Randomized Clinical Trial by Conglomerates on the Efficacy of Maintenance of Physical Exercise in Myocardial Ischemia

Study Overview
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Brief Summary
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Main objective: To assess the efficacy of a phase III cardiac rehabilitation program (CRP), based on counseling in the maintenance of physical exercise (time of physical exercise per week) for patients with myocardial ischemia (MI), once the supervised physical exercise program of phase II of CRP is completed. Secondary objectives: To assess the efficacy of a phase III program of CRP based on counseling in the maintenance of physical exercise for the patient with MI in: 1) the energy expenditure per week, 2) body mass index and abdominal perimeter, 3) control of cardiovascular risk factors (smoking, high blood pressure, dyslipidemia and diabetes mellitus), 4) quality of life related to health, 5) assess the adherence to cardiac pharmacological treatment. Method: Randomized clinical trial in conglomerates, open and controlled. The intervention group will carry out phase III of CRP based on counseling in the maintenance of physical exercise. The control group will receive the usual care. The main outcome will be the physical exercise time per week after finish the supervised physical exercise program of phase II of CRP and at 6 and 12 month later according to the 7-day Physical Activity Recall.

Official Title
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Randomized Clinical Trial by Conglomerates on the Efficacy of the Maintenance of Physical Exercise for Patients With Myocardial Ischemia. Study Cardiopathy Prevention and Exercise in Phase 3 (CarPE3)

Conditions
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Myocardial Ischemia, Physical Exercise

Intervention / Treatment
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* Other: Maintenance of physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with myocardial ischemia, angina pectoris, other specific forms of chronic ischemic heart disease or unspecified ischemic heart disease. Patients who have completed the supervised physical exercise program of phase II of the CRP. Absence of cognitive deficit (Pfeiffer test: 0-2 mistakes). Sufficient functional capacity to follow the CRP (Barthel index >60) Residence in catchment area of Bages and Moianès. Providing signed informed consent. Exclusion Criteria: Symptoms of right heart failure producing pulmonary hypertension. Dyspnea caused by severe pulmonary pathology. Additional comorbidities affecting the prognosis of cardiac disease. Major comorbidities or limitations that could interfere with the exercise training programme.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The usual care in patients with myocardial ischemia without other cardiovascular risk factors (CVFR) will be to attend one visit per year with doctor and nurse of the local health center. In this visit, it will be done a blood test and an electrocardiogram. Blood pressure, weight, body mass index, abdominal circumference will be measured and, in case of detecting enolic habit, smoking or sedentary lifestyle, generic advice will be done. If the patient, apart from myocardial ischemia, presents diabetes mellitus type 2, 3-4 follow-up visits per year will be recommended and will be increased according to specific needs. In case of presenting hypertension, will be recommended 2 visits with the nurse and one visit with the doctor per year and will be increased according to specific needs. In addition, in this case the blood pressure is checked every 6 months. During all visits, professionals will reinforce the control of CVRF and the maintenance of a long-term cardio-healthy lifestyle. | |
| Experimental: Intervention group<br>Patient will go to health center to visit the cardiac rehabilitation (CR) reference team, which is composed for a doctor and a nurse. This team will establish the guideline of action in the maintenance and/or increase in the physical exercise practice, in function of the resources of each zone and the preferences and motivations of the patient. They also reinforce the control of CVRF and the maintenance of a long-term cardio-healthy lifestyle. At the end of the visit, control visit will be given with the CR reference team at 3, 6 and 12 months after completing the supervised physical exercise program of phase II of the CRP. In case of detecting specific needs for the patient and/or relapses, the team will consult with the appropriate professional (cardiologist, cardiology nurse, physiotherapist, rehabilitator, nutritionist and/or psychologist). At the same time, the patient will be informed of the possibility of re-evaluating the CR reference team. | Other: Maintenance of physical exercise<br>* Objectives will be established with the patient to increase the practice of physical exercise and reinforce the control of cardiovascular risk factors (CVRF) and the maintenance of a long-term cardio-healthy lifestyle.<br>* Other names: Strengthen the control of cardiovascular risk factors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The physical exercise minutes performed by the patient per week | The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| The physical exercise minutes performed by the patient per week | The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The physical exercise minutes performed by the patient per week | The physical exercise minutes performed by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The energy expenditure by the patient per week | The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| The energy expenditure by the patient per week | The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The energy expenditure by the patient per week | The energy expenditure by the patient per week will be recorded through the 7-day Physical Activity Recall (PAR) questionnaire. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The body mass index (BMI) | BMI is the quotient between the weight (kg) and the square of the height (m). It is usually used for the definition of underweight (BMI <15.99), normal weight (BMI 18.5 to 24.99), overweight (BMI ≥ 25 kg / m2) and obesity (BMI ≥ 30 kg / m2). | At baseline of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The body mass index (BMI) | BMI is the quotient between the weight (kg) and the square of the height (m). It is usually used for the definition of underweight (BMI <15.99), normal weight (BMI 18.5 to 24.99), overweight (BMI ≥ 25 kg / m2) and obesity (BMI ≥ 30 kg / m2). | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The abdominal circumference | Abdominal circumference is the measurement of the abdomen of the patient at the level of the navel. It will be recorded in centimeters using a tape measure. | At baseline of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The abdominal circumference | Abdominal circumference is the measurement of the abdomen of the patient at the level of the navel. It will be recorded in centimeters using a tape measure. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The control of smoking | Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test. | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| The control of smoking | Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test. | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The control of smoking | Smoking:The degree of dependence on tobacco consumption will be recorded through the Fargeström test. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Systolic blood pressure | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Systolic blood pressure | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Systolic blood pressure | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Diastolic blood pressure | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Diastolic blood pressure | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Diastolic blood pressure | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Total cholesterol | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Total cholesterol | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Total cholesterol | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Low-density lipoproteins cholesterol | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Low-density lipoproteins cholesterol | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Low-density lipoproteins cholesterol | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| High-density lipoproteins cholesterol | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| High-density lipoproteins cholesterol | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| High-density lipoproteins cholesterol | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Triglycerides | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Triglycerides | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Triglycerides | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Basal plasma glucose | Physiological parameter | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Basal plasma glucose | Physiological parameter | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Basal plasma glucose | Physiological parameter | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The quality of life related to health. | Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test. | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| The quality of life related to health. | Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test. | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| The quality of life related to health. | Level of perception of the patient regarding their state of health. It will be measured through the EuroQol-5D test. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Assess the adherence to cardiovascular medication. | It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test. | At baseline, when the supervised physical exercise program of phase II of the CRP has been completed. | 
| Assess the adherence to cardiovascular medication. | It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test. | At 6 months of the supervised physical exercise program of phase II of the CRP has been completed. | 
| Assess the adherence to cardiovascular medication. | It will be recorded if the patient is successfully taking the cardiovascular medication through the Haynes-Sackett test. | At 12 months of the supervised physical exercise program of phase II of the CRP has been completed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Rehabilitation, Myocardial Ischemia, Physical Exercise, Cardiovascular Risk Factors, Randomized Controlled Trial