Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from Baseline Systolic Blood Pressure at 3 months
研究概览
简要总结
A total of 240 hypertensive subjects aged 40-69 years (including 126 patients complicated with diabetes) will be included in a few communities in Beijing, and will be divided into 3 groups according to the individual wishes of the subjects: walking group(n=80, including 42 patients complicated with diabetes), Chinese square dancing group(n=80, including 42 patients complicated with diabetes) and control group(n=80, including 42 patients complicated with diabetes). 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 in the real world.
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-69 years of age
- •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
- •Maintain the current state of medication for the next 3 months
- •Lived in the current community in the past six months
- •Have no intention of moving out for the next three months
- •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
- •Sign informed consent
排除标准
- •Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living)
- •Physical disability that prevents patients from walking or Chinese square dancing
- •Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education)
- •Pregnant or planning to become pregnant
- •BMI(body mass index)≥35 kg/m2
- •Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes"
- •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.)
- •Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive
- •Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency
- •Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders
研究组 & 干预措施
Walking group
A total of 240 hypertensive subjects aged 40-69 years (including 126 patients complicated with diabetes) will be included in a few communities in Beijing, and will be divided into 3 groups according to the individual wishes of the subjects: walking group(n=80, including 42 patients complicated with diabetes), Chinese square dancing group(n=80, including 42 patients complicated with diabetes) and control group(n=80, including 42 patients complicated with diabetes).
干预措施: Walking (Behavioral)
Chinese Square Dancing group
A total of 240 hypertensive subjects aged 40-69 years (including 126 patients complicated with diabetes) will be included in a few communities in Beijing, and will be divided into 3 groups according to the individual wishes of the subjects: walking group(n=80, including 42 patients complicated with diabetes), Chinese square dancing group(n=80, including 42 patients complicated with diabetes) and control group(n=80, including 42 patients complicated with diabetes).
干预措施: Chinese square dancing group (Behavioral)
Control group
A total of 240 hypertensive subjects aged 40-69 years (including 126 patients complicated with diabetes) will be included in a few communities in Beijing, and will be divided into 3 groups according to the individual wishes of the subjects: walking group(n=80, including 42 patients complicated with diabetes), Chinese square dancing group(n=80, including 42 patients complicated with diabetes) and control group(n=80, including 42 patients complicated with diabetes).
干预措施: Control group (Behavioral)
结局指标
主要结局
Change from Baseline Systolic Blood Pressure at 3 months
时间窗: 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.
次要结局
- Change from Body Composition at 3 months(Before and after interventions(3 months))
- Change from Cardiorespiratory Fitness at 3 months(Before and after interventions(3 months))
- Change from Balance at 3 months(Before and after interventions(3 months))
- Time and Frequency of Adverse Reactions and Serious Adverse Events through the study completion(Every day during the interventions until the end of the study（3 months）)
- Change from Baseline Fasting Blood Glucose at 3 months(Before and after interventions(3 months))
- Change from Muscle Endurance at 3 months(Before and after interventions(3 months))
- Change from Muscle Strength at 3 months(Before and after interventions(3 months))
- Change from Flexibility at 3 months(Before and after interventions(3 months))