Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With Angioplasty And Stent Coronary

NCT03231631 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular diseases are a leading cause of death worldwide. Some of the risk factors that have been identified are considered as be non-modifiable and modifiable. Among the non-modifiable, gender, age, race, family history and pathological antecedents such as diabetes and hypertension among others are taken into account. The modifiable factors are weight, abdominal circumference, habits such as smoking, alcohol consumption, diet and especially the EXERCISE. In order to modify these risk factors, patients are submitted to a strategy of health promotion, disease prevention, pharmacological treatments, non-invasive and invasive treatments such as cardiac catheterization, balloon coronary angioplasty and / or stent implantation, cardiovascular surgeries etc. However, one of the most important strategies that should be of great importance is to involve the patient and his family in these treatments through education and follow-up strategies whether it is through the telephone, home visit, e-mail, messages, etc. In this way, the patient is brought to a state of self-determination and self-awareness that leads him to perform physical activity routinely so he can change his cardiovascular risk factors and become a patient adherent to exercise or any other treatment. This is where the importance of exercise or aerobic physical activity is emphasized, as it is a low-cost activity that can be performed by any type of patient, and that results are easily observed in physical and physiological changes that can be objectively measurable, such as the levels in serum lipid profile (cholesterol, triglycerides, LDL and HDL), or cardiovascular function tests such as stress tests with METs indicating increased aerobic capacity (Improvement in ability to withstand a stress test). Therefore, the purpose of this study is to submit a group of patients to an education and telephone follow-up plan, emphasizing on the importance of performing physical activity with the appropriate intensity and frequency so that they can include it within their daily routine by itself and ensure "the adherence to physical activity". Physiological changes that these patients may present as a consequence of the acquired routine physical activity by being subject to the education and telephone follow-up plan of this research will be measured with serum HDL levels in a clinical laboratory test and MET in a stress test.

Conditions

Patient Adherence

Keywords

Exercise; Education; Stents; Angioplasty; Cardiac Rehabilitation; Cholesterol, HDL; Metabolic Equivalent

Outcome Measures

Primary Outcomes (1)

• Adherence to exercise

  Perform routine physical activity as a principle of self-determination and convert it into a healthy lifestyle or habit

  Measured at the end of the 12 week monitoring

Secondary Outcomes (1)

• Change in HDL levels and MET

  Measured at baseline HDL and MET and at the end of the 12 week monitoring

Study Arms (2)

Education plan and adherence to exercise

EXPERIMENTAL

* Educational talk about the importance of nutrition and exercise as an important strategy to change cardiovascular risk factors at the start of the study. * It will be sent via text, whatsapp, and / or e-mail on a weekly basis three text messages that remind them of the importance of doing the exercise and how often they should do it, it will be a predetermined text.

Behavioral: Education plan and adherence to exercise

Control

NO INTERVENTION

The blood sample will be taken for the collection of serum HDL and the aerobic capacity test measured in MET will be recorded at the beginning of the study. A survey will be conducted at week 12 of monitoring where adherence to exercise is measured during the 12-week study.

Interventions

Education plan and adherence to exercise BEHAVIORAL

* Send text messages with motivational sense at any time of the day, every 3 or 4 days. * They will be given the option of performing directed exercise at the cardiac rehabilitation center. * It will be recorded in an Excel table every time that text is sent to the patient. * At the beginning and monthly, a brochure will be sent out explaining how physical activity is performed at home in case you can not walk. * A monthly survey will be applied where the adherence to the exercise during the previous month is measured. * These activities will be carried out for 12 weeks. At the end of week 12, patients will be referred to the cardiac rehabilitation unit in order to perform the aerobic capacity test again.

Education plan and adherence to exercise

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postoperative subjects of angioplasty with implantation of coronary stent
• Age between 35 and 65
• Subjects with ability to perform the aerobic capacity test
• Subjects culminating the cardiac rehabilitation program (3 months)

You may not qualify if:

• Active phase of any acute disease
• Poor adherence to the rehabilitation program (failure to comply with appointments or with the recommendations given)
• Patient with cardiovascular decompensation (unstable angina)

Sponsors & Collaborators

• Clínica de Occidente S.A: lead

Study Sites (1)

Juan Carlos Avila

Cali, Valle del Cauca Department, 32, Colombia

Location

Related Publications (30)

• Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.

  PMID: 12160371 BACKGROUND

• Ilarraza-Lomeli H. [Cardiopulmonary exercise testing]. Arch Cardiol Mex. 2012 Apr-Jun;82(2):160-9. Spanish.

  PMID: 22735657 BACKGROUND

• Ilarraza Lomeli H, Herrera Franco R, Lomeli Rivas A, Zavala Ramirez J, Martinez Ramirez L, Ramos Becerril FJ, Romo Escamilla RE, Pacheco Beltran N, Alonso Sanchez J, Mendoza Diaz PM, Alvarez Cerro M, Cassaigne Guasco ME, Mayela Munoz Gutierrez LM. [National Registry of Cardiac Rehabilitation Programs in Mexico]. Arch Cardiol Mex. 2009 Jan-Mar;79(1):63-72. Spanish.

  PMID: 19545077 BACKGROUND

• Antunez de la Rosa Mdel R, Jimenez y Villegas Mdel C. [Nurses' participation in heart rehabilitation]. Arch Cardiol Mex. 2002 Jan-Mar;72 Suppl 1:S247-53. Spanish.

  PMID: 12001856 BACKGROUND

• Gomez LF, Duperly J, Lucumi DI, Gamez R, Venegas AS. [Physical activity levels in adults living in Bogota (Colombia): prevalence and associated factors]. Gac Sanit. 2005 May-Jun;19(3):206-13. doi: 10.1157/13075953. Spanish.

  PMID: 15960953 BACKGROUND

• Pollock JL. Low HDL cholesterol levels. N Engl J Med. 2006 Jan 26;354(4):417-9; author reply 417-9. No abstract available.

  PMID: 16444813 BACKGROUND

• Médicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO ".

  BACKGROUND

• Hernán, V., William, R., Jaime, B., & Jorge R. Fundamentos de medicina. Cardiología. Sexta edic. Biológicas C para I, editor. 2002.

  BACKGROUND

• Claudia V. Anchique M, ; Carmen Pérez-Terzic MD., PhD.; Francisco López-Jiménez, MD., MSc. ; Mery Cortés-Bergoderi M. Estado actual de la rehabilitacion cardiovascular en Colombia. 2010;18(6):305-15. Available from: http://www.discapacidadcolombia.com/Estadisticas.htm

  BACKGROUND

• Global status report on noncommunicable diseases. Who. 2010;ISBN: 978 92 4 156422 9.

  BACKGROUND

• Velasquez G. [Global access to medications in the actual international context ]. Biomedica. 2011 Jun;31(2):162-3. doi: 10.1590/S0120-41572011000200001. No abstract available. Spanish.

  PMID: 22159530 BACKGROUND

• Porqueres IM. Rol del fisioterapeuta en el marco de la rehabilitación cardíaca. Fisioterapia [Internet]. 2003;25(3):170-80. Available from: http://db.doyma.es/cgi-bin/wdbcgi.exe/doyma/mrevista.fulltext?pident=13049838\nhttp://www.sciencedirect.com/science/article/pii/S0211563803730533

  BACKGROUND

• Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.

  PMID: 15668354 BACKGROUND

• Velasco JA, Cosin J, Maroto JM, Muniz J, Casasnovas JA, Plaza I, Abadal LT. [Guidelines of the Spanish Society of Cardiology for cardiovascular disease prevention and cardiac rehabilitation]. Rev Esp Cardiol. 2000 Aug;53(8):1095-120. Spanish.

  PMID: 10956605 BACKGROUND

• Clinicoquir HD, Deportiva M. Influencia del ejercicio físico sobre algunos factores de riesgo de la cardiopatía isquémica. 1998;17(3):214-21.

  BACKGROUND

• Caramés AZI. Impacto de un programa de rehabilitación cardiovascular en perfil antropométrico, alimentario y lipídico en pacientes con enfermedad coronaria. 2012;

  BACKGROUND

• Pico cjr. respuesta del colesterol hdl ante el ejercicio físico aeróbico y anaeróbico".

  BACKGROUND

• Tseng ML, Ho CC, Chen SC, Huang YC, Lai CH, Liaw YP. A simple method for increasing levels of high-density lipoprotein cholesterol: a pilot study of combination aerobic- and resistance-exercise training. Int J Sport Nutr Exerc Metab. 2013 Jun;23(3):271-81. doi: 10.1123/ijsnem.23.3.271. Epub 2012 Nov 19.

  PMID: 23166203 BACKGROUND

• Manuel Wong, Miriam García, Adriana García SC. Resultados del Programa de Rehabilitación Cardíaca Fase II , desarrollado por el Centro Nacional de Rehabilitación , Costa Rica. 2011;

  BACKGROUND

• Janssen V, De Gucht V, van Exel H, Maes S. A self-regulation lifestyle program for post-cardiac rehabilitation patients has long-term effects on exercise adherence. J Behav Med. 2014 Apr;37(2):308-21. doi: 10.1007/s10865-012-9489-y. Epub 2013 Jan 19.

  PMID: 23334387 BACKGROUND

• SÍNDROME CORONARIO AGUDO CON ELEVACIÓN DEL ST. Rev Colomb Cardiol. 2007;17(03):186-317.

  BACKGROUND

• Pavy B, Iliou MC, Verges-Patois B, Brion R, Monpere C, Carre F, Aeberhard P, Argouach C, Borgne A, Consoli S, Corone S, Fischbach M, Fourcade L, Lecerf JM, Mounier-Vehier C, Paillard F, Pierre B, Swynghedauw B, Theodose Y, Thomas D, Claudot F, Cohen-Solal A, Douard H, Marcadet D; Exercise, Rehabilitation Sport Group (GERS); French Society of Cardiology. French Society of Cardiology guidelines for cardiac rehabilitation in adults. Arch Cardiovasc Dis. 2012 May;105(5):309-28. doi: 10.1016/j.acvd.2012.01.010. Epub 2012 Apr 16. No abstract available.

  PMID: 22709472 BACKGROUND

• Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592.

  PMID: 19952757 BACKGROUND

• European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.

  PMID: 20643803 BACKGROUND

• Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based guidelines. ACCP/AACVPR Pulmonary Rehabilitation Guidelines Panel. American College of Chest Physicians. American Association of Cardiovascular and Pulmonary Rehabilitation. Chest. 1997 Nov 5;112(5):1363-96. No abstract available.

  PMID: 9367481 BACKGROUND

• Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.

  PMID: 18436113 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Aznar S, Webster T. Actividad física y salud en la infancia y la adolescencia: Guía para todas las personas [Internet]. 2006. Available from: http://www.msssi.gob.es/ciudadanos/proteccionSalud/adultos/actiFisica/docs/ActividadFisicaSaludEspanol.pdf

  BACKGROUND

• Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.

  PMID: 15674903 BACKGROUND

• Richards J, Hillsdon M, Thorogood M, Foster C. Face-to-face interventions for promoting physical activity. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD010392. doi: 10.1002/14651858.CD010392.pub2.

  PMID: 24085592 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Motor Activity

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Juan Ávila, PT

  Clínica de Occidente S.A

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 27, 2017
• Study Start: January 10, 2017
• Primary Completion: January 29, 2019
• Study Completion: July 30, 2019
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)