ChiCTR2600122917 版本V1.0 版本创建时间2026/04/20 11:43:42 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：

 ChiCTR2600122917 

最近更新日期：

Date of Last Refreshed on：

 2026-04-20 11:43:38 

注册时间：

Date of Registration：

 2026-04-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

户外运动对老年肌少症患者心理社会与生理健康的影响：一项随机对照试验

Public title：

Supervised Outdoor Exercise Versus Clinic-Based Rehabilitation for Older Patients with Sarcopenia: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

户外运动对老年肌少症患者心理社会与生理健康的影响：一项随机对照试验

Scientific title：

Supervised Outdoor Exercise Versus Clinic-Based Rehabilitation for Older Patients with Sarcopenia: A Randomized Controlled Trial

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：

陆晟迪 

研究负责人：

黄莉华 

Applicant：

Lu Shengdi 

Study leader：

Huang Lihua 

申请注册联系人电话：

Applicant telephone：

 +86 21 2405 8046

研究负责人电话：

Study leader's
telephone：

+86 21 2405 8046

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：

 lushendi0828@163.com

研究负责人电子邮件：

Study leader's E-mail：

 huanglihua906@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：

No. 600, Yishan Road, Xuhui District, Shanghai

Study leader's address：

No. 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：

上海交通大学医学院附属第六人民医院

Applicant's institution：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海交通大学医学院附属第六人民医院

Affiliation of the Leader：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong 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：

 2022-KY-008(K)

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：

 2022-03-08 00:00:00

伦理委员会联系人：

孙秀秀

Contact Name of the ethic committee：

Sun Xiuxiu

伦理委员会联系地址：

上海市徐汇区宜山路600号

Contact Address of the ethic committee：

No. 600, Yishan Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 2405 6428

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：

上海交通大学医学院附属第六人民医院

Primary sponsor：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

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：

No. 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)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属第六人民医院

具体地址：

上海市徐汇区宜山路600号

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

No. 600, Yishan Road, Xuhui District, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

研究疾病：

肌少症  

Target disease：

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：

主要目标：评估为期3个月的户外运动方案与传统物理治疗师指导的室内运动方案相比，能否更显著改善老年肌少症患者的整体情绪状态（主要评价指标：心境状态量表总分）。 次要目标： 1. 对比户外与室内运动对其他心理社会指标的影响，包括自尊水平、感知压力及健康相关生活质量（生理与心理维度）； 2. 分析两种方案对肌少症相关生理指标的作用差异，涵盖肌肉力量、肌肉质量、步态速度和功能性测试表现； 3. 评估户外运动方案的依从性、安全性及患者接受度相对于诊所方案的优劣； 4. 追踪两种干预措施在1年周期内的医疗资源使用情况，并进行成本效益分析。  

Objectives of Study：

Main objective: To evaluate whether the 3-month outdoor exercise program can significantly improve the overall emotional state of elderly patients with sarcopenia (the primary evaluation indicator: total score of the mood state scale) compared to the traditional physical therapy-guided indoor exercise program. Secondary objectives: 1. To compare the effects of outdoor and indoor exercise on other psychological and social indicators, including self-esteem levels, perceived stress, and health-related quality of life (both physical and psychological dimensions); 2. To analyze the differences in the effects of the two programs on sarcopenia-related physiological indicators, covering muscle strength, muscle mass, gait speed, and functional test performance; 3. To assess the advantages and disadvantages of the outdoor exercise program in terms of compliance, safety, and patient acceptance compared to the clinic program; 4. To track the use of medical resources for both intervention measures over a 1-year period and conduct a cost-benefit analysis.

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. 年龄>=60岁（老年人），性别不限。 2. 根据亚洲肌少症工作组（AWGS 2019）标准确诊肌少症：表现为肌力低下（男性握力<28kg，女性<18kg）和肌肉量减少（男性四肢骨骼肌质量指数<7.0kg/m^2，女性<5.7kg/m^2，采用生物电阻抗分析法测定；或通过双能X线吸收法测得同等程度肌肉量减少），伴或不伴体能下降（如步速<1.0m/s或简易体能状况量表评分≤9）。符合肌力标准的"疑似肌少症"患者（仅肌力低下但未达肌肉量减少标准）同样具备入选资格，因早期干预仍被认为具有临床获益。 3. 经医师评估具备行动能力（可使用辅助器具）且能参与运动计划（即无影响运动的未控制疾病）。 4. 获得初级保健医师或研究医师开具的"可参与中等强度运动计划"医学许可。 5. 认知功能正常，能签署知情同意书并遵循研究指导（如无中重度痴呆）。 6. 自愿接受随机分组至任一运动方案，并承诺遵守研究流程（包括随访安排）。

Inclusion criteria

1. Age >= 60 years (elderly), gender not restricted. 2. Diagnosed with sarcopenia according to the Asian Working Group for Sarcopenia (AWGS 2019) criteria: manifested by low muscle strength (male grip strength < 28 kg, female < 18 kg) and reduced muscle mass (male limb skeletal muscle mass index < 7.0 kg/m^2, female < 5.7 kg/m^2, measured by bioelectrical impedance analysis; or equivalent degree of muscle reduction measured by dual-energy X-ray absorptiometry), with or without decline in physical function (such as walking speed < 1.0 m/s or Simple Physical Status Scale score ≤ 9). Patients with "suspected sarcopenia" who meet the muscle strength criteria (only having low muscle strength but not reaching the muscle mass reduction criteria) also meet the inclusion criteria, as early intervention is still considered to have clinical benefits. 3. Evaluated by a physician to have the ability to move (able to use assistive devices) and be able to participate in the exercise program (i.e., without uncontrolled diseases that affect exercise). 4. Obtained a medical permission from a primary care physician or research physician to "participate in a moderate-intensity exercise program". 5. Normal cognitive function, able to sign the informed consent form and follow the research guidelines (such as no moderate to severe dementia). 6. Voluntarily accept random grouping to any exercise program and promise to follow the research process (including follow-up arrangements).

排除标准：

1. 存在严重心血管、肺部或骨科疾病，导致运动禁忌或存在安全隐患（例如：近期心肌梗死、未控制的心绞痛、严重慢性阻塞性肺病、未控制的高血压、严重影响活动能力的晚期关节炎）。 2. 患有急性疾病或损伤，可能干扰运动参与（例如：急性骨折、术后3个月内恢复期）。 3. 存在神经系统或精神疾病，可能影响参与能力或安全性（例如：伴随步态不稳的帕金森病、未控制的癫痫发作、伴有自杀倾向的重度抑郁症）。 4. 过去3个月内参加过其他干预性临床试验或结构化运动计划（以避免混杂效应）。 5. 居住于养老院或长期护理机构（本研究针对社区居住人群；机构照护环境可能因护理差异影响结果评估）。 6. 经研究者判断存在任何不适合参与试验的情况（例如：因交通问题无法参加户外课程、环境过敏等因素）。

Exclusion criteria：

1. There are severe cardiovascular, pulmonary or orthopedic diseases that make exercise impossible or pose safety risks (for example: recent myocardial infarction, uncontrolled angina pectoris, severe chronic obstructive pulmonary disease, uncontrolled hypertension, advanced arthritis severely affecting mobility). 2. Suffer from acute diseases or injuries that may interfere with participation in the exercise (for example: acute fractures, recovery period within 3 months after surgery). 3. Have neurological or mental disorders that may affect participation ability or safety (for example: Parkinson's disease accompanied by gait instability, uncontrolled epileptic seizures, severe depression with suicidal tendencies). 4. Have participated in other interventional clinical trials or structured exercise programs within the past 3 months (to avoid confounding effects). 5. Live in a nursing home or long-term care facility (this study is targeted at community-dwelling individuals; the institutional care environment may affect result assessment due to differences in care). 6. The investigator determines that there are any circumstances that make participation in the trial inappropriate (for example: unable to participate in outdoor courses due to transportation issues, environmental allergies, etc.).

研究实施时间：

Study execute time：

从 From 2022-03-01 00:00:00至 To 2025-06-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-04-06 00:00:00 至 To 2024-06-16 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 63

Group：

Experimental group

Sample size：

干预措施：

被随机分配至干预组的研究参与者将参与为期3个月的户外运动计划，所有课程均由专业人员监督指导。运动场地将选择安全便利的户外区域（如医院庭院、社区公园或运动场），并由持证运动生理学家或物理治疗师带队实施。

干预措施代码：

Intervention：

The research participants randomly assigned to the intervention group will participate in a 3-month outdoor exercise program, with all classes supervised and guided by professionals. The exercise venues will be selected from safe and convenient outdoor areas (such as hospital courtyards, community parks or sports fields), and led by certified exercise physiologists or physical therapists for implementation.

Intervention code：

组别：

对照组

样本量：

 63

Group：

Control group

Sample size：

干预措施：

接受由物理治疗师主导的标准院内康复运动训练，该方案在我院代表针对肌少症和衰弱患者的常规干预措施。

干预措施代码：

Intervention：

Receive standard in-hospital rehabilitation exercise training led by physical therapists. This program represents the routine intervention measures for patients with sarcopenia and frailty in our hospital.

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)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海交通大学医学院附属第六人民医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

心境状态量表（POMS）总分

指标类型：

主要指标

Outcome：

Total score of the Profile of Mood States (POMS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

罗森伯格自尊量表

指标类型：

次要指标

Outcome：

Rosenberg Self-Esteem Scale (RSE)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

压力感知量表

指标类型：

次要指标

Outcome：

Perceived Stress Scale (PSS, 10-item version)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SF-36量表

指标类型：

次要指标

Outcome：

SF-36 Scale

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

 其它  

说明

Fate of sample：

0thers  

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）：

完成基线评估后，受试者将以1:1比例随机分配至户外运动组或诊所运动组。为确保随机性，由独立统计学家采用计算机程序（区组随机法，区组大小为4或6）生成分配序列。考虑到性别可能影响基线肌肉量和心理社会指标，我们将按性别（男/女）分层随机，确保各组性别比例均衡。

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

After the baseline assessment is completed, the subjects will be randomly assigned to the outdoor exercise group or the clinic exercise group in a 1:1 ratio. To ensure randomness, an independent statistician will generate the allocation sequence using a computer program (block randomization method, with block sizes of 4 or 6). Considering that gender may affect baseline muscle mass and psychosocial indicators, we will stratify randomly by gender (male/female) to ensure an equal gender ratio 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：

本研究采用单盲设计。由于户外/室内运动形式差异明显，无法对受试者和运动指导者设盲。但我们将对结局评估者和数据分析人员设盲： 1. 结局评估：由不参与干预实施的独立研究人员在3/6/12个月进行随访评估。要求受试者不透露运动方案细节，评估者仅知悉"运动研究"背景而不知具体分组。主观量表（如POMS、PSS）采用自评方式，减少交互导致的解盲风险。体能测试（握力、步速等）均采用标准化流程。 2. 盲态分析：数据编码为无意义标签（如A/B组）后交付生物统计师，确保其分析时不知晓组别对应关系。 盲法效果验证：研究结束时，将要求评估者猜测受试者所属组别（仅用于检验盲法有效性），通过保密表格记录其判断（或标注"不确定"）。若盲法成功，预计正确猜测率不高于随机概率。

Blinding：

This study adopted a single-blind design. Due to the significant differences in outdoor and indoor exercise forms, it was impossible to blind the subjects and the exercise instructors. However, we will blind the outcome assessors and data analysts: 1. Outcome assessment: Independent researchers who were not involved in the intervention implementation will conduct follow-up assessments at 3/6/12 months. The subjects are required not to disclose the details of the exercise plan, and the assessors only know the "exercise research" background but not the specific groups. Subjective scales (such as POMS, PSS) are evaluated through self-reporting to reduce the risk of blinding due to interaction. Physical fitness tests (such as grip strength, walking speed, etc.) all follow standardized procedures. 2. Blinding analysis: The data is encoded as meaningless labels (such as A/B groups) and then delivered to the biostatistician, ensuring that they do not know the correspondence between the groups during the analysis. Blinding effect verification: At the end of the study, the assessors will be required to guess the group to which the subjects belong (only for testing the effectiveness of the blinding method), and their judgments will be recorded in a confidential form (or marked as "uncertain"). If the blinding is successful, it is expected that the correct guessing rate will not be higher than the random probability.

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）：

原始数据将上传至Resman平台进行公开 (http://www.medresman.org.cn/login.aspx)，原始数据将在论文发表后半年内共享

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

The original data will be uploaded to the Resman platform for public access (http://www.medresman.org.cn/login.aspx), and the original data will be shared within six months after the publication of the paper.

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：

数据采集和管理由病例记录表（Case Record Form, CRF）和电子数据采集和管理系统（Electronic Data Capture, EDC）两部分共同实施。研究者在患者访视时根据研究方案规范填写纸质CRF，内容包括人口学信息、基线特征、治疗方案、随访评估指标以及不良事件等各项数据。完成填写后，研究人员在规定的时限内，将纸质CRF中的信息准确录入至EDC系统。数据录入完成后，质控人员通过EDC系统内置的逻辑检查、范围核查、数据一致性比对等功能，及时发现问题并进行数据质疑，研究人员核实后予以修正和确认。所有数据均通过定期备份确保安全存储，且严格限制访问权限。整个过程中，由专人负责数据备份和管理，确保数据的安全性、完整性和可追溯性。

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

Data collection and management are implemented by the Case Record Form (CRF) and the Electronic Data Capture and Management System (EDC). At the time of patient visit, researchers filled in paper CRF according to the study protocol specification, including demographic information, baseline characteristics, treatment regimen, follow-up evaluation indicators, adverse events and other data. After completing the filling, the researchers accurately input the information in the paper CRF into the EDC system within the prescribed time limit. After the data entry is completed, the quality control personnel will find the problem in time and question the data through the built-in functions of the EDC system such as logic check, scope check and data consistency comparison, and the researchers will correct and confirm it after verification. All data is stored securely with regular backups, and access is strictly restricted. During the whole process, a dedicated person is responsible for data backup and management to ensure data security, integrity and traceability.

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：

  2026-04-20 11:43:38