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临床试验/NCT03452709
NCT03452709已完成不适用

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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia2 个研究点 分布在 1 个国家目标入组 3,656 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,656
试验地点
2
主要终点
Cardiovascular risk .

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control group: no intervention

No Intervention

Only the normal practise

therapeutic exercise

Experimental

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.

干预措施: therapeutic exercise (Behavioral)

ABPM

Experimental

In this group the arterial pressure is evaluated with ABPM.

干预措施: ABPM ambulatory blood pressure monitoring (Device)

therapeutic exercise + ABPM

Experimental

干预措施: therapeutic exercise (Behavioral)

therapeutic exercise + ABPM

Experimental

干预措施: ABPM ambulatory blood pressure monitoring (Device)

结局指标

主要结局

Cardiovascular risk .

时间窗: Every 3 months , up to 12 months.

Tables for countries with low cardiovascular risk

Systolic arterial tension

时间窗: Every 3 months , up to 12 months

blood pressure

次要结局

  • diastolic arterial tension(Every 3 months , up to 12 months)
  • Cholesterol levels.(Every 3 months , up to 12 months)
  • Physical Activity(Every 3 months , up to 12 months)
  • EUROFIT battery(Every 3 months , up to 12 months)
  • Pharmacological treatment.(Every 3 months , up to 12 months)

研究者

发起方
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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