Effectiveness of Non-pharmacological Interventions in Patients With Cardiovascular Risk Factors in Primary Care
26 februari 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
3656
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Comunidad Autonoma De La Region De Murcia
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Murcia, Comunidad Autonoma De La Region De Murcia, Spanje, 30003
- Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Control group: no intervention
Only the normal practise
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Experimenteel: 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.
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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.
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Experimenteel: ABPM
In this group the arterial pressure is evaluated with ABPM.
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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.
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Experimenteel: therapeutic exercise + ABPM
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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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cardiovascular risk .
Tijdsspanne: Every 3 months , up to 12 months.
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Tables for countries with low cardiovascular risk
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Every 3 months , up to 12 months.
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Systolic arterial tension
Tijdsspanne: Every 3 months , up to 12 months
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blood pressure
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Every 3 months , up to 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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diastolic arterial tension
Tijdsspanne: Every 3 months , up to 12 months
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blood pressure
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Every 3 months , up to 12 months
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Cholesterol levels.
Tijdsspanne: Every 3 months , up to 12 months
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blood levels.
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Every 3 months , up to 12 months
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Physical Activity
Tijdsspanne: Every 3 months , up to 12 months
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International Physical Activity Questionniare (IPAQ) 600-3000 MET (METs are multiples of the resting metabolic rate
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Every 3 months , up to 12 months
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Pharmacological treatment.
Tijdsspanne: Every 3 months , up to 12 months
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Number of antihypertensive and hypolipemiant drug and dose.
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Every 3 months , up to 12 months
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EUROFIT battery
Tijdsspanne: Every 3 months , up to 12 months
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Score obtained
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Every 3 months , up to 12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: A Lopez-santiago, MD, Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1016/j.ypmed.2006.09.001. Epub 2006 Oct 20.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 december 2011
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
22 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
26 februari 2018
Eerst geplaatst (Werkelijk)
2 maart 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 maart 2018
Laatste update ingediend die voldeed aan QC-criteria
26 februari 2018
Laatst geverifieerd
1 december 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACTIVA
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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