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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: therapeutic exercise
* Device: ABPM ambulatory blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group: no intervention<br>Only the normal practise | |
| Experimental: therapeutic exercise<br>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. | Behavioral: therapeutic exercise<br>* 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.<br>|
| Experimental: ABPM<br>In this group the arterial pressure is evaluated with ABPM. | Device: ABPM ambulatory blood pressure monitoring<br>* 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.<br>|
| Experimental: therapeutic exercise + ABPM<br> | Behavioral: therapeutic exercise<br>* 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.<br>Device: ABPM ambulatory blood pressure monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk . | Tables for countries with low cardiovascular risk | Every 3 months , up to 12 months. | 
| Systolic arterial tension | blood pressure | Every 3 months , up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic arterial tension | blood pressure | Every 3 months , up to 12 months | 
| Cholesterol levels. | blood levels. | Every 3 months , up to 12 months | 
| Physical Activity | 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. | Number of antihypertensive and hypolipemiant drug and dose. | Every 3 months , up to 12 months | 
| EUROFIT battery | Score obtained | Every 3 months , up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Disease;, primary prevention;, physical activity;, Blood Pressure Monitoring, Ambulatory