ChiCTR-TRC-14004650 版本V1.0 版本创建时间2016/11/12 22:40:31 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:

ChiCTR-TRC-14004650 

最近更新时间:

Date of Last Refreshed on:

2015/5/2 19:23:50 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

传统健身功法“八段锦”对强直性脊柱炎躯体功能的影响:一项随机、对照、前瞻性研究 

Public title:

The effect of traditional exercise "Baduanjin" for physical Functioning of Ankylosing spondylitis: a randomized, controlled, prospective study 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

传统健身功法“八段锦”对强直性脊柱炎躯体功能的影响:一项随机、对照、前瞻性研究 

Scientific title:

The effect of traditional exercise "Baduanjin" for physical Functioning of Ankylosing spondylitis: a randomized, controlled, prospective study 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

谢榆 

研究负责人:

谢榆 

Applicant:

Xie Yu 

Study leader:

Xie Yu 

申请注册联系人电话:

Applicant telephone:

+86 13770912038 

研究负责人电话:

Study leader's telephone:

+86 13770912038 

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:

77612802@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

77612802@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:

江苏省南京市汉中路155号江苏省中医院风湿免疫科医生办公室 

研究负责人通讯地址:

江苏省南京市汉中路155号江苏省中医院风湿免疫科医生办公室 

Applicant address:

155 Hanzhong Road, Nanjing, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Nanjing, Jiangsu, 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:

江苏省中医院 

Applicant's institution:

Jiangsu Province hospital of TCM 

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:

2014NL-028-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京中医药大学附属医院(江苏省中医院)伦理委员会 

Name of the ethic committee:

Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial Hospital) Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

2013-08-26

研究实施负责(组长)单位:

江苏省中医院 

Primary sponsor:

Jiangsu province hospital of TCM 

研究实施负责(组长)单位地址:

江苏省中医院 

Primary sponsor's address:

Jiangsu province hospital of TCM 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

江苏省中医院院级课题 

Source(s) of funding:

College subject of Jiangsu province hospital of TCM 

研究疾病:

强直性脊柱炎 

Target disease:

Ankylosing spondylitis 

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 

研究目的:

通过一项规范的随机、对照前瞻性研究,初步探寻传统健身功法“八段锦”对强直性脊柱炎患者躯体功能的影响;并通过观察练习中医健身功法八段锦中出现的不良事件,对其安全性作出评价。 

Objectives of Study:

To expore the effect of traditional exercise "Baduanjin" for physical Functioning of Ankylosing spondylitis by a randomized, controlled prospective study. And evaluate the safety of this exercise by recording the adverse event during the exercise. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 疾病诊断符合强直性脊柱炎1984年修订的纽约标准。 2. 年龄18-60岁,性别不限 3. 未使用药物治疗或原有治疗药物使用≥3月未变动 4. 未正在进行其他锻炼项目者(如瑜伽、太极、规律游泳等) 5. 知情同意,志愿受试。获得知情同意书过程符合GCP规定。 

Inclusion criteria

1.confirmed ankylosing spondylitis by Modified New York criteria for ankylosing spondylitis (1984);2. age 18-60, regardless of sex;3. no use of drug therapy or existing therapies ≥3 months without changes;4. no other exercise projects onging (eg: yoga, tai chi, regular swimming, etc);5. the informed consent form signed. 

排除标准:

1. 医生经评估认为不能完成八段锦者(如:晚期强直性脊柱炎活动严重受限等) 2. 合并有腰椎压缩性骨折、严重腰椎间盘突出、严重心肺疾病、躯体活动严重受限等医生认为不适合练习八段锦者 3. 由于智力或行为障碍不能给予充分知情同意者。 4. 正在进行其他锻炼项目者(如瑜伽、太极、规律游泳等) 5. 怀疑或确有酒精、药物滥用病史。 6. 根据研究者的判断、具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。 

Exclusion criteria:

1. the patients who were assessed by the doctor that could not complete the whole Baduanjin exercise (eg: patients with limited activities severely in the end stage of ankylosing spondylitis, etc.); 2. patients who were assessed by the doctor that not suit for doing baduanjin exercise. etc: the patients with vertebral compression fractures, severe lumbar disc herniation, severe cardiopulmonary disease, severely limited physical activity, et al.; 3. the patients who can not give fully informed consent due to mental or behavioral disorders; 4. the patient who taking other ongoing exercise program (such as yoga, tai chi, regular swimming, etc.); 5. the patients who suspected or indeed alcohol, drug abuse history; 6. According to the investigator's judgment, the patients who suffer from other disease which could reduce the possibility of enrollment or complicate the enrollment, eg: frequent changes in the work environment and other reason to lead to lose of follow-up easily, et al. 

研究实施时间:

Study execute time:

From2014-09-21To 2014-09-21 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

八段锦练习

干预措施代码:

Intervention:

Baduanjin exercise

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

维持现在治疗及生活方式不变

干预措施代码:

Intervention:

Baduanjin exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

china 

Province:

jiangsu 

City:

 

单位(医院):

江苏省中医院 

单位级别:

省级三甲医院 

Institution
hospital:

Jiangsu hospital of TCM  

Level of the institution:

Top three hospitals of Province 

测量指标:

Outcomes:

指标中文名:

Bath强直性脊柱炎疾病活动指数

指标类型:

主要指标 

Outcome:

BASDAI inde

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Bath强直性脊柱炎测量指数

指标类型:

次要指标 

Outcome:

BASMI index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Bath强直性脊柱炎功能指数

指标类型:

次要指标 

Outcome:

BASFI index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

健康调查问卷表

指标类型:

次要指标 

Outcome:

HAQ-9

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者总体评价

指标类型:

次要指标 

Outcome:

patients globa

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:

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 years
最大 Max age 60 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):

研究负责人用SPSS生成随机数字(60个),并用信封进行随机分组

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

Generate 60 random numbers using the SPSS statistical software adn random envelope by the study lead

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

江苏省中医院

Data collection Institution:

jiangsu province hospital of TCM

资料管理单位:

江苏省中医院

Data management Institution:

jiangsu province hospital of TCM

资料分析单位:

江苏省中医院

Data analysis Institution:

jiangsu province hospital of TCM

注册人:

Name on Registration:

 2014-05-16