Back to resultsThe Effect of Different Training Programs on Patients With Chronic Diseases
Primary Purpose
Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Walking
Chinese square dancing group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Garden Road Community Health Service CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Walking group
Chinese Square Dancing group
Control group
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
Change from Baseline Systolic Blood Pressure at 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.
Secondary Outcome Measures
Change from Baseline Fasting Blood Glucose at 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.
Change from Cardiorespiratory Fitness at 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.
Change from Muscle Strength at 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.
Change from Muscle Endurance at 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: stand toe-raise and 30-second arm curl test; 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in seconds and numbers.
Change from Flexibility at 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.
Change from Balance at 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.
Change from Body Composition at 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.
Time and Frequency of Adverse Reactions and Serious Adverse Events through the study completion
This study will collect the following safety information and record it in the CRF, including: research-related adverse reactions and serious adverse events. The relevant definitions and procedures are as follows.
The adverse effects of exercise include: cardiovascular and cerebrovascular diseases, aggravation of complications associated with diabetes/hypertension, and sports injuries. Severe adverse events (SAEs) are defined as conditions that result in any of the following outcomes after exercise intervention: death, life-threatening, hospitalization, permanent or significant disability, dysfunction.
If a SAE occurs during the course of the study, the investigator should immediately take appropriate treatment on the subject and terminate the trial. Adverse reactions are asked daily by the researcher. In the event of an adverse reaction, the investigator is required to record the following in the CRF: the time, severity, end time, measures taken, and outcome of the adverse event.
Full Information
NCT ID
NCT04092959
First Posted
September 16, 2019
Last Updated
January 29, 2021
Sponsor
Beijing Sport University
Collaborators
Peking University
1. Study Identification
Unique Protocol Identification Number
NCT04092959
Brief Title
The Effect of Different Training Programs on Patients With Chronic Diseases
Official Title
Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Sport University
Collaborators
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
Keywords
Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Walking group
Arm Type
Experimental
Arm Description
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).
Arm Title
Chinese Square Dancing group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chinese square dancing group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Walking group , Chinese square dancing group and control group are given the same health education brochures or health education lectures once a month . Specific contents of the brochure or lecture include : type 2 diabetes , hypertension related medical knowledge and the significance of intervention treatment ; prevention of type 2 diabetes , hypertension nutrition and exercise recommendations ; basic knowledge of scientific exercise and its matters needing attention .
Primary Outcome Measure Information:
Title
Change from Baseline Systolic Blood Pressure at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Secondary Outcome Measure Information:
Title
Change from Baseline Fasting Blood Glucose at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Change from Cardiorespiratory Fitness at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Change from Muscle Strength at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Change from Muscle Endurance at 3 months
Description
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: stand toe-raise and 30-second arm curl test; 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in seconds and numbers.
Time Frame
Before and after interventions(3 months)
Title
Change from Flexibility at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Change from Balance at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Change from Body Composition at 3 months
Description
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.
Time Frame
Before and after interventions(3 months)
Title
Time and Frequency of Adverse Reactions and Serious Adverse Events through the study completion
Description
This study will collect the following safety information and record it in the CRF, including: research-related adverse reactions and serious adverse events. The relevant definitions and procedures are as follows.
The adverse effects of exercise include: cardiovascular and cerebrovascular diseases, aggravation of complications associated with diabetes/hypertension, and sports injuries. Severe adverse events (SAEs) are defined as conditions that result in any of the following outcomes after exercise intervention: death, life-threatening, hospitalization, permanent or significant disability, dysfunction.
If a SAE occurs during the course of the study, the investigator should immediately take appropriate treatment on the subject and terminate the trial. Adverse reactions are asked daily by the researcher. In the event of an adverse reaction, the investigator is required to record the following in the CRF: the time, severity, end time, measures taken, and outcome of the adverse event.
Time Frame
Every day during the interventions until the end of the study（3 months）
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengzhen Wang, Doctor
Phone
13691302589
Email
zhengzhenwang1005@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wang, Doctor
Phone
15201061266
Email
wyweiwei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengzhen Wang, Doctor
Organizational Affiliation
Beijing Sport University
Official's Role
Study Director
Facility Information:
Facility Name
Garden Road Community Health Service Center
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyun Chi, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Different Training Programs on Patients With Chronic Diseases
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