The Effect of Different Training Programs on Patients With Chronic Diseases

NCT04092959 | Unknown

• 1 other identifier: BSU2016YFC1300202
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypertension Complicated With Type 2 Diabetes; Walking; Chinese Square Dancing

Keywords

Hypertension; Hypertension Complicated With Type 2 Diabetes; Walking; Chinese Square Dancing

Outcome Measures

Primary Outcomes (1)

• 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.

  Before and after interventions(3 months)

Secondary Outcomes (8)

• Change from Baseline Fasting Blood Glucose at 3 months

  Before and after interventions(3 months)

• Change from Cardiorespiratory Fitness at 3 months

  Before and after interventions(3 months)

• Change from Muscle Strength at 3 months

  Before and after interventions(3 months)

• Change from Muscle Endurance at 3 months

  Before and after interventions(3 months)

• Change from Flexibility at 3 months

  Before and after interventions(3 months)

Study Arms (3)

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).

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).

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).

Behavioral: Control group

Interventions

Walking 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.

Walking group

Chinese square dancing group 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.

Chinese Square Dancing group

Control group 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 .

Control group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Meet any one of the two conditions:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sport University: lead
• Peking University: collaborator

Study Sites (1)

Garden Road Community Health Service Center

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Walking; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhengzhen Wang, Doctor

  Beijing Sport University

  STUDY DIRECTOR

Central Study Contacts

Zhengzhen Wang, Doctor

CONTACT

13691302589; zhengzhenwang1005@126.com

Yan Wang, Doctor

CONTACT

15201061266; wyweiwei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 17, 2019
• Study Start: September 20, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)