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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100084
- School of Sport Medicine and Rehabilitation，Beijing Sport University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Experimental: 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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Experimental: 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. |
El grupo de caminantes, el grupo de baile de la plaza china y el grupo de control reciben los mismos folletos de educación para la salud o conferencias sobre educación para la salud una vez al mes.
Los contenidos específicos del folleto o conferencia incluyen: diabetes tipo 2, conocimientos médicos relacionados con la hipertensión y la importancia del tratamiento de intervención; prevención de la diabetes tipo 2, hipertensión, recomendaciones de nutrición y ejercicio; conocimientos básicos del ejercicio científico y sus materias que requieren atención.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from Baseline Systolic Blood Pressure at 3 months
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Tiempo y frecuencia de reacciones adversas y eventos adversos graves hasta la finalización del estudio
Periodo de tiempo: Todos los días durante las intervenciones hasta el final del estudio (3 meses)
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Este estudio recopilará la siguiente información de seguridad y la registrará en el CRF, que incluye: reacciones adversas relacionadas con la investigación y eventos adversos graves. Las definiciones y procedimientos pertinentes son los siguientes. Los efectos adversos del ejercicio incluyen: enfermedades cardiovasculares y cerebrovasculares, agravamiento de las complicaciones asociadas a la diabetes/hipertensión y lesiones deportivas. Los eventos adversos graves (SAE) se definen como condiciones que dan lugar a cualquiera de los siguientes resultados después de la intervención con ejercicios: muerte, peligro para la vida, hospitalización, discapacidad permanente o significativa, disfunción. Si ocurre un SAE durante el curso del estudio, el investigador debe tomar inmediatamente el tratamiento apropiado en el sujeto y terminar el ensayo. Las reacciones adversas son preguntadas diariamente por el investigador. En caso de una reacción adversa, el investigador debe registrar lo siguiente en el CRF: el tiempo, la gravedad, la hora de finalización, las medidas tomadas y el resultado del evento adverso. |
Todos los días durante las intervenciones hasta el final del estudio (3 meses)
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Change from Cardiorespiratory Fitness at 3 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Zhengzhen Wang, Doctor, Beijing Sport Uninversity
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016YFC1300202
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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