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临床试验/NCT03231631
NCT03231631已完成不适用

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

Clínica de Occidente S.A2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
2
主要终点
Adherence to exercise

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

Adherence to exercise

时间窗: 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

次要结局

  • Change in HDL levels and MET(Measured at baseline HDL and MET and at the end of the 12 week monitoring)

研究者

发起方
Clínica de Occidente S.A
申办方类型
Other
责任方
Sponsor

研究点 (2)

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