HypertensionNCT04092959
The Effect of Different Training Programs on Patients With Chronic Diseases
A study testing Walking and Chinese square dancing group in people with Hypertension and Hypertension Complicated With Type 2 Diabetes, run by Beijing Sport University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking
- What is being tested?
- Walking and Chinese square dancing group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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"
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Garden Road Community Health Service Center
Beijing, Beijing Municipality
Hongyun Chi, Doctor
About this study
Official title: Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension 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). 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.
Read the 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.
- Conditions
- Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
- Being tested
- Walking, Chinese square dancing group, Control group
- Keywords
- Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
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.
Chinese square dancing groupBehavioural
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.
Control groupBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| Walking group | Experimental | 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). Receives: Behavioral: Walking |
| Chinese Square Dancing group | Experimental | 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). Receives: Behavioral: Chinese square dancing group |
| Control group | Experimental | 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). Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after interventions(3 months)
Secondary outcomes (8)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Before and after interventions(3 months)
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.
Measured: Every day during the interventions until the end of the study（3 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start20 Sep 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Zhengzhen Wang, Doctor, Study director, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092959
- Sponsor's protocol ID
- BSU2016YFC1300202
- Status last verified
- Jan 2021
- First submitted
- 16 Sep 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
- ClinicalTrials.gov ID
- NCT04092959
- Acronym / sponsor ID
- BSU2016YFC1300202
- Conditions
- Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
- Keywords
- Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking, Chinese Square Dancing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking group | Experimental | Behavioral: WalkingA 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). |
| Chinese Square Dancing group | Experimental | Behavioral: Chinese square dancing groupA 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). |
| Control group | Experimental | Behavioral: Control groupA 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). |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingSubjects 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. | Behavioural | Walking group |
| Chinese square dancing groupChinese 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. | Behavioural | Chinese Square Dancing group |
| Control groupWalking 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 . | Behavioural | Control group |
Primary outcome
Change from Baseline Systolic Blood Pressure at 3 months
Time frame: 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.
8 secondary outcomes
Change from Baseline Fasting Blood Glucose at 3 months
Time frame: Before and after interventions(3 months)
Change from Cardiorespiratory Fitness at 3 months
Time frame: Before and after interventions(3 months)
Change from Muscle Strength at 3 months
Time frame: Before and after interventions(3 months)
Change from Muscle Endurance at 3 months
Time frame: Before and after interventions(3 months)
Change from Flexibility at 3 months
Time frame: Before and after interventions(3 months)
Change from Balance at 3 months
Time frame: Before and after interventions(3 months)
Change from Body Composition at 3 months
Time frame: Before and after interventions(3 months)
Time and Frequency of Adverse Reactions and Serious Adverse Events through the study completion
Time frame: Every day during the interventions until the end of the study（3 months）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengzhen Wang, Doctor study director
Beijing Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking and Chinese square dancing group in people with Hypertension and Hypertension Complicated With Type 2 Diabetes, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengzhen Wang, Doctor (13691302589, zhengzhenwang1005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure at 3 months (time frame: Before and after interventions(3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.