Abstract
Objetivos
Evaluar la efectividad de un innovador programa de promoción de la actividad física (PEPAF) implantado en la consulta diaria del médico de familia
Diseño
Ensayo clínico controlado y aleatorizado por conglomerados de 100 pacientes, atendidos por cada uno de los 70 médicos colaboradores, asignados a dos grupos paralelos y seguidos durante 24 meses
Emplazamiento
Trece centros de atención primaria coordinados a través de la Red de Investigación en Actividades Preventivas y de Promoción de la Salud realizadas en Atención Primaria (redIAPP)
Participantes
Muestra probabilística de 7.000 pacientes sedentarios, seleccionada entre todos los que consulten por cualquier motivo a su médico de familia durante el tercer trimestre de 2003. Se excluirán los pacientes con enfermedades cardiovasculares u tros problemas en los que el ejercicio pudiera provocar efectos adversos
Intervenciones
Los médicos asignados al PEPAF diseñarán un plan de actividad física con los pacientes preparados para el cambio. A los no preparados les aconsejarán brevemente y les entregarán materiales de ayuda. Todos serán objeto de un seguimiento oportunista. Los médicos del grupo control pospondrán cualquier intervención sistemática sobre el ejercicio hasta después de 2005, excepto con los pacientes cuyo problema de salud esté directamente relacionado con el sedentarismo
Mediciones
La principal medida de resultados será el incremento en el nivel de actividad física, entre la medición basal y la realizada a los 3, 6, 12 y 24 meses, medida con el 7-day Physical Activity Recall. Se medirá también la calidad de vida relacionada con la salud (SF-36) y la forma física. Se considerarán las variables predictoras y de confusión, como el sexo, la edad, la comorbilidad, la clase social, etc
Análisis
Se compararán los cambios promedio observados en ambos grupos, según la intención de tratar, mediante análisis de la covarianza. Usaremos modelos de efectos mixtos para tener en cuenta la correlación intrasujeto, intramédico e intracentro
Palabras clave: Ejercicio, Forma física, Calidad de vida, Promoción de la salud, Atención primaria, Medicina de familia, Ensayo clínico aleatorizado, Estudio multicéntrico
Abstract
Objective
To evaluate the effectiveness of an innovative programme to promote physical activity (PEPAF) introduced into the daily consultations of the family doctor
Design
Clinical trial with control, randomised for groups of 100 patients seen by one of the 70 doctors taking part, allocated to two parallel groups and monitored for 24 months
Setting
13 primary care centres coordinated through the Network of Research into Preventive and Health Promotion Activities conducted in primary care
Participants
Sample with probability of 7000 sedentary patients, selected from among those who consulted for any reason their family doctor during the third quarter of 2003. Patients with cardiovascular disease or other problems meaning that exercise could cause adverse effects will be excluded
Interventions
The doctors allocated to the PEPAF will design a plan of physical activity with those patients prepared to make the change. Those not prepared to will be briefly counselled and given material to help them. All will be monitored at random. The control group doctors will postpone any systematic intervention on exercise until after 2005, excepting those patients whose health problem is directly related to a sedentary life-style
Measurements
The main measurement of results will be the increase in the level of physical activity from the base measurement to those at 3, 6, 12 and 24 months, using 7-day physical activity recall. Health-related quality of life (SF 36) and physical fitness will also be measured. Variables that might be predictive or confusing, such as sex, age, comorbidity, social class, etc., will be considered
Analysis
The average changes observed in the two groups will be compared, on the basis of intention to treat, through analysis of covariance. We will use mixed-effect models able to cover the intra-patient, intra-doctor and intra-centre correlation
Key words: Exercise, Physical fitness, Quality of life, Health promotion, Primary care, Family medicine, Randomised clinical trial, Multi-centre study
Bibliografía
- 1.US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion; Atlanta: 1996. (US Department of Health and Human Services. Physical activity and health: a report of the Surgeon General). [Google Scholar]
- 2.Eden K.B., Orleans C.T., Mulrow C.D., Pender N.J., Teutsch S.M. Does counseling by clinicians improve physical activityα A summary of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2002;137:208–215. doi: 10.7326/0003-4819-137-3-200208060-00015. [DOI] [PubMed] [Google Scholar]
- 3.López de Munain J., Torcal J., López Torcal, Garay J. Prevention in routine general practice: activity patterns and potential promoting factors. Prev Med. 2001;32:13–22. doi: 10.1006/pmed.2000.0777. [DOI] [PubMed] [Google Scholar]
- 4.Pinto B.M., Goldstein M.G., Marcus B.H. Activity counseling by primary care physicians. Prev Med. 1998;27:506–513. doi: 10.1006/pmed.1998.0335. [DOI] [PubMed] [Google Scholar]
- 5.Calfas K.J., Long B.J., Sallis J.F., Wooten W.J., Pratt M., Patrick K. A controlled trial of physician counseling to promote the adoption of physical activity. Prev Med. 1996;25:225–233. doi: 10.1006/pmed.1996.0050. [DOI] [PubMed] [Google Scholar]
- 6.Effects of physical activity counseling in primary care. The Activity Counseling Trial: a randomnized controlled trial. Jama. 2001;286:677–687. doi: 10.1001/jama.286.6.677. [DOI] [PubMed] [Google Scholar]
- 7.Eakin E.G., Glasgow R.E., Riley K.M. Review of primary care-based physical activity intervention studies. J Fam Pract. 2000;49:158–168. [PubMed] [Google Scholar]
- 8.Wee C.C. Physical activity counseling in primary care. The challenge of effecting behavioral change. Jama. 2001;286:717–719. doi: 10.1001/jama.286.6.717. [DOI] [PubMed] [Google Scholar]
- 9.Varo Cenarruzabeitia J.J., Martínez Gónzalez M.A., Sánchez-Villegas A., Martínez Hernández J.A., De Irala Estévez J., Gibney M.J. Actitudes y prácticas en actividad física: situación en España respecto al conjunto europeo. Aten Primaria. 2003;31:77–86. doi: 10.1016/S0212-6567(03)79141-0. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Martínez Gónzalez M.A., Varo J.J., Santos J.L., De Irala J., Gibney M., Kearney J. Prevalence of physical activity during leisure time in the European Union. Med Sci Sports Exerc. 2001;33:1142–1146. doi: 10.1097/00005768-200107000-00011. [DOI] [PubMed] [Google Scholar]
- 11.Williams P.T. Physical fitness and activity as separate heart disease risk factors: a meta-analysis. Med Sci Sports Exerc. 2001;33:754–761. doi: 10.1097/00005768-200105000-00012. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Thomas S., Reading J., Shephard R.J. Revision of the physical activity readiness questionnaire (PAR-Q) Can J Sport Sci. 1992;17:338–345. [PubMed] [Google Scholar]
- 13.Murray D.M. Oxford University Press; New York: 1998. (Design and analysis of group-randomized trials). [Google Scholar]
- 14.Activity Counseling Research Group. Activity Counseling Trial (ACT): rationale, design, and methods. Med Sci Sports Exerc. 1998;30:1097–1106. doi: 10.1097/00005768-199807000-00012. [DOI] [PubMed] [Google Scholar]
- 15.Prochaska J.O., DiClemente C.C. Stages and processes of selfchange in smoking: towards an integrative model of change. J Consulting Clin Psychol. 1983;51:390–395. doi: 10.1037//0022-006x.51.3.390. [DOI] [PubMed] [Google Scholar]
- 16.Sallis J.F., Haskell W.L., Wood P.D. Physical activity assessment methodology in the Five-City Project. Am J Epidemiol. 1985;121:91–106. doi: 10.1093/oxfordjournals.aje.a113987. [DOI] [PubMed] [Google Scholar]
- 17.ACSM's Guidelines for Exercise Testing and Prescription. 6th. Lippincott Williams & Wilkins; Baltimore: 2000. [Google Scholar]
- 18.Alonso J., Prieto L., Antó J.M. La versión española del SF-36 Health Survey (Cuestionario de Salud SF-36): un instrumento para la medida de resultados clínicos. Med Clin (Barc) 1995;104:771–776. [PubMed] [Google Scholar]
- 19.Brazier J., Roberts J., Deverill M. The estimation of a preferencebased measure of health from the SF-36. J Health Economics. 2002;21:271–292. doi: 10.1016/s0167-6296(01)00130-8. [DOI] [PubMed] [Google Scholar]
- 20.Ortega Sánchez-Pinilla R., Bueno Ortiz J.M., Anton Álvarez J.J., Duran Bellido E., Muñoz López J., Smithson Hodgson A., Grupo de Ejercicio Fisico de la sem FYC Ejercicio físico: una intervención poco desarrollada en atención primaria. Aten Primaria. 2000;26:583–584. doi: 10.1016/S0212-6567(00)78727-0. [DOI] [PMC free article] [PubMed] [Google Scholar]