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Effects of Different Training Programs in Chronic Disease Patients

Primary Purpose

Hypertension, Hypertension Complicated With Type 2 Diabetes, Walking

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Walking group

Chinese square dancing group

Control group

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, hypertension complicated with type diabetes, walking, Chinese square dancing

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

School of Sport Medicine and Rehabilitation，Beijing Sport University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Walking group

Chinese Square Dancing group

Control group

Arm Description

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.

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.

Secondary Outcome Measures

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: push-ups(male) or sit-ups(female), 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in 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

NCT03785886

First Posted

November 29, 2018

Last Updated

December 21, 2018

Sponsor

Beijing Sport University

Collaborators

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03785886

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

December 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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 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

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Walking group

Arm Type

Experimental

Arm Description

Arm Title

Chinese Square Dancing group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Walking group

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)

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