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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452709
• Other study ID #: ACTIVA
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: February 26, 2018
• Start date: December 2011
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3656
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Fundación para la Formación e Investigación Sanitarias de la Región de Murcia	Murcia	Comunidad Autonoma De La Region De Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Consejeria de sanidad.Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion., MurciaSalud

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Elley CR, Garrett S, Rose SB, O'Dea D, Lawton BA, Moyes SA, Dowell AC. Cost-effectiveness of exercise on prescription with telephone support among women in general practice over 2 years. Br J Sports Med. 2011 Dec;45(15):1223-9. doi: 10.1136/bjsm.2010.072439. Epub 2010 Nov 16. — View Citation

Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. Review. — View Citation

Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23. — View Citation

Hypertension: clinical management of primary hypertension in adults NICE guideline. Draft for consultation, February 2011. access (29/3/2011: http://www.nice.org.uk/nicemedia/live/12167/53225/53225.pdf).

Lee LL, Arthur A, Avis M. Evaluating a community-based walking intervention for hypertensive older people in Taiwan: a randomized controlled trial. Prev Med. 2007 Feb;44(2):160-6. Epub 2006 Oct 20. — View Citation

Martín-Baranera M, Campo C, Coca A, de la Figuera M, Marín R, Ruilope LM; en representación del Grupo de Investigadores DICOPRESS. [Stratification and degree of control of cardiovascular risk factors in hypertensive Spanish population. Results of the DICOPRESS study]. Med Clin (Barc). 2007 Jul 14;129(7):247-51. Spanish. — View Citation

Medrano MJ, Cerrato E, Boix R, Delgado-Rodríguez M. [Cardiovascular risk factors in Spanish population: metaanalysis of cross-sectional studies]. Med Clin (Barc). 2005 Apr 30;124(16):606-12. Spanish. — View Citation

Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Oct 18;124(16):e426. Circulation. 2011 Feb 15;123(6):e240. — View Citation

Sierra C, De la Sierra A, Sobrino J, Segura J, Banegas JR, Gorostidi M, Ruilope LM; en representación de los Investigadores del Registro Nacional de MAPA. Sociedad Española de Hipertensión-Liga Española para la Lucha contra la Hipertensión Arterial (SEH-LELHA). [Ambulatory blood pressure monitoring (CABPM): clinical characteristics of 31,530 patients]. Med Clin (Barc). 2007 Jun 2;129(1):1-5. Spanish. — View Citation

Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44. — View Citation

Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk .	Tables for countries with low cardiovascular risk	Every 3 months , up to 12 months.
Primary	Systolic arterial tension	blood pressure	Every 3 months , up to 12 months
Secondary	diastolic arterial tension	blood pressure	Every 3 months , up to 12 months
Secondary	Cholesterol levels.	blood levels.	Every 3 months , up to 12 months
Secondary	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
Secondary	Pharmacological treatment.	Number of antihypertensive and hypolipemiant drug and dose.	Every 3 months , up to 12 months
Secondary	EUROFIT battery	Score obtained	Every 3 months , up to 12 months

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