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

February 26, 2018 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

3656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad Autonoma De La Region De Murcia
      • Murcia, Comunidad Autonoma De La Region De Murcia, Spain, 30003
        • Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Collaborators

MurciaSalud
Public Health Service, Murcia

Investigators

  • Principal Investigator: A Lopez-santiago, MD, Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIVA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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