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.
