 00:00:00

伦理委员会联系人：

郭迪

Contact Name of the ethic committee：

Di Guo

伦理委员会联系地址：

吉林省长春市新民大街1号

Contact Address of the ethic committee：

1 Xinmin Street, Changchun City, Jilin Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 187 4404 7115

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：

吉林大学第一医院

Primary sponsor：

The First Hospital of Jilin University

研究实施负责（组长）单位地址：

吉林省长春市新民大街1号

Primary sponsor's address：

1 Xinmin Street, Changchun City, Jilin Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林省

市(区县)：

长春市

Country：

China

Province：

Jilin province

City：

Changchun city

单位(医院)：

吉林大学第一医院

具体地址：

吉林省长春市新民大街1号

Institution
hospital：

The First Hospital of Jilin University

Address：

1 Xinmin Street, Changchun City, Jilin Province, China

经费或物资来源：

无

Source(s) of funding：

no

Target disease：

chronic kidney disease

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：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

本研究以自我效能理论为研究框架，探讨基于自我效能理论的运动干预对老年非透析慢性肾脏病患者体力活动水平的影响，并分析其对肌肉力量、运动自我效能、焦虑及抑郁情绪的影响。  

Objectives of Study：

This study used self-efficacy theory as the research framework to explore the effects of exercise intervention based on self-efficacy theory on physical activity level in elderly non-dialysis patients with chronic kidney disease, and to analyze its effects on muscle strength, exercise self-efficacy, anxiety and depression.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

以下七条同时符合者方能纳入试验 符合性肾脏病诊断标准； 年龄≥60岁的非透析慢性肾脏病患者； 预期三个月内将不接受肾脏替代治疗； 无运动禁忌症(美国运动医学会定义)； 低体力活动水平者； 家属或患者一方可熟练使用微信； 知情同意，愿意参与本研究。

Inclusion criteria

Only those who met the following seven criteria were included in the study Diagnostic criteria of kidney disease Non-dialysis patients with chronic kidney disease aged ≥60 years No renal replacement therapy is expected for three months No contraindications to exercise (American College of Sports Medicine definition) People with low physical activity level Family members or patients can use wechat skillfully Informed consent and willingness to participate in this study

排除标准：

凡符合以下任意一项者予以排除试验 不能配合完成手握力、坐立测试者； 消耗性疾病、严重呼吸、循环及其他系统疾病； 严重水肿、关节炎等不能配合运动者； 血压异常(＞180/110mmHg，90/60mmHg）； 存在认知障碍者； 同时参与其他临床试验的研究者。

Exclusion criteria：

Patients who met any of the following criteria were excluded from the trial Those who could not cooperate to complete the grip strength and sit-to-stand test Wasting diseases, severe respiratory, circulatory and other system diseases Severe edema, arthritis, etc. can not cooperate with exercise Abnormal blood pressure (> 180/110mmHg, 90/60mmHg) People with cognitive impairment Investigators who also participated in other clinical trials

研究实施时间：

Study execute time：

从 From 2023-11-01 00:00:00至 To 2024-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-11-14 00:00:00 至 To 2024-02-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

37

Group：

intervention group

Sample size：

干预措施：

病情稳定后，给予干预组基于自我效能理论的运动干预，共持续12周，前一周于医院进行，后11周随访：第1天与患者建立信任关系；询问日常体力活动情况、运动量及对运动的认识和看法（如您觉得慢性肾脏病患者是否应该进行体力活动？是什么阻碍您进行体力活动？有没有运动的兴趣？）；了解其对疾病掌握程度；帮助患者明确自身问题及运动障碍，鼓励他们学会表达自己的想法；并介绍本研究目的、干预过程及注意事项。第2天采用言语劝说，通过解释、说服性建议、劝告和自我引导，改变患者自我效能感。首先向患者宣教慢性肾脏病相关知识、运动类型及方法，详细说明运动优势及其对CKD的积极作用，使其明白运动重要性和必要性，改善认知和态度，减少顾虑并树立信心，促进运动。其次根据患者目前疾病状态、运动情况和存在问题，提出合理建议并纠正问题，帮助其调节心理障碍，提高运动兴趣，改善运动自我效能。同时依据患者存在问题，与其进一步沟通，建立积极认知，理解运动的意义，说服其相信自己具有完成给定目标的能力和信心, 在遇到困境时能付出更大的努力成功的完成任务, 提高自我效能。最后研究者多使用鼓励的语气和态度，说服患者相信自己拥有运动的技能和能力，拥有更强的自信心，充分发挥主观能动性，提高运动积极性。第3天改善患者生理和情绪状态，个体的情绪和生理状态将影响自我效能感。首先指导患者逐渐暴露在不愿运动有关的画面或记忆中，通过放松等方式缓解不良情绪；同时，通过反复想象与练习,不断降低对运动敏感性,最终在模拟运动情境中达到脱敏效果；在干预期间密切关注患者情绪变化，出现不良情绪时及时根据其实际情况予以针对性心理开导，维持最佳功能状态。在这个过程中，当患者体验到成功或失败时，鼓励患者从结果寻找导致其的内在动力因素，使其意识到运动失败也存在外在客观条件的限制，并非完全因为自身能力和努力不够，如自身水肿、疲劳、肌酐升高等问题，帮助患者学会进行正确的情况分析，减轻心理压力。随后通过暗示或自我暗示，使患者情绪和肌肉都处于松弛状态；给予个体化心理支持，教会患者掌握音乐疗法、深呼吸、肌肉放松等自我放松技巧；给予其充分支持与理解,缓解患者心理负担及不良情绪。第4天运用间接经验，通过现场示范和象征性示范来提高自我效能感。首先由研究者亲自示范运动详细步骤，患者观察获得间接经验，加强其对运动的领悟和理解；其次请已经学会运动方法的患者进行现场示范并介绍成功经验，大大提高准备运动患者自我效能期望, 促进运动。随后，向患者提供一份运动手册，并详细讲解慢性肾脏病疾病相关知识及运动方法、注意事项等，进一步增强对相关知识的了解，提高自我效能感；再使用幻灯片给患者观看相关视频资料，发挥榜样示范作用；并传达目前运动研究进展、相关结果及经验，帮助患者学习有效运动方法，进一步提高自我效能感；建立病友群，方便经验交流和互相激励。第5-7天通过掌握的亲历性经验提高自我效能感。首先，研究者根据疾病状况和日常体力活动水平与患者共同制定合理运动处方，随后引导患者进行肌肉放松训练，将其置于运动的环境中，进行简单低强度到中等强度运动，实地体验，逐渐降低对运动敏感性，消除恐惧和焦虑。随后引导患者自主进行运动，运动后评估其理解及掌握情况，对患者理解错误或未掌握部分进行补充讲解，不会的动作由研究者示范，患者尝试运动，先观察，再运动，接着再观察，再运动，反复多次，直到掌握，成功的经验将提高自我效能感，使患者感到有能力运动。学会后，患者依据运动处方进行有规律适度运动，并重复进行，总结反思再练习；运动结束后将内容、频次，时间进行记录，通过此方法将对其自身成功经验进行不断强化，提升运动决心。为了保证科学性，研究者根据文献及指南的建议，基于患者的生理功能、基础活动状况给出运动处方。运动处方如下：对于基本不活动，偶尔活动一次者每天走3000-3500步；对于少量活动者每天走3500-4000步；对于能独立完成日常生活，平常很少进行有意义运动训练患者每周进行四次运动康复操（研究者自行设计），每次20分钟。第2-12周进行随访，运用亲历的掌握性经验、间接经验、言语劝说、改善生理和情绪状态等理论；要求患者根据运动处方每周一、三、五、七进行运动；并在微信群进行打卡(报告有无发生不良事件)，不打卡者由研究者联系，提醒打卡；每周研究者在微信群分享与CKD相关的运动资料；邀请依从性较好的患者进行经验分享，以激励锻炼过程不顺的患者，减少不良情绪;每周五根据较多存在的问题，统一给与解答；每周日一对一电话随访，给与个性化帮助;鼓励患者在微信群表达自己的困惑，给与及时适当解答；运动失败时，学会从结果寻找导致行为的内在动力因素，并通过放松训练减轻心理压力。

干预措施代码：

Intervention：

After the condition was stable, the intervention group was given exercise intervention based on self-efficacy theory for 12 weeks. The first week was carried out in the hospital, and the last 11 weeks were followed up: on the first day, trust relationship was established with the patient; Ask about daily physical activity, the amount of exercise, and your knowledge and views on exercise (e.g., do you think patients with chronic kidney disease should do physical activity? What prevents you from being physically active? Are you interested in sports? ; To understand their mastery of the disease; Help patients to identify their own problems and movement disorders, and encourage them to learn to express their ideas; The purpose of this study, intervention process and precautions were introduced. On the second day, verbal persuasion was used to change patients' self-efficacy through explanation, persuasive advice, counseling and self-guidance. Firstly, patients were educated about CKD related knowledge, exercise types and methods, and the advantages of exercise and its positive effect on CKD were explained in detail, so that patients could understand the importance and necessity of exercise, improve their cognition and attitude, reduce their concerns and build up confidence, and promote exercise. Secondly, according to the patient's current disease state, exercise situation and existing problems, reasonable suggestions were put forward and problems were corrected to help them adjust their psychological disorders, improve their exercise interest and improve their exercise self-efficacy. At the same time, according to the problems of patients, they should be further communicated with them to establish positive cognition, understand the significance of exercise, and convince them to believe that they have the ability and confidence to complete the given goal. When they encounter difficulties, they can make greater efforts to successfully complete the task and improve their self-efficacy. Finally, researchers use more encouraging tone and attitude to convince patients that they have the skills and ability to exercise, have stronger self-confidence, give full play to their subjective initiative, and improve their exercise enthusiasm. The third day can improve the physical and emotional state of patients, and the individual's emotional and physiological state will affect the self-efficacy. Firstly, the patients were instructed to gradually expose themselves to the images or memories related to unwilling to exercise, and relieve their bad emotions by relaxing. At the same time, through repeated imagination and practice, the sensitivity to motion was continuously reduced, and finally the desensitization effect was achieved in the simulated motion situation. During the intervention period, we paid close attention to the emotional changes of patients, and timely gave targeted psychological guidance according to the actual situation when there was a bad mood, so as to maintain the best functional state. In this process, when patients experience success or failure, they are encouraged to find the internal motivation factors from the results, make them realize that exercise failure is also limited by external objective conditions, not entirely due to their own ability and effort, such as edema, fatigue, increased creatinine and other problems, and help patients learn to carry out correct situation analysis and reduce psychological pressure. Then through suggestion or self-suggestion, the patient's emotions and muscles are relaxed; Individualized psychological support was given, and patients were taught to master self-relaxation skills such as music therapy, deep breathing, and muscle relaxation. Give them full support and understanding to relieve their psychological burden and negative emotions. On day 4, indirect experience was used to enhance self-efficacy through live demonstration and symbolic demonstration. Firstly, the researchers demonstrated the detailed steps of exercise in person, and the patients observed the indirect experience to strengthen their understanding of exercise. Secondly, patients who have learned exercise methods should demonstrate and introduce successful experiences on the spot, which can greatly improve the self-efficacy expectations of patients who are ready to exercise and promote exercise. Then, an exercise manual was provided to the patients, and the patients were explained in detail the knowledge of chronic kidney disease, exercise methods, precautions, etc., to further enhance the understanding of relevant knowledge and improve their self-efficacy. Then the slides were used to show the patients relevant video materials to play the role of example. And convey the current exercise research progress, related results and experience to help patients learn effective exercise methods and further improve their self-efficacy. Establish a group of patients to facilitate experience exchange and encourage each other. On days 5-7, self-efficacy was improved through the personal experience of mastery. Firstly, the researchers worked with the patients to formulate a reasonable exercise prescription according to the disease status and daily physical activity level, and then guided the patients to carry out muscle relaxation training, put them in the exercise environment, and perform simple low-intensity to moderate-intensity exercise, so as to gradually reduce their sensitivity to exercise and eliminate fear and anxiety. Then the patients were guided to exercise independently, and their understanding and mastery were evaluated after exercise, and the patients were given supplementary explanations for the part that the patients did not understand or did not grasp. The actions that the patients could not understand were demonstrated by the researchers, and the patients tried to exercise, first observed, then exercised, and then observed and exercised again, repeated many times until they mastered the exercise. After learning, the patients carried out regular moderate exercise according to the exercise prescription and repeated it, and then practiced it after summarizing and reflecting. After the end of the exercise, the content, frequency and time will be recorded, through this method will continue to strengthen their own successful experience, improve the determination to exercise. In order to ensure the scientificity, researchers give exercise prescriptions based on the physiological function and basic activity of patients according to the recommendations of literature and guidelines. The exercise prescription is as follows: 3000-3500 steps per day for those who are basically inactive and occasionally active; 3500 to 4000 steps per day for lightly active people; Patients who were able to perform activities of daily living independently and who did not normally engage in meaningful exercise performed an investigator-designed exercise program for 20 minutes four times weekly. The patients were followed up from week 2 to week 12. The theory of mastering experience, indirect experience, verbal persuasion, and improving physical and emotional state were used. Patients were asked to exercise every Monday, Wednesday, Friday and July according to the exercise prescription. Patients who did not punch in the wechat group were contacted by the researchers to remind them to punch in. Each week, researchers shared CKD-related exercise data in a wechat group. Patients with good compliance were invited to share their experiences, so as to encourage patients who had difficulties in exercise and reduce negative emotions. Every Friday according to more existing problems, unified give answers; One-to-one telephone follow-up every Sunday to give personalized help; Encourage patients to express their confusion in the wechat group and give timely and appropriate answers; When exercise fails, learn to look for the internal motivation factors leading to behavior from the results, and reduce psychological pressure through relaxation training.

Intervention code：

组别：

对照组

样本量：

37

Group：

control group

Sample size：

干预措施：

住院期间给与3-5次常规运动指导，包括运动方式、强度、时间和注意事项。出院后要求微信群运动打卡，并每周电话随访。

干预措施代码：

Intervention：

Routine exercise instruction was given 3-5 times during hospitalization, including exercise mode, intensity, time and precautions. After discharge, patients were required to punch in the wechat group for exercise and follow up by telephone every week.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林省 

市(区县)：

 长春市 

Country：

China 

Province：

Jilin province 

City：

Changchun city 

单位(医院)：

吉林大学第一医院 

单位级别：

三甲 

Institution
hospital：

The First Hospital of Jilin University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体力活动水平

指标类型：

主要指标

Outcome：

physical activity level

Type：

Primary indicator

测量时间点：

基线和三个月后

测量方法：

国际体力活动问卷长卷

Measure time point of outcome：

Baseline and after three months

Measure method：

International Physical Activity Questionnaire-Long

指标中文名：

上肢和下肢肌肉力量

指标类型：

主要指标

Outcome：

Upper and lower limb muscle strength

Type：

Primary indicator

测量时间点：

基线和三个月后

测量方法：

测量上肢肌肉力量使用广东香山衡器集团股份有限公司制造的CAMRY EH101型电子握力计，下肢肌肉力量采用五次坐立测试

Measure time point of outcome：

Baseline and after three months

Measure method：

The upper limb muscle strength was measured using CAMRY EH101 electronic handgrip dynamometer manufactured by Guangdong Xiangshan Weighing Instrument Group Co., LTD. The lower limb muscle strength was measured using five sit-to-stand tests

指标中文名：

运动自我效能感

指标类型：

次要指标

Outcome：

Exercise self-efficacy

Type：

Secondary indicator

测量时间点：

基线和三个月后

测量方法：

运动自我效能量表

Measure time point of outcome：

Baseline and after three months

Measure method：

The Exercise Self-Efficacy Scale

指标中文名：

焦虑症状

指标类型：

次要指标

Outcome：

anxiety symptom

Type：

Secondary indicator

测量时间点：

基线和三个月后

测量方法：

焦虑自评量表

Measure time point of outcome：

Baseline and after three months

Measure method：

Self-rating anxiety scale

指标中文名：

抑郁症状

指标类型：

次要指标

Outcome：

depressive symptom

Type：

Secondary indicator

测量时间点：

基线和三个月后

测量方法：

简版老年抑郁量表

Measure time point of outcome：

Baseline and after three months

Measure method：

Geriatric Depression Scale-15

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：

intravenous infusion

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 60 岁 years
最大 Max age 90 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）：

采用随机数字表进行随机化，将所有入选患者从1到74编号，然后在随机数字表中从任意数字开始依次选取74个随机数字，沿同一顺序方向获取每个病历对应的随机数字，然后除以2，余数为1的分到对照组，若整除分到干预组。每组各37例。

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

All patients were numbered from 1 to 74 in the random number table, and then 74 random numbers were selected from any number in the random number table. The corresponding random number of each medical record was obtained in the same order direction, and then divided by 2. There were 37 cases in each group.

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：

由于干预的性质，不能对护士和参与者进行盲法。因此，本研究仅对统计分析者和数据收集者设盲。

Blinding：

Blinding of nurses and participants could not be done due to the nature of the intervention. Therefore, the study was blinded only to the statistical analysts and data collectors.

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）：

试验结束后共享原始数据

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

The raw data were shared after the trial

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：

数据采集通过量表和测量的形式进行。对收回的问卷进行统一编号，对各项项目的内容进行仔细检查，双人核对、双人录入以确保数据准确无误。研究数据将存储并备份在有密码保护的电脑上。将有效数据录入EpiData3.1进行保存。原始问卷将被锁在一个安全的柜子里，钥匙由指定的小组成员保管。

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

Data collection was carried out in the form of scales and measurements. The collected questionnaires were numbered uniformly, and the content of each item was carefully checked, double-checked and double-entered to ensure the accuracy of the data. The study data will be stored and backed up on a password-protected computer. The valid data were entered into EpiData3.1 for saving. The original questionnaire will be locked in a secure cabinet with the key held by a designated panel member.

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：

  2023-11-14 09:34:36