Patient AdherenceNCT03231631
Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With Angioplasty And Stent Coronary
A study testing Education plan and adherence to exercise in people with Patient Adherence, run by Clínica de Occidente S.A at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Patient Adherence
- What is being tested?
- Education plan and adherence to exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jan 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the detailed description
According to the population of the cardiac rehabilitation center of the Private IPS of Cali, it will be analyzed by the program coordinator (Cardiac Rehabilitation Center) who are the patients that finished the 36 sessions or finished their rehabilitation treatment scheme and that will become potential candidates for the study.
If the patient is considered a candidate to enter the study, an interview will be made to explain what the study is about and to verify whether or not he wishes to participate, without indicating to which group he will belong (follow-up or control). If the patient agrees to participate in the study, the process of signing the informed consent and the application of the clinical trail where the basic patient information necessary for the study entrance is collected.
Once the informed consent is signed, the patient is given a physical examination of his clinical and physical condition (anthropometric parameters - exercise test) at the beginning of the exercise, which consists of physical ergonomic tests (exercise test).
The test was performed from a symptom-limited ergometry in a treadmill stress test kit. The Bruce protocol was used in the treadmill, which started after a warm-up period of three minutes. During the test, continuous electrocardiographic monitoring and blood pressure measurements were performed with a blood pressure monitor and heart rate monitor. The test was terminated by the onset of fatigue, severe dyspnea, dizziness or when the patient reached the highest heart rate expected for age, accompanied by the medical internist of the private IPS program.
Additionally, a medical order is given with the respective recommendations (identifying that the patient belongs to the study), for the collection of HDL blood in the clinical laboratory hired for this purpose, in this way, the clinical laboratory does not perform authorization requirements or that the patient has obstacles with HDL taking).
Allocation concealment: Once the physical tests and anthropometric parameters were completed and the clinical survey was applied, the information was stored in a closed envelope and a consecutive number was assigned according to the order of the exercise. The envelopes were sent to the person responsible for the implementation of the tracking plan that according to the order and the consecutive number will be added on the database.
The randomization of the groups is done in a pre-established template as follows: Simple random sampling with Excel, a list is processed in the table of the study database and where variables are collected, the numbering of anger from 1 to 80 according to the number of patients required to enter the study, apply a simple randomization formula and a different Excel spreadsheet, up to number 40 (the amount corresponding to the entire follow-up group (group A) and control group B)), the numbers that have resulted from this randomization are those assigned to the follow-up group.
In this way, when patients are registered in the database in the numerical order in the envelope, it is automatically assigned according to the randomization of the group to which the patient belongs (Follow-up or control).
After the patients are entered into the database of data collection and variables, the patients belonging to the follow-up group (already marked according to previous randomization) are separated and sent to the responsible nursing assistant with the purpose of starting the established monitoring plan, such the activity must be registered in an Excel table where the control and registration of the same will be carried out.
Once the nursing assistant responsible for the implementation of the follow-up plan will proceed to carry out her activities as follows.
She will check the number of patients entering the study, check the date of entry and date of completion, confirm that all patients have cellphone and land numbers where they can be located, in addition to their residence address and email.
She will verify that the follow-up boxes for each patient are completed, which are performed twice weekly for a total of 24 follow-ups or 12 weeks, duration of the follow-up plan.
She will start with phone calls, text messages and email according to the established schedule in the work template or tracking log format.
In each follow-up box for each patient it will record the type of activity that performed, call, text message or email where she sent the necessary recommendations for patients to exercise.
Once the follow-up and the time are completed, the list of the patients who have completed the data collection will be sent to the program to schedule the second studies in HDL and Exercise TEST in The Center for Cardiac Rehabilitation.
An exercise adherence survey will be applied once the patient goes on week 6 or follow-up number 12 in order to measure adherence to exercise by the patient. This result will be processed in the tracking table, the applied surveys will be saved in a file other than Excel.
Once the follow-up is completed, the patient will stop calling and the record will be handed over to the person responsible for collecting data.
In the control group, according to the dates of entry to the study in week 6 related to the order of admission, a survey of adherence to the exercise will be applied by an administrative assistant who will keep a record of the same in a separate file and the respective result.
As the 12-week study period ends, the cardiac rehabilitation nurse assistant will receive the names of the patients and their respective phones from both the follow-up group and the control group without having any group marking to which one they belong, so that the second physical test or exercise test is performed and their respective order of clinical laboratory HDL is given.
Through email, the laboratory will be requested to deliver physically and in a sealed envelope all the results of tests performed to the patients that belong to the study. These results will be delivered to the database manager and registry of variables.
All the documentation that as a result of the study, will be guarded by the person in charge of the management of the database and registration of variables.
The person in charge of the database and registry of variables is the one who will inform the moment in which the study has finished. Subsequently, the information will be organized and the data will be given to the methodological adviser in order to organize, process and analyze the statistical information as a result of it.
- Conditions
- Patient Adherence
- Being tested
- Education plan and adherence to exercise
- Keywords
- Exercise, Education, Stents, Angioplasty, Cardiac Rehabilitation, Cholesterol, HDL, Metabolic Equivalent
- Medical subject headings
- Patient Compliance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education plan and adherence to exerciseBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to exercise
Perform routine physical activity as a principle of self-determination and convert it into a healthy lifestyle or habit
Measured: Measured at the end of the 12 week monitoring
Secondary outcomes (1)
Change in HDL levels and MET
Change in HDL level and MET as the difference between baseline HDL and MET and final HDL and MET
Measured: Measured at baseline HDL and MET and at the end of the 12 week monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start10 Jan 2017
- Primary completion29 Jan 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Occidente S.A
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Ávila, PT, Principal investigator, Clínica de Occidente S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231631
- Sponsor's protocol ID
- 0001
- Status last verified
- May 2022
- First submitted
- 1 Jul 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12160371Ilarraza-Lomeli H. [Cardiopulmonary exercise testing]. Arch Cardiol Mex. 2012 Apr-Jun;82(2):160-9. Spanish.
PubMed 22735657Ilarraza 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.
PubMed 19545077Antunez 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.
PubMed 12001856Gomez 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.
PubMed 15960953Pollock JL. Low HDL cholesterol levels. N Engl J Med. 2006 Jan 26;354(4):417-9; author reply 417-9. No abstract available.
PubMed 16444813Médicas 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.
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.
PubMed 22159530Porqueres 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. doi: 10.1161/01.CIR.0000151788.08740.5C.
PubMed 15668354Velasco 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.
PubMed 10956605Clinicoquir HD, Deportiva M. Influencia del ejercicio físico sobre algunos factores de riesgo de la cardiopatía isquémica. 1998;17(3):214-21.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03231631
- Acronym / sponsor ID
- 0001
- Conditions
- Patient Adherence
- Keywords
- Exercise, Education, Stents, Angioplasty, Cardiac Rehabilitation, Cholesterol, HDL, Metabolic Equivalent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Clínica de Occidente S.AUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to the population of the cardiac rehabilitation center of the Private IPS of Cali, it will be analyzed by the program coordinator (Cardiac Rehabilitation Center) who are the patients that finished the 36 sessions or finished their rehabilitation treatment scheme and that will become potential candidates for the study.
If the patient is considered a candidate to enter the study, an interview will be made to explain what the study is about and to verify whether or not he wishes to participate, without indicating to which group he will belong (follow-up or control). If the patient agrees to participate in the study, the process of signing the informed consent and the application of the clinical trail where the basic patient information necessary for the study entrance is collected.
Once the informed consent is signed, the patient is given a physical examination of his clinical and physical condition (anthropometric parameters - exercise test) at the beginning of the exercise, which consists of physical ergonomic tests (exercise test).
The test was performed from a symptom-limited ergometry in a treadmill stress test kit. The Bruce protocol was used in the treadmill, which started after a warm-up period of three minutes. During the test, continuous electrocardiographic monitoring and blood pressure measurements were performed with a blood pressure monitor and heart rate monitor. The test was terminated by the onset of fatigue, severe dyspnea, dizziness or when the patient reached the highest heart rate expected for age, accompanied by the medical internist of the private IPS program.
Additionally, a medical order is given with the respective recommendations (identifying that the patient belongs to the study), for the collection of HDL blood in the clinical laboratory hired for this purpose, in this way, the clinical laboratory does not perform authorization requirements or that the patient has obstacles with HDL taking).
Allocation concealment: Once the physical tests and anthropometric parameters were completed and the clinical survey was applied, the information was stored in a closed envelope and a consecutive number was assigned according to the order of the exercise. The envelopes were sent to the person responsible for the implementation of the tracking plan that according to the order and the consecutive number will be added on the database.
The randomization of the groups is done in a pre-established template as follows: Simple random sampling with Excel, a list is processed in the table of the study database and where variables are collected, the numbering of anger from 1 to 80 according to the number of patients required to enter the study, apply a simple randomization formula and a different Excel spreadsheet, up to number 40 (the amount corresponding to the entire follow-up group (group A) and control group B)), the numbers that have resulted from this randomization are those assigned to the follow-up group.
In this way, when patients are registered in the database in the numerical order in the envelope, it is automatically assigned according to the randomization of the group to which the patient belongs (Follow-up or control).
After the patients are entered into the database of data collection and variables, the patients belonging to the follow-up group (already marked according to previous randomization) are separated and sent to the responsible nursing assistant with the purpose of starting the established monitoring plan, such the activity must be registered in an Excel table where the control and registration of the same will be carried out.
Once the nursing assistant responsible for the implementation of the follow-up plan will proceed to carry out her activities as follows.
She will check the number of patients entering the study, check the date of entry and date of completion, confirm that all patients have cellphone and land numbers where they can be located, in addition to their residence address and email.
She will verify that the follow-up boxes for each patient are completed, which are performed twice weekly for a total of 24 follow-ups or 12 weeks, duration of the follow-up plan.
She will start with phone calls, text messages and email according to the established schedule in the work template or tracking log format.
In each follow-up box for each patient it will record the type of activity that performed, call, text message or email where she sent the necessary recommendations for patients to exercise.
Once the follow-up and the time are completed, the list of the patients who have completed the data collection will be sent to the program to schedule the second studies in HDL and Exercise TEST in The Center for Cardiac Rehabilitation.
An exercise adherence survey will be applied once the patient goes on week 6 or follow-up number 12 in order to measure adherence to exercise by the patient. This result will be processed in the tracking table, the applied surveys will be saved in a file other than Excel.
Once the follow-up is completed, the patient will stop calling and the record will be handed over to the person responsible for collecting data.
In the control group, according to the dates of entry to the study in week 6 related to the order of admission, a survey of adherence to the exercise will be applied by an administrative assistant who will keep a record of the same in a separate file and the respective result.
As the 12-week study period ends, the cardiac rehabilitation nurse assistant will receive the names of the patients and their respective phones from both the follow-up group and the control group without having any group marking to which one they belong, so that the second physical test or exercise test is performed and their respective order of clinical laboratory HDL is given.
Through email, the laboratory will be requested to deliver physically and in a sealed envelope all the results of tests performed to the patients that belong to the study. These results will be delivered to the database manager and registry of variables.
All the documentation that as a result of the study, will be guarded by the person in charge of the management of the database and registration of variables.
The person in charge of the database and registry of variables is the one who will inform the moment in which the study has finished. Subsequently, the information will be organized and the data will be given to the methodological adviser in order to organize, process and analyze the statistical information as a result of it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plan and adherence to exercise | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Education plan and adherence to exercise |
Primary outcome
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
1 secondary outcome
Change in HDL levels and MET
Time frame: Measured at baseline HDL and MET and at the end of the 12 week monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 12160371Eden 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.
- Background: PubMed 22735657Ilarraza-Lomeli H. [Cardiopulmonary exercise testing]. Arch Cardiol Mex. 2012 Apr-Jun;82(2):160-9. Spanish.
- Background: PubMed 19545077Ilarraza 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.
- Background: PubMed 12001856Antunez 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.
- Background: PubMed 15960953Gomez 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.
- Background: PubMed 16444813Pollock JL. Low HDL cholesterol levels. N Engl J Med. 2006 Jan 26;354(4):417-9; author reply 417-9. No abstract available.
- BackgroundMédicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO ".
- BackgroundHernán, V., William, R., Jaime, B., & Jorge R. Fundamentos de medicina. Cardiología. Sexta edic. Biológicas C para I, editor. 2002.
- BackgroundClaudia 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
- BackgroundGlobal status report on noncommunicable diseases. Who. 2010;ISBN: 978 92 4 156422 9.
- Background: PubMed 22159530Velasquez 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.
- BackgroundPorqueres 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Ávila, PT principal investigator
Clínica de Occidente S.A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education plan and adherence to exercise in people with Patient Adherence, run by Clínica de Occidente S.A at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise (time frame: Measured at the end of the 12 week monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231631, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.