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

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ClinicalTrials.gov Identifier: NCT03231631
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Clínica de Occidente S.A

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.


Condition or disease Intervention/treatment Phase
Patient Adherence Behavioral: Education plan and adherence to exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With Angioplasty And Implantation Of Coronary Stent, Measured With Hdl And Met In A Cardiac Rehabilitation Unit - Random Triple Blind Clinical Trial
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Education plan and adherence to exercise
  • 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
  • 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.

No Intervention: Control

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.




Primary Outcome Measures :
  1. Adherence to exercise [ Time Frame: Measured at the end of the 12 week monitoring ]
    Perform routine physical activity as a principle of self-determination and convert it into a healthy lifestyle or habit


Secondary Outcome Measures :
  1. Change in HDL levels and MET [ Time Frame: Measured at baseline HDL and MET and at the end of the 12 week monitoring ]
    Change in HDL level and MET as the difference between baseline HDL and MET and final HDL and MET



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231631


Contacts
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Contact: Ávila, PT 3013369979 rhcardiopulmonar09@gmail.com

Locations
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Colombia
Juan Carlos Avila Recruiting
Cali, Valle, Colombia, 32
Contact: Juan avila    3013369979    rhcardiopulmonar099@gmail.com   
Sponsors and Collaborators
Clínica de Occidente S.A
Investigators
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Principal Investigator: Juan Ávila, PT Clínica de Occidente S.A

Publications:
Médicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO ".
Hernán, V., William, R., Jaime, B., & Jorge R. Fundamentos de medicina. Cardiología. Sexta edic. Biológicas C para I, editor. 2002.
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
Global status report on noncommunicable diseases. Who. 2010;ISBN: 978 92 4 156422 9.
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
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. Erratum in: Circulation. 2005 Apr 5;111(13):1717.
Clinicoquir HD, Deportiva M. Influencia del ejercicio físico sobre algunos factores de riesgo de la cardiopatía isquémica. 1998;17(3):214-21.
Caramés AZI. Impacto de un programa de rehabilitación cardiovascular en perfil antropométrico, alimentario y lipídico en pacientes con enfermedad coronaria. 2012;
Pico cjr. respuesta del colesterol hdl ante el ejercicio físico aeróbico y anaeróbico".
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;
SÍNDROME CORONARIO AGUDO CON ELEVACIÓN DEL ST. Rev Colomb Cardiol. 2007;17(03):186-317.
Ries AL, Carlin BW, Carrieri-Kohlman V, Casaburi R, Celli BR, Emery CF, et al. Pulmonary rehabilitation: Joint ACCP/AACVPR evidence-based guidelines. Chest. 1997;112(5):1363-96.
Crapo RO, Casaburi R, Coates AL, Enright PL, MacIntyre NR, McKay RT, et al. ATS statement: Guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111-7.
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

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Responsible Party: Clínica de Occidente S.A
ClinicalTrials.gov Identifier: NCT03231631     History of Changes
Other Study ID Numbers: 0001
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clínica de Occidente S.A:
Exercise
Education
Stents
Angioplasty
Cardiac Rehabilitation
Cholesterol, HDL
Metabolic Equivalent