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Effects of Different Training Programs in Chronic Disease Patients

21 de dezembro de 2018 atualizado por: Beijing Sport Uninversity

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.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

360

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Yan Wang, Doctor
  • Número de telefone: 15201061266
  • E-mail: wyweiwei@126.com

Locais de estudo

  • China
    • Beijing
      • Beijing, Beijing, China, 100084
        • School of Sport Medicine and Rehabilitation，Beijing Sport University
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 69 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
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.
Comportamental: 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.
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.
Comportamental: Grupo de controle
O grupo de caminhada, o grupo de quadrilha chinesa e o grupo de controle recebem os mesmos folhetos de educação em saúde ou palestras de educação em saúde uma vez por mês. Os conteúdos específicos da brochura ou palestra incluem: diabetes tipo 2, conhecimento médico relacionado à hipertensão e o significado do tratamento de intervenção; prevenção de diabetes tipo 2, hipertensão, nutrição e recomendações de exercícios; conhecimentos básicos do exercício científico e das matérias que carecem de atenção.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline Systolic Blood Pressure at 3 months
Prazo: Before and after interventions（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)
Change from Baseline Fasting Blood Glucose at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Tempo e frequência de reações adversas e eventos adversos graves até a conclusão do estudo
Prazo: Todos os dias durante as intervenções até o final do estudo (3 meses)

Este estudo coletará as seguintes informações de segurança e as registrará no CRF, incluindo: reações adversas relacionadas à pesquisa e eventos adversos graves. As definições e procedimentos relevantes são os seguintes.

Os efeitos adversos do exercício incluem: doenças cardiovasculares e cerebrovasculares, agravamento de complicações associadas ao diabetes/hipertensão e lesões esportivas. Eventos adversos graves (SAEs) são definidos como condições que resultam em qualquer um dos seguintes desfechos após a intervenção com exercícios: morte, risco de vida, hospitalização, incapacidade permanente ou significativa, disfunção.

Se ocorrer um SAE durante o estudo, o investigador deve imediatamente tomar o tratamento adequado do sujeito e encerrar o estudo. As reações adversas são questionadas diariamente pelo pesquisador. No caso de uma reação adversa, o investigador deve registrar o seguinte no CRF: a hora, a gravidade, a hora final, as medidas tomadas e o resultado do evento adverso.
Todos os dias durante as intervenções até o final do estudo (3 meses)
Change from Cardiorespiratory Fitness at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）
Change from Muscle Strength at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）
Change from Muscle Endurance at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）
Change from Flexibility at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）
Change from Balance at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）
Change from Body Composition at 3 months
Prazo: Before and after interventions（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.
Before and after interventions（3 months）

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beijing Sport Uninversity

Colaboradores

Peking University

Investigadores

  • Diretor de estudo: Zhengzhen Wang, Doctor, Beijing Sport Uninversity

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de março de 2019

Conclusão Primária (Antecipado)

1 de novembro de 2019

Conclusão do estudo (Antecipado)

1 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

29 de novembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de dezembro de 2018

Primeira postagem (Real)

24 de dezembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de dezembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de dezembro de 2018

Última verificação

1 de dezembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2016YFC1300202

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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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