Effects of Different Training Programs in Chronic Disease Patients

NCT ID: NCT03785886

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Hypertension Complicated With Type 2 Diabetes Walking Chinese Square Dancing

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension hypertension complicated with type diabetes walking Chinese square dancing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Walking group

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Chinese square dancing group

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Control group

Intervention Type BEHAVIORAL

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 .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Control group

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 .

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University

OTHER

Sponsor Role collaborator

Beijing Sport University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhengzhen Wang, Doctor

Role: STUDY_DIRECTOR

Beijing Sport University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Sport Medicine and Rehabilitation,Beijing Sport University

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhengzhen Wang, Doctor

Role: CONTACT

Phone: 13691302589

Email: [email protected]

Yan Wang, Doctor

Role: CONTACT

Phone: 15201061266

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yan Wang, Doctor

Role: primary

Zhengzhen Wang, Doctor

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016YFC1300202

Identifier Type: -

Identifier Source: org_study_id