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Effectiveness of Non-pharmacological Interventions in Patients With Cardiovascular Risk Factors in Primary Care

Clinical Trial of the Effectiveness of Non-pharmacological Interventions (Physical Activity + ABPM) in Patients With Cardiovascular Risk Factors in Primary Care

The principal objective is analyzed whether a selective intervention no pharmacological (use of ABPM +/- prescription of physical exercise) for cardiovascular risk factors in patients with high cardiovascular risk in primary prevention is associated with a decrease in cardiovascular risk measured using the risk Score tables for countries with a low risk. It will be independently analized the effectiveness of systematic use of ABPM and the prescription of physical exercise.

研究概览

详细说明

Cardiovascular disease continues to be the main cause of death in Western countries, with a very high prevalence (affecting >1 in every 3 adult Americans), and contributes as one of the highest annual healthcare costs. There is still enormous potential for improving prevention although notable efforts have already been made. In the Spanish population, the following cardiovascular risk factors have been identified as being most prevalent: arterial hypertension, dyslipidemia, having a sedentary lifestyle, tobaccoism, obesity and diabetes.

Essential Arterial Hypertension (EAH) is the most prevalent cardiovascular risk factor in the world and the main cause of cardiovascular disease. There are many clinical practice guides which recommend carrying out moderate physical activity to prevent, delay or reduce hypertension, given that the practice of community interventions with physical activity have been efficient.

The indication to perform Itinerant Monitorization blood pressure in the diagnosis of hypertension is included in the latest draft of the clinical practice guideline from NICE, National Institute for Health and Clinical Excellence .

Other cardiovascular risk factor to take into account is dyslipidemia, the prevalence of dyslipidemia is 16.2% in adults aged over 20 years. For this condition, physical activity is also recommended.

When faced with a sedentary lifestyle or physical inactivity two intervention measures are available for reducing its incidence: verbal healthcare advice (taking advantage of the patients visit to the consultation) and the prescription of physical exercise.

Taking into account the interventions mentioned that can be carried out in the face of risk factors, and that a multifactorial intervention is more efficient that individual interventions, the investigators have designed a clinical trial which attempts to improve most of the principal risk factors. The objective is to reduce the cardiovascular risk of patients using a multifactorial intervention on hypertension, dyslipidemia, sedentary lifestyle. The investigators will evaluate the efficiency of a program for official prescriptions for physical exercise compared to structured verbal advice in hypertense patients undergoing treatment and who have another risk factors (dyslipidemia being treated for more than one year or they are smokers), including action to improve the treatment adaptation for the hypertension (ABPM).

研究类型

介入性

注册 (实际的)

3656

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Comunidad Autonoma De La Region De Murcia
      • Murcia、Comunidad Autonoma De La Region De Murcia、西班牙、30003
        • Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Undergoing treatment with at least one hypertense drug due to HTA and at least one hypolipemiant drug prescribed due to hypercholesterolemia, or other risk factor. The treatment should have a minimum duration time of 12 months prior to inclusion in the study.
  • Patient in Primary Prevention.
  • Finding oneself in the sedentary lifestyle category or through activation of the simplified active questionnaire of physical activity extracted from the Lipid Research Clinics prevalence Study

Exclusion Criteria:

  • Serious or terminal diseases.
  • Diagnosis of ischemic and/or cerebrovascular cardiopathy.
  • Patients with a limiting pathology which prevents physical exercise being performed.
  • Serious mental illnesses: Psychosis, Major depressive disorder, Neurosis.
  • Diabetes mellitus.
  • Patients with limiting pathology preventing them from carrying out physical exercise.
  • Serious mental diseases: Psychosis, Major depresive disorder, Neurosis.
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control group: no intervention
Only the normal practise
实验性的:therapeutic exercise
In this group the intervention is the prescription of physical activity. The duration of the groups is planned to be from 12 weeks with 3 programmed sessions per week.
The duration of the groups is planned to be from 12 weeks with 3 programmed sessions per week. physical activity programmed by an instructor in patient with high risk of cardiovascular.
实验性的:ABPM
In this group the arterial pressure is evaluated with ABPM.
Arterial pressure is a biological variable which fluctuates over a 24 hour period depending on the period of activity/rest, which is known as circadian the BP rhythm. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) vary, on average, more than 50 mm Hg throughout the day in a normotensive adult.
实验性的:therapeutic exercise + ABPM
The duration of the groups is planned to be from 12 weeks with 3 programmed sessions per week. physical activity programmed by an instructor in patient with high risk of cardiovascular.
Arterial pressure is a biological variable which fluctuates over a 24 hour period depending on the period of activity/rest, which is known as circadian the BP rhythm. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) vary, on average, more than 50 mm Hg throughout the day in a normotensive adult.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cardiovascular risk .
大体时间:Every 3 months , up to 12 months.
Tables for countries with low cardiovascular risk
Every 3 months , up to 12 months.
Systolic arterial tension
大体时间:Every 3 months , up to 12 months
blood pressure
Every 3 months , up to 12 months

次要结果测量

结果测量
措施说明
大体时间
diastolic arterial tension
大体时间:Every 3 months , up to 12 months
blood pressure
Every 3 months , up to 12 months
Cholesterol levels.
大体时间:Every 3 months , up to 12 months
blood levels.
Every 3 months , up to 12 months
Physical Activity
大体时间:Every 3 months , up to 12 months
International Physical Activity Questionniare (IPAQ) 600-3000 MET (METs are multiples of the resting metabolic rate
Every 3 months , up to 12 months
Pharmacological treatment.
大体时间:Every 3 months , up to 12 months
Number of antihypertensive and hypolipemiant drug and dose.
Every 3 months , up to 12 months
EUROFIT battery
大体时间:Every 3 months , up to 12 months
Score obtained
Every 3 months , up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:A Lopez-santiago, MD、Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年12月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2011年6月22日

首先提交符合 QC 标准的

2018年2月26日

首次发布 (实际的)

2018年3月2日

研究记录更新

最后更新发布 (实际的)

2018年3月2日

上次提交的符合 QC 标准的更新

2018年2月26日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ACTIVA

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

therapeutic exercise的临床试验

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