Patient Adherence Clinical Trial
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
NCT number | NCT03231631 |
Other study ID # | 0001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 10, 2017 |
Est. completion date | July 30, 2019 |
Verified date | May 2022 |
Source | Clínica de Occidente S.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | July 30, 2019 |
Est. primary completion date | January 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Colombia | Juan Carlos Avila | Cali | Valle |
Lead Sponsor | Collaborator |
---|---|
Clínica de Occidente S.A |
Colombia,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 at baseline HDL and MET and at the end of the 12 week monitoring |
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