此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Effects of Different Training Programs in Chronic Disease Patients

2018年12月21日 更新者：Beijing Sport Uninversity

Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes

The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with diabetes) aged 40-69 years. All exercise sessions will be supervised and subject's exercise implementation process will be managed with intelligent equipment. The purpose of the study is to evaluate the effectiveness and safety of different training programs.

The demographics data, physical activity questionnaires, blood pressure, blood glucose, blood lipids, height, weight and physical fitness （cardiorespiratory fitness，muscle strength, muscle endurance, flexibility, body composition） will be measured before and after 3-month exercise training .The adverse reactions in the implementation of the interventions will be recorded. The primary outcomes are blood pressure and blood glucose.

研究概览

地位

未知

条件

干预/治疗

详细说明

The global burden of disease study shows that unreasonable diets and physical inactivity are the largest health risks facing the world today. In recent years, foreign and domestic scholars have gradually introduced the concept of " Exercise is Medicine " guide the the public exercise scientifically. However, under the special cultural background of China, it is urgent to answer how to help the public to realize reasonable scientific exercise, how to choose the popular exercise mode and whether the exercise mode is scientific and effective.

Previous meta-analysis studies on the improvement of blood pressure and blood glucose by walking have been published, but few studies on Chinese square dancing have been conducted. Previous studies on whether Chinese square dancing was scientific and effective were mostly small sample population studies carried out by Chinese scholars. The research results were of large heterogeneity, and the research design lacked reasonable consideration.

This study intends to select two common exercise mode for scientific evaluation, one is walking and the other is Chinese square dancing. The purpose of this study is to evaluate the efficacy and safety of two common types of exercise (walking and Chinese square dancing) in Chinese patients with hypertension and patients with hypertension complicated with diabetes.

研究类型

介入性

注册 (预期的)

360

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Yan Wang, Doctor
  • 电话号码：15201061266
  • 邮箱：wyweiwei@126.com

学习地点

  • 中国
    • Beijing
      • Beijing、Beijing、中国、100084
        • School of Sport Medicine and Rehabilitation，Beijing Sport University
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 69年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 40-69 years of age

  2. Meet any one of the two conditions:

    2.1 Hypertension: diagnosed with hypertension, systolic blood pressure is 130-159 mmHg, take no antihypertensive drug or no more than 2 kinds of antihypertensive drugs

    2.2 Hypertension complicated with diabetes: diagnosed with hypertension and type 2 diabetes, systolic blood pressure is 130-159 mmHg and the fasting blood glucose in the past 2 weeks was 5.6-16.7 mmol/L (13.8-16.7 mmol/L was negative for urinary ketone) , take no more than 4 kinds of antihypertensive and hypoglycemic drugs

  3. Maintain the current state of medication for the next 3 months
  4. Lived in the current community in the past six months
  5. Have no intention of moving out for the next three months
  6. Have no regular exercise habit (moderate intensity activity less than 3 times a week, less than 30 minutes each time or 30 minutes cumulative), at least exercise 3 days a week
  7. Sign informed consent

Exclusion Criteria:

  1. Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living)
  2. Physical disability that prevents patients from walking or Chinese square dancing
  3. Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education)
  4. Pregnant or planning to become pregnant
  5. BMI(body mass index)≥35 kg/m2
  6. Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes"
  7. Cardio-cerebrovascular events have occurred in the past 6 months(heart disease diagnosed by doctors, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.)
  8. Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive
  9. Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency
  10. Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Walking group

The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.

Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years.
行为的：Walking group
Subjects in this group perform exercise consisting of walking for 30 - 60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months . Each training includes 5 min warm-up and 5 min cool-down, and the exercise should start after meals for 1 hour . Heart rate is monitored by sports bracelet . Subjects using β-blockers will not use heart rate to monitor exercise intensity , but RPE scores . And RPE( Borg scale) scores are ranged from 11-13.
实验性的：Chinese Square Dancing group

The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.

Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years.
行为的：Chinese square dancing group

Chinese square dances have been selected from 24 sets of square dances jointly launched in 2015 and 2017. According to the age and physical health status of the subjects, six dance pieces of are selected as the repertoires of the intervention in this study.

Subjects in this group perform exercise consisting of Chinese square dances for 30-60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months. Each training includes 5 min warm-up and 5 min cool-down , and the exercise should start after meals for 1 hour. Make the subjects step for 30 s to 1 min between each track to adjust the heart rate. Heart rate is monitored by sports bracelet. Subjects using β-blockers will not use heart rate to monitor exercise intensity, but RPE scores. And RPE( Borg scale) scores are ranged from 11-13.
实验性的：Control group

The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.

Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years.
行为的：控制组
步行组、广场舞组和对照组每月发一次同样的健康教育手册或健康教育讲座。 宣传册或讲座的具体内容包括：2型糖尿病、高血压相关医学知识及介入治疗的意义；预防2型糖尿病、高血压的营养和运动建议；科学锻炼的基本知识及注意事项。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline Systolic Blood Pressure at 3 months
大体时间：Before and after interventions（3 months)
To evaluate the effect of walking and Chinese square dancing on systolic blood pressure in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Before and after interventions（3 months)
Change from Baseline Fasting Blood Glucose at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on fasting blood glucose in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Before and after interventions（3 months）

次要结果测量

结果测量
措施说明
大体时间
通过研究完成的不良反应和严重不良事件的时间和频率
大体时间：干预期间每天至研究结束（3个月）

本研究将收集以下安全信息并记录在CRF中，包括：研究相关不良反应和严重不良事件。 相关定义和程序如下。

运动带来的不良影响包括：心脑血管疾病、糖尿病/高血压并发症加重、运动损伤等。 严重不良事件 (SAE) 被定义为在运动干预后导致以下任何结果的情况：死亡、危及生命、住院、永久或严重残疾、功能障碍。

如果在研究过程中发生严重不良事件，研究者应立即对受试者进行适当的治疗并终止试验。 研究人员每天询问不良反应。 如果发生不良反应，研究者需要在CRF中记录以下内容：不良事件发生的时间、严重程度、结束时间、采取的措施和结果。
干预期间每天至研究结束（3个月）
Change from Cardiorespiratory Fitness at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on cardiorespiratory fitness in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Cardiorespiratory fitness (2 minutes high knee lift) is in heart beats per minute.
Before and after interventions（3 months）
Change from Muscle Strength at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on muscle strength in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Muscle strength (grip strength) is in kilograms.
Before and after interventions（3 months）
Change from Muscle Endurance at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on muscle endurance in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Muscle endurance (40-59 yrs: push-ups(male) or sit-ups(female), 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in numbers.
Before and after interventions（3 months）
Change from Flexibility at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on flexibility in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Flexibility (40-59 yrs :reach test, 60-69 yrs : chair sit-and-reach test) is in centimeters.
Before and after interventions（3 months）
Change from Balance at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on balance in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Balance (standing on one leg with eyes closed) is in seconds.
Before and after interventions（3 months）
Change from Body Composition at 3 months
大体时间：Before and after interventions（3 months）
To evaluate the effect of walking and Chinese square dancing on body composition in hypertensive patients and patients with hypertension complicated with type 2 diabetes. Body composition (bioelectrical impedance ) is in percentage of weight.
Before and after interventions（3 months）

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beijing Sport Uninversity

合作者

Peking University

调查人员

  • 研究主任：Zhengzhen Wang, Doctor、Beijing Sport Uninversity

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年3月1日

初级完成 (预期的)

2019年11月1日

研究完成 (预期的)

2020年12月1日

研究注册日期

首次提交

2018年11月29日

首先提交符合 QC 标准的

2018年12月21日

首次发布 (实际的)

2018年12月24日

研究记录更新

最后更新发布 (实际的)

2018年12月24日

上次提交的符合 QC 标准的更新

2018年12月21日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2016YFC1300202

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

控制组的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Bosnia & Herzegovina

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅