Clinical trial NCT03785886: Effects of Different Training Programs in Chronic Disease Patients
Official title: Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Hypertension Complicated With Type 2 Diabetes
Walking
Chinese Square Dancing
Keywords: hypertension
hypertension complicated with type diabetes
walking
Chinese square dancing
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2018-12-24
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure at 3 months
timeFrame: Before and after interventions（3 months)
measure: Change from Baseline Fasting Blood Glucose at 3 months
timeFrame: Before and after interventions（3 months）
Secondary outcomes:
measure: Change from Cardiorespiratory Fitness at 3 months
timeFrame: Before and after interventions（3 months）
measure: Change from Muscle Strength at 3 months
timeFrame: Before and after interventions（3 months）
measure: Change from Muscle Endurance at 3 months
timeFrame: Before and after interventions（3 months）
measure: Change from Flexibility at 3 months
timeFrame: Before and after interventions（3 months）
measure: Change from Balance at 3 months
timeFrame: Before and after interventions（3 months）
measure: Change from Body Composition at 3 months
timeFrame: Before and after interventions（3 months）
measure: Time and Frequency of Adverse Reactions and Serious Adverse Events through the study completion
timeFrame: Every day during the interventions until the end of the study（3 months）
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sport Medicine and Rehabilitation，Beijing Sport University
state: Beijing
Study officials:
affiliation: Beijing Sport University
name: Zhengzhen Wang, Doctor
role: STUDY_DIRECTOR
References: