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

NCT03452709 | Completed

• 1 other identifier: ACTIVA
• Study Type: interventional
• Target: 3,656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease;; primary prevention;; physical activity;; Blood Pressure Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• Pharmacological treatment.

  Every 3 months , up to 12 months

• EUROFIT battery

  Every 3 months , up to 12 months

Study Arms (4)

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.

Behavioral: therapeutic exercise

ABPM

EXPERIMENTAL

In this group the arterial pressure is evaluated with ABPM.

Device: ABPM ambulatory blood pressure monitoring

therapeutic exercise + ABPM

EXPERIMENTAL

Behavioral: therapeutic exercise; Device: ABPM ambulatory blood pressure monitoring

Interventions

therapeutic exercise BEHAVIORAL

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.

therapeutic exercise; therapeutic exercise + ABPM

ABPM ambulatory blood pressure monitoring DEVICE

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.

ABPM; therapeutic exercise + ABPM

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead
• MurciaSalud: collaborator
• Public Health Service, Murcia: collaborator

Study Sites (1)

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Murcia, Murcia, 30003, Spain

Location

Related Publications (11)

• 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.

  PMID: 21160056 BACKGROUND

• Medrano MJ, Cerrato E, Boix R, Delgado-Rodriguez M. [Cardiovascular risk factors in Spanish population: metaanalysis of cross-sectional studies]. Med Clin (Barc). 2005 Apr 30;124(16):606-12. doi: 10.1157/13074389. Spanish.

  PMID: 15871776 BACKGROUND

• 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. doi: 10.2337/diacare.16.2.434.

  PMID: 8432214 BACKGROUND

• 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. doi: 10.1016/S0140-6736(02)11403-6.

  PMID: 12423980 BACKGROUND

• Martin-Baranera M, Campo C, Coca A, de la Figuera M, Marin R, Ruilope LM; en representacion 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. doi: 10.1157/13108347. Spanish.

  PMID: 17683705 BACKGROUND

• Sierra C, De la Sierra A, Sobrino J, Segura J, Banegas JR, Gorostidi M, Ruilope LM; en representacion de los Investigadores del Registro Nacional de MAPA. Sociedad Espanola de Hipertension-Liga Espanola para la Lucha contra la Hipertension Arterial (SEH-LELHA). [Ambulatory blood pressure monitoring (CABPM): clinical characteristics of 31,530 patients]. Med Clin (Barc). 2007 Jun 2;129(1):1-5. doi: 10.1157/13106673. Spanish.

  PMID: 17570178 BACKGROUND

• 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).

  BACKGROUND

• 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. doi: 10.1016/j.ypmed.2006.09.001. Epub 2006 Oct 20.

  PMID: 17055561 BACKGROUND

• 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.

  PMID: 21081641 BACKGROUND

• 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.

  PMID: 19364999 BACKGROUND

• 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. doi: 10.7326/0003-4819-136-7-200204020-00006.

  PMID: 11926784 BACKGROUND

Related Links

• MeSH
• MeSH
• MeSH
• MeSH

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• A LOPEZ-SANTIAGO, MD

  Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: March 2, 2018
• Study Start: December 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 2, 2018

Record last verified: 2017-12

Locations

ES (1)