Effects of Different Training Programs in Chronic Disease Patients
Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Zhengzhen Wang, Doctor
- 전화번호: 13691302589
- 이메일: zhengzhenwang1005@126.com
연구 연락처 백업
- 이름: Yan Wang, Doctor
- 전화번호: 15201061266
- 이메일: wyweiwei@126.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100084
- School of Sport Medicine and Rehabilitation，Beijing Sport University
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연락하다:
- Zhengzhen Wang, Doctor
- 전화번호: 13691302589
- 이메일: zhengzhenwang1005@126.com
-
연락하다:
- Yan Wang, Doctor
- 전화번호: 15201061266
- 이메일: wyweiwei@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
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.
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실험적: 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. |
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. |
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실험적: 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. |
워킹그룹, 중국스퀘어댄스그룹, 컨트롤그룹은 월 1회 동일한 보건교육 브로슈어나 보건강좌를 실시한다.
소책자 또는 강의의 구체적인 내용은 다음과 같습니다. 제2형 당뇨병, 고혈압 관련 의학 지식 및 개입 치료의 중요성; 제2형 당뇨병 예방, 고혈압 영양 및 운동 권장 사항; 과학적 운동에 대한 기본 지식과 주의가 필요한 사항.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline Systolic Blood Pressure at 3 months
기간: Before and after interventions（3 months)
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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.
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Before and after interventions（3 months)
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Change from Baseline Fasting Blood Glucose at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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연구 완료를 통한 부작용 및 심각한 부작용의 시간 및 빈도
기간: 개입 기간 동안 연구 종료 시까지(3개월) 매일
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이 연구는 연구 관련 부작용 및 심각한 부작용을 포함하여 다음과 같은 안전성 정보를 수집하고 CRF에 기록합니다. 관련 정의 및 절차는 다음과 같습니다. 운동의 부작용으로는 심혈관 및 뇌혈관 질환, 당뇨병/고혈압과 관련된 합병증의 악화, 스포츠 부상 등이 있습니다. 심각한 부작용(SAE)은 운동 중재 후 다음 결과 중 하나를 초래하는 상태로 정의됩니다: 사망, 생명을 위협하는, 입원, 영구적 또는 상당한 장애, 기능 장애. 연구 과정 중에 SAE가 발생하는 경우, 연구자는 즉시 피험자에 대해 적절한 치료를 취하고 시험을 종료해야 합니다. 부작용은 연구자가 매일 질문합니다. 유해 반응이 발생한 경우 조사자는 CRF에 시간, 심각도, 종료 시간, 취한 조치 및 유해 사례 결과를 기록해야 합니다. |
개입 기간 동안 연구 종료 시까지(3개월) 매일
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Change from Cardiorespiratory Fitness at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Change from Muscle Strength at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Change from Muscle Endurance at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Change from Flexibility at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Change from Balance at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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Change from Body Composition at 3 months
기간: Before and after interventions（3 months）
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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.
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Before and after interventions（3 months）
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공동 작업자 및 조사자
수사관
- 연구 책임자: Zhengzhen Wang, Doctor, Beijing Sport Uninversity
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2016YFC1300202
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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